A Study of Amivantamab and Capmatinib Combination Therapy in Unresectable Metastatic Non-small Cell Lung Cancer

Carcinoma, Non-Small-Cell Lung Clinical Trial

— METalmark  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05488314
• Other study ID #: CR109260
• Secondary ID: 61186372PANSC200
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: December 13, 2022
• Est. completion date: August 22, 2026

Study information

• Verified date: June 2024
• Source: Janssen Research & Development, LLC
• Contact: Study Contact
• Phone: 844-434-4210
• Email: Participate-In-This-Study[@]its.jnj.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 161
• Est. completion date: August 22, 2026
• Est. primary completion date: December 27, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• Capmatinib
Capmatinib will be administered orally.
• Amivantamab
Amivantamab will be administered as IV infusion.

Locations

Country	Name	City	State
Brazil	PERSONAL Oncologia de Precisao e Personalizada	Belo Horizonte
Brazil	CIONC Centro Integrado de Oncologia de Curitiba	Curitiba
Brazil	UPCO Unidade de Pesquisa Clinica em Oncologia	Pelotas
Brazil	Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS	Porto Alegre
Brazil	Instituto D Or de Pesquisa e Ensino (IDOR)	Rio de Janeiro
Brazil	Oncoclinicas Rio de Janeiro S A	Rio de Janeiro
Brazil	Nucleo de Oncologia da Bahia	Salvador
Brazil	Fundacao Antonio Prudente A C Camargo Cancer Center	Sao Paulo
Brazil	Sociedade Beneficente de Senhoras - Hospital Sírio Libanês	São Paulo
Canada	The Ottawa Hospital Research Institute	Ottawa	Ontario
Canada	University Health Network UHN Princess Margaret Cancer Centre	Toronto	Ontario
China	Sichuan Cancer Hospital	Chengdu
China	West China Hospital Sichuan University	Chengdu
China	Chongqing University Cancer Hospital	Chongqing
China	The First Affiliated Hospital Sun Yat sen University	Guangzhou
China	Second Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou
China	Sir Run Run Shaw Hospital, Zhejiang University School of Medicine	Hangzhou
China	Huizhou Municipal Central Hospital	Huizhou
China	Fudan University Shanghai Cancer Center	Shanghai
China	Shanghai Pulmonary Hospital	Shanghai
China	Shengjing Hospital Of China Medical University	Shenyang
China	The First Affiliated Hospital of Xian Jiaotong University	Xi'An
China	Yantai Yuhuangding Hospital	Yantai
China	Henan Cancer Hospital	Zhengzhou
France	Institute Coeur Poumon	Lille
France	CHU de la Timone	Marseille
France	Institut de cancerologie de l'ouest	Saint-Herblain Cedex
France	Nouvel Hopital Civil - CHU Strasbourg	Strasbourg cedex
Germany	Charite Universitaetsmedizin Berlin	Berlin
Germany	Klinikum Chemnitz gGmbH	Chemnitz
Germany	Universitaetsklinikum Carl Gustav Carus TU Dresden	Dresden
Germany	Universitaetsklinikum Essen	Essen
Germany	Universitaetsklinikum Koeln	Koeln
Germany	Universitaetsklinikum Muenster	Muenster
Italy	ASST Grande Ospedale Metropolitano Niguarda	Milano
Italy	Fondazione IRCCS Istituto Nazionale dei Tumori	Milano
Italy	Fondazione G Pascale Istituto Nazionale Tumori IRCCS	Napoli
Italy	Istituto Oncologico Veneto - IRCCS	Padova
Italy	Ospedale S. Maria Delle Croci	Ravenna
Italy	Istituto Nazionale Tumori Regina Elena	Rome
Japan	National Hospital Organization Nagoya Medical Center	Nagoya-shi
Japan	Shizuoka Cancer Center	Sunto-gun
Japan	The Cancer Institute Hospital of JFCR	Tokyo
Korea, Republic of	Chungbuk National University Hospital	Cheongju-si
Korea, Republic of	National Cancer Center	Goyang-Si
Korea, Republic of	Gachon University Gil Hospital	Incheon
Korea, Republic of	Chonnam National University Hwasun Hospital	Jeollanam-do
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital Yonsei University Health System	Seoul
Poland	Uniwersyteckie Centrum Kliniczne	Gdansk
Poland	INSTYTUT GENETYKI I IMMUNOLOGII GENIM Sp z o o	Lublin
Poland	Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy	Warszawa
Spain	Hosp. Univ. A Coruna	A Coruna
Spain	Hosp. Gral. Univ. de Alicante	Alicante
Spain	Hosp Clinic de Barcelona	Barcelona
Spain	Hosp. Del Mar	Barcelona
Spain	Hosp. Univ. Quiron Dexeus	Barcelona
Spain	Hosp. Univ. Vall D Hebron	Barcelona
Spain	Hosp Univ Fund Jimenez Diaz	Madrid
Spain	Hosp. Univ. 12 de Octubre	Madrid
Spain	Hosp. Univ. La Paz	Madrid
Spain	Hosp. Virgen Macarena	Sevilla
Spain	Hosp. Clinico Univ. de Valencia	Valencia
Turkey	Ankara Bilkent City Hospital	Ankara
Turkey	Gazi University Hospital	Ankara
Turkey	Ankara Bilkent City Hospital	Cankaya
United Kingdom	Imperial College London and Imperial College Healthcare NHS Trust	London
United Kingdom	University College London Hospitals Nhs Foundation Trust	London
United Kingdom	Sir Bobby Robson Cancer Trials Research Centre	Newcastle upon Tyne
United Kingdom	Royal Marsden Hospital	Sutton
United States	University of Alabama at Birmingham, Comprehensive Cancer Center	Birmingham	Alabama
United States	Montefiore Einstein Center for Cancer Care	Bronx	New York
United States	The Oncology Institute of Hope and Innovation	Cerritos	California
United States	Virginia Cancer Specialists	Fairfax	Virginia
United States	UCLA	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Brazil,  Canada,  China,  France,  Germany,  Italy,  Japan,  Korea, Republic of,  Poland,  Spain,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase 1: Number of Participants with Adverse events (AEs) by Severity	An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the intervention. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.	Up to 2 years 1 month
Primary	Phase 1: Number of Participants with Dose Limiting Toxicities (DLTs)	The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, hematologic toxicity, pulmonary toxicity, liver enzyme elevation, or treatment delay greater than (>) 28 days due to unresolved toxicity.	Cycle 1 (Day 1 through Day 28)
Primary	Phase 2: Objective Response Rate	ORR is defined as the percentage of participants who achieve either a confirmed partial response (PR) or complete response (CR), using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.	Up to 2 years 1 month
Secondary	Phase 1: Number of Participants with AEs by Severity	An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the intervention. Severity will be graded according to the NCI-CTCAE version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.	Up to 2 years 1 month
Secondary	Phase 1: Number of Participants with Abnormalities in Clinical Laboratory Parameters	Number of participants with abnormalities in clinical laboratory parameters (serum chemistry, hematology, coagulation, serology, and urinalysis) will be reported.	Up to 2 years 1 month
Secondary	Phase 2: Duration of Response (DoR)	DoR is defined as the time from the date of first documented response (PR or CR) until the date of documented progression or death from any case, whichever comes first, for participants who have PR or CR.	Up to 2 years 1 month
Secondary	Phase 2: Disease Control Rate (DCR)	DCR is defined as the percentage of participants who achieve a PR, CR, or stable disease using RECIST version 1.1.	Up to 2 years 1 month
Secondary	Phase 2: Progression Free Survival (PFS)	PFS is defined as the time from first dose date until the date of disease progression or death, whichever comes first, based on investigator assessment using RECIST version 1.1	Up to 2 years 1 month
Secondary	Phase 2: Overall Survival (OS)	OS is defined as the time from the date of administration of the first study treatment until the date of death due to any cause.	Up to 2 years 1 month
Secondary	Phase 2: Time to Subsequent Therapy (TTST)	TTST is defined as the time from the date of administration of the first study treatment to the start date of the subsequent anticancer therapy following study treatment discontinuation, or death, whichever comes first.	Up to 2 years 1 month
Secondary	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	EORTC-QLQ-C30 is a self-administered, 30-item questionnaire developed to assess the HRQoL of cancer participants.	Baseline up to 2 years 1 month
Secondary	Phase 2 (Cohort 1A): HRQoL as Assessed by Non-Small Cell Lung Cancer - Symptom Assessment Questionnaire (NSCLC-SAQ) Scale Score	NSCLC-SAQ assesses patient-reported symptom severity associated with NSCLC.	Up to 2 years 1 month
Secondary	Phase 2 (Cohort 1A): HRQoL as Assessed by EuroQol 5-Dimension 5-Level (EQ-5D-5L) Scale Score	EQ-5D-5L is a self-administered, standardized measure of health status.	Up to 2 years 1 month
Secondary	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	PROMIS PF 8c is an 8-item fixed length short form derived from the PROMIS Physical Function item bank. It assesses activities of daily living, mobility, and global impact of physical functioning.	Up to 2 years 1 month