SAR408701 in Combination With Pembrolizumab and Pembrolizumab Alone in Patients With Non-squamous Non-small Cell Lung Cancer (NSQ NSCLC) (CARMEN-LC05)

SAR408701 in Combination With Pembrolizumab and Pembrolizumab Alone in Patients With Non-squamous Non-small Cell Lung Cancer (NSQ NSCLC) (CARMEN-LC05)

Brief Summary:
Primary Objectives:
- Part A - Part 1 (safety run-in): To assess the tolerability and to confirm the recommended dose of SAR408701 in combination with pembrolizumab in the NSQ NSCLC population
- Part A - Part 2: To assess the antitumor activity of SAR408701 in combination with pembrolizumab and pembrolizumab single agent in the NSQ NSCLC population
- Part B: To assess the tolerability and to determine the recommended dose of SAR408701 in combination with pembrolizumab and platinum-based chemotherapy in the NSQ NSCLC population

Secondary Objectives:
- To assess the durability of the response to treatment with SAR408701 in combination with pembrolizumab and pembrolizumab single agent and SAR408701 in combination with pembrolizumab and platinum-based chemotherapy (Investigator's choice of cisplatin or carboplatin)
- To assess the durability of the response to treatment with SAR408701 in combination with pembrolizumab and pembrolizumab single agent
- To assess the efficacy on progression-free survival (PFS) of SAR408701 in combination with pembrolizumab and pembrolizumab single agent
- To assess the pharmacokinetics (PK) of SAR408701, pembrolizumab, cisplatin, and carboplatin, each when given in combination as a doublet or a triplet, and of pembrolizumab when given as a single agent
- To assess the immunogenicity of SAR408701 when given in combination with pembrolizumab and in combination with pembrolizumab and platinum-based chemotherapy
- To assess the antitumor activity of SAR408701 in combination with pembrolizumab and platinum-based chemotherapy

Detailed Description:
The expected duration of the study intervention for participants may vary based on progression date; median expected duration of study per participant is estimated 10 months (up to 1 month for screening, a median of 6 months for treatment, and a median of 3 months for end-of-treatment assessments and safety follow-up visit).


Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized, Open-label, Phase 2 Study of SAR408701 Combined With Pembrolizumab and Pembrolizumab Alone in Patients With CEACAM5 and PD-L1 Positive Advanced/Metastatic Non-squamous Non-small-cell Lung Cancer (NSQ NSCLC)
Actual Study Start Date: October 26, 2020
Estimated Primary Completion Date: August 2022
Estimated Study Completion Date: April 2023

Arm:
- Experimental: SAR408701 + Pembrolizumab
- Active Comparator: Pembrolizumab
- Experimental: SAR408701 + Pembrolizumab + cisplatin
- Experimental: SAR408701 + Pembrolizumab + carboplatin

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