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Savolitinib Plus Osimertinib Versus Platinum-based Doublet Chemotherapy in Participants With Non-Small Cell Lung Cancer Who Have Progressed on Osimertinib Treatment

NCT05261399 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 345

Last updated 2026-04-06

No results posted yet for this study

Summary

Clinical study to investigate the efficacy and safety 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 NSCLC who have progressed on treatment with Osimertinib.

Conditions

  • Carcinoma
  • Non-Small-Cell Lung

Interventions

DRUG

Savolitinib

300 mg savolitinib (3 × 100 mg tablets twice daily) Administrative route : oral

DRUG

Osimertinib

80 mg osimertinib (1 × 80 mg tablet once daily) Administrative route : oral

DRUG

Pemetrexed

Pemetrexed (500 mg/m2) Administrative route : IV infusion

DRUG

Cisplatin

Cisplatin (75 mg/m2) Administrative route : IV infusion

DRUG

Carboplatin

Carboplatin (AUC5) Administrative route : IV infusion

Sponsors & Collaborators

Principal Investigators

  • Shun Lu, Prof,MD,PhD, · Shanghai Chest Hospital, Shanghai JiaoTong University, #241 Huai Hai Road (west), Shanghai, China.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-03
Primary Completion
2026-06-18
Completion
2026-11-23
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • China
  • France
  • Germany
  • Greece
  • Hong Kong
  • Israel
  • Italy
  • Japan
  • Malaysia
  • Philippines
  • Poland
  • Singapore
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • United Kingdom
  • Vietnam

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05261399 on ClinicalTrials.gov