Study on Pembrolizumab with Chemotherapy Before and After Surgery for Treatable Stage II, IIIA, and IIIB Non-Small Cell Lung Cancer
Sponsor: Merck Sharp & Dohme LLC
ClinicalTrials ID:NCT03425643
This clinical trial is testing the safety and effectiveness of using pembrolizumab with chemotherapy before surgery and pembrolizumab alone after surgery in patients with treatable Stage II, IIIA, and IIIB non-small cell lung cancer (NSCLC). The study aims to see if this approach can improve survival and reduce cancer recurrence.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to evaluate if combining pembrolizumab with chemotherapy before surgery, and continuing pembrolizumab alone after surgery, can help improve outcomes for patients with treatable Stage II, IIIA, and IIIB non-small cell lung cancer (NSCLC). Researchers want to see if this treatment can increase the time patients live without cancer returning and improve overall survival rates.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of treatable Stage II, IIIA, or IIIB (N2) non-small cell lung cancer (NSCLC) that has not been treated before.
- Men must agree to use birth control or abstain from sex and not donate sperm during treatment and for a period after the last dose.
- Women must not be pregnant or breastfeeding and must agree to use birth control during treatment and for a period after the last dose if they are of childbearing potential.
- Must provide a tumor tissue sample for testing.
- Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Have adequate organ function as determined by medical tests.
Exclusion Criteria
- Have certain types of lung cancer, such as those involving the superior sulcus, large cell neuro-endocrine cancer, or sarcomatoid tumors.
- Have a history of lung inflammation that required steroids or currently have lung inflammation needing steroids.
- Have an active infection requiring treatment.
- Have had a tissue or organ transplant.
- Have severe allergies to pembrolizumab or chemotherapy drugs used in the study.
- Have an active autoimmune disease needing treatment in the past 2 years.
- Have a history of HIV, Hepatitis B, Hepatitis C, or active tuberculosis.
- Have any condition or treatment that could interfere with the study results or participation.
- Have psychiatric or substance abuse issues affecting study participation.
- Have received prior treatment with similar drugs or cancer therapies.
- Have had recent radiotherapy or a live vaccine.
- Are participating in another clinical trial or have used an investigational device recently.
- Have a diagnosis of immunodeficiency or are on immunosuppressive therapy.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Banner MD Anderson Cancer Center ( Site 0028) | 85234 | Gilbert | Arizona |
| Western Regional Medical Center, Inc. ( Site 0050) | 85338 | Goodyear | Arizona |
| University of Arizona Cancer Center - Dignity Health ( Site 0062) | 85004 | Phoenix | Arizona |
| University of Arizona Cancer Center ( Site 0012) | 85724 | Tucson | Arizona |
| Pacific Cancer Medical Center, Inc. ( Site 0004) | 92801 | Anaheim | California |
| Providence Saint Joseph Medical Center ( Site 0061) | 91505 | Burbank | California |
| Pacific Cancer Care ( Site 0035) | 93940 | Monterey | California |
| John Wayne Cancer Institute ( Site 0049) | 90404 | Santa Monica | California |
| St Joseph Heritage Healthcare ( Site 0040) | 95403 | Santa Rosa | California |
| Stanford University, Stanford Cancer Center ( Site 0046) | 94305 | Stanford | California |
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