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Randomized, Placebo-controlled Study to Evaluate Safety and Efficacy of Pemetrexed Platinum Chemotherapy Pembrolizumab with or without Lenvatinib as First-line Intervention in Participants with Metastatic Nonsquamous Non-small Cell Lung Cancer

Study Type/Phase: Phase III
Status: Not Recruiting

The purpose of this trial is to evaluate the safety and effectiveness of lenvatinib in metastatic non-squamous non-small cell cancer (NSCLC) that has not yet been treated. Lenvatinib is a type of targeted therapy known as a receptor tyrosine kinase inhibitor (RTKI) that may slow the rate at which cancer cells grow and may help cut off the blood supply that feeds the cancer. This trial will see how well lenvatinib works when combined with standard of care chemotherapy and pembrolizumab, compared to these treatments alone, for this type of NSCLC. In this trial, patients will be randomized to receive lenvatinib or a placebo in addition to their regular treatment regimen for lung cancer.

Speak with your doctor to determine whether you meet the criteria for participation in this study, some of the following criteria are included:

Inclusion Criteria Exclusion Criteria
  • Diagnosed with Stage IV nonsquamous NSCLC
  • Does not have an EGFR mutation, or an ALK or ROS1 gene rearrangement
  • Has enough tissue leftover from a previous biopsy, or willing to undergo additional biopsy
  • ≥18 years of age
  • Adequate organ function, as determined by standard of care laboratory testing
  • Agrees to follow contraceptive guidance per study protocol
  • Has adequately controlled blood pressure with or without medications
  • Has cancer that has spread to the brain that has not been treated
  • Has pneumonitis, or a history of non-infectious pneumonitis that required treatment with steroids
  • Has received prior treatment for NSCLC 
  • Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent
  • Has received prior treatment with lenvatinib or any other RTKI
  • Had an additional invasive cancer requiring treatment in the last 5 years
  • Has a diagnosis of immunodeficiency; active autoimmune disease; history of active tuberculosis; or active infection requiring systemic therapy
  • Has significant cardiac disease; history of HIV infection or hepatitis B; or active hepatitis C

Principal Investigator

Shiva Singhal, MD

Sponsor

Merck Sharp & Dohme Corp. (a subsidiary of Merck & Co., Inc.) in collaboration with Eisai 

NCT Number

NCT03829319

Contact

Kathy Miller, Clinical Research Coordinator
Taft Center for Clinical Research
650-962-4562
Kathryn_Miller@elcaminohealth.org

For more information about this clinical trial, including trial status, eligibility and full trial listing, visit www.clinicaltrials.gov.

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