Clinical Trials — Solid-Tumor Oncology

9 supported · 3 partial of 12

4 of 8 pass · 4 warn

6/6 links livestats consistentregistered

3 Αlpha¹ Rigor Reviewers · moderate confidenceAI Rigor Reviewers trained on Alpha1 corpus · verify findings

Interventional0/10Action Items · Critical / High

Pembrolizumab plus axitinib versus sunitinib for advanced clear cell renal cell carcinoma: 5-year survival and biomarker analyses of the phase 3 KEYNOTE-426 trial

Rini BI, Plimack ER, Stus V, Gafanov R, Waddell T, Nosov D, Pouliot F, Alekseev B, Soulières D, Melichar B, Vynnychenko I, de Azevedo SJ, Borchiellini D, McDermott RS, Bedke J, Tamada S, Wu S, Markensohn J, Zhang Y, Loboda A, Vajdi A, Perini RF, Burgents J, Powles T.

WARNScore 93

1. Verified MAJOR consistency issue Extended Data Table 3 footnote “In the axitinib arm, non-zero associations (two-tailed test) were hypothesized for all biomarkers.” → In the sunitinib arm, non-zero associations (two-tailed test) were hypothesized for all biomarkers. 2. Verified "The trial was conducted in accordance with the principles of Good Clinical Practice and was approved by the appropriate institutional review boards and regulatory agencies." but no naming of a specific IRB. 3. Verified some not-found citations are conference abstracts.

11 supported · 1 partial of 12

6 of 8 pass · 2 warn

3/3 links livestats consistentregistered

3 Αlpha¹ Rigor Reviewers · high confidenceAI Rigor Reviewers trained on Alpha1 corpus · verify findings

Interventional0/6Action Items · Critical / High

Atezolizumab plus FOLFOX for Stage III Mismatch Repair-Deficient Colon Cancer.

Sinicrope FA, Ou FS, Arnold D, Peters WR, Behrens RJ, Lieu CH, Matin K, Cohen DJ, Potter SL, Nixon AB, Kottschade LA, Kathol E, Frankel WL, Shergill A, Hsu D, Reinacher-Schick A, Mehan P, Gold PJ, Khalil MF, Zemla T, Gatten C, O'Reilly EM, Meyerhardt JA

WARNScore 96

1. Confirmed that while sex and age are reported, weight and race/ethnicity are missing in the entire main text/Table 1. 2. Confirmed that no data nor code is appropriately shared.

7 supported · 3 partial of 10

5 of 8 pass · 3 warn

1/3 links livestats consistentregistered

3 Αlpha¹ Rigor Reviewers · high confidenceAI Rigor Reviewers trained on Alpha1 corpus · verify findings

Interventional0/5Action Items · Critical / High

Encorafenib, Cetuximab, and mFOLFOX6 in BRAF-Mutated Colorectal Cancer.

Elez E, Yoshino T, Shen L, Lonardi S, Van Cutsem E, Eng C, Kim TW, Wasan HS, Desai J, Ciardiello F, Yaeger R, Maughan TS, Morris VK, Wu C, Usari T, Laliberte R, Dychter SS, Zhang X, Tabernero J, Kopetz S, BREAKWATER Trial Investigators

PASSScore 75

9 supported · 3 partial of 12

7 of 8 pass · 1 warn

6/8 links livestats consistentregistered

3 Αlpha¹ Rigor Reviewers · high confidenceAI Rigor Reviewers trained on Alpha1 corpus · verify findings

Interventional0/6Action Items · Critical / High

Fecal microbiota transplantation plus pembrolizumab and axitinib in metastatic renal cell carcinoma: the randomized phase 2 TACITO trial.

Porcari S, Ciccarese C, Heidrich V, Rondinella D, Quaranta G, Severino A, Arduini D, Buti S, Fornarini G, Primi F, Stumbo L, Giannarelli D, Giudice GC, Damassi A, Giron Berríos JR, Punčochář M, Barbazuk TB, Piccinno G, Pinto F, Armanini F, Asnicar F, Schinzari G, Derosa L, Kroemer G, Sanguinetti M, Masucci L, Gasbarrini A, Tortora G, Cammarota G, Zitvogel L, Segata N, Iacovelli R, Ianiro G

PASSScore 78

1. Confirmed that 67% does not match the reported count 33/50 2. Confirmed that hazard ratio = 0.36 (95% CI: 0.13–0.99), P = 0.167 --> P should be 0.049 so it's actually significant w/o multiple testing correction

5/5 links live3 decision errorsregistered

3 Αlpha¹ Rigor Reviewers · high confidenceAI Rigor Reviewers trained on Alpha1 corpus · verify findings

Interventional0/6Action Items · Critical / High

Duration of androgen deprivation therapy with postoperative radiotherapy for prostate cancer: a comparison of long-course versus short-course androgen deprivation therapy in the RADICALS-HD randomised trial.

Parker CC, Kynaston H, Cook AD, Clarke NW, Catton CN, Cross WR, Petersen PM, Persad RA, Pugh CA, Saad F, Logue J, Payne H, Bower LC, Brawley C, Rauchenberger M, Barkati M, Bottomley DM, Brasso K, Chung HT, Chung PWM, Conroy R, Falconer A, Ford V, Goh CL, Heath CM, James ND, Kim-Sing C, Kodavatiganti R, Malone SC, Morris SL, Nabid A, Ong AD, Raman R, Rodda S, Wells P, Worlding J, Parulekar WR, Parmar MKB, Sydes MR, RADICALS investigators

PASSScore 91

1. Confirm that In Table 1, the Denmark row for short-course ADT shows '35 (95%)', which is likely a typo since 35/761 ≈ 4.6%.

8 supported · 1 partial of 9

7 of 8 pass · 1 warn

4/4 links livestats consistentregistered

3 Αlpha¹ Rigor Reviewers · high confidenceAI Rigor Reviewers trained on Alpha1 corpus · verify findings

Interventional0/3Action Items · Critical / High

Niraparib and abiraterone acetate plus prednisone for HRR-deficient metastatic castration-sensitive prostate cancer: a randomized phase 3 trial

Attard G, Agarwal N, Graff JN, Sandhu S, Efstathiou E, Özgüroğlu M, Pereira de Santana Gomes AJ, Vianna K, Luo H, Gotto GT, Cheng HH, Kim W, Varela CR, Schaeffer D, Kramer K, Li S, Baron B, Shen F, Mundle SD, McCarthy SA, Olmos D, Chi KN, Rathkopf DE.

2/2 links live3 stat inconsistentregistered

3 Αlpha¹ Rigor Reviewers · high confidenceAI Rigor Reviewers trained on Alpha1 corpus · verify findings

Interventional0/5Action Items · Critical / High

Sacituzumab tirumotecan versus docetaxel for previously treated <i>EGFR</i>-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.

PASSScore 92

1. The agent's stat test was two-sided where as the paper presented one-sided HR. The vast majority of oncology RCTs report two-sided p-values by default for overall survival and PFS comparisons, even when the clinical hypothesis is directional (i.e., "does the new drug improve survival, not just change it"). This is the regulatory and academic standard. The CI itself is two-sided. 2. The last reference not resolved is a post from a company website.

11 supported · 1 overstated of 12

8 of 8 pass

5/5 links live2 stat inconsistentregistered

3 Αlpha¹ Rigor Reviewers · high confidenceAI Rigor Reviewers trained on Alpha1 corpus · verify findings