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NCT03003962 · ClinicalTrials.gov registry record · Phase 3
Study of Durvalumab Alone or Chemotherapy for Patients With Advanced Non Small-Cell Lung Cancer (PEARL)
A Phase 3 study of Non-Small-Cell Lung Carcinoma NSCLC, sponsored by AstraZeneca.
- Active
- Registry status
- Phase 3
- Development phase
- 669
- Enrollment target
- 20
- Study locations
NCT03003962: Active Phase 3 study of Non-Small-Cell Lung Carcinoma NSCLC, sponsored by AstraZeneca.
NCT03003962 is a Phase 3 study of Non-Small-Cell Lung Carcinoma NSCLC that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 669 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (13% lower). The trial reports 20 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03003962, a Phase 3 study of Non-Small-Cell Lung Carcinoma NSCLC, is active but no longer recruiting, sponsored by AstraZeneca.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 669 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a randomized, open-label, multi-center Phase III study to determine the efficacy and safety of durvalumab versus platinum-based SoC chemotherapy in the first-line treatment of advanced NSCLC in patients who are epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type and with PD-L1 high expression (PEARL)
Primary Outcome
OS is defined as the time from the date of randomization until death due to any cause (date of death or censoring-date of randomization + 1). Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive.
Conditions Studied
Interventions
- DRUG Gemcitabine + cisplatin
- DRUG Gemcitabine + carboplatin
- DRUG Durvalumab (MEDI4736)
- DRUG Paclitaxel + carboplatin
- DRUG Pemetrexed + cisplatin
Study Locations (20)
Other
- Research Site - Box Hill
- Research Site - Gosford
- Research Site - Kogarah
- Research Site - St Leonards
- Research Site - Beijing
- Research Site - Beijing
- Research Site - Beijing
- Research Site - Bengbu
- Research Site - Changchun
- Research Site - Changsha
- Research Site - Chengdu
- Research Site - Chongqing
- Research Site - Guangzhou
- Research Site - Guangzhou
- Research Site - Haikou
- Research Site - Hangzhou
- Research Site - Hangzhou
- Research Site - Hangzhou
- Research Site - Hangzhou
California
- Research Site - Anaheim
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 669 participants |
| Start Date | 2017-01-02 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 3 |
What the registry record for NCT03003962 still lists
NCT03003962 is an interventional study that assigns participants to a tested intervention. The registered 669 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 (13% lower).
The record links to 1 condition, with Non-Small-Cell Lung Carcinoma NSCLC appearing as the primary indexed condition, and to 5 interventions - of which Gemcitabine + cisplatin is the first listed.
NCT03003962 names 20 study sites across 2 states, led by Other, California.
Frequently Asked Questions
What is clinical trial NCT03003962 about?
NCT03003962 is a clinical study titled "Study of Durvalumab Alone or Chemotherapy for Patients With Advanced Non Small-Cell Lung Cancer (PEARL)". This is a randomized, open-label, multi-center Phase III study to determine the efficacy and safety of durvalumab versus platinum-based SoC chemotherapy in the first-line treatment of advanced NSCLC in patients who are epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild...
What is the current status of trial NCT03003962?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 669 participants. The study started on 2017-01-02. Estimated completion is 2026-06-30.
What conditions does trial NCT03003962 study?
This clinical trial studies the following conditions: Non-Small-Cell Lung Carcinoma NSCLC.
What interventions are being tested in trial NCT03003962?
The interventions under investigation include: Gemcitabine + cisplatin (DRUG), Gemcitabine + carboplatin (DRUG), Durvalumab (MEDI4736) (DRUG), Paclitaxel + carboplatin (DRUG), Pemetrexed + cisplatin (DRUG).
Who is sponsoring clinical trial NCT03003962?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03003962 being conducted?
This trial has 20 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT03003962's enrollment target sits among peer trials
669 547th of 2000 higher than 1,453 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
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