Study on Treatment for Advanced Non-small Cell Lung Cancer with Specific Gene Changes After Targeted Treatment and Chemotherapy
Sponsor: SWOG Cancer Research Network
ClinicalTrials ID:NCT07393555
This clinical trial is testing different treatments for patients with advanced non-small cell lung cancer (NSCLC) that has specific gene changes and has returned or is at stage IV. The study compares the effectiveness of sacituzumab govitecan alone, ivonescimab alone, or both drugs together.
Patient Parameters
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Program Overview
This study is exploring how well different treatments work for patients with advanced non-small cell lung cancer (NSCLC) that has specific gene changes, known as actionable genomic alterations (AGA). These changes can be targeted by certain treatments to fight the cancer. The trial compares three treatment options: sacituzumab govitecan alone, ivonescimab alone, or a combination of both. Sacituzumab govitecan is a targeted therapy that delivers a toxic drug to cancer cells, while ivonescimab is an antibody that may boost the immune system and block tumor growth. The study aims to find out if these treatments can shrink tumors better than standard treatments.
Description
The main goal of this study is to compare how long patients live without their cancer getting worse when treated with sacituzumab govitecan and ivonescimab together versus each drug alone. Researchers will also look at how well each treatment works in shrinking tumors and how safe they are.
Participants will be randomly assigned to one of three groups:
- Group 1: Receive both sacituzumab govitecan and ivonescimab.
- Group 2: Receive sacituzumab govitecan alone.
- Group 3: Receive ivonescimab alone.
Each treatment cycle lasts 21 days, and patients will continue treatment as long as it is effective and side effects are manageable. Throughout the study, participants will have regular scans and blood tests to monitor their health and the cancer's response to treatment.
After finishing the study treatment, patients will have follow-up visits every 12 weeks or more often if needed, and then every 6 months for up to 3 years to check on their health and cancer status.
Eligibility Criteria
Inclusion Criteria
- Must be part of the S1900N study group and have non-small cell lung cancer (NSCLC) with specific gene changes that can be targeted by treatments.
- Must have measurable cancer that can be seen on a CT or MRI scan.
- Must have had a brain scan to check for cancer spread within 42 days before starting the study.
- Must have previously received targeted therapy and chemotherapy for lung cancer.
- Must not have had more than 3 previous chemotherapy treatments for NSCLC.
- Must not have received certain previous treatments, including TROP2-targeted drugs or anti-PD-1/PD-L1 therapies.
- Must have good overall health and meet specific blood test requirements.
- Must not be pregnant or breastfeeding and agree to use effective birth control.
- Must agree to provide blood samples for research purposes.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Alta Bates Summit Medical Center-Herrick Campus | 94704 | Berkeley | California |
| Palo Alto Medical Foundation Health Care | 94301 | Palo Alto | California |
| University of California Davis Comprehensive Cancer Center | 95817 | Sacramento | California |
| Northeast Georgia Medical Center-Gainesville | 30501 | Gainesville | Georgia |
| 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 |
| Illinois CancerCare-Bloomington | 61704 | Bloomington | Illinois |
| Illinois CancerCare-Canton | 61520 | Canton | Illinois |
| Illinois CancerCare-Carthage | 62321 | Carthage | Illinois |
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