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A Phase 2b, Open-Label, Two-cohort Study of Subcutaneous Amivantamab in Combination With Lazertinib as First-Line Treatment, or Subcutaneous Amivantamab in Combination With Platinum-Based Chemotherapy as Second-line Treatment, for Common EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Overall Recruitment Status: Active, currently enrolling
 
Official Title
A Phase 2b, Open-Label, Two-cohort Study of Subcutaneous Amivantamab in Combination With Lazertinib as First-Line Treatment, or Subcutaneous Amivantamab in Combination With Platinum-Based Chemotherapy as Second-line Treatment, for Common EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
 
Region Sponsors
California - Northern
Janssen Research & Development, LLC
 
Acronym NCT No.
COPERNICUS NCT06667076
 
Study Type Phase
INTERVENTIONAL
Phase II
 
Purpose
The primary purpose of the study is to assess how well amivantamab subcutaneous (SC) administration in combination with lazertinib or in combination with chemotherapy works (antitumor activity) in participants with epidermal growth factor receptor mutated (EGFRm) non-small cell lung cancer (NSCLC; that is one of the major types of lung cancer).
 
Detailed Description
 
 
 
Inclusion Criteria
  • Have histologically or cytologically confirmed advanced or metastatic non-small cell lung cancer (NSCLC) that is not amenable to curative intent therapy
  • Epidermal growth factor resistance-mutation (EGFRm) must be an Ex19del or Ex21 L858R substitution, as detected by food and drug administration (FDA)-approved or other validated test in a clinical laboratory improvement amendments (CLIA)-certified laboratory in accordance with site standard of care
  • Have at least 1 measurable lesion, according to RECIST version (v)1.1, that has not been previously irradiated
  • Any toxicities from prior systemic anticancer therapy must have resolved to national cancer institute common terminology criteria for adverse events (NCI-CTCAE) version 5.0 grade 1 or baseline level (except for alopecia \[any grade\], grade \<=2 peripheral neuropathy, or grade \<=2 hypothyroidism stable on hormone replacement)
  • Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1
 
Exclusion Criteria
  • Medical history of active interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis
  • Had major surgery excluding placement of vascular access or tumor biopsy or had significant traumatic injury within 4 weeks before the first dose of anticancer treatments or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study
  • Participant has uncontrolled tumor-related pain (symptomatic lesions amenable to palliative radiotherapy should be treated prior to first dosing)
  • Received an investigational treatment that has not been cleared (based on at least 5 half lives of any pharmaceutical treatment) or within 12 months before the planned first dose of study treatment or is currently enrolled in an investigational study
  • Has a prior or concurrent second malignancy (other than the disease under study) which natural history or treatment could likely interfere with any study endpoints of safety or the efficacy of the study treatment(s)
 
Keywords and/or Specific Medical Conditions
  • Bronchial Neoplasms
  • Non-Small-Cell Lung
  • Bronchogenic
  • Oncology (Adult)
  • Carcinoma
  • Respiratory Tract Diseases
  • Lung Diseases
  • Respiratory Tract Neoplasms
  • Lung Neoplasms
  • Thoracic Neoplasms
  • Neoplasms
  • Carcinoma
  • Neoplasms by Site
 
KP Clinical Facility
  • Vallejo Medical Center
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Jennifer Maire Suga
Contact Information:
- CTP Collaborate Team
-CTPCollaborate@kp.org
-All Kaiser Permanente Northern California Medical Centers


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