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NCT03940703 · ClinicalTrials.gov registry record · Phase 2
A Study of Tepotinib Plus Osimertinib in Osimertinib Relapsed MET Amplified NSCLC (INSIGHT 2)
A Phase 2 study of Non-Small Cell Lung Cancer, sponsored by EMD Serono Research & Development Institute.
- Active
- Registry status
- Phase 2
- Development phase
- 140
- Enrollment target
- 20
- Study locations
NCT03940703: Active Phase 2 study of Non-Small Cell Lung Cancer, sponsored by EMD Serono Research & Development Institute.
NCT03940703 is a Phase 2 study of Non-Small Cell Lung Cancer that is active but no longer recruiting, run by EMD Serono Research & Development Institute. The registered enrollment target is 140 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (79% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03940703, a Phase 2 study of Non-Small Cell Lung Cancer, is active but no longer recruiting, sponsored by EMD Serono Research & Development Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 140 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study was to assess the antitumor activity, safety, tolerability, and pharmacokinetics (PK) of the Mesenchymal-epithelial Transition Factor (MET) inhibitor tepotinib combined with the 3rd generation EGFR inhibitor osimertinib in participants with advanced or metastatic non-small cell lung cancer (NSCLC).
Primary Outcome
DLTs are defined as any of the following toxicities and judged by the Investigator and/or the Sponsor to be not attributable to the disease or disease-related processes under investigation: Grade 4 neutropenia for more than 7 days; Grade greater than or equal to (\>=) 3 febrile neutropenia; Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with non-traumatic bleeding; Grade \>= 3 nausea/vomiting and/or diarrhea that has not improved within 72 hours despite adequate and optimal treatment; Any
Conditions Studied
Interventions
- DRUG Osimertinib
- DRUG Tepotinib
Study Locations (20)
California
- Compassionate Care Research Group Inc - Edinger Medical Group, Inc. - Fountain Valley
- Memorial Care - Long Beach
- Ventura County Hematology Oncology Specialists - Oxnard
- Innovative Clinical Research Institute - Whittier
Florida
- Holy Cross - Fort Lauderdale
- Memorial Healthcare System - Hollywood
- Cancer Specialists of North Florida - Jacksonville
- Ocala Oncology - Ocala
Indiana
- Fort Wayne Medical Oncology and Hematology - Fort Wayne
- Community Health Network - Indianapolis
- Beacon Health - South Bend
Maryland
- Medstar Franklin Square Clinical Research Center - Baltimore
- The Center for Cancer & Blood Disorders - Maryland - Bethesda
Arizona
- Yuma Regional Medical Center - Yuma
Connecticut
- Eastern Connecticut Hematology & Oncology Associates - Norwich
Georgia
- University Cancer and Blood Center - Athens
Hawaii
- Hawaii Cancer Care - Honolulu
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2019-09-19 |
| Est. Completion | 2026-05-01 |
| Phase | Phase 2 |
What the registry record for NCT03940703 still lists
NCT03940703 is an interventional study that assigns participants to a tested intervention. The registered 140 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 (79% lower).
The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which Osimertinib is the first listed.
NCT03940703 names 20 study sites across 11 states, led by California, Florida, Indiana.
Frequently Asked Questions
What is clinical trial NCT03940703 about?
NCT03940703 is a clinical study titled "A Study of Tepotinib Plus Osimertinib in Osimertinib Relapsed MET Amplified NSCLC (INSIGHT 2)". This study was to assess the antitumor activity, safety, tolerability, and pharmacokinetics (PK) of the Mesenchymal-epithelial Transition Factor (MET) inhibitor tepotinib combined with the 3rd generation EGFR inhibitor osimertinib in participants with advanced or metastatic non-small cell lung cance...
What is the current status of trial NCT03940703?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 140 participants. The study started on 2019-09-19. Estimated completion is 2026-05-01.
What conditions does trial NCT03940703 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer.
What interventions are being tested in trial NCT03940703?
The interventions under investigation include: Osimertinib (DRUG), Tepotinib (DRUG).
Who is sponsoring clinical trial NCT03940703?
This trial is sponsored by EMD Serono Research & Development Institute, which has 81 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03940703 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Non-Small Cell Lung Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03940703's enrollment target sits among peer trials
140 206th of 454 higher than 247 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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