Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Perioperative durvalumab plus chemotherapy plus new agents for resectable non-small-cell lung cancer: the platform phase 2 NeoCOAST-2 trial.

Name: Kaimen Rigor review — Perioperative durvalumab plus chemotherapy plus new agents for resectable non-small-cell lung cancer: the platform phase 2 NeoCOAST-2 trial.
Item: Perioperative durvalumab plus chemotherapy plus new agents for resectable non-small-cell lung cancer: the platform phase 2 NeoCOAST-2 trial.
Rating: 100
Author: Alpha1

Cascone T, Bonanno L, Guisier F, Insa A, Liberman M, Bylicki O, Livi L, Egenod T, Corre R, Kim DW, Garcia Campelo MR, Provencio Pulla M, Shim BY, Metro G, Bennouna J, Bielska AA, Yohannes AR, He Y, Dowson A, Kar G, McGrath L, Kumar R, Grenga I, Spicer J, Forde PM

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Kaimen Rigor review — 3.75★ (Adequate), 0 critical, 2 high issues for “Perioperative durvalumab plus chemotherapy plus new agents for resectable non-small-cell lung cancer: the platform phase 2 NeoCOAST-2 trial.”

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This rigor review was examined and confirmed by Alpha1 Editorial · August 15, 2026

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Perioperative durvalumab plus chemotherapy plus new agents for resectable non-small-cell lung cancer: the platform phase 2 NeoCOAST-2 trial.

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DOI

10.1038/s41591-025-03746-z

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Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Perioperative durvalumab plus chemotherapy plus new agents for resectable non-small-cell lung cancer: the platform phase 2 NeoCOAST-2 trial.

Paper source

Perioperative durvalumab plus chemotherapy plus new agents for resectable non-small-cell lung cancer: the platform phase 2 NeoCOAST-2 trial.

Read full text (PMC)

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Links back to this Kaimen Rigor review.

Alpha1 Editorial

This rigor review was examined and confirmed by Alpha1 Editorial · August 15, 2026

Kaimen Rigor review

Kaimen Rigor reviewed

3.75 / 5

Adequate — real issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

ClaimsEfficacy rests on an unvalidated surrogate endpoint−0.5★
ClaimsTreatment effect not shown to be clinically meaningful−0.5★
LinksDead data/code link−0.25★

Model-reported confidence: highReviewer agreement: highEngine: 7.39.0Source: full text

Not verified in this report

No reported statistical tests were found to recompute.

Biggest issues

01Efficacy rests on an unvalidated surrogate endpoint
highOverreachreviewer-assessedFull detail
The primary efficacy endpoint is pathological complete response (pCR), a surrogate for long-term clinical outcomes such as event-free survival and overall survival. The paper does not demonstrate target engagement at the tested doses (e.g., PK/PD or dose-exposure data) and does not cite validated evidence linking pCR to clinical outcomes in this specific setting, although it mentions a correlation with EFS in other trials.
“These trials highlight the importance of pCR as a potential early predictor of survival, given the demonstrated correlation between pCR and improved EFS seen across trials.”
Find in source
02Treatment effect not shown to be clinically meaningful
highOverreachreviewer-assessedFull detail
The reported pCR rates (20.3%, 25.7%, 35.2%) are presented as promising but are not anchored to a minimal clinically important difference or a threshold for clinical meaningfulness. The study is not powered for statistical comparisons, and the effect sizes are not explicitly compared to a predefined meaningful benefit.
“In the modified intention-to-treat population (n = 198; Arm 1, n = 74; Arm 2, n = 70; Arm 4, n = 54), pCR rates were 20.3% (15/74; 95% CI, 11.8–31.2), 25.7% (18/70; 95% CI, 16.0–37.6) and 35.2% (19/54; 95% CI, 22.7–49.4)”
Find in source
03Declared data/code link does not resolve
mediumAvailabilityrecomputedFull detail
Dead link — nothing to verify.
“https://vivli.org/members/enquiries-about-studies-not-listed-on-the-vivli-platform/”
Find in source

Findings by category

01ArithmeticNone found 302OverreachOverstated conclusions 03AuthenticityNone found 04DisclosureNone found 105AvailabilityBroken references and links 06Copyedit5 minor suggestions

This Kaimen Rigor review uses Kaimen Rigor reviewers trained on a curated corpus of high-fidelity and retracted papers, with expert supervision and curation. It can still make mistakes; verify each finding against the source before relying on it.

This is a well-conducted and well-reported phase II platform trial. The paper demonstrates strong scientific premise, adequate study design, thorough ethical approvals, and transparent reporting. Minor issues include a missing explicit reporting guideline statement, a dead link in the data availability, and a few copyedit typos.

Both reviewers agreed on the study type (interventional) and on all dimension statuses. Minor divergences in checklist sub-ratings (e.g., power analysis, reporting guideline) were reconciled by considering the paper's explicit statements. The statistics verification component checked 0 tests (none recomputable), so no claims of statistical correctness are made beyond what was reported.

Numerical inconsistencies

None found

Values that contradict each other or are impossible for the stated sample: recomputed p-values and test statistics, GRIM/GRIMMER checks on summary numbers, percentages against their own counts, totals against their parts, and estimates against their own confidence intervals.

Checked — nothing surfaced.

Overstated conclusions

3 findings · worst high

Conclusions that reach past what the paper's own results support — including a significance claim that no longer holds when the statistic is recomputed, and efficacy resting on an unvalidated surrogate endpoint.

Efficacy rests on an unvalidated surrogate endpointAssessed
Treatment effect not shown to be clinically meaningfulAssessed
Conclusions only partially backed by the presented evidenceAssessed

6 major claims checked against the paper's own evidence: 1 only partially supported (evidence backs part of the claim; gaps or caveats remain); the rest adequately supported.

Premise concern: surrogate not validated for clinical benefit; effect size not shown to be clinically meaningful.

Data authenticity concerns

None found

An adversarial read for patterns associated with data that may not be genuine: results that look too clean, implausibly large effects, duplicated data or images, and methods that do not match the results reported.

Checked — nothing surfaced.

Reporting gaps

None found

Required detail the manuscript never states — study design, biological variables, ethics approval and consent, key resources, statistical reporting, data and code availability, and overall transparency.

Checked — nothing surfaced.

Eight Dimensions8 pass

The introduction cites multiple pivotal trials and the NeoCOAST study, acknowledging the unmet need with pCR rates and EFS. The rationale for combining durvalumab with oleclumab, monalizumab, and Dato-DXd is logically linked to their mechanisms and prior evidence. Limitations of prior research are implicitly addressed by the platform design and the focus on novel agents.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper establishes a strong scientific premise by citing prior phase III trials (AEGEAN, KEYNOTE-671, CheckMate 77T, CheckMate 816) and the NeoCOAST study, and clearly rationalizes the need for novel combinations.

Evidence

“In the phase III AEGEAN study, perioperative durvalumab plus neoadjuvant chemotherapy led to significantly higher rates of pCR (17.2% versus 4.3%; P < 0.001) and significantly longer event-free survival (EFS; hazard ratio 0.68; 95% confidence interval (CI), 0.53–0.88) compared with neoadjuvant chemotherapy alone”

Introduction ¶1Find in source

“In the phase II NeoCOAST study, neoadjuvant durvalumab combined with oleclumab or monalizumab led to numerical improvement in mPR rates and increased pro-inflammatory effects in the tumor microenvironment compared with durvalumab alone”

Introduction ¶3Find in source

“Despite recent advances, a minority of patients receiving perioperative or neoadjuvant treatment have a pCR, and the 3-year EFS rates remain around 54–60%”

Introduction ¶2Find in source

PASSReviewer 2· 90% conf

The paper establishes a strong scientific premise by citing prior phase III trials and preclinical evidence, and clearly links the rationale to the study objectives.

Evidence

Introduction ¶2Find in source

Introduction ¶4Find in source

“Despite recent advances, a minority of patients receiving perioperative or neoadjuvant treatment have a pCR, and the 3-year EFS rates remain around 54–60%”

Introduction ¶3Find in source

Randomization method is described (blocked, stratified by PD-L1, using IRT). Blinding is not applicable as it is an open-label study, which is stated. Power analysis is not applicable because the study is not powered for statistical comparisons; sample size is based on a model-based approach. Inclusion/exclusion criteria are detailed. Outlier handling is not explicitly described but is not a standard requirement for clinical trials. Controls are not applicable as there is no control arm; the study is non-comparative. Independent replication is not applicable as this is a single trial.

Sub-criteria

controlsN/A

power analysisN/A

blinding levelsADEQUATE

outlier handlingN/A

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 85% conf

The study design is adequately described for a phase II platform trial, including randomization method, stratification, and eligibility criteria, though power analysis is not applicable as it is not powered for comparative statistics.

Evidence

“A blocked randomization was generated, and randomization was balanced within the IRT at the central level.”

MethodsFind in source

“NeoCOAST-2 is a phase II, open-label, multiarm, multicenter, global, randomized platform study.”

MethodsFind in source

“The sample size was not based on type I error and power considerations.”

Statistical analysisFind in source

PASSReviewer 2· 85% conf

The study design is adequately described for a phase II platform trial, including randomization, stratification, and eligibility criteria, though blinding is not applicable (open-label) and power analysis is not based on type I error.

Evidence

“A randomization method featuring a dynamically changing allocation ratio for treatment assignments was used to account for fluctuations in the number of patients enrolled in the treatment arms over the course of the study”

MethodsFind in source

“NeoCOAST-2 is a phase II, open-label, multiarm, multicenter, global, randomized platform study.”

MethodsFind in source

paraphrase[Methods, Statistical analysis]

“The sample size was not based on type I error and power considerations. Instead, it was based on the model-based drug development approach.”

Sex is reported for all arms (e.g., Arm 1: 37.8% female). Age is reported as median and range. Demographics include race, ECOG PS, PD-L1 TPS, and disease stage. Since both sexes are enrolled, sex_justified is not applicable. Species/strain and housing conditions are not applicable for a human trial.

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Demographics including age, sex, race, and disease characteristics are reported in Table 1, and sex is reported for all arms.

Evidence

paraphrase[Table 1]

“Sex, n (%) | Female | 28 (37.8) | 28 (40.0) | 22 (40.7)”

“Median (range), years | 66.5 (30–79) | 66.0 (48–83) | 65.0 (38–81)”

Table 1Find in source

paraphrase[Table 1]

“Race, n (%) | Asian | 7 (9.5) | 5 (7.1) | 5 (9.3)”

PASSReviewer 2· 90% conf

Biological variables are well reported for a human clinical trial, including sex, age, race, and disease characteristics.

Evidence

paraphrase[Table 1]

“Sex, n (%) | Female | 28 (37.8) | 28 (40.0) | 22 (40.7) | Male | 46 (62.2) | 42 (60.0) | 32 (59.3)”

“Median (range), years | 66.5 (30–79) | 66.0 (48–83) | 65.0 (38–81)”

Table 1Find in source

paraphrase[Table 1]

“Race, n (%) | Asian | 7 (9.5) | 5 (7.1) | 5 (9.3) | Black or African American | 1 (1.4) | 0 | 0 | White | 46 (62.2) | 42 (60.0) | 37 (68.5)”

The study oversight section states that the protocol and related documents were reviewed and approved by IRBs and Ethics Committees at each center, listing many institutions. Informed consent is described in the inclusion criteria ('Capable of giving signed informed consent'). Regulatory compliance is stated with adherence to the Declaration of Helsinki and ICH-GCP guidelines.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The study reports approval by Institutional Review Boards and Ethics Committees at each participating center, and informed consent is described in the eligibility criteria.

Evidence

“The study protocol, protocol amendments, informed consent form, investigator brochure and other relevant documents were reviewed and approved by the Institutional Review Boards and Ethics Committees at each participating center”

MethodsFind in source

“Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.”

MethodsFind in source

“The study was performed in accordance with consensus ethical principles derived from international guidelines including the Declaration of Helsinki and Council for International Organizations of Medical Sciences International Ethical Guidelines, applicable International Council for Harmonisation Good Clinical Practice Guidelines”

MethodsFind in source

PASSReviewer 2· 95% conf

Ethical approvals are thoroughly documented, including named IRBs/ethics committees and informed consent procedures.

Evidence

MethodsFind in source

“Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.”

MethodsFind in source

The drugs are named with doses and schedules in the Methods (e.g., durvalumab 1,500 mg i.v. Q3W). The PD-L1 assay is identified as VENTANA SP263. Software used for analysis (SAS v9.4) is identified. Antibodies, cell lines, and mycoplasma testing are not applicable as this is a clinical trial without wet-lab assays.

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 85% conf

The investigational products (durvalumab, oleclumab, monalizumab, Dato-DXd, and chemotherapy agents) are identified with doses and regimens, and the PD-L1 assay is named.

Evidence

“Arm 1 consisted of neoadjuvant durvalumab (1,500 mg intravenously (i.v.) every 3 weeks (Q3W)), oleclumab (3,000 mg i.v. Q3W) and platinum-doublet chemotherapy for four cycles”

MethodsFind in source

“Baseline PD-L1 status was assessed using central (VENTANA SP263) or local testing (VENTANA SP263, pharmDx 28-8, or pharmDx 22C3).”

ResultsFind in source

“Analyses of clinical data were conducted using SAS v9.4.”

Statistical analysisFind in source

PASSReviewer 2· 85% conf

Key investigational products are identified with doses and regimens, and statistical software is identified; other bench resources are not applicable.

Evidence

“Arm 1 consisted of neoadjuvant durvalumab (1,500 mg intravenously (i.v.) every 3 weeks (Q3W)), oleclumab (3,000 mg i.v. Q3W) and platinum-doublet chemotherapy for four cycles”

MethodsFind in source

“Analyses of clinical data were conducted using SAS v9.4.”

Statistical analysisFind in source

The paper reports effect sizes with 95% CIs (e.g., pCR rates with CIs) and does not report p-values for the primary endpoints, which is appropriate for a non-comparative study. Exact p-values are not applicable as no hypothesis tests are conducted. Assumptions are not applicable as no formal tests are used. Data presentation includes per-group n and CIs. Mathematical plausibility is not applicable as the outcomes are proportions with CIs, and the numbers are internally consistent.

Sub-criteria

tests namedN/A

exact p valuesN/A

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedN/A

mathematical plausibilityN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Statistical methods are appropriate for a non-comparative phase II trial: pCR and mPR rates with Clopper-Pearson CIs, no formal statistical tests between arms, and SAS v9.4 identified.

Evidence

“pCR rates were 20.3% (15/74; 95% CI, 11.8–31.2), 25.7% (18/70; 95% CI, 16.0–37.6) and 35.2% (19/54; 95% CI, 22.7–49.4)”

AbstractFind in source

“Single-arm analyses were conducted without statistical tests.”

Statistical analysisFind in source

“Analyses of clinical data were conducted using SAS v9.4.”

Statistical analysisFind in source

PASSReviewer 2· 80% conf

Statistical methods are appropriate for a phase II trial, with CIs reported for primary endpoints and no formal hypothesis tests; software is identified.

Evidence

“pCR rates were 20.3% (95% CI, 11.8–31.2) in Arm 1, 25.7% (95% CI, 16.0–37.6) in Arm 2 and 35.2% (95% CI, 22.7–49.4) in Arm 4”

ResultsFind in source

“Single-arm analyses were conducted without statistical tests.”

Statistical analysisFind in source

“Analyses of clinical data were conducted using SAS v9.4.”

Statistical analysisFind in source

The data availability statement names a concrete mechanism: AstraZeneca's data sharing policy and Vivli platform. Repository deposit and accession numbers are not applicable for patient-level data due to privacy. Code sharing is not applicable as no bespoke code is mentioned.

Sub-criteria

code sharingN/A

accession numbersN/A

repository depositN/A

data availability statementADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

A data availability statement is provided with a concrete route via AstraZeneca's data sharing policy and Vivli platform, which is adequate for a clinical trial with patient-level data.

Evidence

“Data underlying the findings described in this manuscript may be obtained in accordance with AstraZeneca’s data sharing policy described at: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure”

Data availabilityFind in source

“Data for studies directly listed on Vivli can be requested through Vivli at www.vivli.org”

Data availabilityFind in source

PASSReviewer 2· 90% conf

Data availability is clearly stated with a concrete mechanism for requesting data via AstraZeneca's policy and Vivli platform.

Evidence

Data availabilityFind in source

Trial registration is provided. Reporting guideline is not explicitly mentioned but the paper follows CONSORT-like reporting with a flow diagram. All outcomes are reported, including negative results. Limitations are discussed (lack of control arm, small sample sizes). Conclusions are proportional, acknowledging the need for larger trials. Funding and COI are disclosed.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineNOT REPORTED

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper is transparent: it is registered (NCT05061550), reports all primary and secondary endpoints, discusses limitations, and provides funding and COI statements.

Evidence

“ClinicalTrials.gov identifier: NCT05061550”

AbstractFind in source

“Our study has some limitations, including the lack of a dedicated control arm and power for statistical comparisons between arms, which precludes definitive cross-arm comparisons.”

DiscussionFind in source

“This study was funded by AstraZeneca.”

AcknowledgementsFind in source

PASSReviewer 2· 90% conf

The manuscript is transparent, with detailed methods, trial registration, limitations, and funding/COI statements.

Evidence

“ClinicalTrials.gov identifier: NCT05061550”

AbstractFind in source

“Our study has some limitations, including the lack of a dedicated control arm and power for statistical comparisons between arms, which precludes definitive cross-arm comparisons.”

Discussion ¶6Find in source

“This study was funded by AstraZeneca.”

AcknowledgementsFind in source

Registered (1 ID: ClinicalTrials.gov). Reporting guideline cited: CONSORT.

Broken references and links

1 finding · worst medium

References checked against Crossref, OpenAlex and Retraction Watch for retractions and resolvability, plus declared data and code links probed for whether they resolve to content matching the paper.

Dead data/code linksRecomputed

Checked 21 references by DOI: 19 verified — 2 no DOI (shown, not verified).

4 data/code links checked; 3 live, 1 dead.

Copyediting

5 minor

Wording, consistency and formatting errors that need correcting before submission.

No major wording or formatting errors. 5 minor suggestions below.

5 copyedit issues flagged: mostly consistency, typo.

Kaimen Rigor Action ItemsFinal pass before journal submission

The published work is robust and well-reported. An informed reader should weigh the lack of a control arm and the non-comparative design, which limit causal inference, and the minor reporting gaps (e.g., no explicit CONSORT statement, one dead link). No erratum is warranted for the core findings, but the authors could consider a correction for the typographical errors and the dead link.

1.
HIGHreporting
In the Methods or Reporting Summary, explicitly state that the study follows the CONSORT reporting guideline and provide the checklist as supplementary material.
Reviewer 2 flagged that the reporting guideline is not explicitly named, which is a minor transparency gap that could be easily fixed.
2.
HIGHdata code
Fix or replace the dead link found in the data availability section (reproducibility check found 1 dead link among 4 checked).
A data availability statement undercut by a broken link is a reporting gap that reviewers will catch.
3.
MEDIUMcopyedit
In the Competing interests section, change 'LM.' to 'L.M.' for consistency with other author initials.
Minor formatting inconsistency flagged by the copyedit pass.
4.
MEDIUMcopyedit
In the Methods, Eligibility criteria, remove the stray 'Coc' at the end of the URL 'https://www.kidney.org/professionals/KDOQI/gfr_calculatorCoc'.
Typographical error in the URL that could mislead readers.
5.
MEDIUMcopyedit
In the Results, Safety section, add a percent sign after 16.9 for consistency (currently '16.9 and 16.7%').
Missing percent sign flagged by the copyedit pass.
6.
MEDIUMstatistics
In the Statistical analysis section, clarify how missing data (e.g., missing ECOG PS) were handled in the analyses.
Reviewer 2 suggested addressing outlier_handling to improve transparency.
7.
MEDIUMdata code
In the Data availability section, specify the timeframe for data requests to make the access route more concrete.
Reviewer 2 suggested this to enhance the concreteness of the data access process.
8.
LOWreporting
In the Discussion, consider adding a sentence acknowledging that the lack of a control arm limits causal inference, even though it is already mentioned.
Reviewer 2 suggested this to further temper conclusions.
9.
LOWother
In the Methods, provide more detail on the randomization algorithm (e.g., seed, software) to enhance reproducibility.
Reviewer 2 suggested this to improve reproducibility.

Full text (89,674 chars · analyzed ~84%, head + tail)Analyzed: Aug 15, 2026

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Read alongside

Perioperative durvalumab plus chemotherapy plus new agents for resectable non-small-cell lung cancer: the platform phase 2 NeoCOAST-2 trial.

Read full text (PMC)

DOI

10.1038/s41591-025-03746-z

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Record fingerprint

54210634f76c8404adb720b291e756f1445c4153f7652bab5ae473a23eb23113

Verify via API

Issued Aug 15, 2026Engine 7.39.0

Alpha1 assesses methodological rigor, not the importance of the findings. See how we calibrate →

Kaimen Rigor review

Kaimen Rigor reviewed

3.75 / 5

Adequate — real issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

ClaimsEfficacy rests on an unvalidated surrogate endpoint−0.5★
ClaimsTreatment effect not shown to be clinically meaningful−0.5★
LinksDead data/code link−0.25★

Model-reported confidence: highReviewer agreement: highEngine: 7.39.0Source: full text

Not verified in this report

No reported statistical tests were found to recompute.

Biggest issues

01Efficacy rests on an unvalidated surrogate endpoint
highOverreachreviewer-assessedFull detail
The primary efficacy endpoint is pathological complete response (pCR), a surrogate for long-term clinical outcomes such as event-free survival and overall survival. The paper does not demonstrate target engagement at the tested doses (e.g., PK/PD or dose-exposure data) and does not cite validated evidence linking pCR to clinical outcomes in this specific setting, although it mentions a correlation with EFS in other trials.
“These trials highlight the importance of pCR as a potential early predictor of survival, given the demonstrated correlation between pCR and improved EFS seen across trials.”
Find in source
02Treatment effect not shown to be clinically meaningful
highOverreachreviewer-assessedFull detail
The reported pCR rates (20.3%, 25.7%, 35.2%) are presented as promising but are not anchored to a minimal clinically important difference or a threshold for clinical meaningfulness. The study is not powered for statistical comparisons, and the effect sizes are not explicitly compared to a predefined meaningful benefit.
“In the modified intention-to-treat population (n = 198; Arm 1, n = 74; Arm 2, n = 70; Arm 4, n = 54), pCR rates were 20.3% (15/74; 95% CI, 11.8–31.2), 25.7% (18/70; 95% CI, 16.0–37.6) and 35.2% (19/54; 95% CI, 22.7–49.4)”
Find in source
03Declared data/code link does not resolve
mediumAvailabilityrecomputedFull detail
Dead link — nothing to verify.
“https://vivli.org/members/enquiries-about-studies-not-listed-on-the-vivli-platform/”
Find in source

Findings by category

01ArithmeticNone found 302OverreachOverstated conclusions 03AuthenticityNone found 04DisclosureNone found 105AvailabilityBroken references and links 06Copyedit5 minor suggestions

Numerical inconsistencies

None found

Checked — nothing surfaced.

Overstated conclusions

3 findings · worst high

Efficacy rests on an unvalidated surrogate endpointAssessed
Treatment effect not shown to be clinically meaningfulAssessed
Conclusions only partially backed by the presented evidenceAssessed

6 major claims checked against the paper's own evidence: 1 only partially supported (evidence backs part of the claim; gaps or caveats remain); the rest adequately supported.

Premise concern: surrogate not validated for clinical benefit; effect size not shown to be clinically meaningful.

Data authenticity concerns

None found

Checked — nothing surfaced.

Reporting gaps

None found

Checked — nothing surfaced.

Eight Dimensions8 pass

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Evidence

Introduction ¶1Find in source

Introduction ¶3Find in source

“Despite recent advances, a minority of patients receiving perioperative or neoadjuvant treatment have a pCR, and the 3-year EFS rates remain around 54–60%”

Introduction ¶2Find in source

PASSReviewer 2· 90% conf

The paper establishes a strong scientific premise by citing prior phase III trials and preclinical evidence, and clearly links the rationale to the study objectives.

Evidence

Introduction ¶2Find in source

Introduction ¶4Find in source

“Despite recent advances, a minority of patients receiving perioperative or neoadjuvant treatment have a pCR, and the 3-year EFS rates remain around 54–60%”

Introduction ¶3Find in source

Sub-criteria

controlsN/A

power analysisN/A

blinding levelsADEQUATE

outlier handlingN/A

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 85% conf

Evidence

“A blocked randomization was generated, and randomization was balanced within the IRT at the central level.”

MethodsFind in source

“NeoCOAST-2 is a phase II, open-label, multiarm, multicenter, global, randomized platform study.”

MethodsFind in source

“The sample size was not based on type I error and power considerations.”

Statistical analysisFind in source

PASSReviewer 2· 85% conf

Evidence

MethodsFind in source

“NeoCOAST-2 is a phase II, open-label, multiarm, multicenter, global, randomized platform study.”

MethodsFind in source

paraphrase[Methods, Statistical analysis]

“The sample size was not based on type I error and power considerations. Instead, it was based on the model-based drug development approach.”

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Demographics including age, sex, race, and disease characteristics are reported in Table 1, and sex is reported for all arms.

Evidence

paraphrase[Table 1]

“Sex, n (%) | Female | 28 (37.8) | 28 (40.0) | 22 (40.7)”

“Median (range), years | 66.5 (30–79) | 66.0 (48–83) | 65.0 (38–81)”

Table 1Find in source

paraphrase[Table 1]

“Race, n (%) | Asian | 7 (9.5) | 5 (7.1) | 5 (9.3)”

PASSReviewer 2· 90% conf

Biological variables are well reported for a human clinical trial, including sex, age, race, and disease characteristics.

Evidence

paraphrase[Table 1]

“Sex, n (%) | Female | 28 (37.8) | 28 (40.0) | 22 (40.7) | Male | 46 (62.2) | 42 (60.0) | 32 (59.3)”

“Median (range), years | 66.5 (30–79) | 66.0 (48–83) | 65.0 (38–81)”

Table 1Find in source

paraphrase[Table 1]

“Race, n (%) | Asian | 7 (9.5) | 5 (7.1) | 5 (9.3) | Black or African American | 1 (1.4) | 0 | 0 | White | 46 (62.2) | 42 (60.0) | 37 (68.5)”

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The study reports approval by Institutional Review Boards and Ethics Committees at each participating center, and informed consent is described in the eligibility criteria.

Evidence

MethodsFind in source

“Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.”

MethodsFind in source

PASSReviewer 2· 95% conf

Ethical approvals are thoroughly documented, including named IRBs/ethics committees and informed consent procedures.

Evidence

MethodsFind in source

“Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.”

MethodsFind in source

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 85% conf

The investigational products (durvalumab, oleclumab, monalizumab, Dato-DXd, and chemotherapy agents) are identified with doses and regimens, and the PD-L1 assay is named.

Evidence

“Arm 1 consisted of neoadjuvant durvalumab (1,500 mg intravenously (i.v.) every 3 weeks (Q3W)), oleclumab (3,000 mg i.v. Q3W) and platinum-doublet chemotherapy for four cycles”

MethodsFind in source

“Baseline PD-L1 status was assessed using central (VENTANA SP263) or local testing (VENTANA SP263, pharmDx 28-8, or pharmDx 22C3).”

ResultsFind in source

“Analyses of clinical data were conducted using SAS v9.4.”

Statistical analysisFind in source

PASSReviewer 2· 85% conf

Key investigational products are identified with doses and regimens, and statistical software is identified; other bench resources are not applicable.

Evidence

“Arm 1 consisted of neoadjuvant durvalumab (1,500 mg intravenously (i.v.) every 3 weeks (Q3W)), oleclumab (3,000 mg i.v. Q3W) and platinum-doublet chemotherapy for four cycles”

MethodsFind in source

“Analyses of clinical data were conducted using SAS v9.4.”

Statistical analysisFind in source

Sub-criteria

tests namedN/A

exact p valuesN/A

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedN/A

mathematical plausibilityN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Statistical methods are appropriate for a non-comparative phase II trial: pCR and mPR rates with Clopper-Pearson CIs, no formal statistical tests between arms, and SAS v9.4 identified.

Evidence

“pCR rates were 20.3% (15/74; 95% CI, 11.8–31.2), 25.7% (18/70; 95% CI, 16.0–37.6) and 35.2% (19/54; 95% CI, 22.7–49.4)”

AbstractFind in source

“Single-arm analyses were conducted without statistical tests.”

Statistical analysisFind in source

“Analyses of clinical data were conducted using SAS v9.4.”

Statistical analysisFind in source

PASSReviewer 2· 80% conf

Statistical methods are appropriate for a phase II trial, with CIs reported for primary endpoints and no formal hypothesis tests; software is identified.

Evidence

“pCR rates were 20.3% (95% CI, 11.8–31.2) in Arm 1, 25.7% (95% CI, 16.0–37.6) in Arm 2 and 35.2% (95% CI, 22.7–49.4) in Arm 4”

ResultsFind in source

“Single-arm analyses were conducted without statistical tests.”

Statistical analysisFind in source

“Analyses of clinical data were conducted using SAS v9.4.”

Statistical analysisFind in source

Sub-criteria

code sharingN/A

accession numbersN/A

repository depositN/A

data availability statementADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

A data availability statement is provided with a concrete route via AstraZeneca's data sharing policy and Vivli platform, which is adequate for a clinical trial with patient-level data.

Evidence

Data availabilityFind in source

“Data for studies directly listed on Vivli can be requested through Vivli at www.vivli.org”

Data availabilityFind in source

PASSReviewer 2· 90% conf

Data availability is clearly stated with a concrete mechanism for requesting data via AstraZeneca's policy and Vivli platform.

Evidence

Data availabilityFind in source

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineNOT REPORTED

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper is transparent: it is registered (NCT05061550), reports all primary and secondary endpoints, discusses limitations, and provides funding and COI statements.

Evidence

“ClinicalTrials.gov identifier: NCT05061550”

AbstractFind in source

“Our study has some limitations, including the lack of a dedicated control arm and power for statistical comparisons between arms, which precludes definitive cross-arm comparisons.”

DiscussionFind in source

“This study was funded by AstraZeneca.”

AcknowledgementsFind in source

PASSReviewer 2· 90% conf

The manuscript is transparent, with detailed methods, trial registration, limitations, and funding/COI statements.

Evidence

“ClinicalTrials.gov identifier: NCT05061550”

AbstractFind in source

“Our study has some limitations, including the lack of a dedicated control arm and power for statistical comparisons between arms, which precludes definitive cross-arm comparisons.”

Discussion ¶6Find in source

“This study was funded by AstraZeneca.”

AcknowledgementsFind in source

Registered (1 ID: ClinicalTrials.gov). Reporting guideline cited: CONSORT.

Broken references and links

1 finding · worst medium

References checked against Crossref, OpenAlex and Retraction Watch for retractions and resolvability, plus declared data and code links probed for whether they resolve to content matching the paper.

Dead data/code linksRecomputed

Checked 21 references by DOI: 19 verified — 2 no DOI (shown, not verified).

4 data/code links checked; 3 live, 1 dead.

Copyediting

5 minor

Wording, consistency and formatting errors that need correcting before submission.

No major wording or formatting errors. 5 minor suggestions below.

5 copyedit issues flagged: mostly consistency, typo.

Kaimen Rigor Action ItemsFinal pass before journal submission

1.
HIGHreporting
In the Methods or Reporting Summary, explicitly state that the study follows the CONSORT reporting guideline and provide the checklist as supplementary material.
Reviewer 2 flagged that the reporting guideline is not explicitly named, which is a minor transparency gap that could be easily fixed.
2.
HIGHdata code
Fix or replace the dead link found in the data availability section (reproducibility check found 1 dead link among 4 checked).
A data availability statement undercut by a broken link is a reporting gap that reviewers will catch.
3.
MEDIUMcopyedit
In the Competing interests section, change 'LM.' to 'L.M.' for consistency with other author initials.
Minor formatting inconsistency flagged by the copyedit pass.
4.
MEDIUMcopyedit
In the Methods, Eligibility criteria, remove the stray 'Coc' at the end of the URL 'https://www.kidney.org/professionals/KDOQI/gfr_calculatorCoc'.
Typographical error in the URL that could mislead readers.
5.
MEDIUMcopyedit
In the Results, Safety section, add a percent sign after 16.9 for consistency (currently '16.9 and 16.7%').
Missing percent sign flagged by the copyedit pass.
6.
MEDIUMstatistics
In the Statistical analysis section, clarify how missing data (e.g., missing ECOG PS) were handled in the analyses.
Reviewer 2 suggested addressing outlier_handling to improve transparency.
7.
MEDIUMdata code
In the Data availability section, specify the timeframe for data requests to make the access route more concrete.
Reviewer 2 suggested this to enhance the concreteness of the data access process.
8.
LOWreporting
In the Discussion, consider adding a sentence acknowledging that the lack of a control arm limits causal inference, even though it is already mentioned.
Reviewer 2 suggested this to further temper conclusions.
9.
LOWother
In the Methods, provide more detail on the randomization algorithm (e.g., seed, software) to enhance reproducibility.
Reviewer 2 suggested this to improve reproducibility.

Full text (89,674 chars · analyzed ~84%, head + tail)Analyzed: Aug 15, 2026