Osimertinib Plus Savolitinib in EGFRm+/MET+ NSCLC Following Prior Osimertinib

Part of paid clinical trials in La Jolla, California.

Sponsor
AstraZeneca
Study ID
NCT03778229
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Carcinoma

Eligibility Criteria

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

Interventions

  • osimertinib — DRUG
    osimertinib (80 mg oral OD).
  • savolitinib — DRUG
    savolitinib (300 mg oral OD or 300 mg oral BID or 600 mg oral OD)
  • placebo — DRUG
    placebo to osimertinib (oral OD)

Study Details

This study (the SAVANNAH study) will investigate the efficacy of osimertinib in combination with savolitinib in patients with EGFRm+ and MET+, locally advanced or metastatic NSCLC who have progressed following treatment with osimertinib

Key Dates

Start date
Jan 9, 2019
Status verified
Apr 2026
Primary completion
Aug 23, 2024
Completion
Dec 31, 2026

Study Design

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

Arms

  • Experimental: osimertinib + savolitinib
    osimertinib + savolitinib
  • Placebo Comparator: placebo + savolitinib
    placebo + savolitinib

Primary Outcome Measure

Objective Response Rate (ORR) by Investigator Assessment; Target Population Analysis Set [ Time Frame: Time from randomization/first dose of study treatment to progression or last evaluable assessment in the absence of progressionuntil the end of the study, or an approximate maximum of 5.6 years. ]

Locations (11)

FacilityCityStateZIP
Research SiteLa JollaCalifornia92093
Research SiteLos AngelesCalifornia90024
Research SiteSacramentoCalifornia95817
Research SiteWashington D.C.District of Columbia20016
Research SiteBaltimoreMaryland21201
Research SiteBostonMassachusetts02215
Research SiteRochesterMinnesota55905
Research SiteBrooklynNew York11220
Research SitePhiladelphiaPennsylvania19111
Research SitePittsburghPennsylvania15232
Research SiteSeattleWashington98109

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