Description:
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)
Title
- Brief Title: A Study of Durvalumab Versus Standard of Care in Advanced Non Small-Cell Lung Cancer
- 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
Clinical Trial IDs
- ORG STUDY ID:
D419AC00002
- NCT ID:
NCT03003962
Conditions
- Non Small Cell Lung Carcinoma NSCLC
Interventions
Drug | Synonyms | Arms |
---|
Durvalumab (MEDI4736) | | Durvalumab |
Paclitaxel + carboplatin | Platinum based Standard of Care Chemotherapy | Standard of Care |
Gemcitabine + cisplatin | Platinum based Standard of Care Chemotherapy | Standard of Care |
Gemcitabine + carboplatin | Platinum based Standard of Care Chemotherapy | Standard of Care |
Pemetrexed + cisplatin | Platinum based Standard of Care Chemotherapy | Standard of Care |
Pemetrexed + carboplatin | Platinum based Standard of Care Chemotherapy | Standard of Care |
Purpose
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
Detailed Description
Patients will be randomized in a 1:1 ratio to 2 treatment arms (durvalumab or SOC therapy).
The Co-primary objectives of this study are to assess the efficacy of durvalumab compared to
SoC in terms of PFS (Progression Free Survival) and OS (Overall Survival) in patients with
NSCLC
Trial Arms
Name | Type | Description | Interventions |
---|
Durvalumab | Experimental | PD-L1 monoclonal Antibody monotherapy | |
Standard of Care | Active Comparator | Standard of Care Platinum-Based chemotherapy | - Paclitaxel + carboplatin
- Gemcitabine + cisplatin
- Gemcitabine + carboplatin
- Pemetrexed + cisplatin
- Pemetrexed + carboplatin
|
Eligibility Criteria
Inclusion Criteria
- Aged at least 18 years
- Documented evidence of Stage IV NSCLC
- No sensitizing EGFR mutation and ALK rearrangement
- PD-L1 expression at least 25%
- 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]
Maximum Eligible Age: | 130 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | The efficacy of Durvalumab therapy compared to SoC in terms of progression-free survival (PFS) in patients with NSCLC |
Time Frame: | 3 years |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | The efficacy of Durvalumab compared to SoC in terms of Objective response rate (ORR) |
Time Frame: | 3 years |
Safety Issue: | |
Description: | |
Measure: | The efficacy of Durvalumab compared to SoC in terms of Duration of response (DoR) |
Time Frame: | 3 years |
Safety Issue: | |
Description: | |
Measure: | The efficacy of Durvalumab compared to SoC in terms of A Proportion of patients alive and progression free at 12 months from randomization (APF12) |
Time Frame: | 12 months |
Safety Issue: | |
Description: | |
Measure: | The efficacy of Durvalumab compared to SoC in terms of Progression-free survival after subsequent anticancer therapy (PFS2) |
Time Frame: | 3 years |
Safety Issue: | |
Description: | |
Measure: | Disease-related symptoms in subjects treated with durvalumab compared to SoC using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-LC13) |
Time Frame: | 3 years |
Safety Issue: | |
Description: | |
Measure: | Health-related quality of life in subjects treated with durvalumab compared to SoC using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) |
Time Frame: | 3 years |
Safety Issue: | |
Description: | |
Measure: | The immunogenicity of durvalumab by measuring the presence of Anti-drug Antibodies |
Time Frame: | 3 years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | AstraZeneca |
Trial Keywords
- NSCLC
- PD-L1
- Durvalumab
- MEDI4736
- PFS
- OS
Last Updated
April 27, 2018