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NCT03600701 · ClinicalTrials.gov registry record · Phase 2
Atezolizumab and Cobimetinib in Treating Patients With Metastatic, Recurrent, or Refractory Non-small Cell Lung Cancer
A Phase 2 study of Stage IV Lung Cancer AJCC v8 and Metastatic Lung Non-Small Cell Carcinoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 51
- Enrollment target
- 18
- Study locations
NCT03600701: Active Phase 2 study of Stage IV Lung Cancer AJCC v8 and Metastatic Lung Non-Small Cell Carcinoma, sponsored by National Cancer Institute (NCI).
NCT03600701 is a Phase 2 study of Stage IV Lung Cancer AJCC v8 and Metastatic Lung Non-Small Cell Carcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 51 participants, below the 98-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (48% lower). The trial reports 18 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03600701, a Phase 2 study of Stage IV Lung Cancer AJCC v8 and Metastatic Lung Non-Small Cell Carcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 51 participants
- Enrollment target
- 18
- Study locations
Study Summary
This phase II trial studies how well atezolizumab and cobimetinib work in treating patients with non-small cell lung cancer that has spread from where it first started (primary site) to other places in the body (metastatic), has come back (recurrent), or does not respond to treatment (refractory). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cobimetinib is used in patients whose cancer has a mutated (changed) form of a gene called BRAF. It is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells. Giving atezolizumab and cobimetinib may work better in treating patients with non-small cell lung cancer.
Primary Outcome
Response is defined as having a complete response (CR) (disappearance of all lesions) or partial response (PR) (\>= 30% decrease in the sum of target lesions) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria. A durable response is defined as having a CR or PR response which lasts for at least 6 months.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- DRUG Atezolizumab
- PROCEDURE Biopsy Procedure
- DRUG Cobimetinib
Study Locations (18)
Georgia
- Emory University Hospital Midtown - Atlanta
- Emory University Hospital/Winship Cancer Institute - Atlanta
- Emory Saint Joseph's Hospital - Atlanta
North Carolina
- Wake Forest University at Clemmons - Clemmons
- Hayworth Cancer Center - High Point
- Wake Forest University Health Sciences - Winston-Salem
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
California
- UC San Diego Moores Cancer Center - La Jolla
District of Columbia
- MedStar Georgetown University Hospital - Washington D.C.
Florida
- Moffitt Cancer Center - Tampa
Michigan
- Wayne State University/Karmanos Cancer Institute - Detroit
New Hampshire
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center - Lebanon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2018-11-29 |
| Est. Completion | 2026-10-03 |
| Phase | Phase 2 |
What the registry record for NCT03600701 still lists
NCT03600701 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 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 (48% lower).
The record links to 4 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.
NCT03600701 lists 18 locations in 14 states (Georgia, North Carolina, Alabama).
Frequently Asked Questions
What is clinical trial NCT03600701 about?
NCT03600701 is a clinical study titled "Atezolizumab and Cobimetinib in Treating Patients With Metastatic, Recurrent, or Refractory Non-small Cell Lung Cancer". This phase II trial studies how well atezolizumab and cobimetinib work in treating patients with non-small cell lung cancer that has spread from where it first started (primary site) to other places in the body (metastatic), has come back (recurrent), or does not respond to treatment (refractory). I...
What is the current status of trial NCT03600701?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 51 participants. The study started on 2018-11-29. Estimated completion is 2026-10-03.
What conditions does trial NCT03600701 study?
This clinical trial studies the following conditions: Stage IV Lung Cancer AJCC v8, Metastatic Lung Non-Small Cell Carcinoma, Recurrent Lung Non-Small Cell Carcinoma, Refractory Lung Non-Small Cell Carcinoma.
What interventions are being tested in trial NCT03600701?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Atezolizumab (DRUG), Biopsy Procedure (PROCEDURE), Cobimetinib (DRUG).
Who is sponsoring clinical trial NCT03600701?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03600701 being conducted?
This trial has 18 study locations across Alabama, California, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03600701's enrollment target sits among peer trials
51 35th of 81 higher than 47 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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