Study on Pembrolizumab with Chemoradiation Therapy, Followed by Pembrolizumab with or without Olaparib, for Stage III Non-Small Cell Lung Cancer
Sponsor: Merck Sharp & Dohme LLC
ClinicalTrials ID:NCT04380636
This clinical trial is testing the effectiveness and safety of pembrolizumab combined with chemoradiation therapy, followed by pembrolizumab with or without olaparib, compared to another treatment option, in patients with advanced non-small cell lung cancer that cannot be surgically removed.
Patient Parameters
| Parameter | Options |
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Program Overview
The study aims to find out if pembrolizumab, when used with chemoradiation therapy and followed by either pembrolizumab alone or with olaparib, is more effective in improving survival and delaying cancer progression than the current standard treatment with durvalumab. The trial involves three groups: one receiving pembrolizumab with a placebo, another receiving pembrolizumab with olaparib, and a third group receiving the standard treatment with durvalumab.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with non-small cell lung cancer (NSCLC) confirmed by lab tests.
- Have Stage IIIA, IIIB, or IIIC NSCLC, meaning the cancer is locally advanced but not spread to distant parts of the body.
- Cannot have surgery to remove the cancer.
- No evidence of cancer spread to distant organs (Stage IV).
- Have measurable cancer that can be tracked using standard criteria.
- Have not received prior treatment for Stage III NSCLC, except for early-stage treatments.
- Provide a tumor tissue sample for analysis.
- Be in good overall health with a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Have a life expectancy of at least 6 months.
- Men must agree to use contraception and not donate sperm during and after treatment for a specified time.
- Women must not be pregnant or breastfeeding and agree to use contraception and not donate eggs during and after treatment for a specified time.
- Have a negative pregnancy test before starting treatment.
- Have adequate lung and organ function.
- Provide written informed consent to participate.
Exclusion Criteria
- Have small cell lung cancer or a mixed tumor with small cell elements.
- Have certain blood disorders like myelodysplastic syndrome or acute myeloid leukemia.
- Have lost more than 10% of body weight in the last 3 months.
- Have had prior radiation to the chest area.
- Have received certain immune therapies or olaparib before.
- Have had major surgery recently, except for minor procedures.
- Need other cancer treatments during the study.
- Have received a live vaccine recently.
- Are taking certain medications that affect the liver or immune system.
- Cannot stop taking aspirin or other medications as required by the study.
- Have received an investigational drug or device recently.
- Have uncontrolled heart conditions or long QT syndrome.
- Have a weakened immune system or are on immunosuppressive therapy.
- Have another active cancer needing treatment, except for certain skin or bladder cancers.
- Have severe allergies to study drugs.
- Have an active autoimmune disease needing treatment.
- Have a history of lung inflammation needing steroids.
- Have an active infection needing treatment.
- Have a history of HIV, Hepatitis B, or active Hepatitis C.
- Have active tuberculosis.
- Have any condition that might interfere with the study or make participation unsafe.
- Have a psychiatric or substance abuse disorder affecting study participation.
- Cannot swallow pills or have a digestive disorder affecting absorption.
- Have had a tissue or organ transplant.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of South Alabama, Mitchell Cancer Institute ( Site 0003) | 36604 | Mobile | Alabama |
| St. Bernards Medical Center ( Site 0089) | 72401 | Jonesboro | Arkansas |
| St Joseph Heritage Healthcare-Oncology ( Site 0088) | 92835 | Fullerton | California |
| Long Beach Memorial Medical Center ( Site 0006) | 90806 | Long Beach | California |
| UCLA Hematology/Oncology - Santa Monica ( Site 0013) | 90404 | Los Angeles | California |
| St. Joseph Heritage Healthcare Local Lab ( Site 0011) | 95403 | Santa Rosa | California |
| Torrance Memorial Physician Network / Cancer Center ( Site 0093) | 90505 | Torrance | California |
| Memorial Regional Hospital-Memorial Cancer Institute ( Site 0095) | 33021 | Hollywood | Florida |
| Miami VA Healthcare System ( Site 0024) | 33125 | Miami | Florida |
| Mid Florida Hematology and Oncology Center ( Site 0022) | 32763 | Orange City | Florida |
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