OncoMatch/Clinical Trials/NCT05398094
Clinical Trial of AMG510 in Stage III Unresectable NSCLC KRAS p.G12C Patients and Ineligible for Chemo-radiotherapy
Is NCT05398094 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Sotorasib for non-small cell lung cancer stage iii.
Treatment: Sotorasib — Open-label, non-randomised, exploratory, phase II, multi-centre clinical trial. 43 unresectable stage III (IIIA-N2, IIIB, IIIC) KRAS p.G12C non-small cell lung cancer patients will be enrolled in this trial to evaluate the efficacy of induction treatment of AMG510 (Sotorasib) plus AMG510 (Sotorasib) treatment post-induction as measured by Progression Free Survival at 12 months.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: KRAS G12C
Patients who have documentation of KRAS p.G12C prior to enrollment. This determination can be done either by solid or liquid biopsy.
Required: EGFR sensitizing mutation
Patients with a known sensitizing mutation in the epidermal growth factor receptor (EGFR) gene
Required: ALK fusion
ALK translocations
Required: ROS1 mutation
ROS1 mutations
Disease stage
Required: Stage IIIA-N2, IIIB, IIIC
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: anti-neoplastic drugs
Prior treatment with anti-neoplasic drugs
Cannot have received: thoracic radiotherapy
Prior treatment with thoracic radiotherapy for any reason
Lab requirements
Blood counts
Adequate hematologic function
Kidney function
Adequate organ function
Liver function
Adequate organ function
Cardiac function
QTc interval must be ≤ 470 msec in females and ≤ 450 msec in males, based on the average obtained from three ECG
Adequate hematologic and organ function. QTc interval must be ≤ 470 msec in females and ≤ 450 msec in males, based on the average obtained from three ECG.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05398094 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require KRAS?
Yes, KRAS G12C is a required biomarker for enrollment.
Does this trial require EGFR?
Yes, EGFR sensitizing mutation is a required biomarker for enrollment.
Does this trial require ALK?
Yes, ALK fusion is a required biomarker for enrollment.
What disease stage is eligible?
Stage IIIA-N2 or IIIB or IIIC is required.
Is there an age limit?
Yes. Patients must be 80 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify