Clinical Trial: NCT03003962
Study of Durvalumab Alone or Chemotherapy for Patients With Advanced Non Small-Cell Lung Cancer (PEARL)
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 3| Lead Sponsor: | AstraZeneca |
| Information Provided By: | AstraZeneca |
| Last Update Posted: | 2026-06-11 |
Study Overview
Brief 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)
Official Title
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
Conditions
Non Small Cell Lung Carcinoma NSCLC
Intervention / Treatment
- Drug: Durvalumab (MEDI4736)
- Drug: Paclitaxel + carboplatin
- Drug: Gemcitabine + cisplatin
- Drug: Gemcitabine + carboplatin
- Drug: Pemetrexed + cisplatin
- Drug: Pemetrexed + carboplatin
Other Study ID Numbers
- D419AC00002
- 2018-001375-21
- 2018
Start Date (Actual)
2017-01-02
Primary Completion Date (Actual)
2022-10-27
Study Completion Date (Estimated)
2026-06-30
Enrollment (Actual)
669
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | AstraZeneca |
| Information Provided By: | AstraZeneca |
| Last Update Posted: | 2026-06-11 |
Study Overview
Brief 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)
Official Title
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
Conditions
Non Small Cell Lung Carcinoma NSCLC
Intervention / Treatment
- Drug: Durvalumab (MEDI4736)
- Drug: Paclitaxel + carboplatin
- Drug: Gemcitabine + cisplatin
- Drug: Gemcitabine + carboplatin
- Drug: Pemetrexed + cisplatin
- Drug: Pemetrexed + carboplatin
Other Study ID Numbers
- D419AC00002
- 2018-001375-21
- 2018
Start Date (Actual)
2017-01-02
Primary Completion Date (Actual)
2022-10-27
Study Completion Date (Estimated)
2026-06-30
Enrollment (Actual)
669
Study Type
Interventional
Phase
Phase 3