Clinical trial NCT05488314: A Study of Amivantamab and Capmatinib Combination Therapy in Unresectable Metastatic Non-small Cell Lung Cancer
Official title: A Phase 1/2 Study Evaluating the Safety and Efficacy of Amivantamab and Capmatinib Combination Therapy in Unresectable Metastatic Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2022-08-04
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to identify the recommended Phase 2 combination dose (RP2CD\[s\]) of the amivantamab and capmatinib combination therapy in participants with non-small cell lung cancer (NSCLC) in Phase 1 (combination dose selection), and to evaluate the antitumor effect of the amivantamab and capmatinib combination therapy in mesenchymal-epithelial transition (MET) exon 14 skipping mutation and MET amplified NSCLC, when administered at the selected RP2CD(s) in Phase 2 (expansion).


Eligibility criteria: Inclusion Criteria:

* Previously diagnosed with histologically or cytologically confirmed unresectable Stage IV (metastatic) non-small cell lung cancer (NSCLC) (any histology)
* May have: definitively, locally treated brain metastases that are clinically stable and asymptomatic for greater than (\>) 2 weeks and who are off or receiving low-dose corticosteroid treatment (less than or equal to \[\<=\]10 milligrams (mg) prednisone or equivalent) for at least 2 weeks prior to start of study treatment
* May have a prior malignancy (other than the disease under study) the natural history or treatment of which is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s)
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* A participant of childbearing potential must have a negative serum pregnancy 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:

* Medical history of (non-infectious) interstitial lung disease (ILD)/pneumonitis, or has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
* Participant has impairment of the gastrointestinal function that could affect absorption of capmatinib or is unable or unwilling to swallow tablets
* Participant has symptomatic central nervous system (CNS) metastases which are neurologically unstable or have required increasing doses of steroids \>10 mg prednisone or equivalent within the 2 weeks prior to study entry to manage CNS symptoms
* Participant has uncontrolled tumor-related pain: Symptomatic lesions amenable to palliative radiotherapy (example, bone metastases, or metastases causing nerve impingement) should be treated more than 7 days prior to the administration of the first study treatment

Primary outcomes:
measure: Phase 1: Number of Participants with Adverse events (AEs) by Severity
timeFrame: Up to 2 years 1 month
measure: Phase 1: Number of Participants with Dose Limiting Toxicities (DLTs)
timeFrame: Cycle 1 (Day 1 through Day 28)
measure: Phase 2: Objective Response Rate
timeFrame: Up to 2 years 1 month
Secondary outcomes:
measure: Phase 1: Number of Participants with AEs by Severity
timeFrame: Up to 2 years 1 month
measure: Phase 1: Number of Participants with Abnormalities in Clinical Laboratory Parameters
timeFrame: Up to 2 years 1 month
measure: Phase 2: Duration of Response (DoR)
timeFrame: Up to 2 years 1 month
measure: Phase 2: Disease Control Rate (DCR)
timeFrame: Up to 2 years 1 month
measure: Phase 2: Progression Free Survival (PFS)
timeFrame: Up to 2 years 1 month
measure: Phase 2: Overall Survival (OS)
timeFrame: Up to 2 years 1 month
measure: Phase 2: Time to Subsequent Therapy (TTST)
timeFrame: Up to 2 years 1 month
measure: Phase 2 (Cohort 1A): Change from Baseline in Health-related Quality of Life in (HRQoL) as Assessed by European Organization of Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) Scale Score
timeFrame: Baseline up to 2 years 1 month
measure: Phase 2 (Cohort 1A): HRQoL as Assessed by Non-Small Cell Lung Cancer - Symptom Assessment Questionnaire (NSCLC-SAQ) Scale Score
timeFrame: Up to 2 years 1 month
measure: Phase 2 (Cohort 1A): HRQoL as Assessed by EuroQol 5-Dimension 5-Level (EQ-5D-5L) Scale Score
timeFrame: Up to 2 years 1 month
measure: Phase 2 (Cohort 1A): HRQoL as Assessed by Patient-reported Outcomes Measurement Information System Short Form Version 2.0 - Physical Function 8c (PROMIS PF 8c) Scale Score
timeFrame: Up to 2 years 1 month
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham, Comprehensive Cancer Center
state: Alabama
city: Cerritos
country: United States
facility: The Oncology Institute of Hope and Innovation
state: California
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Bronx
country: United States
facility: Montefiore Einstein Center for Cancer Care
state: New York
city: Fairfax
country: United States
facility: Virginia Cancer Specialists
state: Virginia
city: Belo Horizonte
country: Brazil
facility: PERSONAL Oncologia de Precisao e Personalizada
city: Curitiba
country: Brazil
facility: CIONC Centro Integrado de Oncologia de Curitiba
city: Pelotas
country: Brazil
facility: UPCO Unidade de Pesquisa Clinica em Oncologia
city: Porto Alegre
country: Brazil
facility: Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
city: Rio de Janeiro
country: Brazil
facility: Oncoclinicas Rio de Janeiro S A
city: Rio de Janeiro
country: Brazil
facility: Instituto D Or de Pesquisa e Ensino IDOR
city: Salvador
country: Brazil
facility: Nucleo de Oncologia da Bahia
city: Sao Paulo
country: Brazil
facility: Fundacao Antonio Prudente A C Camargo Cancer Center
city: São Paulo
country: Brazil
facility: Sociedade Beneficente de Senhoras Hospital Sirio Libanes
city: Ottawa
country: Canada
facility: The Ottawa Hospital Research Institute
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre University Health Network
state: Ontario
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Chengdu
country: China
facility: Sichuan Cancer Hospital
city: Chengdu
country: China
facility: West China Hospital Sichuan University
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital
city: Guangzhou
country: China
facility: The First Affiliated Hospital Sun Yat sen University
city: Hangzhou
country: China
facility: Second Affiliated Hospital, School of Medicine, Zhejiang University
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital Zhejiang University School of Medicine
city: Huizhou
country: China
facility: Huizhou Municipal Central Hospital
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
city: Shenyang
country: China
facility: Shengjing Hospital Of China Medical University
city: Xi'An
country: China
facility: The First Affiliated Hospital of Xian Jiaotong University
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
city: Lille
country: France
facility: Institute Coeur Poumon
city: Marseille
country: France
facility: CHU de la Timone
city: Saint-Herblain Cedex
country: France
facility: Institut de cancerologie de l'ouest
city: Strasbourg cedex
country: France
facility: Nouvel Hopital Civil - CHU Strasbourg
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz gGmbH
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus TU Dresden
city: Essen
country: Germany
facility: Universitaetsklinikum Essen
city: Koeln
country: Germany
facility: Universitaetsklinikum Koeln
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda
city: Napoli
country: Italy
facility: Fondazione G Pascale Istituto Nazionale Tumori IRCCS
city: Padova
country: Italy
facility: Istituto Oncologico Veneto - IRCCS
city: Ravenna
country: Italy
facility: Ospedale S. Maria Delle Croci
city: Rome
country: Italy
facility: Istituto Nazionale Tumori Regina Elena
city: Nagoya-shi
country: Japan
facility: National Hospital Organization Nagoya Medical Center
city: Sunto Gun
country: Japan
facility: Shizuoka Cancer Center
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital of JFCR
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Goyang-Si
country: Korea, Republic of
facility: National Cancer Center
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Hospital
city: Jeollanam-do
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Lublin
country: Poland
facility: INSTYTUT GENETYKI I IMMUNOLOGII GENIM Sp z o o
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
city: A Coruna
country: Spain
facility: Hosp Univ A Coruna
city: Alicante
country: Spain
facility: Hosp. Gral. Univ. de Alicante
city: Barcelona
country: Spain
facility: Hosp. Del Mar
city: Barcelona
country: Spain
facility: Hosp. Univ. Quiron Dexeus
city: Barcelona
country: Spain
facility: Hosp Univ Vall D Hebron
city: Barcelona
country: Spain
facility: Hosp Clinic de Barcelona
city: Madrid
country: Spain
facility: Hosp Univ Fund Jimenez Diaz
city: Madrid
country: Spain
facility: Hosp. Univ. 12 de Octubre
city: Madrid
country: Spain
facility: Hosp. Univ. La Paz
city: Sevilla
country: Spain
facility: Hosp. Virgen Macarena
city: Valencia
country: Spain
facility: Hosp. Clinico Univ. de Valencia
city: Ankara
country: Turkey
facility: Gazi University Hospital
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
city: Cankaya
country: Turkey
facility: Ankara Bilkent City Hospital
city: London
country: United Kingdom
facility: University College London Hospitals Nhs Foundation Trust
city: London
country: United Kingdom
facility: Imperial College London and Imperial College Healthcare NHS Trust
city: Newcastle upon Tyne
country: United Kingdom
facility: Sir Bobby Robson Cancer Trials Research Centre
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: