Actively Recruiting
Carfilzomib in Combination With Sotorasib for the Treatment of Patients With KRAS G12C Mutated Advanced or Metastatic Non-small Cell Lung Cancer
Led by City of Hope Medical Center · Updated on 2026-04-03
15
Participants Needed
2
Research Sites
134 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase I trial tests the safety, side effects, and best dose of carfilzomib in combination with sotorasib in treating patients with KRAS G12C-mutated non-small cell lung cancer (NSCLC) that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Carfilzomib is a drug that binds to and inhibits the activity of the protein complex that is responsible for degrading other damaged or unneeded proteins. The inhibition of this protein by carfilzomib can then cause tumor growth inhibition and cell death. Sotorasib is a drug that binds to and inhibits the activity of the KRAS G12C mutant. This may inhibit growth in KRAS G12C-expressing tumor cells. Combining carfilzomib and sotorasib may be a safe and effective treatment option for patients with KRAS G12C-mutated advanced or metastatic NSCLC.
CONDITIONS
Official Title
Carfilzomib in Combination With Sotorasib for the Treatment of Patients With KRAS G12C Mutated Advanced or Metastatic Non-small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent by participant or authorized representative
- Age 18 years or older
- ECOG performance status of 0, 1, or 2
- Histologically confirmed metastatic or advanced NSCLC with KRAS G12C mutation confirmed by certified assay
- Measurable disease by RECIST v1.1
- Prior treatment with a KRAS inhibitor with progression
- Fully recovered from recent anti-cancer therapy side effects (except hair loss)
- Cardiac function assessed as New York Heart Association class 2B or better if history of cardiac disease or cardiotoxic treatment
- Patients with new or progressive brain metastases are eligible if immediate CNS treatment is not needed
- Absolute neutrophil count of at least 1,500/mm³ within 14 days before treatment
- Hemoglobin level of at least 9 g/dL within 14 days before treatment
- Platelet count of at least 100,000/mm³ within 14 days before treatment
- Total bilirubin no more than 1.5 times the upper limit of normal unless Gilbert's disease
- AST no more than 3 times upper limit or 5 times if liver metastases present
- ALT no more than 5 times upper limit
- Creatinine clearance no more than 1.5 times upper limit or GFR at least 60 mL/min/1.73 m² within 14 days before treatment
- Negative pregnancy test for women of childbearing potential within 14 days before treatment
- Agreement to use effective contraception or abstain from heterosexual activity during study and for at least 120 days after last dose if of childbearing potential
You will not qualify if you...
- Chemotherapy or immunotherapy within 21 days before treatment start
- Radiation therapy within 14 days before treatment start
- KRAS inhibitor within 14 days before treatment start
- Investigational therapy within 28 days or 5 half-lives before treatment start
- Previous intolerance to 240 mg daily sotorasib
- Allergic reactions to similar compounds to study drugs
- Uncontrolled serious illness
- Detectable chronic hepatitis B infection
- Untreated chronic hepatitis C infection (treated with undetectable viral load allowed)
- Active infection requiring antibiotics at treatment start
- Detectable HIV viral load
- Other malignancies that could interfere with safety or efficacy
- NYHA class III or IV heart failure, recent myocardial infarction, or uncontrolled conduction abnormalities
- Pregnant or breastfeeding females
- Any condition that investigator judges unsafe for study participation
- Inability to comply with study procedures due to feasibility or logistics
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
2
City of Hope at Irvine Lennar
Irvine, California, United States, 92618
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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