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)

View Full Description

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)

View Eligibility Criteria

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]

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

671

Study ID:

NCT03003962

Recruitment Status:

Active, not recruiting

Sponsor:

AstraZeneca

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 87 Locations for this study

See Locations Near You

Research Site
Anaheim California, 92801, United States
Research Site
Box Hill , 3128, Australia
Research Site
Gosford , 2250, Australia
Research Site
Kogarah , 2217, Australia
Research Site
St Leonards , 2065, Australia
Research Site
Beijing , 10003, China
Research Site
Beijing , 10014, China
Research Site
Beijing , 10085, China
Research Site
Bengbu , 23306, China
Research Site
Changchun , 13000, China
Research Site
Changsha , 41001, China
Research Site
Chengdu , 61004, China
Research Site
Chongqing , 40003, China
Research Site
Guangzhou , 51008, China
Research Site
Guangzhou , 51009, China
Research Site
Haikou , 57031, China
Research Site
Hangzhou , 31000, China
Research Site
Hangzhou , 31000, China
Research Site
Hangzhou , 31000, China
Research Site
Hangzhou , 31002, China
Research Site
Jinan , 25003, China
Research Site
Linhai , 31700, China
Research Site
Nanchang , 33000, China
Research Site
Nanjing , 21000, China
Research Site
Ningbo , 31501, China
Research Site
Shanghai , 20003, China
Research Site
Shenyang , 11004, China
Research Site
Shijiazhuang , 05002, China
Research Site
Urumqi , 83000, China
Research Site
Urumqi , 83005, China
Research Site
Wanzhou , 40400, China
Research Site
Wenzhou , CN-32, China
Research Site
Wuhan , 43001, China
Research Site
Wuhan , 43002, China
Research Site
Wuhan , 43003, China
Research Site
Xi'an , 71003, China
Research Site
Xi'an , 71006, China
Research Site
Zhengzhou , 45000, China
Research Site
Zhuhai , 51909, China
Research Site
Budapest , 1083, Hungary
Research Site
Budapest , 1121, Hungary
Research Site
Budapest , 1122, Hungary
Research Site
Deszk , 6772, Hungary
Research Site
Farkasgyepü , 8582, Hungary
Research Site
Gyöngyös - Mátraháza , 3200, Hungary
Research Site
Székesfehérvár , 8000, Hungary
Research Site
Törökbálint , 2045, Hungary
Research Site
Changwon-si , 51353, Korea, Republic of
Research Site
Cheongju-si , 28644, Korea, Republic of
Research Site
Daegu , 42415, Korea, Republic of
Research Site
Incheon , 21565, Korea, Republic of
Research Site
Jinju-si , 660-7, Korea, Republic of
Research Site
Seoul , 03722, Korea, Republic of
Research Site
Suwon-si , 16499, Korea, Republic of
Research Site
Almelo , 7600S, Netherlands
Research Site
Bialystok , 15-02, Poland
Research Site
Grudziądz , 86-30, Poland
Research Site
Koszalin , 75-58, Poland
Research Site
Lublin , 20-09, Poland
Research Site
Mrozy , 05-32, Poland
Research Site
Warszawa , 02-78, Poland
Research Site
Wroclaw , 53-41, Poland
Research Site
Arkhangelsk , 16304, Russian Federation
Research Site
Moscow , 11547, Russian Federation
Research Site
Novosibirsk , 63010, Russian Federation
Research Site
Omsk , 64401, Russian Federation
Research Site
Rostov-on-Don , 34403, Russian Federation
Research Site
Saint Petersburg , 19734, Russian Federation
Research Site
Saint Petersburg , 19775, Russian Federation
Research Site
Saint-Petersburg , 19429, Russian Federation
Research Site
Saint-Petersburg , 19718, Russian Federation
Research Site
Sankt-Peterburg , 19660, Russian Federation
Research Site
St. Petersburg , 19775, Russian Federation
Research Site
Volgograd , 40013, Russian Federation
Research Site
Taichung City , 402, Taiwan
Research Site
Taichung , 40705, Taiwan
Research Site
Taipei , 112, Taiwan
Research Site
Taipei , 235, Taiwan
Research Site
Bangkok , 10330, Thailand
Research Site
Bangkok , 10700, Thailand
Research Site
Muang , 50200, Thailand
Research Site
Songkla , 90110, Thailand
Research Site
Ankara , 06490, Turkey
Research Site
Istanbul , 34030, Turkey
Research Site
Istanbul , 34854, Turkey
Research Site
Malatya , 44100, Turkey
Research Site
Pamukkale , 20070, Turkey
Research Site
Can Tho , 90000, Vietnam
Research Site
Hanoi , 10000, Vietnam
Research Site
Hanoi , 10000, Vietnam
Research Site
Ho Chi Minh , 10000, Vietnam
Research Site
Ho Chi Minh , 70000, Vietnam
Research Site
Ho Chi Minh , 70000, Vietnam

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

671

Study ID:

NCT03003962

Recruitment Status:

Active, not recruiting

Sponsor:


AstraZeneca

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.