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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Primary outcome measure(s)
Major Pathologic response (MPR) — Up to 1 year 8 months MPR is defined as less than or equal to (\<= ) 10 percent (%) residual cancer cells in the surgical specimen, per independent centralized pathology review.
Trial sites (20)
Facility
City
Region
Status
City of Hope
Duarte
California
Recruiting
City of Hope 1
Irvine
California
Recruiting
Providence Cancer Center
Portland
Oregon
Recruiting
Providence Oncology and Hematology Care Clinic Westside
Portland
Oregon
Recruiting
Princess Margaret Hospital
Toronto
Ontario
Recruiting
Sichuan Cancer Hospital
Cheng Du Shi
China
Recruiting
West China Hospital Sichuan University
Chengdu
China
Recruiting
Guangdong Provincial People's Hospital
Guangzhou
China
Recruiting
Shandong Cancer Hospital
Jinan
China
Recruiting
Tianjin Chest Hospital
Tianjin
China
Recruiting
Kyungpook National University Chilgok Hospital
Buk Gu
South Korea
Recruiting
Pusan National University Hospital
Busan
South Korea
Recruiting
Samsung Medical Center
Seoul
South Korea
Recruiting
Korea University Guro Hospital
Seoul
South Korea
Recruiting
Hosp. Gral. Univ. Dr. Balmis
Alicante
Spain
Recruiting
Hosp. Gral. Univ. Gregorio Maranon
Madrid
Spain
Recruiting
Taichung Veterans General Hospital
Taichung
Taiwan
Recruiting
Chi Mei Medical Center Liouying Branch
Tainan
Taiwan
Recruiting
Taipei Medical University Hospital
Taipei
Taiwan
Recruiting
NTU Biomedical Park Hospital
Zhubei
Taiwan
Recruiting
More Janssen Research & Development, LLC trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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