Actively Recruiting
Carfilzomib Combined With Sotorasib for KRAS G12C Mutated Advanced or Metastatic Non-Small Cell Lung Cancer A Phase I Clinical Trial
Led by City of Hope Medical Center · Updated on 2026-04-03
15
Participants Needed
2
Research Sites
N/A
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
Researchers are evaluating the safety, side effects, and best dose of combining carfilzomib with sotorasib in patients who have advanced or metastatic non-small cell lung cancer (NSCLC) with a KRAS G12C mutation. This phase I study focuses on patients whose cancer has progressed after prior KRAS inhibitor therapy. The goal is to find a safe dose and understand how well this combination may work in treating this specific lung cancer. Participants receive carfilzomib through an intravenous (IV) infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle, while sotorasib is taken orally once daily on days 1 through 28. Treatment cycles continue unless the disease worsens or side effects become unacceptable. Patients undergo echocardiography (ECHO) at screening and have CT or MRI scans plus blood samples collected during the study. Optional biopsies may also be performed. Throughout the study, patients are monitored for side effects and tumor responses using scans and blood tests. Researchers measure dose limiting toxicities and treatment-related severe side effects during the first cycle and up to 30 days after treatment ends. They also track how the cancer responds, progression-free survival, and overall survival. After treatment, patients have a follow-up visit 30 days later. The study is conducted under careful medical supervision by the City of Hope Medical Center.
CONDITIONS
Brief 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...
- Provided informed consent
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Histologically confirmed advanced or metastatic non-small cell lung cancer with KRAS G12C mutation confirmed by CLIA-certified test
- Measurable disease by RECIST v1.1 criteria
- Prior treatment with a KRAS inhibitor with disease progression
- Fully recovered from acute toxic effects of prior anticancer therapy except hair loss
- Cardiac function classified as New York Heart Association class 2B or better for those with cardiac history
- Patients with stable brain metastases not requiring immediate CNS treatment
- Adequate blood counts and organ function within 14 days before starting treatment
- Negative pregnancy test for women of childbearing potential
- Agreement to use effective birth control or abstain from heterosexual activity during and 120 days after study treatment
You will not qualify if you...
- Chemotherapy or immunotherapy within 21 days before study treatment
- Radiation therapy within 14 days prior to starting treatment
- KRAS inhibitor treatment within 14 days before treatment
- Investigational therapy within 28 days prior to treatment
- Inability to tolerate sotorasib at 240 mg daily
- Allergic reactions to similar compounds
- Uncontrolled illnesses
- Active hepatitis B infection or detectable viral load
- Untreated hepatitis C infection (unless undetectable viral load on treatment)
- Active infection needing antibiotics at treatment start
- Detectable HIV viral load
- Other malignancies that may interfere with study
- Severe heart failure or recent heart attack
- Pregnancy or breastfeeding
- Any condition that contraindicates study participation due to safety
- Inability to comply with study procedures as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening visit including echocardiography and imaging (CT or MRI)
Duration - Repeated 28-day cycles until disease progression or unacceptable toxicity
Participants receive carfilzomib intravenously on specific days of each 28-day cycle and take sotorasib orally once daily. Treatment cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Blood samples are collected and optional biopsies may be performed during treatment.
Multiple visits for drug administration and assessments each cycle (carfilzomib on days 1, 2, 8, 9, 15, 16; sotorasib daily)
Duration - 30 days after completion of study treatment
Participants are followed up for safety and survival outcomes after completing study treatment.
1 follow-up visit at 30 days post-treatment
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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