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Recruiting NCT07586202

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

Phase II Interventional Carcinoma, Non-Small-Cell Lung

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Amivantamab, Lazertinib, Carboplatin, Pemetrexed.
Who it may be relevant to
Registry conditions: Carcinoma, Non-Small-Cell Lung. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada, China, South Korea, Spain, Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Amivantamab
    Amivantamab will be administered.
  • Drug Lazertinib
    Lazertinib will be administered.
  • Drug Carboplatin
    Carboplatin will be administered.
  • Drug Pemetrexed
    Pemetrexed will be administered.

Primary outcome measures

  • Major Pathologic response (MPR) [Time frame: Up to 1 year 8 months]
Secondary outcome measures (5)
  • Pathological Complete Response (pCR) [Time frame: Up to 1 year 8 months]
  • Number of Participants with Pathologic Nodal Downstaging at the Time of Surgery [Time frame: Baseline and up to 1 year 8 months]
  • Disease Control Rate (DCR) [Time frame: Up to 1 year 8 months]
  • Number of Participants with Adverse Events (AEs) by Severity [Time frame: Up to 1 year 8 months]
  • Number of Participants with Abnormalities in Clinical Laboratory Parameters [Time frame: Up to 1 year 8 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 2 centers
  • West China Hospital Sichuan University — Chengdu
  • Guangdong Provincial People's Hospital — Guangzhou
Spain · 2 centers
  • Hosp. Gral. Univ. Dr. Balmis — Alicante
  • Hosp. Gral. Univ. Gregorio Maranon — Madrid
Taiwan · 2 centers
  • Chi Mei Medical Center Liouying Branch — Tainan
  • Taipei Medical University Hospital — Taipei
Canada · 1 center
  • Princess Margaret Hospital — Toronto
South Korea · 1 center
  • Samsung Medical Center — Seoul

Identifiers

NCT: NCT07586202 · 61186372PANSC2005 · 61186372PANSC2005

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗