Study on Sotorasib and Trastuzumab Deruxtecan for Treating Advanced Non-Small Cell Lung Cancer with KRAS G12C Mutation
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT07012031
This clinical trial is testing a combination of two drugs, sotorasib and trastuzumab deruxtecan, to see if they are safe and effective in treating patients with advanced non-small cell lung cancer that has a specific KRAS G12C mutation.
Patient Parameters
| Parameter | Options |
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Program Overview
The study aims to find out if combining sotorasib, a targeted therapy, with trastuzumab deruxtecan, an antibody-drug conjugate, can help treat non-small cell lung cancer (NSCLC) that has spread locally or to other parts of the body and has a KRAS G12C mutation. Sotorasib targets a protein made by the mutated KRAS gene, while trastuzumab deruxtecan targets HER2 positive tumor cells and delivers chemotherapy directly to them. The trial will assess the safety, side effects, and best dose of this combination treatment.
Description
The main goals of this study are to determine the safety and tolerability of combining sotorasib with trastuzumab deruxtecan in patients with advanced non-small cell lung cancer (NSCLC) that has a KRAS G12C mutation. The study will also evaluate how well this combination works in shrinking tumors and improving patient outcomes.
The study is divided into two phases:
- Phase I: Focuses on finding the safest dose of the drug combination and observing any anti-tumor activity.
- Phase II: Looks at how effective the treatment is in terms of tumor response, progression-free survival, and overall survival.
Participants will receive trastuzumab deruxtecan through an IV and take sotorasib orally. The treatment cycles repeat every 21 days unless the disease progresses or side effects become unacceptable. Patients will undergo various tests, including tumor biopsies, imaging scans, and blood tests, to monitor their response to the treatment.
After completing the study treatment, patients will be followed up every three months for up to five years to monitor their health and any long-term effects of the treatment.
Eligibility Criteria
Inclusion Criteria
- Have advanced or metastatic non-small cell lung cancer (NSCLC) with a KRAS G12C mutation.
- Previously treated with a KRAS G12C inhibitor, immune checkpoint inhibitor, and chemotherapy.
- Have measurable disease as defined by standard imaging criteria.
- Be 18 years or older.
- Have good overall health with an ECOG performance status of 0 to 2.
- Meet specific blood count and organ function criteria.
- Have a life expectancy of at least 12 weeks.
- Agree to use effective contraception during the study and for a specified period after the last dose.
- Be willing to undergo a pre-treatment biopsy and follow study procedures.
- Have the ability to take oral medications.
Exclusion Criteria
- Have a history of interstitial lung disease (ILD) or severe lung conditions.
- Have had recent chest radiation therapy or major surgery.
- Have uncontrolled infections or other serious medical conditions.
- Have a history of severe allergic reactions to similar drugs.
- Be pregnant or breastfeeding.
- Have significant heart disease or uncontrolled cardiovascular conditions.
- Have received a live vaccine within 30 days before starting the study.
- Have other conditions that would make participation unsafe or interfere with the study results.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of California Davis Comprehensive Cancer Center | 95817 | Sacramento | California |
| Moffitt Cancer Center-International Plaza | 33607 | Tampa | Florida |
| Moffitt Cancer Center - McKinley Campus | 33612 | Tampa | Florida |
| Moffitt Cancer Center | 33612 | Tampa | Florida |
| Moffitt Cancer Center at Wesley Chapel | 33544 | Wesley Chapel | Florida |
| Case Western Reserve University | 44106 | Cleveland | Ohio |
| Ohio State University Comprehensive Cancer Center | 43210 | Columbus | Ohio |
| University of Pittsburgh Cancer Institute (UPCI) | 15232 | Pittsburgh | Pennsylvania |
| University of Virginia Cancer Center | 22908 | Charlottesville | Virginia |
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