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NCT04487080 · ClinicalTrials.gov registry record · Phase 3
A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer
A Phase 3 study of Carcinoma, Non-Small Cell Lung, sponsored by Janssen Research & Development.
- Active
- Registry status
- Phase 3
- Development phase
- 1,074
- Enrollment target
- 20
- Study locations
NCT04487080: Active Phase 3 study of Carcinoma, Non-Small Cell Lung, sponsored by Janssen Research & Development.
NCT04487080 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 1,074 participants, above the 316-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (240% higher). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04487080, 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
- 1,074 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to assess the efficacy of the amivantamab and lazertinib combination, compared with osimertinib, in participants with epidermal growth factor receptor (EGFR) mutation (Exon 19 deletions \[Exon 19del\] or Exon 21 L858R substitution) positive, locally advanced or metastatic non-small cell lung cancer (NSCLC).
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) the absence of progression, whichever came first. Disease progression was defined using RECIST 1.1 as a 20 percent (%) increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 millimeters (mL). Participants who have not progressed or have not died at the time of ana
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Osimertinib
- DRUG Amivantamab
- DRUG Lazertinib
Study Locations (20)
Arizona
- Arizona Oncology Associates, PC - HAL - Goodyear
- Yuma Regional Medical Center - Yuma
California
- City of Hope Long Beach Elm - Long Beach
- University of California Irvine - Orange
Minnesota
- Minnesota Oncology Hematology P A - Edina
- Mayo Clinic - Rochester
Texas
- Texas Oncology P A - Austin
- Oncology Consultants Texas - Houston
Colorado
- Rocky Mountain Cancer Centers - Lone Tree
Florida
- Cancer Specialists of North Florida - Jacksonville
Georgia
- University Cancer And Blood Center LLC - Athens
Louisiana
- East Jefferson General Hospital - Metairie
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,074 participants |
| Start Date | 2020-09-30 |
| Est. Completion | 2027-06-29 |
| Phase | Phase 3 |
What the registry record for NCT04487080 still lists
NCT04487080 is an interventional study that assigns participants to a tested intervention. Its 1,074 participants enrollment target places it among the larger protocols in the corpus, above the 316-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (240% higher).
The record links to 1 condition, with Carcinoma, Non-Small Cell Lung appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT04487080 names 20 study sites across 16 states, led by Arizona, California, Minnesota.
Frequently Asked Questions
What is clinical trial NCT04487080 about?
NCT04487080 is a clinical study titled "A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer". The purpose of this study is to assess the efficacy of the amivantamab and lazertinib combination, compared with osimertinib, in participants with epidermal growth factor receptor (EGFR) mutation (Exon 19 deletions \[Exon 19del\] or Exon 21 L858R substitution) positive, locally advanced or metastati...
What is the current status of trial NCT04487080?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,074 participants. The study started on 2020-09-30. Estimated completion is 2027-06-29.
What conditions does trial NCT04487080 study?
This clinical trial studies the following conditions: Carcinoma, Non-Small Cell Lung.
What interventions are being tested in trial NCT04487080?
The interventions under investigation include: Placebo (DRUG), Osimertinib (DRUG), Amivantamab (DRUG), Lazertinib (DRUG).
Who is sponsoring clinical trial NCT04487080?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04487080 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04487080's enrollment target sits among peer trials
1,074 4th of 130 higher than 127 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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