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NCT04154956 · ClinicalTrials.gov registry record · Phase 3
SAR408701 Versus Docetaxel in Previously Treated, Carcinoembryonic Antigen-related Cell Adhesion Molecule 5 (CEACAM5) Positive Metastatic Non-squamous Non-small-cell Lung Cancer Patients
A Phase 3 study of Non Small Cell Lung Cancer Metastatic, sponsored by Sanofi.
- Active
- Registry status
- Phase 3
- Development phase
- 389
- Enrollment target
- 20
- Study locations
NCT04154956: Active Phase 3 study of Non Small Cell Lung Cancer Metastatic, sponsored by Sanofi.
NCT04154956 is a Phase 3 study of Non Small Cell Lung Cancer Metastatic that is active but no longer recruiting, run by Sanofi. The registered enrollment target is 389 participants, roughly in line with the 412-participant average among 16 other Non Small Cell Lung Cancer Metastatic trials with a reported enrollment target. The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04154956, a Phase 3 study of Non Small Cell Lung Cancer Metastatic, is active but no longer recruiting, sponsored by Sanofi.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 389 participants
- Enrollment target
- 20
- Study locations
Study Summary
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
Primary Outcome
PFS was defined as the time from the date of randomization to the date of the first documentation of objective PD as assessed by radiological review committee (IRC) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) definitions or death due to any cause before the study cut-off date, whichever occurred first. PD was defined as unequivocal progression of existing non-target lesions; appearance of 1 or more new lesions; at least a 20% increase in the sum of diameter
Conditions Studied
Interventions
- DRUG Docetaxel
- DRUG SAR408701
Study Locations (20)
Other
- Investigational Site Number : 0320001 - Buenos Aires
- Investigational Site Number : 0320004 - Buenos Aires
- Investigational Site Number : 0320014 - Córdoba
- Investigational Site Number : 0320002 - Salta
- Investigational Site Number : 0560006 - Anderlecht
- Investigational Site Number : 0560004 - Edegem
Florida
- Florida Cancer Specialists South Division- Site Number : 8400020 - Fort Myers
- Florida Cancer Specialists North Division- Site Number : 8400019 - St. Petersburg
Texas
- Renovatio Clinical- Site Number : 8400032 - El Paso
- Renovatio Clinical - Site Number : 8400013 - The Woodlands
Buenos Aires
- Investigational Site Number : 0320009 - CABA
- Investigational Site Number : 0320012 - Capital Federal
New South Wales
- Investigational Site Number : 0360002 - Blacktown
- Investigational Site Number : 0360003 - Waratah
Michigan
- Ca & Hem Center Of W Michigan- Site Number : 8400016 - Grand Rapids
New York
- Roswell Park Cancer Institute Site Number : 8400011 - Buffalo
Pennsylvania
- Lankenau Hospital Cancer Center- Site Number : 8400017 - Wynnewood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 389 participants |
| Start Date | 2020-02-06 |
| Est. Completion | 2026-03-31 |
| Phase | Phase 3 |
What the registry record for NCT04154956 still lists
NCT04154956 is an interventional study that assigns participants to a tested intervention. The registered 389 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 412-participant average among 16 other Non Small Cell Lung Cancer Metastatic trials with a reported enrollment target.
The record links to 1 condition, with Non Small Cell Lung Cancer Metastatic appearing as the primary indexed condition, and to 2 interventions - of which Docetaxel is the first listed.
NCT04154956 names 20 study sites across 11 states, led by Other, Florida, Texas.
Frequently Asked Questions
What is clinical trial NCT04154956 about?
NCT04154956 is a clinical study titled "SAR408701 Versus Docetaxel in Previously Treated, Carcinoembryonic Antigen-related Cell Adhesion Molecule 5 (CEACAM5) Positive Metastatic Non-squamous Non-small-cell Lung Cancer Patients". 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 objectiv...
What is the current status of trial NCT04154956?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 389 participants. The study started on 2020-02-06. Estimated completion is 2026-03-31.
What conditions does trial NCT04154956 study?
This clinical trial studies the following conditions: Non Small Cell Lung Cancer Metastatic.
What interventions are being tested in trial NCT04154956?
The interventions under investigation include: Docetaxel (DRUG), SAR408701 (DRUG).
Who is sponsoring clinical trial NCT04154956?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04154956 being conducted?
This trial has 20 study locations across Florida, Michigan, New York, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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389 4th of 16 higher than 13 of 16 other Non Small Cell Lung Cancer Metastatic trials
participants (enrollment target), bucketed by value
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