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NCT02609776 · ClinicalTrials.gov registry record · Phase 1
Study of Amivantamab, a Human Bispecific EGFR and cMet Antibody, in Participants With Advanced Non-Small Cell Lung Cancer
A Phase 1 study of Non-Small Cell Lung Cancer, sponsored by Janssen Research & Development.
- Active
- Registry status
- Phase 1
- Development phase
- 751
- Enrollment target
- 20
- Study locations
NCT02609776: Active Phase 1 study of Non-Small Cell Lung Cancer, sponsored by Janssen Research & Development.
NCT02609776 is a Phase 1 study of Non-Small Cell Lung Cancer that is active but no longer recruiting, run by Janssen Research & Development. The registered enrollment target is 751 participants, above the 651-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (15% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02609776, a Phase 1 study of Non-Small Cell Lung Cancer, is active but no longer recruiting, sponsored by Janssen Research & Development.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 751 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of study is to evaluate the safety, pharmacokinetics, and preliminary efficacy of Amivantamab as a monotherapy and in combination with lazertinib, and to determine the recommended Phase 2 dose (RP2D) (monotherapy), recommended Phase 2 combination dose (RP2CD) (combination therapy), and to determine recommended Phase 2 Dose (RP2q3W) with combination chemotherapy (Amivantamab in combination with standard of care carboplatin and pemetrexed) in 21 day treatment cycle for participants with advanced non-small cell lung cancer (NSCLC).
Primary Outcome
The Dose Limiting Toxicity (DLT) is based on drug related adverse events and includes unacceptable hematologic toxicity, non-hematologic toxicity of Grade 3 or higher, or elevations in hepatic enzymes suggestive of drug-induced liver injury.
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Pemetrexed
- DRUG Amivantamab
- DRUG Lazertinib
Study Locations (20)
California
- - Duarte
- - La Jolla
- - Orange
- - Santa Monica
- - West Hollywood
Other
- - Camperdown
- - Heidelberg
- - Kogarah
Florida
- - Tampa
Illinois
- - Chicago
Maryland
- - Bethesda
Massachusetts
- - Boston
Michigan
- - Detroit
Minnesota
- - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 751 participants |
| Start Date | 2016-05-24 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
What the registry record for NCT02609776 still lists
NCT02609776 is an interventional study that assigns participants to a tested intervention. The registered 751 participants enrollment target is mid-sized for trials with a published cap, above the 651-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (15% higher).
The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 4 interventions - of which Carboplatin is the first listed.
NCT02609776 names 20 study sites across 14 states, led by California, Other, Florida.
Frequently Asked Questions
What is clinical trial NCT02609776 about?
NCT02609776 is a clinical study titled "Study of Amivantamab, a Human Bispecific EGFR and cMet Antibody, in Participants With Advanced Non-Small Cell Lung Cancer". The purpose of study is to evaluate the safety, pharmacokinetics, and preliminary efficacy of Amivantamab as a monotherapy and in combination with lazertinib, and to determine the recommended Phase 2 dose (RP2D) (monotherapy), recommended Phase 2 combination dose (RP2CD) (combination therapy), and t...
What is the current status of trial NCT02609776?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 751 participants. The study started on 2016-05-24. Estimated completion is 2026-12-31.
What conditions does trial NCT02609776 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer.
What interventions are being tested in trial NCT02609776?
The interventions under investigation include: Carboplatin (DRUG), Pemetrexed (DRUG), Amivantamab (DRUG), Lazertinib (DRUG).
Who is sponsoring clinical trial NCT02609776?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02609776 being conducted?
This trial has 20 study locations across California, Florida, Illinois, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02609776's enrollment target sits among peer trials
751 39th of 454 higher than 416 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer 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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