drugset / Trial / NCT03003962
Study of Durvalumab Alone or Chemotherapy for Patients With Advanced Non Small-Cell Lung Cancer (PEARL)
RandomizedParallel-groupOpen-labelTreatment
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)
Timeline
- Start
- 2017-01-02
- Primary completion
- 2022-10-27
- Completion
- 2026-06-30
Outcome
Mixed primary results
registry analysis (other test); Durvalumab vs Platinum-based SoC; p = 0.037; Hazard Ratio (HR) 0.84 (95% CI 0.706 to 0.989); Stratified Log-rank test NCT03003962 ↗
registry analysis (other test); Durvalumab vs Platinum-based SoC; p = 0.628; Hazard Ratio (HR) 0.96 (95% CI 0.793 to 1.151); Stratified log-rank test NCT03003962 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Carboplatin | Small molecule | — | — |
| Comparator | Cisplatin | Other / unclassified | — | — |
| Subject | Durvalumab | Monoclonal antibody | — | — |
| Comparator | Gemcitabine | Small molecule | — | — |
| Comparator | Paclitaxel | Small molecule | — | — |
| Comparator | Pemetrexed | Small molecule | — | — |