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NCT04880863 · ClinicalTrials.gov registry record · Phase 2
NAP in Combination With Docetaxel Following Obinutuzumab Pretreatment in Subjects With Checkpoint Inhibitor Pretreated Advanced or Metastatic NSCLC
A Phase 2 study of Non-Small Cell Lung Cancer, sponsored by NeoTX Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 38
- Enrollment target
- 11
- Study locations
NCT04880863: Completed Phase 2 study of Non-Small Cell Lung Cancer, sponsored by NeoTX Therapeutics.
NCT04880863 is a Phase 2 study of Non-Small Cell Lung Cancer that has completed, run by NeoTX Therapeutics. The registered enrollment target is 38 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (94% lower). The trial reports 11 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04880863, a Phase 2 study of Non-Small Cell Lung Cancer, has completed, sponsored by NeoTX Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 38 participants
- Enrollment target
- 11
- Study locations
Study Summary
Phase 2a Open-Label, Multicenter Trial of Naptumomab Estafenatox (NAP), following Obinutuzumab Pretreatment, on Days -13 and -12. NAP will be administered on Days 1-4 of treatment cycles 1-6, followed by docetaxel on Day 5. Starting cycle 7, NAP at a higher dose will be administered on Day 1 only and docetaxel on Day 2, in 21 days treatment cycles. When NAP is administered as monotherapy and not earlier than cycle 7, NAP will be administered on Day 1 only and cycles will be of 28 days treatment cycle.
Primary Outcome
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) and iRECIST for target lesions and assessed by CT scans or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Conditions Studied
Interventions
- DRUG Obinutuzumab
- DRUG Docetaxel
- DRUG NAP (Naptumomab estafenatox)
Study Locations (11)
Texas
- NeoTX - 10308 - Austin
- NeoTX - 10309 - Dallas
- NeoTX - 10312 - El Paso
- NeoTX - 10310 - Tyler
Arizona
- NeoTX - 10302 - Scottsdale
- NeoTX - 10303 - Tucson
Alabama
- NeoTX - 10307 - Daphne
Colorado
- NeoTX - 10306 - Lone Tree
Minnesota
- NeoTX - 10304 - Minneapolis
New Jersey
- NeoTX - 10100 - Morristown
Virginia
- NeoTX - 10311 - Fairfax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2021-10-26 |
| Est. Completion | 2024-01-30 |
| Phase | Phase 2 |
What the finished NCT04880863 record still lists
NCT04880863 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 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 (94% lower).
The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 3 interventions - of which Obinutuzumab is the first listed.
NCT04880863 lists 11 locations in 7 states (Texas, Arizona, Alabama).
Frequently Asked Questions
What is clinical trial NCT04880863 about?
NCT04880863 is a clinical study titled "NAP in Combination With Docetaxel Following Obinutuzumab Pretreatment in Subjects With Checkpoint Inhibitor Pretreated Advanced or Metastatic NSCLC". Phase 2a Open-Label, Multicenter Trial of Naptumomab Estafenatox (NAP), following Obinutuzumab Pretreatment, on Days -13 and -12. NAP will be administered on Days 1-4 of treatment cycles 1-6, followed by docetaxel on Day 5. Starting cycle 7, NAP at a higher dose will be administered on Day 1 only an...
What is the current status of trial NCT04880863?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2021-10-26. Estimated completion is 2024-01-30.
What conditions does trial NCT04880863 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer.
What interventions are being tested in trial NCT04880863?
The interventions under investigation include: Obinutuzumab (DRUG), Docetaxel (DRUG), NAP (Naptumomab estafenatox) (DRUG).
Who is sponsoring clinical trial NCT04880863?
This trial is sponsored by NeoTX Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04880863 being conducted?
This trial has 11 study locations across Alabama, Arizona, Colorado, Minnesota, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04880863's enrollment target sits among peer trials
38 373rd of 454 higher than 79 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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