Study on Adding Cemiplimab to Usual Treatment for Advanced Non-Small Cell Lung Cancer After Previous Chemotherapy and Immunotherapy
Sponsor: SWOG Cancer Research Network
ClinicalTrials ID:NCT06616584
This clinical trial is testing whether adding the immunotherapy drug cemiplimab to the usual treatment of docetaxel and ramucirumab can improve outcomes for patients with advanced non-small cell lung cancer that has returned or progressed after previous treatments.
Patient Parameters
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Program Overview
This study is exploring if adding cemiplimab, an immunotherapy drug, to the standard treatment of docetaxel and ramucirumab can help patients with advanced non-small cell lung cancer (NSCLC) that has either reached stage IV or returned after initial improvement. Cemiplimab works by helping the immune system recognize and attack cancer cells. The study aims to see if this combination can kill more cancer cells compared to the standard treatment alone.
Description
The main goal of this study is to compare the overall survival of patients receiving the standard treatment of docetaxel and ramucirumab with or without the addition of cemiplimab. The study will also look at how long patients live without the cancer getting worse, how well the cancer responds to treatment, and the side effects of the treatments.
Participants will be randomly assigned to one of two groups. One group will receive the standard treatment of docetaxel and ramucirumab, while the other group will receive the same treatment plus cemiplimab. All treatments are given in cycles every 21 days, as long as the cancer does not progress or side effects are manageable.
Throughout the study, participants will have regular blood tests and scans to monitor their health and the cancer's response to treatment. After completing the study treatment, participants will have follow-up visits every 3-6 months for up to 3 years.
Eligibility Criteria
Inclusion Criteria
- Must be assigned to the study by the Southwest Oncology Group (SWOG).
- Must have measurable or non-measurable disease confirmed by CT or MRI.
- Must have had a CT or MRI scan of the brain to check for cancer spread to the central nervous system.
- Must have received one anti-PD-1 or anti-PD-L1 therapy for advanced disease.
- Must have experienced disease progression more than 84 days after starting the most recent anti-PD-1 or anti-PD-L1 therapy.
- Must have received platinum-based chemotherapy and experienced disease progression during or after this treatment.
- Must have recovered from any side effects of the most recent cancer treatment.
- Must not have received prior therapy with docetaxel for this disease.
- Must not have received any palliative radiation therapy within 14 days before starting the study.
- Must not be planning to receive any other cancer treatments while on this study.
- Must have adequate blood cell counts and organ function as determined by specific tests.
- Must not have had major surgery within 28 days before starting the study.
- Must not have any active autoimmune disease requiring treatment within the past 2 years.
- Must not have any history of organ transplant requiring immunosuppressive therapy.
- Must not have received a live vaccine within 28 days before starting the study.
- Must not have any active tuberculosis infection.
- Must not have a history of severe lung inflammation requiring steroids.
- Must not have any serious or non-healing wounds or fractures.
- Must not have had any serious heart conditions within 6 months before starting the study.
- Must not have any history of gastrointestinal bleeding within 3 months before starting the study.
- Must not be pregnant or breastfeeding and must agree to use effective contraception if of reproductive potential.
- Must agree to have blood samples collected for research purposes.
- Must be informed about the study and provide written consent to participate.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Lewis Cancer and Research Pavilion at Saint Joseph's/Candler | 31405 | Savannah | Georgia |
| Illinois CancerCare-Bloomington | 61704 | Bloomington | Illinois |
| Illinois CancerCare-Canton | 61520 | Canton | Illinois |
| Illinois CancerCare-Carthage | 62321 | Carthage | Illinois |
| Cancer Care Specialists of Illinois - Decatur | 62526 | Decatur | Illinois |
| Decatur Memorial Hospital | 62526 | Decatur | Illinois |
| Illinois CancerCare-Dixon | 61021 | Dixon | Illinois |
| Crossroads Cancer Center | 62401 | Effingham | Illinois |
| Illinois CancerCare-Eureka | 61530 | Eureka | Illinois |
| Illinois CancerCare-Galesburg | 61401 | Galesburg | Illinois |
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