Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine
Dates
study started
completion around

Description

Summary

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).

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

Keywords

Carcinoma, Non-Small-Cell Lung, Non-Small-Cell Lung Carcinoma, Carboplatin, Pemetrexed, Amivantamab-vmjw, Lazertinib, Amivantamab, Chemotherapy: Pemetrexed, Chemotherapy: Carboplatin, Amivantamab and Lazertinib, Amivantamab and Chemotherapy

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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)

Locations

  • University of California Irvine accepting new patients
    Orange California 92868 United States
  • Valkyrie Clinical Trials accepting new patients
    Los Angeles California 90067 United States
  • Cedars Sinai Medical Center accepting new patients
    Los Angeles California 90048 United States
  • The Oncology Institute of Hope and Innovation accepting new patients
    Glendale California 90015 United States
  • St. Joseph Hospital Center for Cancer Prevention and Treatment accepting new patients
    Orange California 92868 United States
  • Oncology Physicians Network Healthcare accepting new patients
    Glendale California 91203 United States
  • Los Angeles Cancer Network accepting new patients
    Glendale California 91204 United States
  • Glendale Adventist Medical Center accepting new patients
    Glendale California 91206 United States
  • USC Norris Comprehensive Cancer Center accepting new patients
    Los Angeles California 90033 United States
  • Cancer and Blood Specialty Clinic accepting new patients
    Los Alamitos California 90720 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Janssen Research & Development, LLC
ID
NCT06667076
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 365 study participants
Last Updated