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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 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 520

Last updated 2026-05-08

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-11
Primary Completion
2027-08-17
Completion
2028-08-18
FDA Drug
Yes

Countries

  • United States
  • Brazil
  • China
  • France
  • Germany
  • Israel
  • Italy
  • Japan
  • Malaysia
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05498428 on ClinicalTrials.gov