Targeted Treatment for RET Fusion-Positive Advanced Non-Small Cell Lung Cancer
Sponsor: SWOG Cancer Research Network
ClinicalTrials ID:NCT04268550
This clinical trial is testing how well the drug selpercatinib works in treating patients with advanced non-small cell lung cancer (NSCLC) that has a specific genetic change called RET fusion. The study aims to see if selpercatinib can stop the growth of cancer cells by blocking certain enzymes they need to grow.
Patient Parameters
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Program Overview
This study is exploring the effectiveness of selpercatinib in patients with advanced non-small cell lung cancer (NSCLC) that has a genetic change known as RET fusion. The trial is focused on patients whose cancer is at stage IV or has returned after treatment. Selpercatinib may help stop cancer cells from growing by blocking specific enzymes they need. Patients will take selpercatinib by mouth twice a day in 28-day cycles, as long as the cancer does not progress or cause unacceptable side effects. After finishing the treatment, patients will have follow-up visits every six months for two years, and then a final check-up at the end of the third year.
Description
The main goal of this study is to see how well selpercatinib works in shrinking tumors in patients with advanced non-small cell lung cancer (NSCLC) that has a RET fusion. Researchers will also look at how long the response lasts, the side effects, and overall survival rates. For patients with cancer that has spread to the brain, the study will evaluate how well the treatment works in the central nervous system.
The study will also collect blood and tissue samples to help understand the cancer better and develop future treatments. Patients will take selpercatinib by mouth twice a day in 28-day cycles. The treatment will continue as long as it is effective and does not cause unacceptable side effects. After completing the treatment, patients will have follow-up visits every six months for two years, and then a final check-up at the end of the third year.
Eligibility Criteria
Inclusion Criteria
- Have RET fusion-positive non-small cell lung cancer (NSCLC) confirmed by specific lab tests.
- Have received at least one line of platinum-based chemotherapy if previously treated for stage IV or recurrent disease.
- Have no other genetic changes that could make the treatment less effective.
- Have measurable disease as shown by CT or MRI scans.
- Have a CT or MRI scan of the brain to check for cancer spread within 42 days before starting the study.
- Have controlled hepatitis B or C, or HIV if applicable.
- Be able to swallow capsules.
- Have recovered from any side effects of previous treatments.
- Meet specific blood count and organ function requirements.
- Agree to provide blood samples for research purposes.
- Understand the study and agree to participate by signing a consent form.
Exclusion Criteria
- Have received prior treatment with selective anti-RET inhibitors.
- Have untreated or uncontrolled cancer spread to the brain or spinal cord.
- Have received any cancer treatment within 14 days before starting the study.
- Have serious heart conditions or uncontrolled illnesses.
- Have gastrointestinal issues that affect drug absorption.
- Be planning to use certain medications that interact with the study drug.
- Be pregnant or nursing, or not willing to use effective contraception during and after the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Fairbanks Memorial Hospital | 99701 | Fairbanks | Alaska |
| University of Arkansas for Medical Sciences | 72205 | Little Rock | Arkansas |
| Kaiser Permanente-Anaheim | 92806 | Anaheim | California |
| Sutter Auburn Faith Hospital | 95602 | Auburn | California |
| Kaiser Permanente-Baldwin Park | 91706 | Baldwin Park | California |
| Kaiser Permanente-Bellflower | 90706 | Bellflower | California |
| Alta Bates Summit Medical Center-Herrick Campus | 94704 | Berkeley | California |
| Kaiser Permanente-Fontana | 92335 | Fontana | California |
| Palo Alto Medical Foundation-Fremont | 94538 | Fremont | California |
| Kaiser Permanente - Harbor City | 90710 | Harbor City | California |
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