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NCT07586202RecruitingPhase 2

A Study of Neoadjuvant Amivantamab With Either Lazertinib or Chemotherapy in Participants With Resectable EGFR-Mutated NSCLC

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

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
68 (estimated)
First submitted
8 May 2026
Start date
28 Jul 2026
Primary completion date
2 Mar 2028
Lead sponsor
Janssen Research & Development, LLC
Diseases
Lung cancer
NCT number
NCT07586202

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 68
  • From 28 Jul 2026 to the primary completion date, 2 Mar 2028
  • 27 sites in 6 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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

Lab values

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (27)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Princess Margaret Hospital
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TorontoCanadaRecruiting
Beijing Cancer Hospital of Peking University
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BeijingChinaRecruiting
West China Hospital,Sichuan University
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ChengduChinaRecruiting
Sichuan Cancer Hospital
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Cheng Du ShiChinaRecruiting
Guangdong Provincial People's Hospital
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GuangzhouChinaRecruiting
Shandong Cancer Hospital
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JinanChinaRecruiting
Shanghai Pulmonary Hospital
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ShanghaiChinaRecruiting
Tianjin Chest Hospital
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TianjinChinaRecruiting
Hosp. Gral. Univ. Dr. Balmis
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AlicanteSpainRecruiting
Hosp Univ Vall D Hebron
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BarcelonaSpainRecruiting
Hosp. Gral. Univ. Gregorio Maranon
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MadridSpainRecruiting
Kyungpook National University Chilgok Hospital
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Buk GuSouth KoreaRecruiting
Pusan National University Hospital
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BusanSouth KoreaRecruiting
Korea University Guro Hospital
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SeoulSouth KoreaRecruiting
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaRecruiting
Samsung Medical Center
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SeoulSouth KoreaRecruiting
Taichung Veterans General Hospital
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TaichungTaiwanRecruiting
Chi Mei Medical Center Liouying Branch
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TainanTaiwanRecruiting
Taipei Medical University Hospital
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TaipeiTaiwanRecruiting
National Taiwan University Hospital
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TaipeiTaiwanRecruiting
NTU Biomedical Park Hospital
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ZhubeiTaiwanRecruiting
City of Hope
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DuarteUnited StatesRecruiting
Virginia Cancer Specialists
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FairfaxUnited StatesRecruiting
City of Hope 1
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IrvineUnited StatesRecruiting
Providence Oncology and Hematology Care Clinic - Westside
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PortlandUnited StatesRecruiting
Providence Cancer Center
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PortlandUnited StatesRecruiting
Stanford Cancer Institute
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StanfordUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.