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Small Molecule Kinase Inhibitor

Study Evaluating Efficacy and Safety of Capmatinib in Combination With Osimertinib in Adult Subjects With Non-small Cell Lung Cancers as Second Line Therapy (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.

Eligible Conditions

Cancer
Non-Small Cell Lung Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ planned to be assessed up to 37 months

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

~1120

Capmatinib

2021

Completed Phase 3

~570