Testing the Timing of Pembrolizumab Alone or With Chemotherapy as First Line Treatment and Maintenance in Non-small Cell Lung Cancer

June 01, 2021
INSIGNA (EA5163)
Lung Cancer
Maria Quejada, MD
Edward Cancer Center - Naperville
Edward Cancer Center - Plainfield
Nancy Knowles Cancer Center - Elmhurst

This phase III trial studies whether pembrolizumab alone as a first-line treatment, followed by pemetrexed and carboplatin with or without pembrolizumab after disease progression is superior to induction with pembrolizumab, pemetrexed and carboplatin followed by pembrolizumab and pemetrexed maintenance in treating patients with stage IV non-squamous non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as pemetrexed and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving first-line pembrolizumab followed by pemetrexed and carboplatin with or without pembrolizumab works better in treating patients with non-squamous non-small cell cancer.

Sponsor: ECOG-ACRIN

https://clinicaltrials.gov/ct2/show/NCT03793179

  • Stage IV non-squamous non-small cell lung cancer (NSCLC). Patients with Stage IIIB and IIIC disease are eligible if they are not candidates for combined chemotherapy and radiation
  • Must NOT have received prior chemo or immunotherapy for advanced metastatic NSCLC or any prior checkpoint inhibitors for metastatic lung cancer
  • Must not have known pre-existing and clinically active interstitial lung disease, or a known history of (non infectious) pneumonitis that required steroids, or current pneumonitis
  • Must not have significant gastrointestinal disorders with diarrhea as a major symptom (e.g. Crohn's disease, malabsorption, etc.)
  • Must not have history of auto-immune condition requiring ongoing or intermittent systemic treatment in the past 2 years 
 
Up to 5 years
Accepting Participants
Interventional
III
Sofia Mikac, BSN
630-646-6073
630-646-6074
630-646-6072