Trial Profile

EA5163/S1709 INSIGNA : A Randomized, Phase III Study of Firstline Immunotherapy Alone or in Combination With Chemotherapy in Induction/Maintenance or Postprogression in Advanced Nonsquamous Non-Small Cell Lung Cancer (NSCLC) With Immunobiomarker SIGNature-Driven Analysis

Status: Active, no longer recruiting

Phase of Trial: Phase III

Latest Information Update: 25 May 2025

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At a glance

Drugs Carboplatin (Primary) ; Pembrolizumab (Primary) ; Pemetrexed (Primary)
Indications Carcinoma; Non-small cell lung cancer
Focus Biomarker; Therapeutic Use
Acronyms EA5163/S1709 INSIGNA

02 Mar 2024 Status changed from recruiting to active, no longer recruiting.
24 Oct 2023 Initial results (n=29) of evaluating QVT in assessing IO related treatment changes in EA5163, specifically associating changes in QVT with changes in tumor volume between baseline (B) and 6 week post-treatment scans presented at the 48th European Society for Medical Oncology Congress
29 Aug 2023 Planned number of patients changed from 846 to 600.

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