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

Running, not enrolling · Phase 3

Conditions studied: Carcinoma, Non-Small-Cell Lung

In brief

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.

Key facts

Study ID

NCT04538664

Run by

Janssen Research & Development, LLC

People needed

308

Starts

2020-10-13

Expected to finish

2027-08-02

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California Irvine — Orange, California, United States
• UCLA — Santa Monica, California, United States
• Georgetown University Hospital — Washington D.C., District of Columbia, United States
• H. Lee Moffitt Cancer & Research Institute — Tampa, Florida, United States
• University Cancer And Blood Center LLC — Athens, Georgia, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Washington University Medical Center — St Louis, Missouri, United States
• Regional Cancer Care Associates LLC — East Brunswick, New Jersey, United States
• Langone Health at NYC University, NYU School of Medicine — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Providence Portland Medical Center — Portland, Oregon, United States
• Sanford Health — Sioux Falls, South Dakota, United States
• Texas Oncology Pa — Tyler, Texas, United States
• Utah Cancer Specialists — Salt Lake City, Utah, United States
• Virginia Cancer Specialists — Fairfax, Virginia, United States
• Blue Ridge Cancer Care — Salem, Virginia, United States
• Chris O'Brien Lifehouse — Camperdown, Australia
• St George Hospital — Kogarah, Australia
• Cabrini Medical Centre — Malvern, Australia
• Sir Charles Gairdner Hospital — Nedlands, Australia
• UZ Leuven — Leuven, Belgium
• Algemeen Ziekenhuis Delta — Roeselare, Belgium
• CHU UCL Namur - Site Godinne — Yvoir, Belgium
• Fundacao Pio XII — Barretos, Brazil
• City of Hope 2 — Duarte, California, United States

Full record on ClinicalTrials.gov

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