A Prospective Randomized Study of Ramucirumab plus Pembrolizumab versus Standard of Care for Participants Previously Treated with Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer.
Primary Objective:
To compare overall survival (OS) in participants previously treated with platinum-based chemotherapy and immunotherapy for Stage IV or recurrent non-small cell lung cancer (NSCLC) randomized to pembrolizumab and ramucirumab versus standard of care.
Secondary Objective:
To summarize reports of serious and unexpected high-grade (≥ Grade 3) treatment-related adverse events determined by the treating physician within each treatment arm.
Ramucirumab
- Rutgers Cancer Institute of New Jersey
- Principal Investigator
- Missak Haigentz MD
- Principal Investigator
- RWJBarnabas Health
- Community Medical Center
- Cooperman Barnabas, Livingston
- Jersey City Medical Center, Jersey City
- Monmouth Medical Center
- Monmouth Medical Center Southern Campus
- Monmouth Medical Center Vantage Point Center
- Newark Beth Israel Medical Center
- Robert Wood Johnson University Hospital, Hamilton
- Robert Wood Johnson University Hospital, Somerset
- Trinitas Hospital and Comprehensive Cancer Center
Inclusion Criteria
- Participants must have histologically or cytologically confirmed non-small cell lung
cancer (NSCLC) which is stage IV or recurrent
- Participants must have received at least one line of anti-PD-1 or anti-PD-L1 therapy
for any stage of NSCLC. Anti-PD-1 or anti-PD-L1 may have been given alone or in
combination with other therapy
- Participants must have experienced disease progression (in the opinion of the treating
physician) more than (>) 84 days following initiation (cycle 1 day 1) of their most
recent anti-PD-1 or PD-L1 therapy
- Participants who received anti-PD-1 or anti-PD-L1 therapy for stage IV or recurrent
disease, must have had a best response on anti-PD-1 or anti-PD-L1 therapy of stable,
partial response or complete response (in the opinion of the treating physician)
- Participants who received neoadjuvant, adjuvant, and/or consolidation anti-PD-1 or
anti-PD-L1 therapy as their only line of anti-PD-1 or anti-PD-L1 therapy must have
experienced disease progression within (=<) 365 days from initiation (cycle 1 day 1)
of anti-PD-1 or PD-L1 therapy
- Participants must have received platinum-based chemotherapy and experienced disease
progression (in the opinion of the treating physician) during or after this regimen
- Participants with a known sensitizing mutation for which an Food and Drug
Administration (FDA)-approved targeted therapy for NSCLC exists (e.g., EGFR, ALK,
ROS1, BRAF, RET, NTRK, KRAS, HER2 and MET sensitizing mutations), must have previously
received at least one of the approved therapy(s). Prior targeted therapy for
participants with targetable alterations is allowed if all other eligibility criteria
are also met
- Participants must be >= 18 years old
- Participants must be able to safely receive the investigational drug combination and
the investigator's choice of standard of care regimens per the current FDA approved
package insert(s), treating investigator's discretion, and institutional guidelines
- Participants must have Zubrod performance status of 0-2
Exclusion Criteria
- Participants must not have received more than one line of anti-PD-1 or anti-PD-L1 for
stage IV or recurrent disease
- Participants must not be receiving or planning to receive another investigational
therapy during study participation
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
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