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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: Completed Phase 3 study, sponsored by AstraZeneca.
NCT02352948 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 597 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
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®)
Primary Outcome
The OS was defined as the time from the date of randomization until death due to any cause.
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 |
What the finished NCT02352948 record still lists
NCT02352948 is an interventional study that assigns participants to a tested intervention. The registered 597 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 5 interventions - of which Gemcitabine is the first listed.
NCT02352948 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02352948's enrollment target sits among peer trials
597 640th of 2000 higher than 1,361 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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