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

NCT05488314 · tracked via the Priya Life Science Germany tracker

Sponsor

Janssen Research & Development, LLC

Phase

Phase 1/2

Started

2022-12-13

Last updated

2026-09-25

Condition(s) studied

Carcinoma, Non-Small-Cell Lung

Investigational drug(s) / intervention(s)

Capmatinib →Amivantamab →

Capmatinib: Capmatinib will be administered orally.

Amivantamab: Amivantamab will be administered as IV infusion.

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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 outcome measure(s)

Phase 1: Number of Participants with Adverse events (AEs) by Severity — Up to 2 years 1 month
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.
Phase 1: Number of Participants with Dose Limiting Toxicities (DLTs) — Cycle 1 (Day 1 through Day 28)
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.
Phase 2: Objective Response Rate — Up to 2 years 1 month
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.

Trial sites (78)

Facility	City	Region
University of Alabama at Birmingham, Comprehensive Cancer Center	Birmingham	Alabama
The Oncology Institute of Hope and Innovation	Cerritos	California
UCLA	Los Angeles	California
Montefiore Einstein Center for Cancer Care	The Bronx	New York
Virginia Cancer Specialists	Fairfax	Virginia
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
Oncoclinicas Rio de Janeiro S A	Rio de Janeiro	Brazil
Instituto D Or de Pesquisa e Ensino IDOR	Rio de Janeiro	Brazil
Nucleo de Oncologia da Bahia	Salvador	Brazil
Sociedade Beneficente de Senhoras Hospital Sirio Libanes	São Paulo	Brazil
Fundacao Antonio Prudente A C Camargo Cancer Center	São Paulo	Brazil
The Ottawa Hospital Research Institute	Ottawa	Ontario
Princess Margaret Cancer Centre University Health Network	Toronto	Ontario
Beijing Cancer Hospital	Beijing	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	China
Institute Coeur Poumon	Lille	France
CHU de la Timone	Marseille	France
Institut de cancerologie de l'ouest	Saint-Herblain	France
Nouvel Hopital Civil - CHU Strasbourg	Strasbourg	France
Charite Universitaetsmedizin Berlin	Berlin	Germany
Klinikum Chemnitz gGmbH	Chemnitz	Germany
Universitaetsklinikum Koeln	Cologne	Germany
Universitaetsklinikum Carl Gustav Carus TU Dresden	Dresden	Germany
Universitaetsklinikum Essen	Essen	Germany
Universitaetsklinikum Muenster	Münster	Germany

+ 38 more sites — see the full list on the official registry below.

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Other trials for the same condition

A Study of Investigational Agents in Participants With Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01H/KEYMAKER-U01) Recruiting

A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer Recruiting

A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung Cancer Active, not recruiting

A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer Active, not recruiting

A Study of TAK-788 in Adults With Non-Small Cell Lung Cancer Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05488314 on ClinicalTrials.gov ↗ ← All trials in Germany