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NCT06031688 · ClinicalTrials.gov registry record · Phase 2
Targeted Treatment for Advanced Non-Small Cell Lung Cancer That Has a MET Exon 14 Skipping Gene Change (An Expanded Lung-MAP Treatment Trial)
A Phase 2 study of Stage IV Lung Cancer AJCC v8 and Recurrent Lung Non-Small Cell Carcinoma, sponsored by SWOG Cancer Research Network.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 56
- Enrollment target
- 20
- Study locations
NCT06031688: Recruiting Phase 2 study of Stage IV Lung Cancer AJCC v8 and Recurrent Lung Non-Small Cell Carcinoma, sponsored by SWOG Cancer Research Network.
NCT06031688 is a Phase 2 study of Stage IV Lung Cancer AJCC v8 and Recurrent Lung Non-Small Cell Carcinoma that is actively recruiting participants, run by SWOG Cancer Research Network. The registered enrollment target is 56 participants, below the 98-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (43% lower). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06031688, a Phase 2 study of Stage IV Lung Cancer AJCC v8 and Recurrent Lung Non-Small Cell Carcinoma, is actively recruiting participants, sponsored by SWOG Cancer Research Network.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 56 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II Expanded Lung-MAP treatment trial tests tepotinib with or without ramucirumab for the treatment of patients with advanced non-small cell lung cancer that has spread from where it first started (primary site) to other places in the body (stage IV) or that has come back after a period of improvement (recurrent). Tepotinib is used in patients whose cancer has a mutated (changed) form of a gene called MET. It is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal MET protein that signals tumor cells to multiply. This helps slow or stop the spread of tumor cells. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Giving tepotinib with ramucirumab may lower the chance of the cancer from growing or spreading in patients with stage IV or recurrent non-small cell lung cancer.
Primary Outcome
Rates will be compared using a chi-squared test at the 1-sided 10% level and also presented as the difference in response rates with the associated 80% confidence interval for the difference, Further, response rates and associated 80% confidence interval will be estimated for each arm.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- BIOLOGICAL Ramucirumab
- PROCEDURE Lymphoscintigraphy
Study Locations (20)
California
- Kaiser Permanente-Anaheim - Anaheim
- Sutter Auburn Faith Hospital - Auburn
- Kaiser Permanente-Baldwin Park - Baldwin Park
- Kaiser Permanente-Bellflower - Bellflower
- Alta Bates Summit Medical Center-Herrick Campus - Berkeley
- Tower Cancer Research Foundation - Beverly Hills
- Kaiser Permanente-Fontana - Fontana
- Palo Alto Medical Foundation-Fremont - Fremont
- Kaiser Permanente South Bay - Harbor City
- Kaiser Permanente-Irvine - Irvine
- UC San Diego Moores Cancer Center - La Jolla
- Kaiser Permanente Los Angeles Medical Center - Los Angeles
- Kaiser Permanente West Los Angeles - Los Angeles
- Cedars Sinai Medical Center - Los Angeles
Alabama
- Gulf Health Hospitals Inc/Infirmary Cancer Care - Malbis - Daphne
- Thomas Hospital - Fairhope
- Mobile Infirmary Medical Center - Mobile
- Gulf Health Hospitals Inc/Infirmary Cancer Care - Saraland - Saraland
Arkansas
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro - Jonesboro
- University of Arkansas for Medical Sciences - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2024-08-08 |
| Est. Completion | 2028-05-31 |
| Phase | Phase 2 |
What NCT06031688 shows while recruiting
NCT06031688 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 98-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (43% lower).
The record links to 2 conditions, with Stage IV Lung Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06031688 names 20 study sites across 3 states, led by California, Alabama, Arkansas.
Frequently Asked Questions
What is clinical trial NCT06031688 about?
NCT06031688 is a clinical study titled "Targeted Treatment for Advanced Non-Small Cell Lung Cancer That Has a MET Exon 14 Skipping Gene Change (An Expanded Lung-MAP Treatment Trial)". This phase II Expanded Lung-MAP treatment trial tests tepotinib with or without ramucirumab for the treatment of patients with advanced non-small cell lung cancer that has spread from where it first started (primary site) to other places in the body (stage IV) or that has come back after a period of...
What is the current status of trial NCT06031688?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 56 participants. The study started on 2024-08-08. Estimated completion is 2028-05-31.
What conditions does trial NCT06031688 study?
This clinical trial studies the following conditions: Stage IV Lung Cancer AJCC v8, Recurrent Lung Non-Small Cell Carcinoma.
What interventions are being tested in trial NCT06031688?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Ramucirumab (BIOLOGICAL), Lymphoscintigraphy (PROCEDURE).
Who is sponsoring clinical trial NCT06031688?
This trial is sponsored by SWOG Cancer Research Network, which has 270 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06031688 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06031688's enrollment target sits among peer trials
56 31st of 81 higher than 49 of 81 other Stage IV Lung Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage IV Lung Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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