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RecruitingPhase 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests amivantamab with either lazertinib or chemotherapy (carboplatin and pemetrexed) before surgery to see if it slows or stops cancer growth. It is for people with stage II–IIIB non-small cell lung cancer that has an EGFR gene change and can be fully removed by surgery.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have non-squamous non-small cell lung cancer confirmed by a tissue or cell test. The cancer must be stage II–IIIB N2, which describes its size and spread to nearby lymph nodes.
  • A team of medical specialists must agree that surgery can fully remove the lung cancer.
  • Agree to a biopsy (removal of a small tissue sample) if there is not enough tumor tissue for testing and a biopsy is medically possible.
  • Another past or current cancer may be allowed if it is unlikely to affect study safety or results. The study’s medical monitor must approve.
  • Be fully active or able to do light work, with limits only on hard physical activity (ECOG score of 0 or 1).

Who can't join

  • Have a history of an illness that is not under control.
  • Have or previously had lung inflammation or scarring called ILD or pneumonitis that was not caused by infection, or have possible disease that screening scans cannot rule out.
  • Have a known or suspected allergy, sensitivity, or intolerance to added ingredients in amivantamab, lazertinib, carboplatin, or pemetrexed.
  • Have other main cancer-driving gene changes besides EGFR Exon 19del or Exon 21 L858R, found by local gene testing. These include ALK, MET, HER2, ROS1, NTRK, BRAF, RET, or KRAS changes.
  • Have already received lung cancer medicine that travels through the body, such as EGFR-targeted drugs, chemotherapy, biologic therapy, immunotherapy, or an experimental drug.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (4)

CA

OR