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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

GEOMETRY-E Trial Summary

This trial is testing a new combination therapy of drugs to treat lung cancer that has progressed after other treatments. The new therapy will be compared to the standard of care to see if it is more effective.

GEOMETRY-E Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Randomized Part: Progression Free Survival (PFS) Based on BIRC Assessment

Run-in Part: Number of Participants With Dose Limiting Toxicities (DLTs)

Secondary outcome measures

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

GEOMETRY-E 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

~1010

Capmatinib

2021

Completed Phase 3

~570

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,855 Previous Clinical Trials

4,197,347 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people have been chosen to take part in this clinical trial?

"At the moment, this clinical trial is not seeking new patients. The trial was originally posted on September 22nd, 2021 and was edited on October 28th, 2022. However, there are presently 1390 trials actively searching for patients with carcinoma, non-small-cell lung and 1320 studies for capmatinib that are recruiting participants."

Answered by AI

Does treatment with capmatinib have any lasting side effects?

"Capmatinib's safety is well-supported by both efficacy data from Phase 3 clinical trials and additional rounds of safety testing."

Answered by AI

For what reasons is capmatinib commonly prescribed?

"Capmatinib is frequently used to treat lymphoma and non-hodgkin, but can also help with advanced sarcoma and neoplasm metastasis."

Answered by AI

Is this trial mostly being conducted in urban or rural areas?

"So far, this study has taken place in Baylor Health Care System/Sammons Cancer Center Baylor Texas Oncology in Dallas, Texas, Tacoma General Hospital in Tacoma, Washington, and UCLA Santa Monica Hematology / Oncology in Santa Monica, California. There are plans to expand to 6 additional locations."

Answered by AI

Are there any other relevant clinical trials that have used capmatinib?

"As of right now, 1320 research trials are being conducted on capmatinib. 415 of those trials are in their third stage of testing. Most of the trials for this medication are taking place in Shanghai, but there are 71021 total locations running these studies."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "Study Evaluating Efficacy and Safety of Capmatinib in Combination With Osimertinib in Adult Subjects With Non-small Cell Lung Cancers as Second Line Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04816214.