A Study Comparing Savolitinib Plus Osimertinib vs Savolitinib Plus Placebo in Patients With EGFRm+ and MET Amplified Advanced NSCLC

Part of paid clinical trials in Duarte, California.

Sponsor
AstraZeneca
Study ID
NCT04606771
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

Study Details

This study will compare the activity of the combination of savolitinib and osimertinib against the combination of savolitinib with placebo to osimertinib in patients with Epidermal Growth Factor Receptor Mutation Positive and MET amplified, locally advanced or metastatic non-small cell lung cancer who have progressed following treatment with osimertinib.

Key Dates

First listed
Oct 28, 2020
Start date
Sep 28, 2020
Status verified
Jul 2026
Primary completion
Dec 21, 2022
Completion
Mar 15, 2027

Study Design

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

Arms

  • Experimental: Arm A
    Savolitinib 300 mg oral QD Osimertinib 80 mg oral QD
  • Experimental: Arm B
    Savolitinib 300 mg oral QD Placebo to Osimertinib 80mg oral QD

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Tumour assessments every 6 weeks from randomisation up to 24 weeks, then every 8 weeks until objective disease progression (maximum of approximately 25 months) ]

Locations (2)

FacilityCityStateZIPSite coordinators
Research SiteDuarteCalifornia91010-
Research SiteSacramentoCalifornia95817-

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