OncoMatch/Clinical Trials/NCT05118854
A Phase II Study of Neoadjuvant Sotorasib in Combination With Cisplatin or Carboplatin and Pemetrexed for Surgically Resectable Stage IIA-IIIB Non-Squamous Non-Small Cell Lung Cancer With a KRAS p.G12C Mutation
Is NCT05118854 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including AMG 510 and Cisplatin for lung cancer.
Treatment: AMG 510 · Cisplatin · Carboplatin · Pemetrexed — This is a phase II, single-arm, open-label study evaluating the efficacy, safety and tolerability of neoadjuvant sotorasib in combination with cisplatin (or carboplatin) and pemetrexed chemotherapy for patients with surgically resectable stage IIA - IIIB (T3-T4/N2) (based on AJCC 8th edition), non-squamous NSCLC with a KRAS p.G12C mutation. The primary objective of the study is to determine whether neoadjuvant therapy with 4 cycles of at least one dose of sotorasib plus cisplatin (or carboplatin) and pemetrexed can be administered safely and result in improved MPR rate in patients with KRAS p.G12C-mutant non-squamous NSCLC compared with the historical control MPR rate for platinum-based chemotherapy alone.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: KRAS G12C
Identification of a KRAS p.G12C mutation in tumor tissue or plasma by an approved diagnostic device for detection of KRAS p.G12C in NSCLC or through any nucleic acid-based diagnostic testing method [...] performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified or equivalently accredited laboratory.
Disease stage
Required: Stage IIA, IIB, IIIA, IIIB (T3-4N2)
Excluded: Stage IIIB N3, IIIC, IVA, IVB
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic anticancer therapy
Exception: Concurrent use of hormonal therapy for non-cancer-related conditions (such as hormone replacement therapy) is allowed.
Current or prior systemic anticancer therapy (chemotherapy, immunotherapy, biological therapy, hormonal therapy or other investigational anti-cancer drug) or radiation therapy for treatment of the current lung cancer.
Cannot have received: radiation therapy
Current or prior systemic anticancer therapy (chemotherapy, immunotherapy, biological therapy, hormonal therapy or other investigational anti-cancer drug) or radiation therapy for treatment of the current lung cancer.
Lab requirements
Blood counts
ANC ≥ 1500/µl (no G-CSF within 10 days), hemoglobin ≥ 9.0 g/dL (no transfusion within 2 weeks), platelets ≥ 100,000/µl (no transfusion within 2 weeks)
Kidney function
calculated creatinine clearance ≥ 60 mL/min (Cockroft-Gault formula)
Liver function
AST and ALT ≤ 2.5x ULN, except if alkaline phosphatase > 2.5x ULN then AST/ALT ≤ 1.5x ULN; serum bilirubin ≤ 1.0x ULN (or <2.0 mg/dL if Gilbert Syndrome)
Cardiac function
QTcF ≤ 470 msec (females), QTcF ≤ 450 msec (males), based on average of screening triplicates
Patients must have adequate hematologic laboratory assessments [...] Prothrombin time (PT) ≤1.5 x ULN or INR ≤1.5 x ULN (or within target range if on prophylactic anticoagulation therapy) and (activated) partial thromboplastin time (PTT or aPTT) ≤1.5 x ULN unless the patient is receiving therapeutic anticoagulation in which case they should be within therapeutic target limits. Patients must have adequate liver function, defined as the following: AST and ALT ≤ 2.5x ULN, except if alkaline phosphatase > 2.5x ULN then AST/ALT ≤ 1.5x ULN; serum bilirubin ≤ 1.0x ULN (or <2.0 mg/dL if Gilbert Syndrome). Subjects must have calculated creatinine clearance ≥ 60 mL/min (Cockroft-Gault formula). Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≤ 470 msec in females and QTcF ≤ 450 msec in males.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Memorial Sloan Kettering Cancer Center · New York, New York
- M D Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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