← Back to Search

Small Molecule Kinase Inhibitor

Randomized part: Capmatinib + Osimertinib for Non-Small Cell Lung Cancer (GEOMETRY-E Trial)

Phase 3
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up planned to be assessed up to 37 months
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial tested a combination of two drugs, capmatinib and osimertinib, for treating a specific type of advanced lung cancer in patients who did not respond to earlier treatments. The drugs aim to block proteins that help cancer grow. The study was stopped for business reasons, not because of safety issues. Osimertinib is approved for treating advanced non-small cell lung cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~planned to be assessed up to 37 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and planned to be assessed up to 37 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Randomized Part: Progression Free Survival (PFS) Based on BIRC Assessment
Run-in Part: Number of Participants With Dose Limiting Toxicities (DLTs)
Secondary study objectives
Randomized Part: Change From Baseline in the EORTC QLQ Lung Cancer Module (EORTC QLQ-LC13) Score
Randomized Part: Change From Baseline in the EuroQoL-5 Dimension-5 Level (EQ-5D-5L) Score
Randomized Part: Change From Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (EORTC QLQ-C30) Score
+30 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Run-in part: Capmatinib + OsimertinibExperimental Treatment2 Interventions
In the run-in part, up to two dose levels of capmatinib in combination with osimertinib were planned to be investigated. The initial dose level for the combination therapy was capmatinib 400 mg orally twice daily (b.i.d) and osimertinib 80 mg orally once per day (q.d). If a dose de-escalation was necessary, a lower dose level was defined as capmatinib 400 mg orally b.i.d and osimertinib 40 mg orally q.d.
Group II: Randomized part: Capmatinib + OsimertinibExperimental Treatment2 Interventions
In the randomized part, capmatinib in combination with osimertinib was to be administered at the recommended Phase III regimen (defined in the safety run-in part). The study was terminated early based on Sponsor's decision unrelated to safety concerns and the randomized part of the study was not initiated.
Group III: Randomized Part: Platinum + Pemetrexed Based Doublet ChemotherapyActive Control3 Interventions
In the randomized part, platinum-pemetrexed based doublet chemotherapy was to follow local guidelines as per standard of care and products labels. Participants randomized to platinum-pemetrexed based doublet chemotherapy arm were to be allowed to crossover to receive capmatinib in combination with osimertinib. The study was terminated early based on Sponsor's decision unrelated to safety concerns and the randomized part of the study was not initiated.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Osimertinib
2017
Completed Phase 4
~1100
Capmatinib
2021
Completed Phase 3
~570

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,896 Previous Clinical Trials
4,201,520 Total Patients Enrolled
~1 spots leftby Oct 2025