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.
Written informed consent;
Male or female patient aged ≥18 years;
Histologically or cytologically confirmed stage IV or recurrent non-squamous NSCLC harboring EGFR exon20 insertion mutation;
No prior systemic treatment;
Uncontrolled infectious liver disease;
Positive hepatitis B (hepatitis B virus [HBV]) surface antigen (HBsAg) Note: participants with a prior history of HBV demonstrated by positive hepatitis B core antibody are eligible if they have at Screening 1) a negative HBsAg and 2) a HBV DNA (viral load) below the lower limit of quantification, per local testing. Subjects with a positive HBsAg due to recent vaccination are eligible if HBV DNA (viral load) is below the lower limit of quantification, per local testing.
Positive hepatitis C antibody (anti-HCV). Note: participants with a prior history of HCV, who have completed antiviral treatment and have subsequently documented HCV RNA below the lower limit of quantification per local testing are eligible.
Uncontrolled (persistent) hypertension: systolic blood pressure >160 mm Hg; diastolic blood pressure >100 mm Hg.
Single group
Amivantamab
DrugSubcutaneous amivantamab at the dose of 1600 mg (2240 mg, ≥80 kg) on cycle 1 day 1, than at the dose of 2400 mg (3360 mg, ≥80 kg) on cycle 1 day 8 and 15 and than every 3 weeks starting from cycle 2 day 1, in combination with monochemoterapy (investigator's choice between pemetrexed 500 mg/m2 IV Q3W or gemcitabine 1000 mg/m2 IV day 1-8 Q3W)
ORR
Objective Response Rate (ORR) according to RECIST 1.1
Click on the lead sponsor to view all of their trials.
