Study on Timing of Pembrolizumab Alone or With Chemotherapy for First-Line Treatment in Advanced Non-Small Cell Lung Cancer
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT03793179
This clinical trial is exploring whether using pembrolizumab alone or with chemotherapy as the first treatment can better manage advanced non-small cell lung cancer. The study aims to find the most effective approach to improve patient outcomes.
Patient Parameters
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Program Overview
This study is investigating the best way to use pembrolizumab, an immunotherapy drug, either alone or with chemotherapy drugs pemetrexed and carboplatin, as the first treatment for patients with advanced non-small cell lung cancer. Pembrolizumab helps the immune system attack cancer cells, while chemotherapy works to stop cancer cells from growing and spreading. The trial will compare different treatment sequences to see which one offers better results for patients.
Description
The main goal of this study is to compare the overall survival of patients receiving different treatment combinations. Patients will be divided into three groups:
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Group A: Patients receive pembrolizumab alone every 21 days for up to 2 years. If the cancer progresses, they will then receive pemetrexed and carboplatin every 21 days for up to 4 cycles, followed by pemetrexed alone if needed.
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Group B: Patients receive pembrolizumab alone every 21 days for up to 2 years. If the cancer progresses, they will receive pembrolizumab, pemetrexed, and carboplatin every 21 days for up to 4 cycles, followed by pembrolizumab and pemetrexed if needed.
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Group C: Patients receive pembrolizumab, pemetrexed, and carboplatin every 21 days for up to 4 cycles, followed by pembrolizumab and pemetrexed if needed.
Throughout the study, patients will undergo regular imaging tests and blood sample collections to monitor their response to treatment. After completing the study treatment, patients will be followed up for 5 years to assess long-term outcomes.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with stage IV non-squamous non-small cell lung cancer.
- Cancer must express PD-L1 with a score of 1% or higher.
- Must have measurable or non-measurable disease.
- Aged 18 years or older.
- Good overall health with an ECOG performance status of 0 or 1.
- No prior systemic chemotherapy or immunotherapy for advanced lung cancer.
- No known EGFR, BRAF, ALK, or ROS1 mutations treatable with specific inhibitors.
- Treated brain metastases are allowed if stable.
- No history of severe lung disease or autoimmune conditions requiring treatment.
- Not pregnant or breastfeeding and willing to use contraception.
- Adequate blood counts and organ function as determined by specific tests.
- No active infections like tuberculosis or recent live vaccinations.
- HIV-positive patients are eligible if on effective treatment with undetectable viral load.
- Hepatitis B or C patients must have controlled or treated infections.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of South Alabama Mitchell Cancer Institute | 36688 | Mobile | Alabama |
| Anchorage Associates in Radiation Medicine | 98508 | Anchorage | Alaska |
| Anchorage Radiation Therapy Center | 99504 | Anchorage | Alaska |
| Alaska Breast Care and Surgery LLC | 99508 | Anchorage | Alaska |
| Alaska Oncology and Hematology LLC | 99508 | Anchorage | Alaska |
| Alaska Women's Cancer Care | 99508 | Anchorage | Alaska |
| Anchorage Oncology Centre | 99508 | Anchorage | Alaska |
| Katmai Oncology Group | 99508 | Anchorage | Alaska |
| Providence Alaska Medical Center | 99508 | Anchorage | Alaska |
| Fairbanks Memorial Hospital | 99701 | Fairbanks | Alaska |
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