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

Condition(s) studied

Investigational drug(s) / intervention(s)

Durvalumab (MEDI4736): Anti-PD-L1 monoclonal Antibody monotherapy

Paclitaxel + carboplatin: Chemotherapy Agents

Gemcitabine + cisplatin: Chemotherapy Agents

Gemcitabine + carboplatin: Chemotherapy Agents

Pemetrexed + cisplatin: Chemotherapy Agent

Pemetrexed + carboplatin: Chemotherapy Agent

Study 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)

Eligibility

Primary outcome measure(s)

• Overall Survival (OS) — 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]
  OS is defined as the time from the date of randomization until death due to any cause (date of death or censoring-date of randomization + 1). Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive.
• OS in Participants With LREM — From date of randomization until death due to any cause. Assessed up to a maximum of approximately 69 months (DCO 27 October 2022)
  OS is defined as the time from the date of randomization until death due to any cause (date of death or censoring-date of randomization + 1). Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive.

Trial sites (92)

+ 52 more sites — see the full list on the official registry below.