Study on Pembrolizumab with or without Chemotherapy for Stage IV Non-small Cell Lung Cancer
Sponsor: Merck Sharp & Dohme LLC
ClinicalTrials ID:NCT04165070
This clinical trial is testing the effectiveness and safety of pembrolizumab, with or without chemotherapy, combined with other investigational drugs, in patients with advanced non-small cell lung cancer (NSCLC) who have not received prior treatment.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to evaluate how well pembrolizumab, a type of immunotherapy, works when used alone or with chemotherapy in combination with other investigational drugs like vibostolimab, boserolimab, and others. This study is for patients with advanced non-small cell lung cancer (NSCLC) who have not been treated before. It is part of a larger research program focused on pembrolizumab.
Description
This study is part of a larger research effort to understand the effects of pembrolizumab in treating advanced non-small cell lung cancer (NSCLC). Participants will receive pembrolizumab, with or without chemotherapy, along with other investigational drugs. The study aims to determine the safety and effectiveness of these combinations in shrinking tumors and improving patient outcomes. Participants will undergo various tests and procedures to monitor their health and the treatment's impact.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with Stage IV non-small cell lung cancer (NSCLC), either squamous or non-squamous type.
- Not eligible for approved targeted therapy if they have non-squamous NSCLC.
- Able to provide a tumor tissue sample from a previous biopsy or a new biopsy taken within 90 days before starting treatment.
- Have not received any prior systemic treatment for their metastatic NSCLC.
- Able to complete all required screening procedures within the specified time frames.
Exclusion Criteria
- Diagnosed with small cell lung cancer.
- Have an immune system deficiency or are taking high doses of steroids or other immune-suppressing medications.
- Have another active cancer that is progressing or required treatment in the past 2 years.
- Have cancer that has spread to the brain or spinal cord.
- Have an active autoimmune disease needing treatment in the past 2 years.
- Have a history of lung inflammation requiring steroids or current lung inflammation.
- Have an active infection needing treatment.
- Have significant heart disease, such as recent heart attack or severe heart failure.
- Have uncontrolled HIV, Hepatitis B, or Hepatitis C infections.
- Have had major surgery within 3 weeks before starting the study treatment.
- Need other cancer treatments while on the study.
- Have digestive or liver conditions affecting medication absorption.
- Have moderate nerve damage.
- Have received certain cancer treatments or radiation therapy recently.
- Have had severe allergic reactions to similar treatments.
- Have had a tissue or organ transplant.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Banner MD Anderson Cancer Center ( Site 0001) | 85234 | Gilbert | Arizona |
| City of Hope ( Site 0014) | 91010 | Duarte | California |
| UCSF Medical Center at Mission Bay ( Site 0007) | 94158 | San Francisco | California |
| Georgetown University ( Site 0036) | 20007 | Washington | District of Columbia |
| University of Kentucky Markey Cancer Center ( Site 0019) | 40536-0293 | Lexington | Kentucky |
| MedStar Franklin Square Medical Center ( Site 0033) | 21237 | Baltimore | Maryland |
| Massachusetts General Hospital ( Site 0003) | 02114 | Boston | Massachusetts |
| Dana Farber Cancer Institute ( Site 0002) | 02215 | Boston | Massachusetts |
| Oncology Hematology West, PC DBA Nebraska Cancer Specialists ( Site 0031) | 68130 | Omaha | Nebraska |
| Dartmouth Hitchcock Medical Center ( Site 0016) | 03766 | Lebanon | New Hampshire |
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