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Osimertinib With or Without Savolitinib as 1L in de Novo MET+, EGFR+ NSCLC

NCT05163249 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2024-02-09

No results posted yet for this study

Summary

This is a prospective, pilot, two-arm, randomized, multicenter study exploring the efficacy and safety of osimertinib with or without savolitinib as first-line therapy in patients with de novo MET positive, EGFR-mutant advanced NSCLC.

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

DRUG

Osimertinib

osimertinib, 80mg, daily, P.O. Until objective disease progression, unacceptable toxicity occurs, consent is withdrawn or another discontinuation criteria is met

DRUG

Savolitinib

savolitinib 300mg BID, P.O. Until objective disease progression, unacceptable toxicity occurs, consent is withdrawn or another discontinuation criteria is met

Sponsors & Collaborators

  • Guangdong Association of Clinical Trials

    lead OTHER

Principal Investigators

  • Jin-Ji Yang, MD · Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-31
Primary Completion
2024-04-30
Completion
2026-08-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT05163249 on ClinicalTrials.gov