CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 367 enrolled
Drug / intervention
osimertinib +2 moredrug
Likely dose
Osimertinib 80 mg orally once daily combined with savolitinib 300–600 mg orally once or twice dailyAI-extracted
Key inclusion· 6
  • ✓Age ≥18 years (≥20 in Japan).
  • ✓Histologically or cytologically confirmed locally advanced or metastatic NSCLC with EGFR mutation (exon 19 deletion and/or L858R) associated with EGFR TKI sensitivity.
  • ✓Documented radiologic disease progression on first-line osimertinib.
  • ✓MET amplification and/or overexpression confirmed by central FISH (≥10+) and/or central IHC (≥90+) on tumor sample collected after osimertinib progression.
Key exclusion· 17
  • ✕Unresolved toxicities from prior therapy greater than CTCAE Grade 1, except alopecia and Grade 2 platinum-related neuropathy.
  • ✕Active gastrointestinal disease or condition significantly impairing oral drug absorption.
  • ✕Cardiac disease within last 6 months: unstable angina, congestive heart failure (NYHA ≥Grade 2), acute MI, stroke/TIA, or uncontrolled hypertension (≥150/95 mmHg).
  • ✕QTcF prolongation (>470 msec women, >450 msec men) or factors increasing QT prolongation risk.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03778229
NCT03778229Phase 2Active
CompareCT.gov

A Phase II Study Assessing the Efficacy of Osimertinib in Combination With Savolitinib in Patients With EGFRm+ and MET+, Locally Advanced or Metastatic Non Small Cell Lung Cancer Who Have Progressed Following Treatment With Osimertinib.

AstraZeneca·interventional·Posted Dec 19, 2018·Updated Apr 23, 2026

In Brief

A Phase 2 clinical trial evaluating osimertinib, savolitinib, and 1 other intervention for Carcinoma. Active but no longer recruiting, targeting 367 participants across 90 sites in 13 countries.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma
CountriesBrazil, Canada, Chile, Denmark, France, India, Italy, Japan, South Korea, Spain, Taiwan, United States, Vietnam
CollaboratorsHutchison Medipharma Limited

Timeline

Phase 2Active
201920202021202220232024202520262027
First PostedDec 19, 2018
Enrollment StartJan 9, 2019
Primary CompletionAug 23, 2024
Study CompletionDec 31, 2026
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 7.5 years ago

Interventions

osimertinibdrug

osimertinib (80 mg oral OD).

savolitinibdrug

savolitinib (300 mg oral OD or 300 mg oral BID or 600 mg oral OD)

placebodrug

placebo to osimertinib (oral OD)