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NCT02352948 · ClinicalTrials.gov registry record · Phase 3
A Global Study to Assess the Effects of MEDI4736 (Durvalumab), Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer
A Phase 3 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 597
- Enrollment target
NCT02352948 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 597 participants.
The verdict
NCT02352948, a Phase 3 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 597 participants
- Enrollment target
Study Summary
This study is a Phase III, randomised, open label, multi-centre study assessing the efficacy and safety of MEDI4736 (durvalumab) versus Standard of Care in NSCLC patients with PD-L1 positive tumours and the combination of MEDI4736 (durvalumab) plus tremelimumab (MEDI4736+treme) versus Standard of Care in NSCLC patients with PD-L1-negative tumours in the treatment of male and female patients with locally advanced or metastatic NSCLC (Stage IIIB-IV), who have received at least 2 prior systemic treatment regimens including 1 platinum-based chemotherapy regimen for NSCLC. Patients with known EGFR (Epidermal growth factor receptor) tyrosine kinase (TK) activating mutations and anaplastic lymphoma kinase (ALK) rearrangements are not eligible for the study (prospective testing is not planned within this study). The Standard of Care options are: an EGFR tyrosine kinase inhibitor (erlotinib \[TARCEVA®\]), gemcitabine or vinorelbine (NAVELBINE®)
Interventions
- DRUG Gemcitabine
- DRUG Vinorelbine
- DRUG Erlotinib
- DRUG MEDI4736 (durvalumab)
- DRUG MEDI4736 (durvalumab) in combination with tremelimumab (anti-CTLA4)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 597 participants |
| Start Date | 2015-01-13 |
| Est. Completion | 2023-08-30 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02352948
The ClinicalTrials.gov registry entry for NCT02352948 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 597 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Gemcitabine is the first listed.
NCT02352948 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02352948 about?
NCT02352948 is a clinical study titled "A Global Study to Assess the Effects of MEDI4736 (Durvalumab), Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer". This study is a Phase III, randomised, open label, multi-centre study assessing the efficacy and safety of MEDI4736 (durvalumab) versus Standard of Care in NSCLC patients with PD-L1 positive tumours and the combination of MEDI4736 (durvalumab) plus tremelimumab (MEDI4736+treme) versus Standard of Ca...
What is the current status of trial NCT02352948?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 597 participants. The study started on 2015-01-13. Estimated completion is 2023-08-30.
What interventions are being tested in trial NCT02352948?
The interventions under investigation include: Gemcitabine (DRUG), Vinorelbine (DRUG), Erlotinib (DRUG), MEDI4736 (durvalumab) (DRUG), MEDI4736 (durvalumab) in combination with tremelimumab (anti-CTLA4) (DRUG).
Who is sponsoring clinical trial NCT02352948?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
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