Savolitinib plus osimertinib versus platinum-based doublet chemotherapy in participants with Non-Small Cell Lung Cancer who have progressed on Osimertinib treatment - SAFFRON

Study identifier:D5087C00001

ClinicalTrials.gov identifier:NCT05261399

EudraCT identifier:2021-006374-24

CTIS identifier:N/A

Recruiting

Official Title

A Phase III, Randomised, Open-Label Study of Savolitinib in Combination With Osimertinib Versus Platinum-Based Doublet Chemotherapy in Participants With EGFR Mutated, MET-Overexpressed and/or Amplified, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Progressed on Treatment With Osimertinib (SAFFRON).

Medical condition

Carcinoma

Phase

Phase 3

Healthy volunteers

No

Study drug

Savolitinib, Osimertinib, Pemetrexed, Cisplatin, Carboplatin

Sex

All

Estimated Enrollment

324

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 03 Aug 2022
Estimated Primary Completion Date: 26 Jun 2025
Estimated Study Completion Date: 17 Dec 2026

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Oct 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria