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NCT04036682 · ClinicalTrials.gov registry record · Phase 1
A Phase 1/2 Trial of CLN-081 in Patients With Non-Small Cell Lung Cancer
A Phase 1 study of Non-Small Cell Lung Cancer and EGFR Exon 20 Mutation, sponsored by Cullinan Therapeutics.
- Active
- Registry status
- Phase 1
- Development phase
- 284
- Enrollment target
- 20
- Study locations
NCT04036682: Active Phase 1 study of Non-Small Cell Lung Cancer and EGFR Exon 20 Mutation, sponsored by Cullinan Therapeutics.
NCT04036682 is a Phase 1 study of Non-Small Cell Lung Cancer and EGFR Exon 20 Mutation that is active but no longer recruiting, run by Cullinan Therapeutics. The registered enrollment target is 284 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (56% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04036682, a Phase 1 study of Non-Small Cell Lung Cancer and EGFR Exon 20 Mutation, is active but no longer recruiting, sponsored by Cullinan Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 284 participants
- Enrollment target
- 20
- Study locations
Study Summary
CLN-081-001 is a Phase 1/2, open label, multi-center study of CLN-081 in patients with non-small cell lung cancer (NSCLC) harboring EGFR (epidermal growth factor receptor) exon 20 insertion mutations, to characterize the safety, determine the recommended Phase 2 dose (RP2D), and evaluate efficacy.
Conditions Studied
Interventions
- DRUG CLN-081
Study Locations (20)
California
- Pacific Cancer Medical Center, Inc - Anaheim
- City of Hope Comprehensive Cancer Center - Duarte
- City of Hope at Irvine Lennar - Irvine
- Pacific Shores Medical Group - Long Beach
New York
- Perlmutter Cancer Center at NYU Langone Hospital - Long Island - Mineola
- New York University Langone Health - New York
- Columbia University Irving Medical Center - New York
- Memorial Sloan Kettering Cancer Center - New York
Oregon
- Providence Cancer Center - Portland
- Providence Oncology & Hematology Care Clinic-Westside - Portland
Other
- Hong Kong University - Queen Mary Hospital - Hong Kong
- Azienda Ospedaliero Universitaria Careggi - Careggi
Florida
- AdventHealth - Orlando
Massachusetts
- Massachusetts General Hospital - Boston
Michigan
- University of Michigan Health System - University Hospital - Ann Arbor
New Jersey
- Summit Medical Group PA - Florham Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 284 participants |
| Start Date | 2019-10-31 |
| Est. Completion | 2026-03-31 |
| Phase | Phase 1 |
What the registry record for NCT04036682 still lists
NCT04036682 is an interventional study that assigns participants to a tested intervention. The registered 284 participants enrollment target is mid-sized for trials with a published cap, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (56% lower).
The record links to 2 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 1 intervention - of which CLN-081 is the first listed.
NCT04036682 names 20 study sites across 12 states, led by California, New York, Oregon.
Frequently Asked Questions
What is clinical trial NCT04036682 about?
NCT04036682 is a clinical study titled "A Phase 1/2 Trial of CLN-081 in Patients With Non-Small Cell Lung Cancer". CLN-081-001 is a Phase 1/2, open label, multi-center study of CLN-081 in patients with non-small cell lung cancer (NSCLC) harboring EGFR (epidermal growth factor receptor) exon 20 insertion mutations, to characterize the safety, determine the recommended Phase 2 dose (RP2D), and evaluate efficacy.
What is the current status of trial NCT04036682?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 284 participants. The study started on 2019-10-31. Estimated completion is 2026-03-31.
What conditions does trial NCT04036682 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, EGFR Exon 20 Mutation.
What interventions are being tested in trial NCT04036682?
The interventions under investigation include: CLN-081 (DRUG).
Who is sponsoring clinical trial NCT04036682?
This trial is sponsored by Cullinan Therapeutics, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04036682 being conducted?
This trial has 20 study locations across California, Florida, Massachusetts, Michigan, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04036682's enrollment target sits among peer trials
284 132nd of 454 higher than 323 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer 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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