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NCT04285671 · ClinicalTrials.gov registry record · Phase 1
Necitumumab and Trastuzumab in Combination With Osimertinib for the Treatment of Refractory Epidermal Growth Factor Receptor (EGFR)-Mutated Stage IV Non-small Cell Lung Cancer
A Phase 1 study of Metastatic Lung Non-Small Cell Carcinoma and Stage IVA Lung Cancer AJCC v8, sponsored by Jonsson Comprehensive Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT04285671 is a Phase 1 study of Metastatic Lung Non-Small Cell Carcinoma and Stage IVA Lung Cancer AJCC v8 that is active but no longer recruiting, run by Jonsson Comprehensive Cancer Center. The registered enrollment target is 30 participants, below the 77-participant average among 39 other Metastatic Lung Non-Small Cell Carcinoma trials with a reported enrollment target (61% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04285671, a Phase 1 study of Metastatic Lung Non-Small Cell Carcinoma and Stage IVA Lung Cancer AJCC v8, is active but no longer recruiting, sponsored by Jonsson Comprehensive Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase Ib/II trial studies the side effects and best dose of trastuzumab and necitumumab together with osimertinib, and to see how well they work for the treatment of stage IV non-small cell lung cancer that is EGFR-mutated, resistant to osimertinib, and has not responded to previous treatment (refractory). Immunotherapy with monoclonal antibodies, such as trastuzumab and necitumumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving trastuzumab and necitumumab together with osimertinib may work better than osimertinib alone in treating patients with stage IV EGFR-mutated non-small cell lung cancer.
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- DRUG Osimertinib
- OTHER Questionnaire Administration
- BIOLOGICAL Trastuzumab
- BIOLOGICAL Necitumumab
Study Locations (1)
California
- UCLA / Jonsson Comprehensive Cancer Center - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-01-29 |
| Est. Completion | 2027-12-02 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04285671
The ClinicalTrials.gov registry entry for NCT04285671 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 77-participant average among 39 other Metastatic Lung Non-Small Cell Carcinoma trials with a reported enrollment target (61% lower). The listed sponsor is Jonsson Comprehensive Cancer Center, which has 321 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Metastatic Lung Non-Small Cell Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Quality-of-Life Assessment is the first listed.
NCT04285671 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT04285671 about?
NCT04285671 is a clinical study titled "Necitumumab and Trastuzumab in Combination With Osimertinib for the Treatment of Refractory Epidermal Growth Factor Receptor (EGFR)-Mutated Stage IV Non-small Cell Lung Cancer". This phase Ib/II trial studies the side effects and best dose of trastuzumab and necitumumab together with osimertinib, and to see how well they work for the treatment of stage IV non-small cell lung cancer that is EGFR-mutated, resistant to osimertinib, and has not responded to previous treatment (...
What is the current status of trial NCT04285671?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2021-01-29. Estimated completion is 2027-12-02.
What conditions does trial NCT04285671 study?
This clinical trial studies the following conditions: Metastatic Lung Non-Small Cell Carcinoma, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8, Refractory Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer American Joint Committee on Cancer (AJCC) v8.
What interventions are being tested in trial NCT04285671?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Osimertinib (DRUG), Questionnaire Administration (OTHER), Trastuzumab (BIOLOGICAL), Necitumumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04285671?
This trial is sponsored by Jonsson Comprehensive Cancer Center, which has 321 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04285671 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.