What this study is
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.
What's being tested
- Amivantamab
Intervention · DRUG
Amivantamab will be administered.
- Lazertinib
Intervention · DRUG
Lazertinib will be administered.
- Carboplatin
Intervention · DRUG
Carboplatin will be administered.
- Pemetrexed
Intervention · DRUG
Pemetrexed will be administered.
Study details
- Official title
- 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
- Sponsor
- Janssen Research & Development, LLC
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Enrolling
- 68 people
- Starts
- 2026-07-28
- Est. completion
- 2028-04-03
- Design
- Open-label, non-randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- History of uncontrolled illness
- Medical history of (non-infectious) interstitial lung disease (ILD)/pneumonitis, or has current interstitial lung disease (ILD)/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
- Suspected or known allergies, hypersensitivity, or intolerance to excipients of: the combination of amivantamab and lazertinib or carboplatin and pemetrexed
- Presence of primary driver mutations (anaplastic lymphoma kinase [ALK], mesenchymal-epithelial transition [MET], human epidermal growth factor receptor 2 [HER2], proto-oncogene tyrosine-protein kinase ROS [ROS1], neurotrophic tyrosine receptor kinase [NTRK], B-Raf proto-oncogene [BRAF], REarranged during transfection [RET], or kirsten rat sarcoma viral oncogene homolog [KRAS]) , besides EGFR Exon 19del or Exon 21 L858R mutations, as determined by local genomic testing
- Prior treatment with any systemic anti-cancer therapy for NSCLC including EGFR-tyrosine kinase inhibitor (TKI) therapy, chemotherapy, biologic therapy, immunotherapy, or any investigational drug
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (27)
27 openCity of Hope
Duarte, California, United States
RecruitingCity of Hope 1
Irvine, California, United States
RecruitingStanford Cancer Institute
Stanford, California, United States
RecruitingProvidence Cancer Center
Portland, Oregon, United States
RecruitingProvidence Oncology and Hematology Care Clinic Westside
Portland, Oregon, United States
RecruitingVirginia Cancer Specialists
Fairfax, Virginia, United States
Recruiting
21 sites outside the US
Princess Margaret Hospital
Toronto, Ontario, Canada
RecruitingBeijing Cancer Hospital of Peking University
Beijing, China
RecruitingSichuan Cancer Hospital
Cheng Du Shi, China
RecruitingWest China Hospital Sichuan University
Chengdu, China
RecruitingGuangdong Provincial People's Hospital
Guangzhou, China
RecruitingShandong Cancer Hospital
Jinan, China
RecruitingShanghai Pulmonary Hospital
Shanghai, China
RecruitingTianjin Chest Hospital
Tianjin, China
RecruitingKyungpook National University Chilgok Hospital
Buk Gu, South Korea
RecruitingPusan National University Hospital
Busan, South Korea
RecruitingSeverance Hospital Yonsei University Health System
Seoul, South Korea
RecruitingSamsung Medical Center
Seoul, South Korea
RecruitingKorea University Guro Hospital
Seoul, South Korea
RecruitingHosp. Gral. Univ. Dr. Balmis
Alicante, Spain
RecruitingHosp Univ Vall D Hebron
Barcelona, Spain
RecruitingHosp. Gral. Univ. Gregorio Maranon
Madrid, Spain
RecruitingTaichung Veterans General Hospital
Taichung, Taiwan
RecruitingChi Mei Medical Center Liouying Branch
Tainan, Taiwan
RecruitingNational Taiwan University Hospital
Taipei, Taiwan
RecruitingTaipei Medical University Hospital
Taipei, Taiwan
RecruitingNTU Biomedical Park Hospital
Zhubei, Taiwan
Recruiting
Study team
Sponsor
Janssen Research & Development, LLC
Study ID 61186372PANSC2005
Study director
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.