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NCT04077463 · ClinicalTrials.gov registry record · Phase 1
A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer
A Phase 1 study of Carcinoma, Non-Small Cell Lung, sponsored by Janssen Research & Development.
- Active
- Registry status
- Phase 1
- Development phase
- 701
- Enrollment target
- 20
- Study locations
NCT04077463: Active Phase 1 study of Carcinoma, Non-Small Cell Lung, sponsored by Janssen Research & Development.
NCT04077463 is a Phase 1 study of Carcinoma, Non-Small Cell Lung that is active but no longer recruiting, run by Janssen Research & Development. The registered enrollment target is 701 participants, above the 318-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (120% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04077463, a Phase 1 study of Carcinoma, Non-Small Cell Lung, is active but no longer recruiting, sponsored by Janssen Research & Development.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 701 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to confirm the tolerability of recommended Phase 2 dose (RP2D) of Lazertinib (Phase 1), to determine the tolerability and identify the recommended Phase 2 combination dose of Lazertinib when combined with Amivantamab (JNJ-61186372) (Phase 1b), to characterize the safety and tolerability of Lazertinib and Amivantamab combinations at the RP2CD in participants with advanced non-small cell lung cancer (NSCLC) with documented advanced or metastatic epidermal growth factor receptor (EGFR) mutation (Phase 1b expansion cohorts A, B, C, D and E), to estimate the antitumor activity of Lazertinib and Amivantamab combinations at the RP2CD in participants with advanced NSCLC with documented advanced or metastatic EGFR mutation (Phase 1b expansion cohorts A, B, C, and D), to validate the biomarker identified in Phase 1b expansion Cohort D as a predictor of antitumor activity of Lazertinib and Amivantamab combination (Cohort E) or Amivantamab monotherapy (Cohort F) in participants with osimertinib-relapsed, chemotherapy-naïve, EGFR Exon19del or L858R mutated NSCLC, to identify the recommended Phase 2 dose (RP2ChD) of Lazertinib when combined with Amivantamab and standard of care chemotherapy and to determine the tolerability of the Lazertinib, Amivantamab, and platinum-doublet chemotherapy (LACP) combination (Phase 1b LACP combination cohort) and to characterize the safety and tolerability of Lazertinib at the RP2ChD and Amivantamab and standard of care chemotherapy in participants with advanced or metastatic EGFR-mutated NSCLC (Phase 1b LACP combination cohort), to assess 2 potential biomarker strategies to identify participants at increased, or decreased, probability of tumor response with JNJ-61186372 and lazertinib combination in participants with EGFR Exon19del or L858R mutated NSCLC progressed on or after osimertinib (Phase 1b expansion Cohort D).
Primary Outcome
DLTs are defined as certain non-hematologic and hematologic toxicities of Grade 3 or higher.
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Pemetrexed
- DRUG Amivantamab
- DRUG Lazertinib
Study Locations (20)
California
- USC Norris Comprehensive Cancer Center - Los Angeles
- University of California Irvine - Orange
- UCSF Helen Diller Comprehensive - San Francisco
- Stanford University Medical Center - Stanford
- Cedars Sinai Medical Center - West Hollywood
Massachusetts
- Massachusetts General Hospital - Boston
- Dana Farber Cancer Institute - Boston
- Boston University Medical Center - Boston
New York
- Langone Health at NYC University, NYU School of Medicine - New York
- Columbia University Medical Center - New York
Other
- Beijing Cancer Hospital - Beijing
- The First Bethune Hospital of Jilin University - Changchun
Florida
- H. Lee Moffitt Cancer & Research Institute - Tampa
Michigan
- Barbara Ann Karmanos Cancer Institute - Detroit
Missouri
- Washington University School Of Medicine - St Louis
Oregon
- Providence Portland Medical Center - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 701 participants |
| Start Date | 2019-09-04 |
| Est. Completion | 2028-03-27 |
| Phase | Phase 1 |
What the registry record for NCT04077463 still lists
NCT04077463 is an interventional study that assigns participants to a tested intervention. The registered 701 participants enrollment target is mid-sized for trials with a published cap, above the 318-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (120% 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 Carboplatin is the first listed.
NCT04077463 names 20 study sites across 12 states, led by California, Massachusetts, New York.
Frequently Asked Questions
What is clinical trial NCT04077463 about?
NCT04077463 is a clinical study titled "A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer". The purpose of this study is to confirm the tolerability of recommended Phase 2 dose (RP2D) of Lazertinib (Phase 1), to determine the tolerability and identify the recommended Phase 2 combination dose of Lazertinib when combined with Amivantamab (JNJ-61186372) (Phase 1b), to characterize the safety ...
What is the current status of trial NCT04077463?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 701 participants. The study started on 2019-09-04. Estimated completion is 2028-03-27.
What conditions does trial NCT04077463 study?
This clinical trial studies the following conditions: Carcinoma, Non-Small Cell Lung.
What interventions are being tested in trial NCT04077463?
The interventions under investigation include: Carboplatin (DRUG), Pemetrexed (DRUG), Amivantamab (DRUG), Lazertinib (DRUG).
Who is sponsoring clinical trial NCT04077463?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04077463 being conducted?
This trial has 20 study locations across California, Florida, Massachusetts, Michigan, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04077463's enrollment target sits among peer trials
701 19th of 130 higher than 112 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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