For patients with advanced non-squamous NSCLC

Study ID: EA5163

A randomized, phase III study of first-line immunotherapy alone or in combination with chemotherapy in induction/maintenance or post-progression in advanced NSCLC with immunobiomarker signature‐driven analysis.

This phase III clinical trial is studying the safety and efficacy of administering a combined use of FDA-approved medications to treat patients who have been diagnosed with stage 4 non-squamous, non-small cell lung cancer (NSCLC).

All study participants are administered intravenously the immunotherapy drugs Keytruda® (pembrolizumab) and Alimta® (pemetrexed), as well as the anti-cancer medication Paraplatin® (carboplatin). Patients are randomized into three groups; the dosages and timing of drug administration vary by group. Patients are followed for up to two years.

This study is for patients diagnosed with stage 4 NSCLC. The primary objective is to compare overall survival among patients in each of the two experimental arms (Arms A and B) to the control group (Arm C).

Arm A: Patients receive pembrolizumab IV over 30 minutes on day one. Cycles repeat every 21 days for up to two years. Within six weeks of disease progression, patients receive pemetrexed IV over 10 minutes and carboplatin IV over 30 minutes on day one. Treatment repeats every 21 days for up to four cycles. Trial participants then may receive pemetrexed IV over 10 minutes on day one. Cycles repeat every 21 days.

Arm B: Patients receive pembrolizumab IV over 30 minutes on day one. Cycles repeat every 21 days for up to two years. Within six weeks of disease progression, patients receive pembrolizumab IV over 30 minutes, pemetrexed IV over 10 minutes, and carboplatin IV over 30 minutes on day one. Treatment repeats every 21 days for up to four cycles. Patients then receive pembrolizumab IV over 30 minutes and pemetrexed IV over 10 minutes on day one. Cycles repeat every 21 days for up to two years for pembrolizumab.

Arm C (Comparator Arm): Patients receive pembrolizumab IV over 30 minutes, pemetrexed IV over 10 minutes, and carboplatin IV over 30 minutes on day one. Treatment repeats every 21 days for up to four cycles. Patients then receive pembrolizumab IV over 30 minutes and pemetrexed IV over 10 minutes on day one. Cycles repeat every 21 days for up to two years for pembrolizumab.

Inclusion Snapshot

  • Must have been diagnosed with advanced (stage 4) NSCLC
  • Must have PD-L1 expression Tumor Proportion Score (TPS) >= 1% in tumor cells
  • No prior systemic chemotherapy or immunotherapy for advanced metastatic NSCLC
  • Other inclusion and exclusion criteria apply

Contact Information

Lankenau Institute for Medical Research trial