Treatment for Advanced Non-Small Cell Lung Cancer with Actionable Genomic Alterations after Targeted Treatment and Chemotherapy
What is the purpose of this clinical trial?
This study tests treatment for advanced non-small cell lung cancer (NSCLC) that has an actionable genomic alteration (AGA). An AGA is a change in a gene that certain treatments can target to fight the cancer.
The study is for people whose cancer got worse during or after earlier treatment. It’s testing these medicines that target AGAs:
- sacituzumab govitecan and ivonescimab together
- sacituzumab govitecan alone
- ivonescimab alone
| Genes are pieces of DNA that carry instructions for the body. This study focuses on actionable genomic alterations in these genes: ALK, EGFR, HER2, MET, NTRK, RET, and ROS1. |
This trial is set up to find out:
- If these drugs (together or alone) work better than standard treatments at shrinking the cancer
- If the combination of sacituzumab govitecan and ivonescimab works better than either drug alone at keeping the cancer from growing or spreading
- What side effects people have from these drugs
Why is this trial important?
Usually, when NSCLC with an AGA gets worse during or after treatment, people then get chemotherapy. This chemotherapy is considered standard treatment — but its benefit is small for most patients.
Based on past studies, researchers think sacituzumab govitecan and ivonescimab (together or on their own) might be better treatment options than standard chemotherapy for this group of patients. This study is a chance to learn if that’s true.
Who can be in this trial?
This trial is for adults, age 18 or older, with advanced NSCLC.
This trial may be for people who:
- Have lung cancer with an AGA in at least 1 of these genes: ALK, EGFR, HER2 (ERBB2), MET, NTRK, RET, ROS1
- Have cancer that got worse during or after earlier treatments with targeted therapy and platinum-based chemotherapy
This trial is not for people who:
- Previously received sacituzumab govitecan or another TROP2-targeted drug
- Previously received an anti-PD-1 or anti-PD-L1 antibody treatment (like pembrolizumab, nivolumab, or durvalumab)
- Are pregnant or breastfeeding
What treatments will I get?
A computer will randomly assign you to one of these groups.
|
Group 1 sacituzumab govitecan |
Group 2 sacituzumab govitecan |
Group 3 ivonescimab |
Your doctor won’t have control over which group you’re assigned to. This helps make sure the study results are fair and reliable.
Both drugs are given through an IV (a needle placed in a vein in your arm). No matter which group you’re in, you’ll get treatment in cycles, and each cycle lasts 21 days (3 weeks).
- Sacituzumab govitecan is given on Day 1 and Day 8 of every cycle.
- Ivonescimab is given on Day 1 of every cycle.
The study drugs are not approved by the U.S. Food and Drug Administration (FDA) for treating lung cancer, but sacituzumab govitecan is approved for treating breast cancer and urothelial cancer.
How long will I be in the trial?
You’ll be in the study for 3 years total. You can keep receiving study treatment until the cancer gets worse or the side effects get so bad that you decide to stop.
If you stop getting treatment and the cancer hasn’t gotten worse, you’ll have a visit with your study doctor every 3 months. If you stop treatment and the cancer has gotten worse, you’ll have a study visit every 6 months until 2 years from the time you joined the study, and then a final visit 3 years from the time you joined the study.
At these visits, you’ll have a physical exam, blood tests, and scans. Your doctor may also do other tests or procedures that are part of usual care for your condition.
This trial is part of a larger study called Lung-MAP. If the cancer gets worse, you may have the option to join another Lung-MAP study.
Are there costs? Will I get paid?
Sacituzumab govitecan and ivonescimab are free for people in the study. To learn more about what costs will and won’t be covered, talk to your health care provider and insurance provider.
You will not be paid for joining the study.
Where can I find more information about this trial?
- Talk with your health care provider
- Call the National Cancer Institute at 1-800-4-CANCER
- Go to www.ClinicalTrials.gov and search the national clinical trial number: NCT07393555
- For a list of trial locations, visit swog.org/NCI-S1900N