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SAR408701 Versus Docetaxel in Previously Treated, Carcinoembryonic Antigen-related Cell Adhesion Molecule 5 (CEACAM5) Positive Metastatic Non-squamous Non-small-cell Lung Cancer Patients

NCT04154956 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 389

Last updated 2026-05-18

Study results available
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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

Conditions

  • Non-small Cell Lung Cancer Metastatic

Interventions

DRUG

SAR408701

Pharmaceutical form: Concentrate for solution for intravenous infusion Route of administration: intravenous (IV) infusion

DRUG

Docetaxel

Pharmaceutical form: Concentrate for solution for intravenous infusion Route of administration: IV infusion

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-06
Primary Completion
2023-09-22
Completion
2026-04-16
FDA Drug
Yes

Countries

  • United States
  • 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)

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04154956 on ClinicalTrials.gov