Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Carcinoma NSCLC | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Durvalumab (MEDI4736) | Drug | Durvalumab | ALIAS |
| Gemcitabine + carboplatin | Drug | — | UNRESOLVED |
| Gemcitabine + cisplatin | Drug | — | UNRESOLVED |
| Paclitaxel + carboplatin | Drug | Carboplatin/Paclitaxel Regimen | ALIAS |
| Pemetrexed + carboplatin | Drug | — | UNRESOLVED |
| Pemetrexed + cisplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1: Durvalumab
- description
- Anti-PD-L1 monoclonal Antibody monotherapy
- interventionNames
- Drug: Durvalumab (MEDI4736)
- type
- ACTIVE_COMPARATOR
- label
- Arm 2: Standard of Care
- description
- Standard of Care Platinum-Based chemotherapy
- interventionNames
- Drug: Paclitaxel + carboplatin
- Drug: Gemcitabine + cisplatin
- Drug: Gemcitabine + carboplatin
- Drug: Pemetrexed + cisplatin
- Drug: Pemetrexed + carboplatin
Primary outcomes (2)
- measure
- Overall Survival (OS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 130 Years
Show eligibility criteria text
Inclusion Criteria * Aged at least 18 years * Documented evidence of Stage IV NSCLC * No sensitizing EGFR mutation and ALK rearrangement * PD-L1 high expression * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Exclusion Criteria: * Prior chemotherapy or any other systemic therapy for advanced NSCLC * Prior exposure to immune-mediated therapy, including, but not limited to, other anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), anti-programmed cell death1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti PD-L2 antibodies, excluding therapeutic anticancer vaccines * Brain metastases or spinal cord compression unless the patient is stable and off steroids for at least 14 days prior to start of study treatment * Mixed small-cell lung cancer and NSCLC histology, sarcomatoid variant * Active or prior documented autoimmune or inflammatory disorders (e.g., colitis or Crohn's disease\]
References
Publications (0)
Data not yet available