Trials / Active Not Recruiting
Active Not RecruitingNCT03003962
Study of Durvalumab Alone or Chemotherapy for Patients With Advanced Non Small-Cell Lung Cancer (PEARL)
A Phase III Randomized, Open-Label, Multi-Center Study of Durvalumab (MEDI4736) Versus Standard of Care (SoC) Platinum-Based Chemotherapy as First Line Treatment in Patients With PD-L1-High Expression Advanced Non Small-Cell Lung Cancer
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 669 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 18 Years – 130 Years
- Healthy volunteers
- Not accepted
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)
Detailed description
Patients with stage IV NSCLC will be randomized in a 1:1 ratio to 2 treatment arms (durvalumab or SOC therapy). The dual primary objectives of this study are to assess the efficacy of durvalumab versus SoC in terms of OS (Overall Survival) in all randomized patients and in patients who are at low risk of EM (early mortality)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Durvalumab (MEDI4736) | Anti-PD-L1 monoclonal Antibody monotherapy |
| DRUG | Paclitaxel + carboplatin | Chemotherapy Agents |
| DRUG | Gemcitabine + cisplatin | Chemotherapy Agents |
| DRUG | Gemcitabine + carboplatin | Chemotherapy Agents |
| DRUG | Pemetrexed + cisplatin | Chemotherapy Agent |
| DRUG | Pemetrexed + carboplatin | Chemotherapy Agent |
Timeline
- Start date
- 2017-01-02
- Primary completion
- 2022-10-27
- Completion
- 2026-06-30
- First posted
- 2016-12-28
- Last updated
- 2026-03-11
- Results posted
- 2023-12-26
Locations
92 sites across 12 countries: United States, Australia, China, Hungary, Netherlands, Poland, Russia, South Korea, Taiwan, Thailand, Turkey (Türkiye), Vietnam
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03003962. Inclusion in this directory is not an endorsement.