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NCT04538664 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Carcinoma, Non-Small Cell Lung, sponsored by Janssen Research & Development.
- Active
- Registry status
- Phase 3
- Development phase
- 308
- Enrollment target
- 20
- Study locations
NCT04538664 is a Phase 3 study of Carcinoma, Non-Small Cell Lung that is active but no longer recruiting, run by Janssen Research & Development. The registered enrollment target is 308 participants, roughly in line with the 321-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target. The trial reports 20 study locations across 14 states.
The verdict
NCT04538664, a Phase 3 study of Carcinoma, Non-Small Cell Lung, is active but no longer recruiting, sponsored by Janssen Research & Development.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 308 participants
- Enrollment target
- 20
- Study locations
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.
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Pemetrexed
- DRUG Amivantamab
Study Locations (20)
California
- City of Hope 2 - Duarte
- University of California Irvine - Orange
- UCLA - Santa Monica
Other
- Chris O'Brien Lifehouse - Camperdown
- St George Hospital - Kogarah
- Cabrini Medical Centre - Malvern
New York
- Langone Health at NYC University, NYU School of Medicine - New York
- Columbia University Medical Center - New York
Virginia
- Virginia Cancer Specialists - Fairfax
- Blue Ridge Cancer Care - Salem
District of Columbia
- Georgetown University Hospital - Washington D.C.
Florida
- H. Lee Moffitt Cancer & Research Institute - Tampa
Georgia
- University Cancer And Blood Center LLC - Athens
Michigan
- Henry Ford Hospital - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 308 participants |
| Start Date | 2020-10-13 |
| Est. Completion | 2027-08-02 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04538664
The ClinicalTrials.gov registry entry for NCT04538664 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 308 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 321-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target. The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Carcinoma, Non-Small Cell Lung appearing as the primary indexed condition, and to 3 interventions - of which Carboplatin is the first listed.
NCT04538664 reports 20 study locations spanning 14 distinct geographic areas - top geographies include California, Other, New York.
Frequently Asked Questions
What is clinical trial NCT04538664 about?
NCT04538664 is a clinical study titled "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". 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) charac...
What is the current status of trial NCT04538664?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 308 participants. The study started on 2020-10-13. Estimated completion is 2027-08-02.
What conditions does trial NCT04538664 study?
This clinical trial studies the following conditions: Carcinoma, Non-Small Cell Lung.
What interventions are being tested in trial NCT04538664?
The interventions under investigation include: Carboplatin (DRUG), Pemetrexed (DRUG), Amivantamab (DRUG).
Who is sponsoring clinical trial NCT04538664?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04538664 being conducted?
This trial has 20 study locations across California, District of Columbia, Florida, Georgia, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.