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NCT03041181 · ClinicalTrials.gov registry record · Phase 2
Single Agent Chemotherapy +/- Nivolumab in Patients With Advanced Squamous or Non-squamous NSCLC With Primary Resistance to Prior PD-1 or PDL-1 Inhibitor
A Phase 2 study, sponsored by Nasser Hanna, M.D..
- Terminated
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT03041181 is a Phase 2 study that was terminated before completion, run by Nasser Hanna, M.D.. The registered enrollment target is 3 participants.
The verdict
NCT03041181, a Phase 2 study, was terminated before completion, sponsored by Nasser Hanna, M.D..
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study Summary
This is a randomized phase II study assessing the activity of single agent chemotherapy combined with nivolumab (Arm A) compared to single agent chemotherapy alone (Arm B) in squamous or non-squamous NSCLC subjects with primary resistance to prior PD-1 or PDL-1 inhibitor. The single agent chemotherapy chosen is at the discretion of the site investigator and may include pemetrexed, gemcitabine or taxotere. Institutional standards should be used for administration of the single agent chemotherapy. For both treatment arms, 21 days equals 1 cycle of therapy and subjects will be eligible to continue treatment until progressive disease by RECIST v1.1 or unacceptable toxicity. Upon registration, subjects will be randomized in a 1:1 ratio to either treatment with single agent chemotherapy or single agent chemotherapy in combination with nivolumab. Randomization is un-blinded and open-label; therefore there will be no placebo treatment for subjects randomized to single agent chemotherapy
Interventions
- DRUG Docetaxel
- DRUG Pemetrexed
- DRUG Nivolumab
- DRUG Gemcitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2017-01-27 |
| Est. Completion | 2019-05-23 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03041181
The ClinicalTrials.gov registry entry for NCT03041181 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nasser Hanna, M.D., which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Docetaxel is the first listed.
NCT03041181 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03041181 about?
NCT03041181 is a clinical study titled "Single Agent Chemotherapy +/- Nivolumab in Patients With Advanced Squamous or Non-squamous NSCLC With Primary Resistance to Prior PD-1 or PDL-1 Inhibitor". This is a randomized phase II study assessing the activity of single agent chemotherapy combined with nivolumab (Arm A) compared to single agent chemotherapy alone (Arm B) in squamous or non-squamous NSCLC subjects with primary resistance to prior PD-1 or PDL-1 inhibitor. The single agent chemothera...
What is the current status of trial NCT03041181?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2017-01-27. Estimated completion is 2019-05-23.
What interventions are being tested in trial NCT03041181?
The interventions under investigation include: Docetaxel (DRUG), Pemetrexed (DRUG), Nivolumab (DRUG), Gemcitabine (DRUG).
Who is sponsoring clinical trial NCT03041181?
This trial is sponsored by Nasser Hanna, M.D., which has 8 total clinical trials registered on ClinicalTrials.gov.
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