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NCT05845671 · ClinicalTrials.gov registry record · Phase 1
Amivantamab With Tyrosine Kinase Inhibitors (TKI) for Advanced NSCLC With ALK, ROS1, or RET Alterations
A Phase 1 study of Non-Small Cell Lung Cancer and Lung Cancer, sponsored by University of Colorado, Denver.
- Active
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 4
- Study locations
NCT05845671: Active Phase 1 study of Non-Small Cell Lung Cancer and Lung Cancer, sponsored by University of Colorado, Denver.
NCT05845671 is a Phase 1 study of Non-Small Cell Lung Cancer and Lung Cancer that is active but no longer recruiting, run by University of Colorado, Denver. The registered enrollment target is 12 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (98% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05845671, a Phase 1 study of Non-Small Cell Lung Cancer and Lung Cancer, is active but no longer recruiting, sponsored by University of Colorado, Denver.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 4
- Study locations
Study Summary
Although non-small cell lung cancer (NSCLC) patients with anaplastic lymphoma kinase (ALK), c-ros oncogene 1(ROS1), and ret proto-oncogene (RET) gene fusions initially respond well to tyrosine kinase inhibitor (TKI) therapies, acquired resistance is inevitable. In many of these cases, increased activation of the erythroblastic leukemia viral oncogene homologue (ERBB) or cMet pathways appears to be a bypass signaling mechanism that allows these cancer cells to circumvent the selective pressure from TKIs. Recent data have suggested that these pathways compensate for each other in situations where one pathway is inhibited, leading to "kinase switch" drug resistance. Thus, the expected inhibition of both pathways via treatment with the amivantamab and combination TKI combination may improve overall efficacy by limiting the compensatory pathway activation.
Primary Outcome
The MTD is defined as the dose combination with a DLT rate closest to the target DLT rate of 22%. An unevaluable patient is one who fails to complete dosing in C1 unless due to drug-related toxicities. The starting dose level will be dose level 0.
Conditions Studied
Interventions
- DRUG Amivantamab 1050mg
- DRUG Amivantamab 1400mg
- DRUG Amivantamab (to be determined)
Study Locations (4)
Colorado
- Outpatient CTRC - Aurora
- University of Colorado Hospital - Aurora
California
- City of Hope Cancer Center - Duarte
Michigan
- University of Michigan Rogel Cancer Center - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2023-07-17 |
| Est. Completion | 2028-01 |
| Phase | Phase 1 |
What the registry record for NCT05845671 still lists
NCT05845671 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 3 interventions - of which Amivantamab 1050mg is the first listed.
NCT05845671 reports a single indexed study location in Colorado, California, Michigan.
Frequently Asked Questions
What is clinical trial NCT05845671 about?
NCT05845671 is a clinical study titled "Amivantamab With Tyrosine Kinase Inhibitors (TKI) for Advanced NSCLC With ALK, ROS1, or RET Alterations". Although non-small cell lung cancer (NSCLC) patients with anaplastic lymphoma kinase (ALK), c-ros oncogene 1(ROS1), and ret proto-oncogene (RET) gene fusions initially respond well to tyrosine kinase inhibitor (TKI) therapies, acquired resistance is inevitable. In many of these cases, increased acti...
What is the current status of trial NCT05845671?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2023-07-17. Estimated completion is 2028-01.
What conditions does trial NCT05845671 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Lung Cancer.
What interventions are being tested in trial NCT05845671?
The interventions under investigation include: Amivantamab 1050mg (DRUG), Amivantamab 1400mg (DRUG), Amivantamab (to be determined) (DRUG).
Who is sponsoring clinical trial NCT05845671?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05845671 being conducted?
This trial has 4 study locations across California, Colorado, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05845671's enrollment target sits among peer trials
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