Open-label, Single-arm Trial to Evaluate Antitumor Activity, Safety, and Pharmacokinetics of SAR408701 Used in Combination With Ramucirumab in Metastatic, Non-squamous, Non-small-cell Lung Cancer (NSQ NSCLC) Patients With CEACAM5-positive Tumors, Previously Treated With Platinum-based Chemotherapy and an Immune Checkpoint Inhibitor (CARMEN-LC04)
Part 1 (safety run-in): To assess the tolerability and to confirm the recommended dose of
SAR408701 in combination with ramucirumab in the NSQ NSCLC population.
Part 2: To assess the antitumor activity of SAR408701 in combination with ramucirumab in
the NSQ NSCLC population.
To assess the safety and tolerability of SAR408701 in combination with ramucirumab
To assess the durability of the response to treatment with SAR408701 in combination with
To assess efficacy of SAR408701 in combination with ramucirumab on progression free
To assess the pharmacokinetic (PK) profile of SAR408701 and ramucirumab when given in
To assess the immunogenicity of SAR408701 when given in combination with ramucirumab
The expected duration of the study intervention for participants may vary, based on
progression date ; median expected duration of study per participant is estimated 11 months
(up to 1 month for screening, a median of 6 months for treatment, and a median of 4 months
for end-of-treatment assessments and safety follow-up visit)
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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