Lung Cancer Clinical Trial
Study of Durvalumab Alone or Chemotherapy for Patients With Advanced Non Small-Cell Lung Cancer (PEARL)
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)
Full Description
Patients with stage IV NSCLC will be randomized in a 1:1 ratio to 2 treatment arms (durvalumab or SOC therapy). The dual primary objectives of this study are to assess the efficacy of durvalumab versus SoC in terms of OS (Overall Survival) in all randomized patients and in patients who are at low risk of EM (early mortality)
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]
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There are 87 Locations for this study
Anaheim California, 92801, United States
Box Hill , 3128, Australia
Gosford , 2250, Australia
Kogarah , 2217, Australia
St Leonards , 2065, Australia
Beijing , 10003, China
Beijing , 10014, China
Beijing , 10085, China
Bengbu , 23306, China
Changchun , 13000, China
Changsha , 41001, China
Chengdu , 61004, China
Chongqing , 40003, China
Guangzhou , 51008, China
Guangzhou , 51009, China
Haikou , 57031, China
Hangzhou , 31000, China
Hangzhou , 31000, China
Hangzhou , 31000, China
Hangzhou , 31002, China
Jinan , 25003, China
Linhai , 31700, China
Nanchang , 33000, China
Nanjing , 21000, China
Ningbo , 31501, China
Shanghai , 20003, China
Shenyang , 11004, China
Shijiazhuang , 05002, China
Urumqi , 83000, China
Urumqi , 83005, China
Wanzhou , 40400, China
Wenzhou , CN-32, China
Wuhan , 43001, China
Wuhan , 43002, China
Wuhan , 43003, China
Xi'an , 71003, China
Xi'an , 71006, China
Zhengzhou , 45000, China
Zhuhai , 51909, China
Budapest , 1083, Hungary
Budapest , 1121, Hungary
Budapest , 1122, Hungary
Deszk , 6772, Hungary
Farkasgyepü , 8582, Hungary
Gyöngyös - Mátraháza , 3200, Hungary
Székesfehérvár , 8000, Hungary
Törökbálint , 2045, Hungary
Changwon-si , 51353, Korea, Republic of
Cheongju-si , 28644, Korea, Republic of
Daegu , 42415, Korea, Republic of
Incheon , 21565, Korea, Republic of
Jinju-si , 660-7, Korea, Republic of
Seoul , 03722, Korea, Republic of
Suwon-si , 16499, Korea, Republic of
Almelo , 7600S, Netherlands
Bialystok , 15-02, Poland
GrudziÄ…dz , 86-30, Poland
Koszalin , 75-58, Poland
Lublin , 20-09, Poland
Mrozy , 05-32, Poland
Warszawa , 02-78, Poland
Wroclaw , 53-41, Poland
Arkhangelsk , 16304, Russian Federation
Moscow , 11547, Russian Federation
Novosibirsk , 63010, Russian Federation
Omsk , 64401, Russian Federation
Rostov-on-Don , 34403, Russian Federation
Saint Petersburg , 19734, Russian Federation
Saint Petersburg , 19775, Russian Federation
Saint-Petersburg , 19429, Russian Federation
Saint-Petersburg , 19718, Russian Federation
Sankt-Peterburg , 19660, Russian Federation
St. Petersburg , 19775, Russian Federation
Volgograd , 40013, Russian Federation
Taichung City , 402, Taiwan
Taichung , 40705, Taiwan
Taipei , 112, Taiwan
Taipei , 235, Taiwan
Bangkok , 10330, Thailand
Bangkok , 10700, Thailand
Muang , 50200, Thailand
Songkla , 90110, Thailand
Ankara , 06490, Turkey
Istanbul , 34030, Turkey
Istanbul , 34854, Turkey
Malatya , 44100, Turkey
Pamukkale , 20070, Turkey
Can Tho , 90000, Vietnam
Hanoi , 10000, Vietnam
Hanoi , 10000, Vietnam
Ho Chi Minh , 10000, Vietnam
Ho Chi Minh , 70000, Vietnam
Ho Chi Minh , 70000, Vietnam
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