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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: Active Phase 1 study of Carcinoma, Non-Small Cell Lung, sponsored by Janssen Research & Development.

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. According to ClinicalTrials.gov, the official US trial registry.

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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).

Primary Outcome

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

Conditions Studied

Carcinoma, Non-Small Cell Lung

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

FieldValue
Enrollment Target 57 participants
Start Date 2022-12-13
Est. Completion 2027-04-28
Phase Phase 1
Janssen Research & Development

593 total trials

What the registry record for NCT05488314 still lists

NCT05488314 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 323-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (82% lower).

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 names 20 study sites across 6 states, led by 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.

Learn More About Clinical Trials

Similar trials for Carcinoma, Non-Small Cell Lung

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05488314's enrollment target sits among peer trials

57 90th of 130 higher than 41 of 130 other Carcinoma, Non-Small Cell Lung trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Carcinoma, Non-Small Cell Lung trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT05488314, the US trial registry maintained by the National Library of Medicine. NCT05488314 (small enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.