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NCT05908734 · ClinicalTrials.gov registry record · Phase 1
A Study of Combination Therapy With Amivantamab and Cetrelimab in Participants With 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
- 71
- Enrollment target
- 20
- Study locations
NCT05908734: Active Phase 1 study of Carcinoma, Non-Small Cell Lung, sponsored by Janssen Research & Development.
NCT05908734 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 71 participants, below the 323-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (78% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05908734, 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
- 71 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to identify the recommended Phase 2 (combination) dose (RP2CD) of the amivantamab and cetrelimab 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 combination at the selected RP2CD in participants with NSCLC characterized on the basis of epidermal growth factor receptor (EGFR) and Programmed-cell death Ligand (PD-L)1 status, in the 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
Interventions
- DRUG Amivantamab
- DRUG Cetrelimab
Study Locations (20)
Other
- Fundacao Pio XII - Barretos
- Cetus Oncologia - Belo Horizonte
- PERSONAL Oncologia de Precisao e Personalizada - Belo Horizonte
- CIONC Centro Integrado de Oncologia de Curitiba - Curitiba
- Hospital do Cancer de Londrina - Londrina
- Hospital Nossa Senhora da Conceicao S A - Porto Alegre
- Hospital Santa Izabel Santa Casa de Misericordia da Bahia - Salvador
- Fundacao Antonio Prudente A C Camargo Cancer Center - São Paulo
- European Institute of Oncology - Milan
- ASST Grande Ospedale Metropolitano Niguarda - Milan
- Aou San Luigi Gonzaga - Orbassano
- Centro Ricerche Cliniche di Verona S r l - Verona
- University Malaya Medical Centre - Kuala Lumpur
California
- City of Hope - Duarte
- City of Hope Orange County Lennar Foundation Cancer Center - Irvine
- Cancer and Blood Specialty Clinic - Los Alamitos
Oregon
- Providence Portland Medical Center - Portland
- Providence Oncology and Hematology Care Clinic Westside - Portland
Texas
- MD Anderson Cancer Center - Houston
Virginia
- Virginia Cancer Specialists - Fairfax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2023-05-18 |
| Est. Completion | 2027-03-31 |
| Phase | Phase 1 |
What the registry record for NCT05908734 still lists
NCT05908734 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 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 (78% 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 Amivantamab is the first listed.
NCT05908734 names 20 study sites across 5 states, led by Other, California, Oregon.
Frequently Asked Questions
What is clinical trial NCT05908734 about?
NCT05908734 is a clinical study titled "A Study of Combination Therapy With Amivantamab and Cetrelimab in Participants With Metastatic Non-small Cell Lung Cancer". The purpose of this study is to identify the recommended Phase 2 (combination) dose (RP2CD) of the amivantamab and cetrelimab 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 combination a...
What is the current status of trial NCT05908734?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 71 participants. The study started on 2023-05-18. Estimated completion is 2027-03-31.
What conditions does trial NCT05908734 study?
This clinical trial studies the following conditions: Carcinoma, Non-Small Cell Lung.
What interventions are being tested in trial NCT05908734?
The interventions under investigation include: Amivantamab (DRUG), Cetrelimab (DRUG).
Who is sponsoring clinical trial NCT05908734?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05908734 being conducted?
This trial has 20 study locations across California, Oregon, Texas, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05908734's enrollment target sits among peer trials
71 81st of 130 higher than 49 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.
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