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OncoMatch/Clinical Trials/NCT06249282

Carfilzomib in Combination With Sotorasib for the Treatment of Patients With KRAS G12C Mutated Advanced or Metastatic Non-small Cell Lung Cancer

Is NCT06249282 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Carfilzomib and Sotorasib for advanced lung non-small cell carcinoma.

Phase 1RecruitingCity of Hope Medical CenterNCT06249282Data as of May 2026

Treatment: Carfilzomib · SotorasibThis 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.

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Extracted eligibility criteria

Cancer type

Non-Small Cell Lung Carcinoma

Biomarker criteria

Required: KRAS g12c

Disease stage

Required: Stage III, IV (AJCC v8)

Metastatic disease required

Stage III Lung Cancer AJCC v8; Stage IV Lung Cancer AJCC v8; Histologically confirmed NSCLC that is metastatic or advanced

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 1 prior line

Must have received: KRAS inhibitor

Failed prior KRAS inhibitor

Cannot have received: chemotherapy

Chemotherapy or immunotherapy within 21 days prior to day 1 of protocol therapy

Cannot have received: immunotherapy

Chemotherapy or immunotherapy within 21 days prior to day 1 of protocol therapy

Cannot have received: radiation therapy

Radiation therapy within 14 days prior to day 1 of protocol therapy

Cannot have received: KRAS inhibitor

KRAS inhibitor within 14 days prior to day 1 of protocol therapy

Cannot have received: investigational therapy

Investigational therapy within 28 days prior to day 1 of protocol therapy (or 5 half-lives, use whichever is shorter)

Lab requirements

Blood counts

ANC ≥ 1,500/mm^3; Hemoglobin (Hb) ≥ 9 g/dL; Platelets ≥ 100,000/mm^3

Kidney function

Creatinine clearance of ≤ 1.5 x ULN or GFR ≥ 60 mL/min/1.73 m^2

Liver function

Total bilirubin ≤ 1.5 x ULN (unless has Gilbert's disease); AST ≤ 3 x ULN (or ≤ 5 x ULN in the setting of liver metastatic disease); ALT ≤ 5 x ULN (or ≤ 5 x ULN in the setting of liver metastatic disease)

Cardiac function

Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better

ANC ≥ 1,500/mm^3; Hemoglobin (Hb) ≥ 9 g/dL; Platelets ≥ 100,000/mm^3; Total bilirubin ≤ 1.5 x ULN (unless has Gilbert's disease); AST ≤ 3 x ULN (or ≤ 5 x ULN in the setting of liver metastatic disease); ALT ≤ 5 x ULN (or ≤ 5 x ULN in the setting of liver metastatic disease); Creatinine clearance of ≤ 1.5 x ULN or GFR ≥ 60 mL/min/1.73 m^2; NYHA class 2B or better

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • City of Hope Medical Center · Duarte, California
  • City of Hope at Irvine Lennar · Irvine, California

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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