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NCT07586202From ClinicalTrials.govRecruiting

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

  • Carcinoma, Non-Small-Cell Lung

At a glance

Phase
Phase 2
Study type
Interventional
Sponsor
Janssen Research & Development, LLC
Enrolment target
68
Started
28 July 2026
Main results due
2 March 2028
Study sites
23
Registry updated
25 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
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

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(23)

  • City of Hope

    Duarte, California, United States

    Recruiting

  • City of Hope 1

    Irvine, California, United States

    Recruiting

  • Providence Cancer Center

    Portland, Oregon, United States

    Recruiting

  • Providence Oncology and Hematology Care Clinic Westside

    Portland, Oregon, United States

    Recruiting

  • Princess Margaret Hospital

    Toronto, Ontario, Canada

    Recruiting

  • Beijing Cancer Hospital of Peking University

    Beijing, China

    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

  • Shanghai Pulmonary Hospital

    Shanghai, 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

  • Severance Hospital Yonsei University Health System

    Seoul, 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

Showing 23 of 23 sites. 23 of the 23 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07586202. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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A Study of Neoadjuvant Amivantamab With Either Lazertinib or Chemotherapy in Participants With Resectable EGFR | Trialion