Amivantamab with Lazertinib or Chemotherapy before surgery in EGFR-mutated NSCLC

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 trial examines neoadjuvant therapy for resectable stage II–IIIB NSCLC with EGFR mutations. Participants receive amivantamab plus either lazertinib or standard chemotherapy (carboplatin and pemetrexed) before surgical tumor removal. The goal is to see if this combination can shrink tumors or halt progression prior to surgery while monitoring safety. Eligible participants include those with non-squamous NSCLC and good performance status who are candidates for complete resection. The study is conducted at several California sites with Janssen as the lead sponsor.

Why it matters

Who can join: the full rules

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

Where it's running

• City of Hope
  Duarte, California, United States Recruiting
• City of Hope 1
  Irvine, California, United States Recruiting
• Stanford Cancer Institute
  Stanford, California, United States Recruiting
• Providence Cancer Center
  Portland, Oregon, United States Recruiting
• Providence Oncology and Hematology Care Clinic Westside
  Portland, Oregon, United States Recruiting
• Virginia Cancer Specialists
  Fairfax, Virginia, United States Recruiting

Study contacts

• Study coordinator: Study Contact
• Email: Participate-In-This-Study1@its.jnj.com
• Phone: 844-434-4210

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Amivantamab with intrathecal pemetrexed for leptomeningeal metastasis from EGFR-mutated lung adenocarcinoma

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.