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NCT04394624 · ClinicalTrials.gov registry record · Phase 2
Tusamitamab Ravtansine (SAR408701) in Combination With Ramucirumab or Ramucirumab and Pembrolizumab in Pretreated Patients With NSQ NSCLC (CARMEN-LC04)
A Phase 2 study, sponsored by Sanofi.
- Terminated
- Registry status
- Phase 2
- Development phase
- 31
- Enrollment target
NCT04394624: Clinical Trial Phase 2 study, sponsored by Sanofi.
NCT04394624 is a Phase 2 study that was terminated before completion, run by Sanofi. The registered enrollment target is 31 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04394624, a Phase 2 study, was terminated before completion, sponsored by Sanofi.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 31 participants
- Enrollment target
Study Summary
Primary Objectives: Doublet Cohort Part 1 (safety run-in): To assess the tolerability and to confirm the recommended dose of tusamitamab ravtansine in combination with ramucirumab in the NSQ NSCLC population. Part 2: To assess the antitumor activity of tusamitamab ravtansine in combination with ramucirumab in the NSQ NSCLC population. Triplet cohort To assess the tolerability and to confirm the recommended dose of tusamitamab ravtansine in combination with ramucirumab and pembrolizumab in the NSQ NSCLC population. Secondary Objectives: Doublet Cohort To assess the safety and tolerability of tusamitamab ravtansine in combination with ramucirumab. To assess the durability of the response to treatment with tusamitamab ravtansine in combination with ramucirumab. To assess anti-tumor activity of tusamitamab ravtansine in combination with ramucirumab on progression free survival (PFS) and disease control rate (DCR). To assess the pharmacokinetic (PK) profiles of tusamitamab ravtansine (SAR408701) and ramucirumab when given in combination. To assess the immunogenicity of tusamitamab ravtansine (SAR408701) when given in combination with ramucirumab. Triplet cohort To assess the safety and tolerability of tusamitamab ravtansine in combination with ramucirumab and pembrolizumab To assess the antitumor activity of tusamitamab ravtansine in combination with ramucirumab and pembrolizumab in the NSQ NSCLC population. To assess the immunogenicity of tusamitamab ravtansine when given in combination with ramucirumab and pembrolizumab
Primary Outcome
The following AEs occurred during the first 2 cycles of treatment, unless due to disease progression or to a cause obviously unrelated to study drug, were considered DLTs: • Grade 4 neutropenia for 7 or more consecutive days. • Grade 3 to 4 neutropenia complicated by fever. • Grade \>=3 thrombocytopenia. • Elevated urine protein \>=3 gram(g)/24 hour. • Grade 4 non-hematologic AE. • Grade \>=3 keratopathy. • Grade 4 or refractory hypertension. In addition, any other AE that the Investigators and
Interventions
- DRUG pembrolizumab
- DRUG SAR408701
- DRUG ramucirumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2020-08-31 |
| Est. Completion | 2024-10-24 |
| Phase | Phase 2 |
Why NCT04394624 stopped before completion
NCT04394624 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 3 interventions - of which pembrolizumab is the first listed.
NCT04394624 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04394624 about?
NCT04394624 is a clinical study titled "Tusamitamab Ravtansine (SAR408701) in Combination With Ramucirumab or Ramucirumab and Pembrolizumab in Pretreated Patients With NSQ NSCLC (CARMEN-LC04)". Primary Objectives: Doublet Cohort Part 1 (safety run-in): To assess the tolerability and to confirm the recommended dose of tusamitamab ravtansine in combination with ramucirumab in the NSQ NSCLC population. Part 2: To assess the antitumor activity of tusamitamab ravtansine in combination with...
What is the current status of trial NCT04394624?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 31 participants. The study started on 2020-08-31. Estimated completion is 2024-10-24.
What interventions are being tested in trial NCT04394624?
The interventions under investigation include: pembrolizumab (DRUG), SAR408701 (DRUG), ramucirumab (DRUG).
Who is sponsoring clinical trial NCT04394624?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04394624's enrollment target sits among peer trials
31 1578th of 2000 higher than 419 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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