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NCT04533451 · ClinicalTrials.gov registry record · Phase 2
Testing the Effects of MK-3475 (Pembrolizumab) With or Without the Usual Chemotherapy Treatment for Patients 70 Years of Age and Older With Advanced 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 Alliance for Clinical Trials in Oncology.
- Active
- Registry status
- Phase 2
- Development phase
- 101
- Enrollment target
- 20
- Study locations
NCT04533451 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 Alliance for Clinical Trials in Oncology. The registered enrollment target is 101 participants, roughly in line with the 97-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target. The trial reports 20 study locations across 4 states.
The verdict
NCT04533451, 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 Alliance for Clinical Trials in Oncology.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 101 participants
- Enrollment target
- 20
- Study locations
Study Summary
This trial studies the side effects of pembrolizumab with or without chemotherapy in treating patients with stage IV non-small cell lung cancer that has come back (recurrent) and has spread to other places in the body (advanced). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as pemetrexed and carboplatin, 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 pembrolizumab with or without chemotherapy may shrink the tumor in older patients with non-small cell lung cancer.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Carboplatin
- DRUG Pemetrexed
- OTHER Questionnaire Administration
- OTHER Comprehensive Geriatric Assessment
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
California
- Mission Hope Medical Oncology - Arroyo Grande - Arroyo Grande
- PCR Oncology - Arroyo Grande
- UC San Diego Moores Cancer Center - La Jolla
- Pacific Central Coast Health Center-San Luis Obispo - San Luis Obispo
- Mission Hope Medical Oncology - Santa Maria - Santa Maria
- Saint Helena Hospital - St. Helena
Colorado
- Rocky Mountain Cancer Centers-Aurora - Aurora
- The Medical Center of Aurora - Aurora
- Boulder Community Foothills Hospital - Boulder
- Rocky Mountain Cancer Centers-Boulder - Boulder
Arizona
- Kingman Regional Medical Center - Kingman
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2020-11-16 |
| Est. Completion | 2027-05-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04533451
The ClinicalTrials.gov registry entry for NCT04533451 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 101 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 97-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target. The listed sponsor is Alliance for Clinical Trials in Oncology, which has 446 total studies on file at ClinicalTrials.gov.
The record links to 7 conditions, with Stage IV Lung Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT04533451 reports 20 study locations spanning 4 distinct geographic areas - top geographies include Alaska, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT04533451 about?
NCT04533451 is a clinical study titled "Testing the Effects of MK-3475 (Pembrolizumab) With or Without the Usual Chemotherapy Treatment for Patients 70 Years of Age and Older With Advanced Non-small Cell Lung Cancer". This trial studies the side effects of pembrolizumab with or without chemotherapy in treating patients with stage IV non-small cell lung cancer that has come back (recurrent) and has spread to other places in the body (advanced). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may h...
What is the current status of trial NCT04533451?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 101 participants. The study started on 2020-11-16. Estimated completion is 2027-05-31.
What conditions does trial NCT04533451 study?
This clinical trial studies the following conditions: Stage IV Lung Cancer AJCC v8, Metastatic Lung Non-Small Cell Carcinoma, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8, Recurrent Lung Non-Small Cell Carcinoma.
What interventions are being tested in trial NCT04533451?
The interventions under investigation include: Pembrolizumab (DRUG), Carboplatin (DRUG), Pemetrexed (DRUG), Questionnaire Administration (OTHER), Comprehensive Geriatric Assessment (OTHER).
Who is sponsoring clinical trial NCT04533451?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04533451 being conducted?
This trial has 20 study locations across Alaska, Arizona, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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