PRISM Study: Personalized Treatments for Extensive Stage Small Cell Lung Cancer Using Biomarker Tests
Sponsor: SWOG Cancer Research Network
ClinicalTrials ID:NCT06769126
This study is exploring how biomarker tests can help doctors choose personalized treatments for patients with extensive stage small cell lung cancer (ES-SCLC). The trial also examines different maintenance treatments to keep the cancer under control after initial therapy.
Patient Parameters
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Program Overview
This phase II study is investigating how well biomarker tests on tumor samples can help select personalized treatments for patients with extensive stage small cell lung cancer (ES-SCLC). Biomarker tests identify specific features in cancer cells that can guide doctors in choosing the best treatment. Based on these test results, doctors can determine the subtype of ES-SCLC and select targeted treatments. The study also tests different maintenance treatments, including drugs like durvalumab, saruparib, ceralasertib, and monalizumab, to help keep the cancer from worsening after initial treatment. These treatments include immunotherapy, which may help the immune system attack cancer, and targeted therapies that prevent cancer cells from repairing themselves.
Description
The PRISM study aims to use biomarker tests to select personalized treatments for patients with extensive stage small cell lung cancer (ES-SCLC). The study is divided into several steps:
Induction Treatment: Patients may receive standard chemotherapy with platinum and etoposide, along with the immunotherapy drug durvalumab, for 4-6 cycles.
Maintenance Treatment: After initial treatment, patients are assigned to one of three groups based on their cancer subtype and biomarker status. Each group tests different combinations of maintenance treatments:
- Cohort A: Patients with certain subtypes receive durvalumab alone or with saruparib.
- Cohort B: Patients with other subtypes receive durvalumab alone or with ceralasertib.
- Cohort C: Patients with another subtype receive durvalumab alone or with monalizumab.
Throughout the study, patients will have regular scans and tests to monitor their cancer and overall health. Tissue and blood samples will be collected for further analysis. After completing the study treatment, patients will be followed for up to 3 years to track their progress.
Eligibility Criteria
Inclusion Criteria
- Must not have another cancer that could interfere with this study.
- Must not have a history of limited stage small cell lung cancer.
- Must be 18 years or older.
- Must be able to safely receive the initial treatment with platinum, etoposide, and durvalumab.
- Must have a good performance status (able to carry out daily activities).
- Must not have had an organ transplant.
- Must not have medical conditions that prevent receiving immunotherapy.
- Must not be pregnant or breastfeeding and must agree to use effective contraception during and after the study.
- Must have enough tumor tissue available for testing.
- Must agree to have leftover tissue used for future research.
- Must have completed initial treatment with platinum, etoposide, and durvalumab.
- Must not have received certain other cancer treatments before or during the study.
- Must have adequate blood counts and organ function.
- Must not have experienced severe side effects from previous treatments.
- Must not have received a live vaccine recently.
- Must be willing to participate in specimen banking for future research.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Helen F Graham Cancer Center | 19713 | Newark | Delaware |
| Medical Oncology Hematology Consultants PA | 19713 | Newark | Delaware |
| Kootenai Health - Coeur d'Alene | 83814 | Coeur d'Alene | Idaho |
| Kootenai Clinic Cancer Services - Post Falls | 83854 | Post Falls | Idaho |
| Kootenai Clinic Cancer Services - Sandpoint | 83864 | Sandpoint | Idaho |
| Loyola University Medical Center | 60153 | Maywood | Illinois |
| Mary Greeley Medical Center | 50010 | Ames | Iowa |
| McFarland Clinic - Ames | 50010 | Ames | Iowa |
| UI Health Care Mission Cancer and Blood - Ankeny Clinic | 50023 | Ankeny | Iowa |
| McFarland Clinic - Boone | 50036 | Boone | Iowa |
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