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NCT04310007 · ClinicalTrials.gov registry record · Phase 2
Testing the Addition of the Pill Chemotherapy, Cabozantinib, to the Standard Immune Therapy Nivolumab Compared to Standard Chemotherapy for Non-small Cell Lung Cancer
A Phase 2 study of Stage IV Lung Cancer AJCC v8 and Metastatic Lung Non-Squamous Non-Small Cell Carcinoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 117
- Enrollment target
- 20
- Study locations
NCT04310007 is a Phase 2 study of Stage IV Lung Cancer AJCC v8 and Metastatic Lung Non-Squamous Non-Small Cell Carcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 117 participants, above the 97-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (21% higher). The trial reports 20 study locations across 5 states.
The verdict
NCT04310007, a Phase 2 study of Stage IV Lung Cancer AJCC v8 and Metastatic Lung Non-Squamous 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
- 117 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial compares cabozantinib alone and the combination of cabozantinib and nivolumab to standard chemotherapy in the treatment of patients with non-squamous non-small cell lung cancer (NSCLC). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Ramucirumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as docetaxel, gemcitabine hydrochloride, paclitaxel, and nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving cabozantinib alone or in combination with nivolumab may be more effective than standard chemotherapy in treating patients with non-small cell lung cancer.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- DRUG Docetaxel
- DRUG Cabozantinib S-malate
- PROCEDURE Echocardiography Test
Study Locations (20)
Alaska
- Anchorage Associates in Radiation Medicine - Anchorage
- Anchorage Radiation Therapy Center - Anchorage
- Alaska Breast Care and Surgery LLC - Anchorage
- Alaska Oncology and Hematology LLC - Anchorage
- Alaska Women's Cancer Care - Anchorage
- Anchorage Oncology Centre - Anchorage
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
- Fairbanks Memorial Hospital - Fairbanks
Arizona
- CTCA at Western Regional Medical Center - Goodyear
- Kingman Regional Medical Center - Kingman
- Cancer Center at Saint Joseph's - Phoenix
- Banner University Medical Center - Tucson - Tucson
- University of Arizona Cancer Center-North Campus - Tucson
California
- Mission Hope Medical Oncology - Arroyo Grande - Arroyo Grande
- PCR Oncology - Arroyo Grande
- Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs - Hot Springs
Alabama
- Veterans Administration Medical Center - Birmingham - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 117 participants |
| Start Date | 2020-07-13 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04310007
The ClinicalTrials.gov registry entry for NCT04310007 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 117 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 97-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (21% higher). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 3 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.
NCT04310007 reports 20 study locations spanning 5 distinct geographic areas - top geographies include Alaska, Arizona, California.
Frequently Asked Questions
What is clinical trial NCT04310007 about?
NCT04310007 is a clinical study titled "Testing the Addition of the Pill Chemotherapy, Cabozantinib, to the Standard Immune Therapy Nivolumab Compared to Standard Chemotherapy for Non-small Cell Lung Cancer". This phase II trial compares cabozantinib alone and the combination of cabozantinib and nivolumab to standard chemotherapy in the treatment of patients with non-squamous non-small cell lung cancer (NSCLC). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cel...
What is the current status of trial NCT04310007?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 117 participants. The study started on 2020-07-13. Estimated completion is 2026-12-31.
What conditions does trial NCT04310007 study?
This clinical trial studies the following conditions: Stage IV Lung Cancer AJCC v8, Metastatic Lung Non-Squamous Non-Small Cell Carcinoma, Recurrent Lung Non-Squamous Non-Small Cell Carcinoma.
What interventions are being tested in trial NCT04310007?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Docetaxel (DRUG), Cabozantinib S-malate (DRUG), Echocardiography Test (PROCEDURE).
Who is sponsoring clinical trial NCT04310007?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04310007 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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