Study of Durvalumab Alone or Chemotherapy for Patients With Advanced Non Small-Cell Lung Cancer (PEARL)
NCT ID: NCT03003962
Last Updated: 2025-12-24
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
669 participants
INTERVENTIONAL
2017-01-02
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1: Durvalumab
Anti-PD-L1 monoclonal Antibody monotherapy
Durvalumab (MEDI4736)
Anti-PD-L1 monoclonal Antibody monotherapy
Arm 2: Standard of Care
Standard of Care Platinum-Based chemotherapy
Paclitaxel + carboplatin
Chemotherapy Agents
Gemcitabine + cisplatin
Chemotherapy Agents
Gemcitabine + carboplatin
Chemotherapy Agents
Pemetrexed + cisplatin
Chemotherapy Agent
Pemetrexed + carboplatin
Chemotherapy Agent
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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\]
18 Years
130 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Anaheim, California, United States
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Box Hill, , Australia
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Gosford, , Australia
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Kogarah, , Australia
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St Leonards, , Australia
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Beijing, , China
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Beijing, , China
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Beijing, , China
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Bengbu, , China
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Changchun, , China
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Changsha, , China
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Chengdu, , China
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Chongqing, , China
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Guangzhou, , China
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Guangzhou, , China
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Haikou, , China
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Hangzhou, , China
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Hangzhou, , China
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Hangzhou, , China
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Hangzhou, , China
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Jinan, , China
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Linhai, , China
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Nanchang, , China
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Nanjing, , China
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Ningbo, , China
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Shanghai, , China
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Shenyang, , China
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Shijiazhuang, , China
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Ürümqi, , China
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Ürümqi, , China
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Wanzhou, , China
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Wenzhou, , China
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Wuhan, , China
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Wuhan, , China
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Wuhan, , China
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Xi'an, , China
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Xi'an, , China
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Zhengzhou, , China
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Zhuhai, , China
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Deszk, , Hungary
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Farkasgyepü, , Hungary
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Gyöngyös - Mátraháza, , Hungary
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Székesfehérvár, , Hungary
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Törökbálint, , Hungary
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Almelo, , Netherlands
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Bialystok, , Poland
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Grudziądz, , Poland
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Koszalin, , Poland
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Lublin, , Poland
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Mrozy, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Arkhangelsk, , Russia
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Moscow, , Russia
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Novosibirsk, , Russia
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Omsk, , Russia
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Rostov-on-Don, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Volgograd, , Russia
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Changwon-si, , South Korea
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Cheongju-si, , South Korea
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Daegu, , South Korea
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Incheon, , South Korea
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Jinju, , South Korea
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Seoul, , South Korea
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Suwon, , South Korea
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Taichung, , Taiwan
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Taichung, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Bangkok, , Thailand
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Bangkok, , Thailand
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Muang, , Thailand
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Songkhla, , Thailand
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Ankara, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Malatya, , Turkey (Türkiye)
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Pamukkale, , Turkey (Türkiye)
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Can Tho, , Vietnam
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Hanoi, , Vietnam
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Hanoi, , Vietnam
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Ho Chi Minh City, , Vietnam
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Ho Chi Minh City, , Vietnam
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Ho Chi Minh City, , Vietnam
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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2018-001375-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D419AC00002
Identifier Type: -
Identifier Source: org_study_id