Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04988295
The ClinicalTrials.gov registry entry for NCT04988295 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 776 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 318-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (144% higher). The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 14 distinct geographic areas - top geographies include 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
Similar trials for Carcinoma, Non-Small Cell Lung
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.
-
A Global Phase III Study of Rilvegostomig or Pembrolizumab Monotherapy for First-Line Treatment of PD-L1-high Metastatic Non-small Cell Lung Cancer
RECRUITING · Phase 3
-
A Study to Investigate the Efficacy of Durvalumab Plus Tremelimumab in Combination With Chemotherapy Compared With Pembrolizumab in Combination With Chemotherapy in Metastatic NSCLC Patients With Non-squamous Histology Who Have Mutations and/or Co-mutations in STK11, KEAP1, or KRAS
RECRUITING · Phase 3
-
This is a Study to Learn About How the Combination of the Study Medicines Sigvotatug Vedotin Plus Pembrolizumab Works in People With Non-small Cell Lung Cancer With High Levels of PD-L1.
RECRUITING · Phase 3
-
Study of Olomorasib (LY3537982) in Combination With Standard of Care in Participants With Resected or Unresectable KRAS G12C-mutant Non-Small Cell Lung Cancer
RECRUITING · Phase 3
-
A Study of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)
RECRUITING · Phase 3
-
A Study of Pembrolizumab (MK-3475) With or Without Intismeran Autogene (V940) in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009)
RECRUITING · Phase 3
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.