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

Sponsor
Guangdong Association of Clinical Trials
Study ID
NCT05163249
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Osimertinib — DRUG
    osimertinib, 80mg, daily, P.O. Until objective disease progression, unacceptable toxicity occurs, consent is withdrawn or another discontinuation criteria is met
  • Savolitinib — DRUG
    savolitinib 300mg BID, P.O. Until objective disease progression, unacceptable toxicity occurs, consent is withdrawn or another discontinuation criteria is met

Study Details

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.

Key Dates

Start date
May 31, 2022
Status verified
Feb 2024
Primary completion
Apr 30, 2024
Completion
Aug 31, 2026

Study Design

Enrollment
44 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Cohort 1: osimertinib, 80mg, daily, P.O.
    Patients will continue to receive study medication in 28 day cycles until objective disease progression, unacceptable toxicity occurs, consent is withdrawn or another discontinuation criterion is met. Patients who progress on first-line treatment of osimertinib monotherapy will have the opportunity to receive second-line treatment of osimertinib plus savolitinib after confirmation of MET status at disease progression.
  • Experimental: Cohort 2: osimertinib 80mg daily, P.O. and savolitinib 300mg BID, P.O.
    All eligible patients will be randomized to receive treatment with osimertinib (80 mg daily) or osimertinib (80 mg daily) in combination with savolitinib (300 mg BID) in this study. Treatment will continue until either objective disease progression, unacceptable toxicity occurs, consent is withdrawn or another discontinuation criterion is met. Patients in Cohort 2 can continue on savolitinib monotherapy (if osimertinib was stopped earlier) or osimertinib monotherapy (if savolitinib was stopped earlier) until objective disease progression or meet any of the discontinuation criteria.

Primary Outcome Measure

ORR [ Time Frame: 12 weeks after the last patient enrolled ]

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