Recruiting
Phase 2

Amivantamab & Lazertinib, Amivantamab & Chemotherapy

Sponsor:

Janssen Research & Development, LLC

Code:

NCT07586202

Conditions

Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Amivantamab

Lazertinib

Carboplatin

Pemetrexed

Study Details

Brief summary:

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Study ID

NCT07586202

Start date

Jul 28, 2026

Status verified date

Aug, 2026

Completion date

Apr 3, 2028

Anticipated

Primary completion date

Mar 2, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

68 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort 1: Amivantamab plus Lazertinib

Participants will receive amivantamab in combination with lazertinib.

experimental: Cohort 2: Amivantamab plus Carboplatin and Pemetrexed

Participants will receive amivantamab in combination with carboplatin and pemetrexed.

Interventions

Amivantamab

Amivantamab will be administered.

Lazertinib

Lazertinib will be administered.

Carboplatin

Carboplatin will be administered.

Pemetrexed

Pemetrexed will be administered.

Primary outcome measure

  • Major Pathologic response (MPR) [ Time Frame: Up to 1 year 8 months ]

Central Contacts and Locations

Central contacts

Study Contact

844-434-4210Participate-In-This-Study1@its.jnj.com

Locations

City of Hope

Recruiting

Duarte, California, United States, 91010

City of Hope 1

Recruiting

Irvine, California, United States, 92618

Providence Cancer Center

Recruiting

Portland, Oregon, United States, 97213

Providence Oncology and Hematology Care Clinic Westside

Recruiting

Portland, Oregon, United States, 97225

Princess Margaret Hospital

Recruiting

Toronto, Ontario, Canada, M5G 2C1

More Information

Sponsor

Janssen Research & Development, LLC

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Janssen Research & Development, LLC on 2026-08-28.