SAR408701 Versus Docetaxel in Previously Treated, Carcinoembryonic Antigen-related Cell Adhesion Molecule 5 (CEACAM5) Positive Metastatic Non-squamous Non-small-cell Lung Cancer Patients
Public ClinicalTrials.gov record NCT04154956. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Primary Objectives: * Study was designed with multiple primary endpoints analyzed on randomized participants at the time of the cut-off date for each given analysis (progression free survival \[PFS\] and overall survival \[OS\]) * Study success was defined either on PFS or OS * The primary objective was to determine whether tusamitamab ravtansine improves the progression free survival (PFS) when compared to docetaxel in participants with metastatic non-squamous non-small-cell lung cancer (NSCLC) expressing CEACAM5 greater than or equal to 2+ in intensity in at least 50% of the tumor cell population and previously treated with standard-of-care platinum-based chemotherapy and an immune checkpoint inhibitor (ICI) * The primary objective was to determine whether tusamitamab ravtansine improves the overall survival (OS) when compared with docetaxel in participants with metastatic non-squamous NSCLC expressing CEACAM5 greater than or equal to 2+ in intensity in at least 50% of the tumor cell population and previously treated with standard-of-care platinum-based chemotherapy and an immune checkpoint inhibitor. Secondary Objectives: * Compared the objective response rate (ORR) of tusamitamab ravtansine with docetaxel * Compared the health-related quality of life (HRQOL) of tusamitamab ravtansine with docetaxel * Evaluated the safety of tusamitamab ravtansine compared to docetaxel * Assessed the duration of response (DOR) of tusamitamab ravtansine as compared with docetaxel
Study identification
- NCT ID
- NCT04154956
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 389 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 5, 2020
- Primary completion
- Sep 21, 2023
- Completion
- Apr 15, 2026
- Last update posted
- May 17, 2026
2020 – 2026
United States locations
- U.S. sites
- 8
- U.S. states
- 6
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Florida Cancer Specialists South Division- Site Number : 8400020 | Fort Myers | Florida | 33901 | — |
| Florida Cancer Specialists North Division- Site Number : 8400019 | St. Petersburg | Florida | 33705 | — |
| Ca & Hem Center Of W Michigan- Site Number : 8400016 | Grand Rapids | Michigan | 49546 | — |
| Roswell Park Cancer Institute Site Number : 8400011 | Buffalo | New York | 14263-0001 | — |
| Lankenau Hospital Cancer Center- Site Number : 8400017 | Wynnewood | Pennsylvania | 19096-3411 | — |
| Renovatio Clinical- Site Number : 8400032 | El Paso | Texas | 79915 | — |
| Renovatio Clinical - Site Number : 8400013 | The Woodlands | Texas | 77380 | — |
| Medical College of Wisconsin- Site Number : 8400006 | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 161 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04154956, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 17, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04154956 live on ClinicalTrials.gov.