NCT05498428

A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer

A Phase 2, Open-Label, Parallel Cohort Study of Subcutaneous Amivantamab in Multiple Regimens in Patients With Advanced or Metastatic Solid Tumors Including EGFR-mutated Non-Small Cell Lung Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 520 (estimated)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the anti-tumor activity and safety of amivantamab which will be administered as a co-formulation with recombinant human hyaluronidase PH20 (rHuPH20) (subcutaneous co-formulation \[SC-CF\]) in combination treatment (all cohorts except Cohort 4) and to characterize the safety of amivantamab SC-CF (Cohort 4).

Conditions

• Carcinoma, Non-small-Cell Lung

Interventions

Type	Name	Description
DRUG	Amivantamab	Amivantamab will be administered subcutaneously by manual injection.
DRUG	Lazertinib	Lazertinib will be administered as an oral tablet.
DRUG	Carboplatin	Carboplatin will be administrated by IV infusion.
DRUG	Pemetrexed	Pemetrexed will be administered by IV infusion.
DRUG	Direct Oral Anticoagulant (DOAC)	DOAC will be administered orally.
DRUG	Low Molecular Weight Heparin (LMWH)	LMWH will be administered subcutaneously.

Timeline

• Start date: 2022-11-11
• Primary completion: 2027-08-17
• Completion: 2028-08-18
• First posted: 2022-08-12
• Last updated: 2026-04-13

Locations

110 sites across 12 countries: United States, Brazil, China, France, Germany, Israel, Italy, Japan, Malaysia, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study