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NCT04988295 · ClinicalTrials.gov registry record · Phase 3
A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure
A Phase 3 study of Carcinoma, Non-Small Cell Lung, sponsored by Janssen Research & Development.
- Active
- Registry status
- Phase 3
- Development phase
- 776
- Enrollment target
- 20
- Study locations
NCT04988295: Active Phase 3 study of Carcinoma, Non-Small Cell Lung, sponsored by Janssen Research & Development.
NCT04988295 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 776 participants, above the 318-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (144% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04988295, 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
- 776 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to assess the efficacy of adding lazertinib to amivantamab, carboplatin, and pemetrexed (LACP/ACP-L dosing strategies) and amivantamab, carboplatin and pemetrexed (ACP) compared with carboplatin and pemetrexed (CP) in participants with locally advanced or metastatic epidermal growth factor receptor (EGFR) Exon 19del or Exon 21 L858R substitution non-small cell lung cancer (NSCLC) after osimertinib failure. The purpose of the extension cohort is to further describe the safety and efficacy for the ACP-L dosing schedule versus ACP with additional data. After completion of the primary analysis, the study may eventually transition to an open-label extension (OLE) or long-term extension (LTE) phase during which participants will have the option to continue their assigned treatment.
Primary Outcome
PFS is defined as the time from randomization until the date of objective disease progression or death, whichever came first, as assessed by BICR according to RECIST version 1.1. Progressed disease: Sum of diameters increased by greater than or equal to (\>=)20 percent (%) and \>=5 millimeter (mm) from nadir (including baseline if it was smallest sum).
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Pemetrexed
- DRUG Amivantamab
- DRUG Lazertinib
Study Locations (20)
California
- City of Hope - Duarte
- Cedars Sinai Medical Center - Los Angeles
- University of California Irvine - Orange
Texas
- Texas Oncology-Medical City Dallas - Dallas
- Texas Oncology Baylor Charles A Sammons Cancer Center - Dallas
- Texas Oncology - Grapevine
Oregon
- Providence Portland Medical Center - Portland
- Kaiser Permanente Northwest - Portland
Pennsylvania
- Alliance Cancer Specialists - Horsham
- University of Pittsburgh Medical Center - Pittsburgh
Alabama
- Southern Cancer Center, PC - Mobile
Arizona
- Arizona Oncology Associates - Tucson
Colorado
- Rocky Mountain Cancer Centers - Colorado Springs
Florida
- Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center - Fort Lauderdale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 776 participants |
| Start Date | 2021-11-17 |
| Est. Completion | 2026-09-30 |
| Phase | Phase 3 |
What the registry record for NCT04988295 still lists
NCT04988295 is an interventional study that assigns participants to a tested intervention. The registered 776 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 (144% 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.
NCT04988295 names 20 study sites across 14 states, led by California, Texas, Oregon.
Frequently Asked Questions
What is clinical trial NCT04988295 about?
NCT04988295 is a clinical study titled "A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure". The purpose of this study is to assess the efficacy of adding lazertinib to amivantamab, carboplatin, and pemetrexed (LACP/ACP-L dosing strategies) and amivantamab, carboplatin and pemetrexed (ACP) compared with carboplatin and pemetrexed (CP) in participants with locally advanced or metastatic epid...
What is the current status of trial NCT04988295?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 776 participants. The study started on 2021-11-17. Estimated completion is 2026-09-30.
What conditions does trial NCT04988295 study?
This clinical trial studies the following conditions: Carcinoma, Non-Small Cell Lung.
What interventions are being tested in trial NCT04988295?
The interventions under investigation include: Carboplatin (DRUG), Pemetrexed (DRUG), Amivantamab (DRUG), Lazertinib (DRUG).
Who is sponsoring clinical trial NCT04988295?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04988295 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04988295's enrollment target sits among peer trials
776 12th of 130 higher than 119 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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