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 (May 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
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)
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.
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