A Study of Amivantamab in Combination With Lazertinib, or Amivantamab in Combination With Platinum-Based Chemotherapy, for Common Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
a study on Lung Cancer Non-Small Cell Lung Cancer
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at UC Davis UC Irvine UCSD UCSF
- Dates
- study startedstudy ends around
Description
Summary
The primary purpose of the study is to assess how well amivantamab 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, amivantamab, lazertinib, 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 (sites in the US), or an accredited local laboratory (sites outside of the US) in accordance with site standard of care. In the European union (EU), the local test must be Conformité Européenne (CE)-marked or an in-house laboratory-developed test from health institutions in the EU in accordance with Article 5(5) of the in vitro diagnostic regulations (IVDR ) 2071/746, as amended
- 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. Participants with medical history of radiation pneumonitis, including radiation pneumonitis which required steroid treatment, should consult with the medical monitor and eligibility be assessed on a case-by-case basis
- 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) 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 San Diego Health
accepting new patients
La Jolla 5363943 California 5332921 92093 United States - University of California Irvine
accepting new patients
Orange 5379513 California 5332921 92868 United States - UC Davis Comprehensive Cancer Center
accepting new patients
Sacramento 5389489 California 5332921 95630 United States - UCSF Zuckerberg San Francisco General Hospital
accepting new patients
San Francisco 5391959 California 5332921 94143 United States - California Pacific Medical Center
accepting new patients
San Francisco 5391959 California 5332921 94115 United States - Kaiser Permanente San Francisco Medical Center
accepting new patients
San Francisco 5391959 California 5332921 94115 United States - Valkyrie Clinical Trials
accepting new patients
Los Angeles 5368361 California 5332921 90067 United States - Cedars Sinai Medical Center
accepting new patients
Los Angeles 5368361 California 5332921 90048 United States - City of Hope Seacliff
accepting new patients
Huntington Beach 5358705 California 5332921 92648 United States - City of Hope Orange County Lennar Foundation Cancer Center
accepting new patients
Irvine 5359777 California 5332921 92618 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 480 study participants
- Last Updated