Study of Durvalumab Alone or Chemotherapy for Patients With Advanced Non Small-Cell Lung Cancer (PEARL)

AstraZeneca

Status and phase: Active, not recruiting; Phase 3

Conditions: Non Small Cell Lung Carcinoma NSCLC

Treatments: Drug: Pemetrexed + carboplatin; Drug: Paclitaxel + carboplatin; Drug: Durvalumab (MEDI4736); Drug: Pemetrexed + cisplatin; Drug: Gemcitabine + cisplatin; Drug: Gemcitabine + carboplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03003962

2018-001375-21 (EudraCT Number)

D419AC00002

Details and patient eligibility

About

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)

Full 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)

Enrollment: 669 patients

Sex: All

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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]

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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669 participants in 2 patient groups

Arm 1: Durvalumab

Experimental group

Description:

Anti-PD-L1 monoclonal Antibody monotherapy

Treatment:

Drug: Durvalumab (MEDI4736)

Arm 2: Standard of Care

Active Comparator group

Description:

Standard of Care Platinum-Based chemotherapy

Treatment:

Drug: Gemcitabine + carboplatin

Drug: Pemetrexed + cisplatin

Drug: Gemcitabine + cisplatin

Drug: Paclitaxel + carboplatin

Drug: Pemetrexed + carboplatin