A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer (NCT04077463)
An Open-label Phase 1/1b Study to Evaluate the Safety and Pharmacokinetics of JNJ-73841937 (Lazertinib), a Third Generation EGFR-TKI, as Monotherapy or in Combinations With JNJ-61186372, a Human Bispecific EGFR and cMet Antibody in Participants With Advanced Non-Small Cell Lung Cancer
🩺 Plain-English Summary (8th-Grade Level)
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).
Who can join: Review the eligibility criteria below.
Location: USC Norris Comprehensive Cancer Center — Los Angeles, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (78 Sites)
Showing the first 25 of 78 sites.
- USC Norris Comprehensive Cancer Center — Los Angeles, California
- University of California Irvine — Orange, California
- UCSF Helen Diller Comprehensive — San Francisco, California
- Stanford University Medical Center — Stanford, California
- Cedars Sinai Medical Center — West Hollywood, California
- H. Lee Moffitt Cancer & Research Institute — Tampa, Florida
- Massachusetts General Hospital — Boston, Massachusetts
- Dana Farber Cancer Institute — Boston, Massachusetts
- Boston University Medical Center — Boston, Massachusetts
- Barbara Ann Karmanos Cancer Institute — Detroit, Michigan
- Washington University School Of Medicine — St Louis, Missouri
- Langone Health at NYC University, NYU School of Medicine — New York, New York
- Columbia University Medical Center — New York, New York
- Providence Portland Medical Center — Portland, Oregon
- University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced Medicine — Philadelphia, Pennsylvania
- Huntsman Cancer Institute — Salt Lake City, Utah
- Virginia Cancer Specialists — Fairfax, Virginia
- University of Washington — Seattle, Washington
- Beijing Cancer Hospital — Beijing,
- The First Bethune Hospital of Jilin University — Changchun,
- Hunan Cancer hospital — Changsha,
- West China School of Medicine/West China Hospital, Sichuan University — Chengdu,
- Chongqing University Cancer Hospital — Chongqing,
- The Fifth Affiliated Hospital of Guangzhou Medical University — Guangzhou,
- Zhejiang Cancer Hospital — Hangzhou,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.