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NCT07227025 · ClinicalTrials.gov registry record · Phase 1
A Study of Amivantamab and Olomorasib Combination Therapy in Participants With Metastatic Non-Small Cell Lung Cancer
A Phase 1 study of Carcinoma, Non-Small Cell Lung, sponsored by Janssen Research & Development.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 16
- Study locations
NCT07227025: Recruiting Phase 1 study of Carcinoma, Non-Small Cell Lung, sponsored by Janssen Research & Development.
NCT07227025 is a Phase 1 study of Carcinoma, Non-Small Cell Lung that is actively recruiting participants, run by Janssen Research & Development. The registered enrollment target is 60 participants, below the 323-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (81% lower). The trial reports 16 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07227025, a Phase 1 study of Carcinoma, Non-Small Cell Lung, is actively recruiting participants, sponsored by Janssen Research & Development.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 16
- Study locations
Study Summary
The main purpose of this study is to find out the most suitable dose (recommended phase 2 combination dose \[RP2CD\]) of amivantamab and olomorasib combination therapy and to assess how well the combination slows down or prevents the growth of tumors in participants with KRAS G12C mutant metastatic non-small cell lung cancer (NSCLC: the most common type of lung cancer; metastatic: has spread to other parts of the body; KRAS G12C mutant: mutation \[change\] in the kirsten rat sarcoma viral oncogene homolog \[KRAS\] gene in tumor cells in which glycine \[G\] at position 12 is replaced with cystine \[C\]).
Primary Outcome
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An assessment of severity grade will be made by the investigator according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 defined as follows: Grade 1 (mild; asymptomatic or mild symptoms; intervention not indicated
Conditions Studied
Interventions
- DRUG Olomorasib
- DRUG Amivantamab
Study Locations (16)
Other
- The First Affiliated Hospital Sun Yat sen University - Guangzhou
- Shanghai East Hospital - Shanghai
- Severance Hospital Yonsei University Health System - Seoul
- Asan Medical Center - Seoul
- Samsung Medical Center - Seoul
- Ankara Universitesi Hastaneleri Tibbi Farmakoloji Anabilim Dali Faz 1 Klinik Arastirma Merkezi - Ankara
- Ankara Bilkent Sehir Hastanesi - Çankaya
- Koc Universitesi Hastanesi Faz 1 Klinik Arastirma Merkezi - Istanbul
California
- University of California Irvine - Irvine
Maine
- New England Cancer Specialists - Topsham
New York
- New York University Langone Medical Center - New York
Pennsylvania
- University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced Medicine - Philadelphia
Texas
- Oncology Consultants Cancer Center - Houston
Virginia
- Virginia Cancer Specialists - Fairfax
Washington
- NorthWest Medical Specialties, PLLC - Puyallup
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2026-03-03 |
| Est. Completion | 2029-04-30 |
| Phase | Phase 1 |
What NCT07227025 shows while recruiting
NCT07227025 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 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 (81% 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 Olomorasib is the first listed.
NCT07227025 lists 16 locations in 9 states (Other, California, Maine).
Frequently Asked Questions
What is clinical trial NCT07227025 about?
NCT07227025 is a clinical study titled "A Study of Amivantamab and Olomorasib Combination Therapy in Participants With Metastatic Non-Small Cell Lung Cancer". The main purpose of this study is to find out the most suitable dose (recommended phase 2 combination dose \[RP2CD\]) of amivantamab and olomorasib combination therapy and to assess how well the combination slows down or prevents the growth of tumors in participants with KRAS G12C mutant metastatic ...
What is the current status of trial NCT07227025?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2026-03-03. Estimated completion is 2029-04-30.
What conditions does trial NCT07227025 study?
This clinical trial studies the following conditions: Carcinoma, Non-Small Cell Lung.
What interventions are being tested in trial NCT07227025?
The interventions under investigation include: Olomorasib (DRUG), Amivantamab (DRUG).
Who is sponsoring clinical trial NCT07227025?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07227025 being conducted?
This trial has 16 study locations across California, Maine, New York, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07227025's enrollment target sits among peer trials
60 88th of 130 higher than 42 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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