NCT05642572|RecruitingPhase 2DMCFDA Drug

Comparing Combinations of Targeted Drugs for Advanced Non-Small Cell Lung Cancer That Has EGFR and MET Gene Changes (A Lung-MAP Treatment Trial)

A Randomized Phase II Study of INC280 (Capmatinib) Plus Osimertinib With or Without Ramucirumab in Participants With EGFR-Mutant, MET-Amplified Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Sub-Study)

SWOG Cancer Research Network ClinicalTrials.gov

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3 other identifiers

S1900GNCI-2022-09254U10CA180888

Study Type

interventional

Target

Locations

1 country

Sites

454

Timeline

RegisteredDec 2022

StartedMay 2023

CompletionMay 2027

Brief Summary

This phase II Lung-MAP treatment trial test the combination of targeted drugs (capmatinib, osimertinib, and/or ramucirumab) in treating patients with non-small cell lung cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and that has EGFR and MET gene changes. Capmatinib and osimertinib are in a class of medications called kinase inhibitors. They work by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop or slow the spread of cancer cells and may help shrink tumors. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Giving capmatinib, osimertinib, and/or ramucirumab and targeting abnormal gene changes in tumor cells may be effective in shrinking or stabilizing advanced non-small cell lung cancer.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_2

Timeline

13mo left

Started May 2023

Typical duration for phase_2

Geographic Reach

1 country

454 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.1 years study duration

Study Progress74%

May 2023May 2027

First Submitted

Initial submission to the registry

November 30, 2022

Completed

8 days until next milestone

First Posted

Study publicly available on registry

December 8, 2022

Completed

5 months until next milestone

Study Start

First participant enrolled

May 5, 2023

Completed

3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Expected

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Last Updated

May 6, 2026

Status Verified

December 1, 2025

Enrollment Period

3.1 years

First QC Date

November 30, 2022

Last Update Submit

May 4, 2026

Conditions

Stage IV Lung Cancer AJCC v8 Recurrent Lung Non-Small Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

Investigator-assessed progression-free survival
Will be estimated using the method of Kaplan-Meier. Medians and their associated 95% confidence intervals will be estimated using the Brookmeyer-Crowley method. Binary proportions and the associated confidence interval will be estimated.
From date of sub-study randomization to date of first documentation of progression assessed by local review or symptomatic deterioration, or death due to any cause, assessed up to 3 years

Secondary Outcomes (2)

Duration of response
From date of first documentation of response to date of first documentation of progression assessed by local review or symptomatic deterioration, or death due to any cause among participants who achieve a response, assessed up to 3 years
Dose limiting toxicity (DLT)
Up to 3 years

Study Arms (2)

Arm A (capmatinib, osimertinib, ramucirumab)

EXPERIMENTAL

Patients receive capmatinib PO, osimertinib PO, and ramucirumab IV on study. Patients also undergo CT scan or MRI and collection of blood samples throughout the trial.

Procedure: Biospecimen CollectionDrug: CapmatinibProcedure: Computed TomographyProcedure: Magnetic Resonance ImagingDrug: OsimertinibBiological: Ramucirumab

Arm B (capmatinib, osimertinib)

EXPERIMENTAL

Patients receive capmatinib PO and osimertinib PO on study. Patients also undergo CT scan or MRI and collection of blood samples throughout the trial.

Procedure: Biospecimen CollectionDrug: CapmatinibProcedure: Computed TomographyProcedure: Magnetic Resonance ImagingDrug: Osimertinib

Interventions

RamucirumabBIOLOGICAL

Given IV

Also known as: Anti-VEGFR-2 Fully Human Monoclonal Antibody IMC-1121B, Cyramza, IMC-1121B, LY3009806, Monoclonal Antibody HGS-ETR2

Arm A (capmatinib, osimertinib, ramucirumab)

Biospecimen CollectionPROCEDURE

Undergo collection of blood samples

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection