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Active Not RecruitingPhase 3NCT04538664
Official study title

A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions

Study summary

The purpose of this study is to compare the efficacy, as demonstrated by progression-free survival (PFS), in participants treated with amivantamab in combination with chemotherapy, versus chemotherapy alone in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) characterized by EGFR Exon 20ins mutations.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedAmivantamab and Pemetrexed

Plus 2 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · EGFR · Locally advanced

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 31, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Active Not Recruiting

The study is underway but is not accepting new participants.

What kind of study?Phase 3

Interventional

Where is it offered?232 U.S. locations

Locations may change over time.

Who runs it?Janssen Research & Development, LLC

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
Janssen Research & Development, LLC
Interventions being studied
Drug: Amivantamab; Drug: Pemetrexed; Drug: Carboplatin; Drug: Pemetrexed
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Locally advanced→Metastatic or stage IV→
Biomarkers
EGFR→
Treatment approach
Chemotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Participant must have histologically or cytologically confirmed, locally advanced or metastatic, nonsquamous non-small cell lung cancer (NSCLC) with documented primary epidermal growth factor receptor (EGFR) Exon 20ins activating mutation
  • Participant must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
  • Participant must have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Participant must agree to genetic characterization of tumor status through the required pretreatment tumor biopsy (or submission of equivalent archival material), as well as baseline and periodic blood samples for analysis of tumor mutations in the bloodstream
  • A female participant of childbearing potential must have a negative serum or urine test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study
Reasons someone may not be able to joinExclusion criteria
  • Participant has evidence of synchronous NSCLC disease (as suggested by genetic characterization or radiographic appearance)
  • Participant has untreated brain metastases (a participant with definitively, locally treated metastases who is clinically stable, asymptomatic, and off corticosteroid treatment for at least 2 weeks prior to randomization is eligible)
  • Participant has history of spinal cord compression that has not been treated definitively with surgery or radiation
  • Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD, or radiation pneumonitis
  • Participant has a contraindication to the use of carboplatin or pemetrexed (refer to local prescribing information for each agent). Participant has a history of hypersensitivity to, or cannot take, vitamin B12 or folic acid

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • City of Hope 2Duarte, California
  • University of California IrvineOrange, California
  • UCLASanta Monica, California
  • Georgetown University HospitalWashington D.C., District of Columbia
  • H. Lee Moffitt Cancer & Research InstituteTampa, Florida
  • University Cancer And Blood Center LLCAthens, Georgia
  • Henry Ford HospitalDetroit, Michigan
  • Washington University Medical CenterSt Louis, Missouri
  • Regional Cancer Care Associates LLCEast Brunswick, New Jersey
  • Langone Health at NYC University, NYU School of MedicineNew York, New York
  • Columbia University Medical CenterNew York, New York
  • Providence Portland Medical CenterPortland, Oregon

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 31, 2026. Always confirm current availability with the study team.

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