{"entity":{"id":"nct04154956","kind":"trial","name":"SAR408701 Versus Docetaxel in Previously Treated, Carcinoembryonic Antigen-related Cell Adhesion Molecule 5 (CEACAM5) Positive Metastatic Non-squamous Non-small-cell Lung Cancer Patients","aka":[],"tldr":"A phase 3 trial of Tusamitamab ravtansine and Docetaxel in Non-small-cell lung cancer, run by Sanofi, recorded as terminated on the registry.","summary":"SAR408701 Versus Docetaxel in Previously Treated, Carcinoembryonic Antigen-related Cell Adhesion Molecule 5 (CEACAM5) Positive Metastatic Non-squamous Non-small-cell Lung Cancer Patients is a phase 3 interventional study registered as NCT04154956 by Sanofi, with 389 participants recorded, started 2020-02-06 and due to reach its primary completion in 2023-09-22. Interventions recorded: SAR408701, Docetaxel. Conditions recorded: Non-small Cell Lung Cancer Metastatic.\n\nLinked to the drug Tusamitamab ravtansine because the registry names it among its interventions and Non-small-cell lung cancer among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04154956","url":"https://clinicaltrials.gov/study/NCT04154956"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["tusamitamab-ravtansine","docetaxel"],"companies":["sanofi"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04154956","phase":"3","setting":"Randomized, Open-label, Phase 3 Study of SAR408701 Versus Docetaxel in Previously Treated, Metastatic Nonsquamous, Non-small-cell Lung Cancer Patients With CEACAM5-positive Tumors","sponsor":"Sanofi","participation":[{"nct":"NCT04154956","source":"https://clinicaltrials.gov/study/NCT04154956","fetchedAt":"2026-10-07T16:53:14.793Z","studySha256":"c0e632e66f29db29dbcb0ed2946fa58a7f214f3373346f6e3d2c49177235f845","overallStatus":"TERMINATED","lastUpdatePosted":"2026-05-18","whyStopped":"Sponsor decision, the decision is not related to any safety concern.","leadSponsor":"Sanofi","collaboratorCount":0,"minimumAge":"18 Years","sex":"ALL","healthyVolunteers":false,"hasEligibility":true,"enrolment":389,"enrolmentType":"ACTUAL","siteCount":169,"recruitingSiteCount":0,"countries":["Argentina","Australia","Belgium","Brazil","Bulgaria","Canada","Chile","China","France","Germany","Greece","Hungary","Israel","Italy","Japan","Mexico","Netherlands","Poland","Portugal","Romania","Russia","Singapore","South Korea","Spain","Turkey (Türkiye)","United States"]}],"started":"2020-02-06","startedType":"actual","yearReported":2024,"enrolled":389,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free Survival (PFS)","primary":true,"unit":"months","arms":[{"name":"Tusamitamab Ravtansine","n":194,"value":5.39,"note":"95% CI 3.713 to 6.998; Figures from the ClinicalTrials.gov results section (first posted 2024-11-01), not from a publication"},{"name":"Docetaxel","n":195,"value":5.85,"note":"95% CI 5.520 to 7.359"}],"hr":1.143,"ci":[0.864,1.512],"p":"0.8204","source":"https://clinicaltrials.gov/study/NCT04154956?tab=results"},{"endpoint":"Overall Survival (OS)","primary":true,"unit":"months","arms":[{"name":"Tusamitamab Ravtansine","n":194,"value":12.81,"note":"95% CI 11.795 to 14.160; Figures from the ClinicalTrials.gov results section (first posted 2024-11-01), not from a publication"},{"name":"Docetaxel","n":195,"value":11.53,"note":"95% CI 8.936 to 15.244"}],"hr":0.846,"ci":[0.644,1.109],"p":"0.1120","source":"https://clinicaltrials.gov/study/NCT04154956?tab=results"},{"endpoint":"Objective Response Rate (ORR)","unit":"%","arms":[{"name":"Tusamitamab Ravtansine","n":189,"value":21.7,"note":"95% CI 16.04 to 28.26; Figures from the ClinicalTrials.gov results section (first posted 2024-11-01), not from a publication"},{"name":"Docetaxel","n":187,"value":24.1,"note":"95% CI 18.13 to 30.84"}],"p":"0.6972","source":"https://clinicaltrials.gov/study/NCT04154956?tab=results"}]},"route":"/trials/nct04154956/","neighbours":{"cancer":[{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"}],"drug":[{"id":"docetaxel","kind":"drug","name":"Docetaxel","route":"/drugs/docetaxel/"},{"id":"tusamitamab-ravtansine","kind":"drug","name":"Tusamitamab ravtansine","route":"/drugs/tusamitamab-ravtansine/"}],"company":[{"id":"sanofi","kind":"company","name":"Sanofi","route":"/companies/sanofi/"}]}}