OncoMatch/Clinical Trials/NCT07392658
Phase II Trial of Amivantamab Plus Monochemotherapy in Platinum Unfit NSCLC Patients With EGFR exon20 Insertion Mutations.
Is NCT07392658 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Amivantamab for metastatic nsclc - non-small cell lung cancer.
Treatment: Amivantamab — To assess safety and efficacy of amivantamab plus monochemotherapy in terms of ORR, PFS and OS in subjects with EGFR exon20 insertion mutations metastatic non-small cell lung cancer unfit for platinum-based chemotherapy.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR exon20 insertion
harboring EGFR exon20 insertion mutation
Disease stage
Required: Stage IV
Metastatic disease required
stage IV or recurrent non-squamous NSCLC harboring EGFR exon20 insertion mutation; At least one radiological measurable disease according to RECIST criteria version 1.1
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Cannot have received: egfr exon20ins-targeted tki
Lab requirements
Blood counts
ANC ≥ 1.5x10^9/L, platelets ≥75x10^9/L, haemoglobin >9 g/dl
Kidney function
Serum creatinine <1.5 x ULN and creatinine clearance >45 mL/min as measured or calculated; Unfit for platinum is defined by a glomerular filtration rate (GFR) value less than 50 ml/min/BSA 1.73 m2 (or a CCR value of <50 ml/min)
Liver function
Total bilirubin ≤1.5 x ULN; subjects with Gilbert's syndrome can enroll if conjugated bilirubin is within normal limits, transaminases no more than 3xULN/<5xULN in presence of liver metastases; Normal level of alkaline phosphatase
Adequate bone marrow function (ANC ≥ 1.5x10^9/L, platelets ≥75x10^9/L, haemoglobin >9 g/dl); Adequate liver function (Total bilirubin ≤1.5 x ULN; subjects with Gilbert's syndrome can enroll if conjugated bilirubin is within normal limits, transaminases no more than 3xULN/<5xULN in presence of liver metastases); Normal level of alkaline phosphatase and Serum creatinine <1.5 x ULN and creatinine clearance >45 mL/min as measured or calculated
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07392658 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 EGFR?
Yes, EGFR exon20 insertion is a required biomarker for enrollment.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
Is there an age limit?
Yes. Patients must be 99 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