Return to Clinical Trials Search Results

A Phase II Randomized Study of Ramucirumab Plus MK3475 (Pemblrolizumab) versus Standard of Care for Patients Previously Treated with Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-Map Non-Matched Sub-Study)

Primary Objective To compare overall survival between patients previously treated with platinum-based chemotherapy and immunotherapy for Stage IV or recurrent non-small cell lung cancer randomized to ramucirumab and MK-3475 (pembrolizumab) versus standard of care (SoC). Secondary Objectives a. To compare response rates between the arms, including complete response (CR) and partial response (PR) (confirmed and unconfirmed). b. To compare the disease control rate (CR, PR, confirmed and unconfirmed and SD) c. To evaluate the duration of response (DoR) among responders within each arm. d. To evaluate the frequency and severity of toxicities within each arm. e. To compare IA-PFS between the arms. f. To evaluate the clinical outcomes (OS, IA-PFS, response) by randomization stratification factors (See Section 6.0) by comparing outcomes within the ramucirumab and MK-3475 (pembrolizumab) arm, performing a sub-group analysis of the arms, and by evaluating an interaction between the factors and treatment arm. Translational Medicine Objectives a. To evaluate if PD-L1 expression levels are associated with clinical outcomes (OS, IA-PFS, and response). b. To evaluate if tumor mutation burden (TMB) as determined by the FMI Foundation One panel is associated with clinical outcomes. c. To collect, process, and bank cell-free (cfDNA) at baseline and progression for future development of a proposal to evaluate comprehensive next-generation sequencing of circulating tumor DNA (ctDNA). Note: The proposal to use these specimens would be submitted as an amendment to CTEP for approval prior to commencing NGS assays. d. To establish a tissue/blood repository to pursue future studies.

Primary Objective To compare overall survival between patients previously treated with platinum-based chemotherapy and immunotherapy for Stage IV or recurrent non-small cell lung cancer randomized to ramucirumab and MK-3475 (pembrolizumab) versus standard of care (SoC). Secondary Objectives a. To compare response rates between the arms, including complete response (CR) and partial response (PR) (confirmed and unconfirmed). b. To compare the disease control rate (CR, PR, confirmed and unconfirmed and SD) c. To evaluate the duration of response (DoR) among responders within each arm. d. To evaluate the frequency and severity of toxicities within each arm. e. To compare IA-PFS between the arms. f. To evaluate the clinical outcomes (OS, IA-PFS, response) by randomization stratification factors (See Section 6.0) by comparing outcomes within the ramucirumab and MK-3475 (pembrolizumab) arm, performing a sub-group analysis of the arms, and by evaluating an interaction between the factors and treatment arm. Translational Medicine Objectives a. To evaluate if PD-L1 expression levels are associated with clinical outcomes (OS, IA-PFS, and response). b. To evaluate if tumor mutation burden (TMB) as determined by the FMI Foundation One panel is associated with clinical outcomes. c. To collect, process, and bank cell-free (cfDNA) at baseline and progression for future development of a proposal to evaluate comprehensive next-generation sequencing of circulating tumor DNA (ctDNA). Note: The proposal to use these specimens would be submitted as an amendment to CTEP for approval prior to commencing NGS assays. d. To establish a tissue/blood repository to pursue future studies.