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Active (not recruiting) Phase 3 NCT05388669

A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer

Phase 3 – large-scale trial before approval
Conditions: Advanced or Metastatic Non-small Cell Lung Cancer

Sponsor: Janssen Research & Development, LLC

trial.available_in: БГ
Overview
The purpose of the study is to simplify amivantamab intravenous administration and to reduce dose times, by assessing a new formulation of amivantamab, amivantamab subcutaneous and co-formulated with recombinant human hyaluronidase (SC-CF), for subcutaneous administration. This formulation has the potential to enhance both the patient and physician experience with amivantamab by providing easier and accelerated administration.
Who can participate
Inclusion Criteria: * Have histologically or cytologically confirmed, advanced or metastatic non-small cell lung cancer (NSCLC), characterized by either epidermal growth factor receptor (EGFR) Exon 19 deletion (Exon 19del) or Exon 21 leucine 858 to arginine substitution (Exon 21 L858R) mutation by an Food and Drug Administration (FDA)-approved or other validated test of either circulating tumor deoxyribonucleic acid (ctDNA) or tumor tissue in a clinical laboratory improvement amendments (CLIA) certified laboratory (sites in the United Started \[US\]) or an accredited local laboratory (sites outside of the US) * Have progressed on or after osimertinib (or another approved 3rd generation epidermal growth factor receptor \[EGFR\] tyrosine kinase inhibitor \[TKI\]) and platinum-based chemotherapy (irrespective of order). a) The 3rd generation EGFR TKI must have been administered as the first EGFR TKI for metastatic disease or as the second TKI after prior treatment with first- or second-generation EGFR TKI in participants with metastatic EGFR T790M mutation positive NSCLC. b) Participants who decline or are otherwise ineligible for chemotherapy may be enrolled after discussion with the medical monitor. c) Any adjuvant or neoadjuvant treatment, whether with a 3rd generation EGFR TKI or platinum based chemotherapy, would count towards the prior treatment requirement if the participant experienced disease * Have at least 1 measurable lesion, according to response evaluation criteria in solid tumors (RECIST) version 1.1 * Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1 * Any toxicities from prior anticancer therapy must have resolved to common terminology criteria for adverse events (CTCAE) Version 5.0 Grade 1 or baseline level (except for alopecia \[any grade\], Grade less than or equal to (\<=) 2 peripheral neuropathy, and Grade \<=2 hypothyroidism stable on hormone replacement) Exclusion Criteria: * Participant has received cytotoxic, investigational, or targeted therapies beyond one regimen of platinum-based chemotherapy and EGFR inhibitors * Participant has received radiotherapy for palliative purposes less than 7 days prior to randomization * Participant has symptomatic or progressive brain metastases * Participant has leptomeningeal disease, or participant has spinal cord compression not definitively treated with surgery or radiation * Participant has uncontrolled tumor-related pain * Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis
Locations 19
Argentina (1)
CEMIC (Centro de Educación Médica e Investigaciones Clínicas)
Buenos Aires
Australia (1)
Cancer Research SA
Adelaide
Brazil (1)
Fundacao Pio XII
Barretos
Canada (1)
The Ottawa Hospital Cancer Centre
Ottawa , Ontario
China (1)
Beijing Shijitan Hospital, Capital Medical University
Beijing
France (1)
CHU Grenoble
La Tronche
Germany (1)
Evangelische Lungenklinik Berlin
Berlin
Israel (1)
Rambam Medical Center
Haifa
Italy (1)
Oncologia Medica - Irccs - Istituto Tumori Giovanni Paolo II
Bari
Japan (1)
National Cancer Center Hospital
Chūōku
Malaysia (1)
Prince Court Medical Centre
Kuala Lumpur
Poland (1)
Centrum Onkologii im Prof F Lukaszczyka w Bydgoszczy
Bydgoszcz
South Korea (1)
National Cancer Center
Gyeonggi-do
Spain (1)
Hosp Univ A Coruna
A Coruña
Taiwan (1)
Changhua Christian Hospital
Changhua
Thailand (1)
Phramongkutklao Hospital and Medical College
Bangkok
Turkey (1)
Adana City Hospital
Adana
United Kingdom (1)
Birmingham Heartlands Hospital
Birmingham
United States (1)
City of Hope Duarte
Duarte , California
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
05.08.2022
Completion date
30.06.2027
Registry ID
NCT05388669
Source
anzctr
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