drugset
drugset / Trial / 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

NCT05498428 ↗

Phase 2 Recruiting 520 enrolled Janssen Research & Development, LLC
Non-randomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start
2022-11-11
Primary completion
2027-08-17
Completion
2028-08-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Amivantamab Monoclonal antibody 1600 mg Subcutaneous
Subject Amivantamab Monoclonal antibody 2240 mg Subcutaneous
Subject Amivantamab Monoclonal antibody 2400 mg Subcutaneous
Subject Amivantamab Monoclonal antibody 3360 mg Subcutaneous
Subject Amivantamab Monoclonal antibody 3520 mg Subcutaneous
Subject Amivantamab Monoclonal antibody 4640 mg Subcutaneous
Subject Carboplatin Small molecule 5 mg/ml Intravenous
Subject Carboplatin Small molecule 750 mg Intravenous
Subject Lazertinib Small molecule 240 mg Oral
Subject Pemetrexed Small molecule 500 mg/m2 Intravenous
Background Enoxaparin sodium Other / unclassified — Subcutaneous
Background Rivaroxaban Other / unclassified — Oral

Indications

non-small cell lung carcinoma