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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: Active Phase 3 study of Carcinoma, Non-Small Cell Lung, sponsored by Janssen Research & Development.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
PFS was defined as the time from randomization until the date of objective disease progression based on BICR using RECIST version 1.1 or death (by any cause) in the absence of progression, whichever came first. Participants who have not progressed or have not died at the time of analysis were censored at the time of the latest date of their last evaluable RECIST version 1.1 assessment. Pharmacodynamic: Sum of diameters increased by greater than or equal to (\>=)20 percent (%) and \>=5 millimeter
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 |
What the registry record for NCT04538664 still lists
NCT04538664 is an interventional study that assigns participants to a tested intervention. The registered 308 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 321-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target.
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 names 20 study sites across 14 states, led by 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04538664's enrollment target sits among peer trials
308 41st of 130 higher than 90 of 130 other Carcinoma, Non-Small Cell Lung trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Carcinoma, Non-Small Cell Lung trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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