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

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Carcinoma, Non-Small-Cell Lung

In brief

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).

Key facts

Study ID

NCT05488314

Run by

Janssen Research & Development, LLC

People needed

57

Starts

2022-12-13

Expected to finish

2027-04-28

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The Oncology Institute of Hope and Innovation — Cerritos, California, United States
• UCLA — Los Angeles, California, United States
• Montefiore Einstein Center for Cancer Care — The Bronx, New York, United States
• Virginia Cancer Specialists — Fairfax, Virginia, United States
• 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, Canada
• Princess Margaret Cancer Centre University Health Network — Toronto, Ontario, Canada
• 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
• University of Alabama at Birmingham, Comprehensive Cancer Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.