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

Part of paid clinical trials in Orlando, Florida.

Sponsor
AstraZeneca
Study ID
NCT05261399
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Carcinoma
  • Non-Small-Cell Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • Savolitinib — DRUG
    300 mg savolitinib (3 × 100 mg tablets twice daily) Administrative route : oral
  • Osimertinib — DRUG
    80 mg osimertinib (1 × 80 mg tablet once daily) Administrative route : oral
  • Pemetrexed — DRUG
    Pemetrexed (500 mg/m2) Administrative route : IV infusion
  • Cisplatin — DRUG
    Cisplatin (75 mg/m2) Administrative route : IV infusion
  • Carboplatin — DRUG
    Carboplatin (AUC5) Administrative route : IV infusion

Study Details

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.

Key Dates

Start date
Aug 3, 2022
Status verified
Mar 2026
Primary completion
Jun 18, 2026
Completion
Nov 23, 2026

Study Design

Enrollment
345 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Chemotherapy
    Pemetrexed (500 mg/m2) with either cisplatin (75 mg/m2) or carboplatin (AUC5) on Day 1 of 21-day cycles (Q3W) for 4 cycles, followed by pemetrexed maintenance (500 mg/m2) Q3W
  • Experimental: Savolitinib + Osimertinib
    300 mg savolitinib BID plus 80 mg osimertinib QD

Primary Outcome Measure

Progression-free survival (PFS) / savolitinib + osimertinib versus platinum doublet chemotherapy in participants with EGFR mutated, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC who have progressed on osimertinib. [ Time Frame: Approximately 36.5 months post first subject randomized ]

Locations (5)

FacilityCityStateZIPSite coordinators
Research SiteOrlandoFlorida32804-
Research SiteHonoluluHawaii96819-
Research SiteNew BrunswickNew Jersey08903-
Research SiteNew YorkNew York10032-
Research SiteNashvilleTennessee37232-

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