Non-Small Cell Lung Cancer (NSCLC) Clinical Trials
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A Phase 2 Study Evaluating the Safety and Efficacy of Neoadjuvant Amivantamab in Combination With Lazertinib or Chemotherapy in Resectable EGFR-Mutated Non-Small Cell Lung Cancer
Status: Recruiting
Location: See all (20) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The purpose of this study is to assess the ability to slow down or stop the growth of cancer with amivantamab combined with either lazertinib or chemotherapy (carboplatin and pemetrexed) in participants with resectable, epidermal growth factor receptor (EGFR) mutated, Stage II-IIIB non-small cell lung cancer (NSCLC). NSCLC is the most common type of lung cancer. NSCLC may occur due to mutations (changes) in many genes, including EGFR.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Participant must have histologically or cytologically confirmed non-squamous non-small cell lung cancer (NSCLC) with completely resectable Stage II-IIIB N2 disease
• Complete surgical resection of the primary NSCLC must be deemed achievable, as assessed by a multidisciplinary team evaluation
• Participant must consent to a screening biopsy, if clinically feasible, if no adequate tumor tissue is available for a baseline sample
• Participant may have a prior or concurrent second malignancy (other than the disease under study) which natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s). Prior or concurrent second malignancies must be reviewed and agreed to with the medical monitor
• Have an eastern cooperative oncology group (ECOG) performance status of 0 or 1
Locations
United States
California
City of Hope
RECRUITING
Duarte
City of Hope 1
RECRUITING
Irvine
Oregon
Providence Cancer Center
RECRUITING
Portland
Providence Oncology and Hematology Care Clinic Westside
RECRUITING
Portland
Other Locations
Canada
Princess Margaret Hospital
RECRUITING
Toronto
China
Sichuan Cancer Hospital
RECRUITING
Cheng Du Shi
West China Hospital Sichuan University
RECRUITING
Chengdu
Guangdong Provincial People's Hospital
RECRUITING
Guangzhou
Shandong Cancer Hospital
RECRUITING
Jinan
Tianjin Chest Hospital
RECRUITING
Tianjin
Republic of Korea
Kyungpook National University Chilgok Hospital
RECRUITING
Buk Gu
Pusan National University Hospital
RECRUITING
Busan
Korea University Guro Hospital
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Spain
Hosp. Gral. Univ. Dr. Balmis
RECRUITING
Alicante
Hosp. Gral. Univ. Gregorio Maranon
RECRUITING
Madrid
Taiwan
Taichung Veterans General Hospital
RECRUITING
Taichung
Chi Mei Medical Center Liouying Branch
RECRUITING
Tainan
Taipei Medical University Hospital
RECRUITING
Taipei
NTU Biomedical Park Hospital
RECRUITING
Zhubei
Contact Information
Primary
Study Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Time Frame
Start Date:2026-07-28
Estimated Completion Date:2028-04-03
Participants
Target number of participants:68
Treatments
Experimental: Cohort 1: Amivantamab plus Lazertinib
Participants will receive amivantamab in combination with lazertinib.
Experimental: Cohort 2: Amivantamab plus Carboplatin and Pemetrexed
Participants will receive amivantamab in combination with carboplatin and pemetrexed.