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

NCT03003962

Active Not RecruitingPhase 3

Sponsor: AstraZeneca

Conditions: Non Small Cell Lung Carcinoma NSCLC

Interventions: Durvalumab (MEDI4736), Paclitaxel + carboplatin, Gemcitabine + cisplatin, Gemcitabine + carboplatin, Pemetrexed + cisplatin

Countries: United States, Australia, China, Hungary, Netherlands, Poland, Russia, South Korea

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 overview

Sex: ALL

Age: 18 Years to 130 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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\]
Locations (92)
  • Anaheim, California, United States
  • Box Hill, Australia
  • Gosford, Australia
  • Kogarah, Australia
  • St Leonards, Australia
  • Beijing, China
  • Beijing, China
  • Beijing, China
  • Bengbu, China
  • Changchun, China
  • Changsha, China
  • Chengdu, China
  • Chongqing, China
  • Guangzhou, China
  • Guangzhou, China
  • Haikou, China
  • Hangzhou, China
  • Hangzhou, China
  • Hangzhou, China
  • Hangzhou, China
  • Jinan, China
  • Linhai, China
  • Nanchang, China
  • Nanjing, China
  • Ningbo, China
  • Shanghai, China
  • Shenyang, China
  • Shijiazhuang, China
  • Ürümqi, China
  • Ürümqi, China
  • + 62 more on CT.gov