Sacituzumab tirumotecan versus docetaxel for previously treated EGFR-mutated advanced non-small cell lung cancer: multicentre, open label, randomised controlled trial.
Fang W, Li X, Wang Q, Meng X, Zheng W, Sun L, Yao W, Zhuang W, Fan Y, Zhuo M, Luo Y, Zhang Z, Song X, Yang R, Yang J, Jin X, Diao Y, Ge J, Zhang L
- DOI
- 10.1136/bmj-2025-085680
- Record issued
- 2026-08-15
- Engine
- 7.39.0
- Exported
- 2026-09-21
Prepared by Alpha1. This document is confidential: it is intended for the recipient it was shared with and must not be redistributed. The live record at alpha1science.com/verify/8eeb793b-e0c8-4d40-a2f4-7e2ae0249124 is authoritative.
How this rating was calculated
- IntegrityIntegrity concern ×2−1★
- ClaimsEfficacy rests on an unvalidated surrogate endpoint−0.5★
- CitationsUnresolved reference−0.25★
- 01Efficacy rests on an unvalidated surrogate endpoint
The primary endpoint is objective response rate (ORR), a surrogate for clinical benefit. Although the trial also reports progression-free survival (PFS) and overall survival (OS) as secondary endpoints, the primary efficacy claim is based on ORR. The paper does not provide evidence of target engagement at the tested dose (e.g., PK/PD data) nor does it cite validated evidence linking ORR to the clinical outcome in this specific setting. The discussion acknowledges ORR as a surrogate endpoint.
“This trial used the surrogate endpoint of objective response rate as the primary endpoint.”
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 transparently reported phase 2 randomised controlled trial. The paper demonstrates strong methodological rigor across all eight dimensions, with clear reporting of design, ethics, statistics, and data availability. Minor reporting gaps (e.g., explicit CONSORT checklist, outlier handling statement) and a few copyedit inconsistencies do not undermine the overall integrity.
Both reviewers independently scored all eight dimensions and agreed on 'pass' for each, with only a minor divergence on the reporting guideline sub-criterion. The study type is interventional (randomised controlled trial). Non-applicable sub-criteria (e.g., animal housing, cell line authentication) were excluded. The statistics verification recomputed only 3 tests consistently; the remaining statistics are unverified, and no claim of overall statistical correctness is made.
Numerical inconsistencies
1 finding · worst lowValues 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.
- Internal contradictions in the reported numbersAssessed
Recomputed 3 tests: 3 consistent, 0 inconsistent; 3 via agent-written checks.
- CONSISTENTreported p < .001 · recomputed p = <.001Reviewers 1, 2Check the p-value for the difference in objective response rate (BIRC) using Fisher's exact test on the reported counts.
“BIRC assessed objective response rate was significantly higher in the sac-TMT group (45% (41/91)) v docetaxel (16% (7/45)), with a difference of 29% (95% confidence interval (CI) 15% to 43%; one sided P<0.001).”
Taken as given: The counts 41 and 7 are the number of responders in each group.; The denominators 91 and 45 are the total number of patients in each group for the full analysis set.; The test is two-sided Fisher's exact test, and the reported p is one-sided, so we compare the two-sided p to 0.001.; The reported p is one-sided, so the two-sided p is expected to be larger, but still less than 0.001.Method: Fisher's exact test (two-sided) on the 2x2 table (41, 50, 7, 38) using pFisher2x2 with midP=0.How we recomputed it: pFisher2x2(41, 50, 7, 38, 0) - CONSISTENTreported p < .001 · recomputed p = <.001Reviewer 1Check the p-value for the difference in progression-free survival (BIRC) using the hazard ratio and confidence interval.
“Median progression-free survival was longer with sac-TMT than with docetaxel assessed by BIRC (6.9 v 2.8 months; hazard ratio 0.30, 95% CI 0.20 to 0.46; one sided P<0.001)”
Taken as given: The hazard ratio is 0.30 with a 95% confidence interval of 0.20 to 0.46.; The p-value is derived from the hazard ratio and its confidence interval using a normal approximation on the log scale.; The reported p is one-sided, so the two-sided p is computed and compared to 0.001.Method: Compute two-sided p from the log hazard ratio and its standard error derived from the CI, then compare to 0.001.How we recomputed it: pCI(0.30, 0.20, 0.46, 1) - CONSISTENTreported p < .001 · recomputed p = <.001Reviewer 2Check the p-value for the hazard ratio of progression-free survival (BIRC) using the CI-based method.
“Median progression-free survival was longer with sac-TMT than with docetaxel assessed by BIRC (6.9 v 2.8 months; hazard ratio 0.30, 95% CI 0.20 to 0.46; one sided P<0.001)”
Taken as given: The hazard ratio is 0.30 with a 95% CI of 0.20 to 0.46.; The CI is two-sided at 95%.; The p-value is one-sided, so the two-sided p is halved.Method: Compute two-sided p from the log hazard ratio and its CI, then halve for one-sided.How we recomputed it: pCI(0.30, 0.20, 0.46, 1)
- lowinternal contradictionThe abstract reports ORR for docetaxel as 16% (7/45), while the randomized number is 46. This is explained by the full analysis set definition (measurable disease at baseline), but the discrepancy might be confusing.
“docetaxel (16% (7/45))”
AbstractFind in source
Overstated conclusions
1 finding · worst highConclusions 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
5 major claims checked against the paper's own evidence: all adequately supported.
- supportedReviewers 1, 2Sac-TMT showed statistically significant and clinically meaningful improvements in objective response rate, progression-free survival, and overall survival compared with docetaxel.The primary endpoint (ORR) and key secondary endpoints (PFS, OS) all show statistically significant improvements with hazard ratios and confidence intervals that exclude the null.Evidence: ORR: 45% vs 16%, difference 29% (95% CI 15-43%, P<0.001); PFS: HR 0.30 (95% CI 0.20-0.46, P<0.001); OS: HR 0.49 (95% CI 0.27-0.88, P=0.007).
“Sac-TMT showed statistically significant and clinically meaningful improvements in objective response rate, progression-free survival, and overall survival compared with docetaxel, with a manageable safety profile in patients with EGFR -mutated locally advanced or metastatic NSCLC.”
AbstractFind in source - supportedReviewers 1, 2Sac-TMT has a manageable safety profile.The safety data show lower rates of grade ≥3 treatment-related adverse events with sac-TMT compared to docetaxel, and no new safety signals.Evidence: Grade ≥3 TRAEs: 56% vs 72%; no febrile neutropenia in sac-TMT group; no new safety signals identified.
“Grade ≥3 treatment related adverse events were less frequent with sac-TMT than with docetaxel (56% v 72%), with no new safety signals identified.”
AbstractFind in source - supportedReviewers 1, 2Sac-TMT is the first trophoblast cell surface antigen 2 directed antibody-drug conjugate approved for the treatment of lung cancer in the world.This claim is based on the approval by the China National Medical Products Administration, which is stated in the conclusions.Evidence: The paper states that the China National Medical Products Administration has recently approved the use of sac-TMT.
“Based on the promising results of the current, OptiTROP-Lung03, trial, the China National Medical Products Administration has recently approved the use of sac-TMT, establishing it as the first trophoblast cell surface antigen 2 directed antibody-drug conjugate approved for the treatment of lung cancer in the world.”
ConclusionFind in source - supportedReviewers 1, 2The overall survival benefit is maintained after adjusting for crossover.The RPSFT model and censoring approach both show significant OS benefit, supporting the robustness of the primary OS analysis.Evidence: RPSFT-adjusted HR 0.36 (95% CI 0.20-0.66); censoring-adjusted HR 0.33 (95% CI 0.18-0.62).
Notably, the supplementary survival analysis adjusted using the rank-preserving structural failure time model to account for crossover showed that sac-TMT reduced the risk of death by 64% (adjusted median overall survival not reached versus 9.3 months; hazard ratio 0.36, 95% CI 0.20 to 0.66).
Resultsreviewer’s wording - supportedReviewer 1Sac-TMT provides benefit across all subgroups.Subgroup analyses show consistent benefit across all subgroups, although these are exploratory and not powered for subgroup comparisons.Evidence: Subgroup analyses of ORR and PFS show benefit across all subgroups (supplementary figures S3A, S3B, S4A, S4B).
“Subgroup analyses of objective response rate and progression-free survival, assessed by both BIRC (see supplementary fig S3A and fig S3B) and investigator (see supplementary fig S4A and fig S4B), showed that sac-TMT provided benefit over docetaxel across all subgroups.”
ResultsFind in source
Premise concern: surrogate not validated for clinical benefit.
- INADEQUATESurrogate endpointThe primary endpoint is objective response rate (ORR), a surrogate for clinical benefit. Although the trial also reports progression-free survival (PFS) and overall survival (OS) as secondary endpoints, the primary efficacy claim is based on ORR. The paper does not provide evidence of target engagement at the tested dose (e.g., PK/PD data) nor does it cite validated evidence linking ORR to the clinical outcome in this specific setting. The discussion acknowledges ORR as a surrogate endpoint.
“This trial used the surrogate endpoint of objective response rate as the primary endpoint.”
- ADEQUATEEffect sizeThe effect sizes are large and clinically meaningful: ORR 45% vs 16% (difference 29%), median PFS 6.9 vs 2.8 months (HR 0.30), and 12-month OS 73% vs 54% (HR 0.49). These are anchored to clinical outcomes and are statistically significant. The improvements are described as 'clinically meaningful' and are supported by survival benefits.
“Sac-TMT showed statistically significant and clinically meaningful improvements in objective response rate, progression-free survival, and overall survival compared with docetaxel”
Data authenticity concerns
1 finding · worst lowAn 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.
- Other integrity concernAssessed
2 integrity concerns flagged (0 high).
- lowotherThe trial is described as phase 2, but the sample size and design are typical of a phase 3 trial. This is not a validity concern but may be a labeling inconsistency.
“Part II of the OptiTROP-Lung03 trial is a phase 2, open label, randomised controlled trial conducted across 48 centres in China.”
MethodsFind in source
Reporting gaps
None foundRequired 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.
The introduction cites prior research on EGFR-mutated NSCLC, the role of trophoblast cell surface antigen 2, and previous antibody-drug conjugate trials, acknowledging their limitations. The rationale for targeting this specific population is well-argued, and the study addresses gaps in prior research by focusing on a molecularly defined subgroup. Limitations of prior studies are discussed in the comparison with other studies.
“However, randomised phase 3 trials of sacituzumab govitecan and datopotamab deruxtecan in biomarker unselected patients with previously treated, advanced NSCLC (regardless of actionable genomic alterations) did not reach statistical significance for overall survival improvement.”
“Notably, EGFR -mutated NSCLC cell lines resistant to tyrosine kinase inhibitors showed an even higher uptake rate of sac-TMT than cells naive to tyrosine kinase inhibitors.”
“Unlike the TROPION-Lung01 and EVOKE-01 studies, which evaluated trophoblast cell surface antigen 2 directed antibody-drug conjugates in NSCLC populations with or without actionable genomic alterations, the current trial specifically focused on patients with NSCLC and sensitising EGFR mutation with disease progression after EGFR-tyrosine kinase inhibitors and platinum chemotherapy.”
“However, the efficacy of docetaxel in this patient population remains suboptimal, and concerns about its toxicities persist.”
“However, randomised phase 3 trials of sacituzumab govitecan and datopotamab deruxtecan in biomarker unselected patients with previously treated, advanced NSCLC (regardless of actionable genomic alterations) did not reach statistical significance for overall survival improvement.”
Randomization method (SAS-generated, stratified block) and unit (patient) are reported. Blinding is open-label but the BIRC is masked, which is acceptable for the primary endpoint. Power analysis is provided with effect size, alpha, and power. Inclusion/exclusion criteria are described, and the analysis populations (ITT, full analysis set, safety) are defined. Outlier handling is not explicitly discussed but is covered by the pre-specified analysis populations. Controls are inherent in the comparator arm. Independent replication is not applicable for a single pivotal trial, but ongoing phase 3 trials are mentioned.
“An independent statistician generated the 2:1 randomisation schedule using SAS software (version 9.4). A stratified block design was applied, with stratification by brain metastases (yes or no).”
“The treatment assignment was not masked to investigators and participants, but the central evaluation by a blinded independent review committee (BIRC) was conducted in a masked manner.”
“With a planned enrolment of about 126 patients, the trial had at least 85% power to detect a 25% difference (docetaxel 10%; sac-TMT 35%) in objective response rate at a one sided α of 0.025.”
“An independent statistician generated the 2:1 randomisation schedule using SAS software (version 9.4). A stratified block design was applied, with stratification by brain metastases (yes or no).”
“The treatment assignment was not masked to investigators and participants, but the central evaluation by a blinded independent review committee (BIRC) was conducted in a masked manner.”
“With a planned enrolment of about 126 patients, the trial had at least 85% power to detect a 25% difference (docetaxel 10%; sac-TMT 35%) in objective response rate at a one sided α of 0.025.”
Sex is reported (44% men), age is reported (median 56 years), and demographics are detailed in Table 1. Since both sexes are enrolled, sex_justified is not applicable. Species/strain and housing conditions are not applicable for a human trial. Health status is captured via ECOG performance status and disease stage.
“The median age of the study population was 56 years, 44% (60/137) were men, 98% had stage IV disease (134/137), and 20% had brain metastases (28/137).”
“Median (range) age (years) | 57 (37-75) | 55 (34-74) | 56 (34-75)”
“The median age of the study population was 56 years, 44% (60/137) were men, 98% had stage IV disease (134/137), and 20% had brain metastases (28/137).”
“Median (range) age (years) | 57 (37-75) | 55 (34-74) | 56 (34-75)”
The study protocol was approved by the ethics committee of Sun Yat-sen University Cancer Centre with a protocol number, and all patients provided written informed consent. Regulatory compliance with the Declaration of Helsinki and GCP is stated.
“The study protocol was reviewed and approved by the ethics committee of Sun Yat-sen University Cancer Centre on 14 October 2022 (A2022-175-01) and at each participating centre before initiation.”
“All patients provided written informed consent before enrolment.”
“This study was conducted in accordance with the principles of the Declaration of Helsinki, good clinical practice guidelines, and applicable laws and regulations.”
“The study protocol was reviewed and approved by the ethics committee of Sun Yat-sen University Cancer Centre on 14 October 2022 (A2022-175-01) and at each participating centre before initiation.”
“All patients provided written informed consent before enrolment.”
“This study was conducted in accordance with the principles of the Declaration of Helsinki, good clinical practice guidelines, and applicable laws and regulations.”
Sac-TMT is described with its mechanism and dosing, and docetaxel is named. The antibody used for immunohistochemistry is identified (EPR20043). Statistical software (SAS 9.4) is identified. No cell lines or animals are used, so those criteria are not applicable.
“Sac-TMT was administered intravenously at 5 mg/kg on days 1 and 15 of each four week cycle.”
“Trophoblast cell surface antigen 2 expression was assessed by immunohistochemistry (monoclonal antibody: EPR20043 (https://www.ncbi.nlm.nih.gov/protein/EPR20043) )”
“All statistical analyses were conducted using SAS software (version 9.4).”
“Sac-TMT was administered intravenously at 5 mg/kg on days 1 and 15 of each four week cycle.”
“All statistical analyses were conducted using SAS software (version 9.4).”
All tests are named (Cochran-Mantel-Haenszel, stratified log-rank, Cox proportional hazards). Assumptions are handled by design (stratified analyses, Cox model). Exact p-values are reported (e.g., P<0.001, P=0.007). Effect sizes with 95% CIs are reported throughout. Software is identified. Data presentation includes Kaplan-Meier curves and forest plots, with per-group n. Mathematical plausibility checks were not possible for most statistics due to model-based estimates, but no inconsistencies were found.
“Treatment groups were compared using the Cochran-Mantel-Haenszel test, stratified by the presence of brain metastases.”
“BIRC assessed objective response rate was significantly higher in the sac-TMT group (45% (41/91)) v docetaxel (16% (7/45)), with a difference of 29% (95% confidence interval (CI) 15% to 43%; one sided P<0.001).”
“Median progression-free survival was longer with sac-TMT than with docetaxel assessed by BIRC (6.9 v 2.8 months; hazard ratio 0.30, 95% CI 0.20 to 0.46; one sided P<0.001)”
“Treatment groups were compared using the Cochran-Mantel-Haenszel test, stratified by the presence of brain metastases.”
“with a difference of 29% (95% confidence interval (CI) 15% to 43%; one sided P<0.001)”
“Median progression-free survival was longer with sac-TMT than with docetaxel assessed by BIRC (6.9 v 2.8 months; hazard ratio 0.30, 95% CI 0.20 to 0.46; one sided P<0.001)”
The data availability statement provides a public Mendeley repository URL. Code is available in supplementary files. Since the data are openly available, repository deposit and accession numbers are satisfied. No bespoke code repository is needed as code is in supplementary files.
“The data underlying the findings in this paper are openly and publicly available and can be found at https://data.mendeley.com/datasets/hts8z9mx4w/1 .”
“The code used to analyse the data in the paper can be found in the supplementary files.”
“The data underlying the findings in this paper are openly and publicly available and can be found at https://data.mendeley.com/datasets/hts8z9mx4w/1”
“The code used to analyse the data in the paper can be found in the supplementary files.”
The trial is registered (NCT05631262). The paper follows CONSORT guidelines implicitly (trial profile, flow diagram). All pre-specified outcomes are reported, including negative results (e.g., no association of TROP2 expression with response). Limitations are discussed. Conclusions are proportional to the evidence. Funding and competing interests are declared.
“Trial registration ClinicalTrials.gov NCT05631262 (https://clinicaltrials.gov/ct2/show/NCT05631262) .”
“Although the modest sample size was appropriate for this phase 2 trial, the enrolled patients were all Chinese, which may limit the generalisability of the findings.”
“Funding: This study was funded by Sichuan Kelun-Biotech Biopharmaceutical and partly supported by the National Natural Science Foundation of China (grants 82241232 and 82272789 awarded to LZ, grants 82173101 and 82373262 awarded to WF) and Noncommunicable Chronic Diseases-National Science and Technology Major Project (2024ZD0519700 awarded to LZ).”
“Trial registration ClinicalTrials.gov NCT05631262”
“Although the modest sample size was appropriate for this phase 2 trial, the enrolled patients were all Chinese, which may limit the generalisability of the findings.”
“Funding: This study was funded by Sichuan Kelun-Biotech Biopharmaceutical and partly supported by the National Natural Science Foundation of China”
Registered (4 IDs: ClinicalTrials.gov). No reporting guideline cited.
Broken references and links
1 finding · worst lowReferences 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.
- References not resolvable to a published paperRecomputed
Checked 30 references by DOI: 29 verified — 1 DOI unresolved.
- UNRESOLVED10.1016/s0140-6736(21Kelun-Biotech’s TROP2-ADC SKB264 (sac-TMT) Third NDA for EGFR-mutant NSCLC Accepted by NMPACited DOI does not resolve to any Crossref record.
1 data/code link checked; 1 live.
- dataMendeley DataLIVEHTTP 200https://data.mendeley.com/datasets/hts8z9mx4w/1Resolves to Mendeley Data (data repository).
Copyediting
5 minorWording, 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, clarity, punctuation.
- MINORconsistencyAbstract, Results“docetaxel (16% (7/45))”→ Consider clarifying that the denominator is 45, not 46, due to one patient not having measurable disease.The denominator for ORR in the docetaxel group is 45, while the randomized number is 46. This is explained in the full analysis set definition but may confuse readers.
- MINORclarityMethods, Statistical analysis“The prespecified interim analysis of overall survival (with an information fraction of at least 60% and maturity of about 34%) was conducted alongside the final progression-free survival analysis, with a one sided α of 0.0123 determined by an α spending function (Hwang-Shih-DeCani with gamma of −1).”→ Consider simplifying the description of the alpha spending function for readability.The sentence is long and technical; a brief explanation of the alpha spending function could improve clarity.
- MINORconsistencyResults, Safety“No cases of febrile neutropenia were observed in the sac-TMT group, compared with 20% in the docetaxel group.”→ Consider specifying the number of patients (0/91 vs 9/46) for consistency with other safety data.The percentage is given without the numerator/denominator, which is inconsistent with other safety reporting.
- MINORconsistencyAbstract, Results“docetaxel (16% (7/45))”→ Ensure the denominator for docetaxel is consistently 45 or 46 throughout the abstract and results.The abstract reports 7/45 for docetaxel ORR, but the randomization was 46 patients. This may be due to one patient not being evaluable, but it should be clarified.
- MINORpunctuationAbstract, Results“Grade ≥3 treatment related adverse events were less frequent with sac-TMT than with docetaxel (56% v 72%), with no new safety signals identified.”→ Use 'vs' instead of 'v' for consistency with the rest of the text.The abbreviation 'v' is used in the abstract but 'vs' is used elsewhere.
The published work is robust and well-reported; an informed reader should weigh the minor reporting gaps (no explicit CONSORT checklist, no explicit outlier-handling statement) and the copyedit inconsistencies (e.g., ORR denominator 45 vs 46, 'v' vs 'vs') as low-severity issues. No erratum is warranted for scientific integrity, but the authors may consider a correction for the denominator clarification and the unresolved reference.
- 1.HIGHreportingAdd an explicit statement in the Methods or a supplementary file that the trial follows the CONSORT reporting guideline, and include a completed CONSORT checklist.Reviewer 2 flagged reporting_guideline as 'reported_but_inadequate'; an explicit checklist would strengthen transparency.
- 2.HIGHreportingClarify in the Abstract and Results that the ORR denominator for docetaxel is 45 (not 46) because one patient lacked measurable disease at baseline, to avoid confusion.The copyedit and integrity checks both flagged the 7/45 vs 46 discrepancy as potentially confusing to readers.
- 3.HIGHreportingVerify or correct the reference 'Kelun-Biotech’s TROP2-ADC SKB264 (sac-TMT) Third NDA for EGFR-mutant NSCLC Accepted by NMPA' (DOI 10.1016/s0140-6736(21) which was not found in the registry; if it is a real publication, provide the correct DOI, otherwise remove it.A reference that cannot be found in any registry is a potential fabrication signal and must be resolved.
- 4.MEDIUMreportingAdd a sentence in the Statistical analysis section stating whether any outliers were excluded and how they were handled, even if none were excluded.Both reviewers noted outlier handling is not explicitly described; a brief statement would close this reporting gap.
- 5.MEDIUMreportingProvide a more detailed description of the randomization implementation (e.g., block sizes) in the supplementary methods.Both reviewers suggested this to improve reproducibility of the randomization procedure.
- 6.MEDIUMreportingReport the exact p-values for secondary endpoints that are only given as thresholds (e.g., P<0.001) in the supplementary tables.Reviewer 1 suggested this to improve statistical transparency.
- 7.MEDIUMdata codeDeposit the statistical analysis code in a public repository (e.g., GitHub or Zenodo) with a DOI, in addition to the supplementary files.Both reviewers suggested this to improve code accessibility and long-term preservation.
- 8.MEDIUMreportingAdd a discussion of the potential impact of the open-label design on investigator-assessed endpoints in the Limitations section.Reviewer 1 suggested this to address a potential bias source.
- 9.MEDIUMreportingClarify the handling of missing data for the primary endpoint in the statistical analysis plan.Reviewer 2 suggested this to ensure the analysis is fully pre-specified.
- 10.MEDIUMreportingAdd a statement on whether the trial was monitored by an independent data safety monitoring board.Reviewer 1 suggested this to document oversight.
- 11.MEDIUMreportingReport the number of patients with each EGFR mutation subtype in the supplementary tables.Reviewer 2 suggested this to provide more detailed baseline characterization.
- 12.LOWcopyeditUse 'vs' instead of 'v' consistently throughout the abstract and text.Copyedit flagged inconsistent abbreviation usage.
- 13.LOWcopyeditSpecify the numerator/denominator for febrile neutropenia (0/91 vs 9/46) in the Safety results for consistency with other safety data.Copyedit noted the percentage is given without counts, which is inconsistent with other safety reporting.
- 14.LOWcopyeditSimplify the description of the alpha spending function in the Statistical analysis section for readability.Copyedit flagged the sentence as long and technical.
The star rating is the report’s one-glance summary. Every paper starts at 5★ and loses stars for the concrete problems the review finds — so a rating is never a vague average, it’s a running total you can read line by line under “How this rating was calculated.”
- Reporting — 8 dimensionseach dimension that fully fails−½★
- each dimension partially met−¼★
- Statistics · Integrity · Claimseach serious problem−1★
- each medium problem−½★
- Citationseach retracted or unverifiable reference−¼★
- Copyeditonly when the manuscript needs a full edit−½★
The rating never drops below 1★, and a demonstrable critical failure (an impossible statistic, a proven ethics violation) caps it at 1★ on its own — so the stars can never look healthy when the verdict is CRITICAL.
The rating draws on a panel of agents. Three independent Kaimen Rigor reviewers grade the eight dimensions below across several independent passes (the shown verdict is their majority vote — steadier than any single run), isolate the paper’s major claims and check its own evidence backs them, and flag integrity concerns. Alongside them, a citation agent resolves every reference against Crossref, OpenAlex, and Retraction Watch; a statistics agent recomputes reported tests; and rule-based checks verify that declared data/code links actually resolve. Full text is required — an abstract-only submission is not analyzed.
Graded against NIH, MDAR, ARRIVE 2.0, CONSORT, EQUATOR, and RRID guidelines. A dimension that doesn’t apply to the study type is skipped, never penalized.
This Kaimen Rigor review is model-assisted and is not a substitute for formal expert review. It complements human evaluation by surfacing potential methodological concerns — verify each finding against the source.