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

NCT03003962 · tracked via the Priya Life Science South Korea tracker

Sponsor

AstraZeneca

Phase

Phase 3

Started

2017-01-02

Last updated

2026-06-11

Condition(s) studied

Non Small Cell Lung Carcinoma NSCLC

Investigational drug(s) / intervention(s)

Durvalumab (MEDI4736) →Paclitaxel + carboplatinAll Paclitaxel trials (424) →All Carboplatin trials (587) →Gemcitabine + cisplatinAll Gemcitabine trials (386) →All Cisplatin trials (506) →Gemcitabine + carboplatinAll Gemcitabine trials (386) →All Carboplatin trials (587) →Pemetrexed + cisplatinAll Pemetrexed trials (246) →All Cisplatin trials (506) →Pemetrexed + carboplatinAll Pemetrexed trials (246) →All Carboplatin trials (587) →

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

Sex

ALL

Min age

18 Years

Max age

130 Years

Healthy volunteers

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\]

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)

Facility	City	Region
Research Site	Anaheim	California
Research Site	Box Hill	Australia
Research Site	Gosford	Australia
Research Site	Kogarah	Australia
Research Site	St Leonards	Australia
Research Site	Beijing	China
Research Site	Beijing	China
Research Site	Beijing	China
Research Site	Bengbu	China
Research Site	Changchun	China
Research Site	Changsha	China
Research Site	Chengdu	China
Research Site	Chongqing	China
Research Site	Guangzhou	China
Research Site	Guangzhou	China
Research Site	Haikou	China
Research Site	Hangzhou	China
Research Site	Hangzhou	China
Research Site	Hangzhou	China
Research Site	Hangzhou	China
Research Site	Jinan	China
Research Site	Linhai	China
Research Site	Nanchang	China
Research Site	Nanjing	China
Research Site	Ningbo	China
Research Site	Shanghai	China
Research Site	Shenyang	China
Research Site	Shijiazhuang	China
Research Site	Ürümqi	China
Research Site	Ürümqi	China
Research Site	Wanzhou	China
Research Site	Wenzhou	China
Research Site	Wuhan	China
Research Site	Wuhan	China
Research Site	Wuhan	China
Research Site	Xi'an	China
Research Site	Xi'an	China
Research Site	Zhengzhou	China
Research Site	Zhuhai	China
Research Site	Budapest	Hungary

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

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A Study of T-DXd for the Treatment of Solid Tumors Harboring HER2 Activating Mutations Active, not recruiting

Study of MEDI4736 (Durvalumab) With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer Active, not recruiting

Study of AZD0120 in Newly Diagnosed Multiple Myeloma Ineligible for ASCT Recruiting

Other trials for the same condition

Study of Durvalumab With Tremelimumab Versus SoC as 1st Line Therapy in Metastatic Non Small-Cell Lung Cancer (NSCLC) (NEPTUNE) Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03003962 on ClinicalTrials.gov ↗ ← All trials in South Korea