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Kinase Inhibitor

Targeted Drug Therapy for Non-Small Cell Lung Cancer

Phase 2
Recruiting
Led By Sarah B Goldberg
Research Sponsored by SWOG Cancer Research Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must have either measurable disease or non-measurable disease documented by CT or MRI. The CT from a combined PET/CT may be used to document only non-measurable disease unless it is of diagnostic quality. Measurable disease must be assessed within 28 days prior to sub-study randomization. Non-measurable disease must be assessed within 42 days prior to sub-study randomization. All known sites of disease must be assessed and documented on the Baseline Tumor Assessment Form. Participants whose only measurable disease is within a previous radiation therapy port must demonstrate clearly progressive disease (in the opinion of the treating investigator) prior to sub-study randomization to be considered measurable
Participants must have recovered (=< grade 1) from any side effects of prior therapy, except for alopecia and vitiligo
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial tests targeted drugs to treat advanced non-small cell lung cancer with gene changes, to help stop or slow the spread of cancer cells and shrink tumors.

Who is the study for?
This trial is for adults with advanced non-small cell lung cancer that has spread and contains specific gene changes (EGFR and MET). Participants must have progressed on osimertinib treatment, be able to swallow pills, have adequate organ function, not be pregnant or breastfeeding, agree to use contraception if of reproductive potential, and not have certain medical conditions or treatments that could interfere with the study.Check my eligibility
What is being tested?
The trial tests a combination of targeted drugs: capmatinib (a kinase inhibitor), osimertinib (another kinase inhibitor), and ramucirumab (a monoclonal antibody). These drugs aim to block proteins signaling cancer cells to multiply and prevent tumor growth by stopping new blood vessels from forming. The effectiveness in shrinking or stabilizing lung cancer will be studied.See study design
What are the potential side effects?
Potential side effects include high blood pressure due to ramucirumab; diarrhea, rash, dry skin from osimertinib; fatigue; liver enzyme changes; possible heart rhythm problems. Side effects vary based on individual responses to the medication.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer can be seen or measured on a scan taken recently.
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I have recovered from previous treatment side effects, except for hair loss or skin color loss.
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My blood tests for pancreas enzymes are normal and I show no signs of pancreas problems.
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I have HIV, am on effective treatment, and my viral load has been undetectable for the last 6 months.
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My heart is healthy enough for the trial, meeting the NYHA class 2B or better.
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My liver function tests are within the required range.
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I can swallow pills without any difficulty.
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My lung cancer has a specific mutation and has worsened despite treatment with osimertinib.
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My recent urine test shows normal or slightly elevated protein levels.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Investigator-assessed progression-free survival
Secondary outcome measures
Dose limiting toxicity (DLT)
Duration of response

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm B (capmatinib, osimertinib)Experimental Treatment5 Interventions
Patients receive capmatinib PO and osimertinib PO on study. Patients also undergo CT scan or MRI and collection of blood samples throughout the trial.
Group II: Arm A (capmatinib, osimertinib, ramucirumab)Experimental Treatment6 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Osimertinib
2017
Completed Phase 4
~1010
Ramucirumab
2017
Completed Phase 3
~5050
Biospecimen Collection
2004
Completed Phase 2
~1730
Capmatinib
2021
Completed Phase 3
~570
Computed Tomography
2017
Completed Phase 2
~2720

Find a Location

Who is running the clinical trial?

SWOG Cancer Research NetworkLead Sponsor
394 Previous Clinical Trials
265,104 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,421 Total Patients Enrolled
Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
261,745 Total Patients Enrolled

Media Library

Capmatinib (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05642572 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: Arm A (capmatinib, osimertinib, ramucirumab), Arm B (capmatinib, osimertinib)
Non-Small Cell Lung Cancer Clinical Trial 2023: Capmatinib Highlights & Side Effects. Trial Name: NCT05642572 — Phase 2
Capmatinib (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05642572 — Phase 2
Non-Small Cell Lung Cancer Patient Testimony for trial: Trial Name: NCT05642572 — Phase 2

Frequently Asked Questions

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

Has the Arm A (capmatinib, osimertinib, ramucirumab) regimen been given regulatory clearance by the FDA?

"This experimental treatment, Arm A (capmatinib, osimertinib, ramucirumab) is currently in Phase 2 clinical trials. As such, the safety of this protocol has been assessed as a score of 2 due to limited efficacy data existing for it."

Answered by AI

What is the total participant count of this clinical exploration?

"Affirmative. Based on information found via clinicaltrials.gov, the study was first listed in May of 2023 and is looking for 66 participants across 33 sites. The trial has been recently updated as well."

Answered by AI

Is there still an opportunity to enroll in this medical study?

"According to clinicaltrials.gov, this research is actively enrolling participants following its posting on May 1st 2023 and latest edit on the same day."

Answered by AI

Are there many sites within this state that are participating in the trial?

"33 medical facilities are overseeing this trial, with Palo Alto Medical Foundation Health Care in Palo Alto, Palo Alto Medical Foundation-Sunnyvale in Sunnyvale, and Northeast Georgia Medical Center-Gainesville in Gainesville among those included."

Answered by AI

Who else is applying?

What state do they live in?
Michigan
What site did they apply to?
ProMedica Flower Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

looking for trial treatment to slow non cell lung cancer.
PatientReceived 1 prior treatment
~44 spots leftby May 2026