Study on Maintenance Therapy for Small Cell Lung Cancer with SLFN11 Positive Biomarker
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT04334941
This clinical trial is exploring whether combining the drugs atezolizumab and talazoparib is more effective than using atezolizumab alone as a maintenance treatment for patients with extensive-stage small cell lung cancer that tests positive for the SLFN11 biomarker.
Patient Parameters
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Program Overview
The study aims to determine if adding talazoparib to atezolizumab can better control the growth and spread of extensive-stage small cell lung cancer (ES-SCLC) in patients with the SLFN11 biomarker. Atezolizumab is an immunotherapy drug that helps the immune system attack cancer cells, while talazoparib is a PARP inhibitor that prevents cancer cells from repairing themselves, potentially stopping their growth. The trial will compare the effectiveness of the combination treatment against atezolizumab alone.
Description
The main goal of this study is to see if the combination of atezolizumab and talazoparib can help patients with SLFN11-positive extensive-stage small cell lung cancer live longer without the cancer getting worse. Researchers will also look at overall survival rates and how well the cancer responds to treatment. Patients will be randomly assigned to receive either atezolizumab alone or atezolizumab with talazoparib. Both treatments are given in cycles every 21 days, as long as the cancer does not progress or cause unacceptable side effects.
Participants will undergo various tests, including MRI and CT scans, to monitor the cancer's response to treatment. Blood samples and tumor biopsies will be collected for further analysis. The study will also evaluate the safety of the treatments and any side effects experienced by participants.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of extensive-stage small cell lung cancer (ES-SCLC).
- Must have completed at least part of the initial treatment with platinum, etoposide, and atezolizumab.
- Must be 18 years or older.
- Must have tumor tissue available for testing the SLFN11 biomarker.
- Must agree to provide informed consent and understand the study's investigational nature.
- Must have adequate organ function and meet specific health criteria, including blood counts and liver function.
- Must not have received prior immunotherapy or investigational treatments for ES-SCLC.
- Must not have any active infections or other serious medical conditions that could interfere with the study.
- Women of childbearing potential and men must agree to use effective contraception during the study and for a period after the last treatment dose.
- Must not be pregnant or breastfeeding.
- Must be able to swallow capsules whole.
- Must not have any known allergies to the study drugs.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| 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 |
| Kingman Regional Medical Center | 86401 | Kingman | Arizona |
| Cancer Center at Saint Joseph's | 85004 | Phoenix | Arizona |
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