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