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NCT05488314 · ClinicalTrials.gov registry record · Phase 1
A Study of Amivantamab and Capmatinib Combination Therapy in Unresectable Metastatic Non-small Cell Lung Cancer
A Phase 1 study of Carcinoma, Non-Small Cell Lung, sponsored by Janssen Research & Development.
- Active
- Registry status
- Phase 1
- Development phase
- 57
- Enrollment target
- 20
- Study locations
NCT05488314 is a Phase 1 study of Carcinoma, Non-Small Cell Lung that is active but no longer recruiting, run by Janssen Research & Development. The registered enrollment target is 57 participants, below the 323-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (82% lower). The trial reports 20 study locations across 6 states.
The verdict
NCT05488314, a Phase 1 study of Carcinoma, Non-Small Cell Lung, is active but no longer recruiting, sponsored by Janssen Research & Development.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 57 participants
- Enrollment target
- 20
- Study locations
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).
Conditions Studied
Interventions
- DRUG Capmatinib
- DRUG Amivantamab
Study Locations (20)
Other
- PERSONAL Oncologia de Precisao e Personalizada - Belo Horizonte
- CIONC Centro Integrado de Oncologia de Curitiba - Curitiba
- UPCO Unidade de Pesquisa Clinica em Oncologia - Pelotas
- Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS - Porto Alegre
- Oncoclinicas Rio de Janeiro S A - Rio de Janeiro
- Instituto D Or de Pesquisa e Ensino IDOR - Rio de Janeiro
- Nucleo de Oncologia da Bahia - Salvador
- Sociedade Beneficente de Senhoras Hospital Sirio Libanes - São Paulo
- Fundacao Antonio Prudente A C Camargo Cancer Center - São Paulo
- Beijing Cancer Hospital - Beijing
- Sichuan Cancer Hospital - Chengdu
- West China Hospital Sichuan University - Chengdu
- Chongqing University Cancer Hospital - Chongqing
California
- The Oncology Institute of Hope and Innovation - Cerritos
- UCLA - Los Angeles
Ontario
- The Ottawa Hospital Research Institute - Ottawa
- Princess Margaret Cancer Centre University Health Network - Toronto
Alabama
- University of Alabama at Birmingham, Comprehensive Cancer Center - Birmingham
New York
- Montefiore Einstein Center for Cancer Care - The Bronx
Virginia
- Virginia Cancer Specialists - Fairfax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2022-12-13 |
| Est. Completion | 2027-04-28 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05488314
The ClinicalTrials.gov registry entry for NCT05488314 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 323-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (82% lower). The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Carcinoma, Non-Small Cell Lung appearing as the primary indexed condition, and to 2 interventions - of which Capmatinib is the first listed.
NCT05488314 reports 20 study locations spanning 6 distinct geographic areas - top geographies include Other, California, Ontario.
Frequently Asked Questions
What is clinical trial NCT05488314 about?
NCT05488314 is a clinical study titled "A Study of Amivantamab and Capmatinib Combination Therapy in Unresectable Metastatic Non-small Cell Lung Cancer". 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 amivantama...
What is the current status of trial NCT05488314?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 57 participants. The study started on 2022-12-13. Estimated completion is 2027-04-28.
What conditions does trial NCT05488314 study?
This clinical trial studies the following conditions: Carcinoma, Non-Small Cell Lung.
What interventions are being tested in trial NCT05488314?
The interventions under investigation include: Capmatinib (DRUG), Amivantamab (DRUG).
Who is sponsoring clinical trial NCT05488314?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05488314 being conducted?
This trial has 20 study locations across Alabama, California, New York, Virginia, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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