Trial Title:
A Study of Amivantamab and Capmatinib Combination Therapy in Unresectable Metastatic Non-small Cell Lung Cancer
NCT ID:
NCT05488314
Condition:
Carcinoma, Non-Small-Cell Lung
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Amivantamab-vmjw
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Capmatinib
Description:
Capmatinib will be administered orally.
Arm group label:
Phase 1 (Combination Dose Selection)
Arm group label:
Phase 2 (Dose Expansion)
Intervention type:
Drug
Intervention name:
Amivantamab
Description:
Amivantamab will be administered as IV infusion.
Arm group label:
Phase 1 (Combination Dose Selection)
Arm group label:
Phase 2 (Dose Expansion)
Other name:
JNJ-61186372
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).
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Alabama at Birmingham, Comprehensive Cancer Center
Address:
City:
Birmingham
Zip:
35233
Country:
United States
Facility:
Name:
The Oncology Institute of Hope and Innovation
Address:
City:
Cerritos
Zip:
90703
Country:
United States
Facility:
Name:
UCLA
Address:
City:
Los Angeles
Zip:
90095
Country:
United States
Facility:
Name:
Montefiore Einstein Center for Cancer Care
Address:
City:
Bronx
Zip:
10467
Country:
United States
Facility:
Name:
Virginia Cancer Specialists
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Facility:
Name:
PERSONAL Oncologia de Precisao e Personalizada
Address:
City:
Belo Horizonte
Zip:
30130-090
Country:
Brazil
Facility:
Name:
CIONC Centro Integrado de Oncologia de Curitiba
Address:
City:
Curitiba
Zip:
80810 050
Country:
Brazil
Facility:
Name:
UPCO Unidade de Pesquisa Clinica em Oncologia
Address:
City:
Pelotas
Zip:
96020 080
Country:
Brazil
Facility:
Name:
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
Address:
City:
Porto Alegre
Zip:
90610-000
Country:
Brazil
Facility:
Name:
Oncoclinicas Rio de Janeiro S A
Address:
City:
Rio de Janeiro
Zip:
22 250 905
Country:
Brazil
Facility:
Name:
Instituto D Or de Pesquisa e Ensino IDOR
Address:
City:
Rio de Janeiro
Zip:
22281 100
Country:
Brazil
Facility:
Name:
Nucleo de Oncologia da Bahia
Address:
City:
Salvador
Zip:
40170 110
Country:
Brazil
Facility:
Name:
Fundacao Antonio Prudente A C Camargo Cancer Center
Address:
City:
Sao Paulo
Zip:
01509 900
Country:
Brazil
Facility:
Name:
Sociedade Beneficente de Senhoras - Hospital Sírio Libanês
Address:
City:
São Paulo
Zip:
01308 901
Country:
Brazil
Facility:
Name:
The Ottawa Hospital Research Institute
Address:
City:
Ottawa
Zip:
K1Y 4E9
Country:
Canada
Facility:
Name:
Princess Margaret Cancer Centre University Health Network
Address:
City:
Toronto
Zip:
M5G 1Z5
Country:
Canada
Facility:
Name:
Sichuan Cancer Hospital
Address:
City:
Chengdu
Zip:
610041
Country:
China
Facility:
Name:
West China Hospital Sichuan University
Address:
City:
Chengdu
Zip:
610041
Country:
China
Facility:
Name:
Chongqing University Cancer Hospital
Address:
City:
Chongqing
Zip:
400030
Country:
China
Facility:
Name:
The First Affiliated Hospital Sun Yat sen University
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Facility:
Name:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Address:
City:
Hangzhou
Zip:
310009
Country:
China
Facility:
Name:
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Address:
City:
Hangzhou
Zip:
310016
Country:
China
Facility:
Name:
Huizhou Municipal Central Hospital
Address:
City:
Huizhou
Zip:
516001
Country:
China
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Facility:
Name:
Shanghai Pulmonary Hospital
Address:
City:
Shanghai
Zip:
200433
Country:
China
Facility:
Name:
Shengjing Hospital Of China Medical University
Address:
City:
Shenyang
Zip:
110055
Country:
China
Facility:
Name:
The First Affiliated Hospital of Xian Jiaotong University
Address:
City:
Xi'An
Zip:
710061
Country:
China
Facility:
Name:
Yantai Yuhuangding Hospital
Address:
City:
Yantai
Zip:
264000
Country:
China
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450008
Country:
China
Facility:
Name:
Institute Coeur Poumon
Address:
City:
Lille
Zip:
59000
Country:
France
Facility:
Name:
CHU de la Timone
Address:
City:
Marseille
Zip:
13005
Country:
France
Facility:
Name:
Institut de cancerologie de l'ouest
Address:
City:
Saint-Herblain Cedex
Zip:
44805
Country:
France
Facility:
Name:
Nouvel Hopital Civil - CHU Strasbourg
Address:
City:
Strasbourg cedex
Zip:
67091
Country:
France
Facility:
Name:
Charite Universitaetsmedizin Berlin
Address:
City:
Berlin
Zip:
12203
Country:
Germany
Facility:
Name:
Klinikum Chemnitz gGmbH
Address:
City:
Chemnitz
Zip:
09116
Country:
Germany
Facility:
Name:
Universitaetsklinikum Carl Gustav Carus TU Dresden
Address:
City:
Dresden
Zip:
01307
Country:
Germany
Facility:
Name:
Universitaetsklinikum Essen
Address:
City:
Essen
Zip:
45147
Country:
Germany
Facility:
Name:
Universitaetsklinikum Koeln
Address:
City:
Koeln
Zip:
50937
Country:
Germany
Facility:
Name:
Universitaetsklinikum Muenster
Address:
City:
Muenster
Zip:
48149
Country:
Germany
Facility:
Name:
Fondazione IRCCS Istituto Nazionale dei Tumori
Address:
City:
Milano
Zip:
20133
Country:
Italy
Facility:
Name:
ASST Grande Ospedale Metropolitano Niguarda
Address:
City:
Milano
Zip:
20162
Country:
Italy
Facility:
Name:
Fondazione G Pascale Istituto Nazionale Tumori IRCCS
Address:
City:
Napoli
Zip:
80131
Country:
Italy
Facility:
Name:
Istituto Oncologico Veneto - IRCCS
Address:
City:
Padova
Zip:
35128
Country:
Italy
Facility:
Name:
Ospedale S. Maria Delle Croci
Address:
City:
Ravenna
Zip:
48121
Country:
Italy
Facility:
Name:
Istituto Nazionale Tumori Regina Elena
Address:
City:
Rome
Zip:
00128
Country:
Italy
Facility:
Name:
National Hospital Organization Nagoya Medical Center
Address:
City:
Nagoya-shi
Zip:
460-0001
Country:
Japan
Facility:
Name:
Shizuoka Cancer Center
Address:
City:
Sunto-gun
Zip:
411-8777
Country:
Japan
Facility:
Name:
The Cancer Institute Hospital of JFCR
Address:
City:
Tokyo
Zip:
135 8550
Country:
Japan
Facility:
Name:
Chungbuk National University Hospital
Address:
City:
Cheongju-si
Zip:
28644
Country:
Korea, Republic of
Facility:
Name:
National Cancer Center
Address:
City:
Goyang-Si
Zip:
10408
Country:
Korea, Republic of
Facility:
Name:
Gachon University Gil Hospital
Address:
City:
Incheon
Zip:
21565
Country:
Korea, Republic of
Facility:
Name:
Chonnam National University Hwasun Hospital
Address:
City:
Jeollanam-do
Zip:
58128
Country:
Korea, Republic of
Facility:
Name:
Seoul National University Bundang Hospital
Address:
City:
Seongnam
Zip:
13620
Country:
Korea, Republic of
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Facility:
Name:
Severance Hospital Yonsei University Health System
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Facility:
Name:
Uniwersyteckie Centrum Kliniczne
Address:
City:
Gdansk
Zip:
80-214
Country:
Poland
Facility:
Name:
INSTYTUT GENETYKI I IMMUNOLOGII GENIM Sp z o o
Address:
City:
Lublin
Zip:
20 609
Country:
Poland
Facility:
Name:
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
Address:
City:
Warszawa
Zip:
02 781
Country:
Poland
Facility:
Name:
Hosp Univ A Coruna
Address:
City:
A Coruna
Zip:
15006
Country:
Spain
Facility:
Name:
Hosp. Gral. Univ. de Alicante
Address:
City:
Alicante
Zip:
03010
Country:
Spain
Facility:
Name:
Hosp. Del Mar
Address:
City:
Barcelona
Zip:
08003
Country:
Spain
Facility:
Name:
Hosp. Univ. Quiron Dexeus
Address:
City:
Barcelona
Zip:
08028
Country:
Spain
Facility:
Name:
Hosp Univ Vall D Hebron
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Facility:
Name:
Hosp Clinic de Barcelona
Address:
City:
Barcelona
Zip:
08036
Country:
Spain
Facility:
Name:
Hosp Univ Fund Jimenez Diaz
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Facility:
Name:
Hosp. Univ. 12 de Octubre
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Facility:
Name:
Hosp. Univ. La Paz
Address:
City:
Madrid
Zip:
28046
Country:
Spain
Facility:
Name:
Hosp. Virgen Macarena
Address:
City:
Sevilla
Zip:
41009
Country:
Spain
Facility:
Name:
Hosp. Clinico Univ. de Valencia
Address:
City:
Valencia
Zip:
46010
Country:
Spain
Facility:
Name:
Gazi University Hospital
Address:
City:
Ankara
Zip:
06560
Country:
Turkey
Facility:
Name:
Ankara Bilkent City Hospital
Address:
City:
Ankara
Zip:
06800
Country:
Turkey
Facility:
Name:
Ankara Bilkent City Hospital
Address:
City:
Cankaya
Zip:
06800
Country:
Turkey
Facility:
Name:
University College London Hospitals Nhs Foundation Trust
Address:
City:
London
Zip:
NW1 2PG
Country:
United Kingdom
Facility:
Name:
Imperial College London and Imperial College Healthcare NHS Trust
Address:
City:
London
Zip:
W2 1NY
Country:
United Kingdom
Facility:
Name:
Sir Bobby Robson Cancer Trials Research Centre
Address:
City:
Newcastle upon Tyne
Zip:
NE7 7DN
Country:
United Kingdom
Facility:
Name:
Royal Marsden Hospital
Address:
City:
Sutton
Zip:
SM2 5PT
Country:
United Kingdom
Start date:
December 13, 2022
Completion date:
August 22, 2026
Lead sponsor:
Agency:
Janssen Research & Development, LLC
Agency class:
Industry
Source:
Janssen Research & Development, LLC
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05488314
