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

Conditions

• Non Small Cell Lung Carcinoma NSCLC

Eligibility Criteria

Sex

ALL

Age

18 Years - 130 Years

Healthy Volunteers

Not accepted

Interventions

• Durvalumab (MEDI4736) — DRUG
  Anti-PD-L1 monoclonal Antibody monotherapy
• Paclitaxel + carboplatin — DRUG
  Chemotherapy Agents
• Gemcitabine + cisplatin — DRUG
  Chemotherapy Agents
• Gemcitabine + carboplatin — DRUG
  Chemotherapy Agents
• Pemetrexed + cisplatin — DRUG
  Chemotherapy Agent
• Pemetrexed + carboplatin — DRUG
  Chemotherapy Agent

Study Details

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)

Key Dates

Start date

Jan 2, 2017

Status verified

Jun 2026

Primary completion

Oct 27, 2022

Completion

Jun 30, 2026

Study Design

Enrollment

669 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm 1: Durvalumab
  Anti-PD-L1 monoclonal Antibody monotherapy
• Active Comparator: Arm 2: Standard of Care
  Standard of Care Platinum-Based chemotherapy

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: From date of randomization until death due to any cause. Assessed up to a maximum of approximately 69 months [data cut-off (DCO) 27 October 2022] ]

Locations (1)

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