EA5163 / INSIGNA — Optimal timing and sequencing of pembrolizumab and chemotherapy in first-line non-squamous NSCLC

Phase 3 · Non-Small Cell Lung Cancer

Population

Untreated metastatic non-squamous NSCLC with PD-L1 ≥1% and no actionable genomic alterations.

Primary Endpoint

Overall survival and progression-free survival

Rationale

It is unclear whether PD-L1-positive lung cancer should begin with pembrolizumab alone — saving chemotherapy for progression — or with upfront chemo-immunotherapy. INSIGNA compares these sequencing strategies head-to-head.

What It Could Change

Could define the optimal sequence of immunotherapy and chemotherapy in PD-L1-positive NSCLC and spare some patients early chemotherapy.