A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions
Phase 3 – large-scale trial before approval
Conditions:
Carcinoma, Non-Small-Cell Lung
Sponsor: Janssen Research & Development, LLC
trial.available_in:
БГ
Overview
The purpose of this study is to compare the efficacy, as demonstrated by progression-free survival (PFS), in participants treated with amivantamab in combination with chemotherapy, versus chemotherapy alone in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) characterized by EGFR Exon 20ins mutations.
Who can participate
Inclusion Criteria:
* Participant must have histologically or cytologically confirmed, locally advanced or metastatic, nonsquamous non-small cell lung cancer (NSCLC) with documented primary epidermal growth factor receptor (EGFR) Exon 20ins activating mutation
* Participant must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
* Participant must have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Participant must agree to genetic characterization of tumor status through the required pretreatment tumor biopsy (or submission of equivalent archival material), as well as baseline and periodic blood samples for analysis of tumor mutations in the bloodstream
* A female participant of childbearing potential must have a negative serum or urine test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study
Exclusion Criteria:
* Participant has evidence of synchronous NSCLC disease (as suggested by genetic characterization or radiographic appearance)
* Participant has untreated brain metastases (a participant with definitively, locally treated metastases who is clinically stable, asymptomatic, and off corticosteroid treatment for at least 2 weeks prior to randomization is eligible)
* Participant has history of spinal cord compression that has not been treated definitively with surgery or radiation
* Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD, or radiation pneumonitis
* Participant has a contraindication to the use of carboplatin or pemetrexed (refer to local prescribing information for each agent). Participant has a history of hypersensitivity to, or cannot take, vitamin B12 or folic acid
Locations
25
Australia (1)
Chris O'Brien Lifehouse
Camperdown
Belgium (1)
UZ Leuven
Leuven
Brazil (1)
Fundacao Pio XII
Barretos
Canada (1)
The Ottawa Hospital Cancer Centre
Ottawa , Ontario
China (1)
Beijing Cancer Hospital Chest Tumor Internal Medicine dept. II
Beijing
France (1)
Institut Bergonie
Bordeaux
Germany (1)
Zentralklinik Bad Berka GmbH
Bad Berka
Hungary (1)
Orszagos Koranyi Tbc es Pulmonologiai Intezet
Budapest
India (1)
Basavatarakam Indo-American Hospital
Hyderabad
Israel (1)
Shaare Zedek Medical Center
Jerusalem
Italy (1)
A O U Sant Orsola Malpighi
Bologna
Japan (1)
Juntendo University Hospital
Bunkyō City
Malaysia (1)
Hospital Pulau Pinang
George Town
Mexico (1)
Centro Oncologico de Chihuahua
Chihuahua City
Poland (1)
Centrum Onkologii im Prof F Lukaszczyka
Bydgoszcz
Puerto Rico (1)
Pan American Center for Oncology Trials LLC
Rio Piedras
Russia (1)
Irkutsk Regional Oncology Dispensary
Irkutsk
South Korea (1)
Inje University Haeundae Paik Hospital
Busan
Spain (1)
Hosp Univ A Coruna
A Coruña
Taiwan (1)
Kaohsiung Medical University Chung Ho Memorial Hospital
Kaohsiung City
Thailand (1)
Phramongkutklao Hospital and Medical College
Bangkok
Turkey (1)
Adana City Hospital
Adana
Ukraine (1)
Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4