Study of Durvalumab Alone or Chemotherapy for Patients With Advanced Non Small-Cell Lung Cancer (PEARL)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03003962 |
Recruitment Status :
Active, not recruiting
First Posted : December 28, 2016
Last Update Posted : May 31, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non Small Cell Lung Carcinoma NSCLC | Drug: Durvalumab (MEDI4736) Drug: Paclitaxel + carboplatin Drug: Gemcitabine + cisplatin Drug: Gemcitabine + carboplatin Drug: Pemetrexed + cisplatin Drug: Pemetrexed + carboplatin | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 671 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase III Randomized, Open-Label, Multi-Center Study of Durvalumab (MEDI4736) Versus Standard of Care (SoC) Platinum-Based Chemotherapy as First Line Treatment in Patients With PD-L1-High Expression Advanced Non Small-Cell Lung Cancer |
Actual Study Start Date : | January 2, 2017 |
Estimated Primary Completion Date : | October 7, 2022 |
Estimated Study Completion Date : | June 30, 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm 1: Durvalumab
Anti-PD-L1 monoclonal Antibody monotherapy
|
Drug: Durvalumab (MEDI4736)
Anti-PD-L1 monoclonal Antibody monotherapy |
Active Comparator: Arm 2: Standard of Care
Standard of Care Platinum-Based chemotherapy
|
Drug: Paclitaxel + carboplatin
Chemotherapy Agents
Other Name: Platinum based Standard of Care Chemotherapy Drug: Gemcitabine + cisplatin Chemotherapy Agents
Other Name: Platinum based Standard of Care Chemotherapy Drug: Gemcitabine + carboplatin Chemotherapy Agents
Other Name: Platinum based Standard of Care Chemotherapy Drug: Pemetrexed + cisplatin Chemotherapy Agent
Other Name: Platinum based Standard of Care Chemotherapy Drug: Pemetrexed + carboplatin Chemotherapy Agent
Other Name: Platinum based Standard of Care Chemotherapy |
- The efficacy of Durvalumab therapy compared to SoC in terms of Overall Survival (OS) in all randomized patients [ Time Frame: 4 years ]
- The efficacy of Durvalumab therapy compared to SoC in terms of OS in patients who are at low risk of early mortality (EM) [ Time Frame: 4 years ]
- The efficacy of Durvalumab compared to SoC in terms of Objective response rate (ORR) [ Time Frame: 4 years ]
- The efficacy of Durvalumab compared to SoC in terms of Duration of response (DoR) [ Time Frame: 4 years ]
- The efficacy of Durvalumab compared to SoC in terms of A Proportion of patients alive and progression free at 12 months from randomization (APF12) [ Time Frame: 12 months ]
- The efficacy of Durvalumab compared to SoC in terms of Progression-free survival after subsequent anticancer therapy (PFS2) [ Time Frame: 4 years ]
- Disease-related symptoms and health-related quality of life in subjects treated with durvalumab compared to SoC using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [ Time Frame: 4 years ]
- The immunogenicity of durvalumab by measuring the presence of Anti-drug Antibodies [ Time Frame: 4 years ]
- The efficacy of Durvalumab therapy compared to SoC in terms of progress-free survival (PFS) in patients with NSCLC [ Time Frame: 4 years ]
- The efficacy of Durvalumab therapy compared to SoC in terms of Overall Survival (OS) in PD-L1 high patients and in PD-L1 high with low risk of EM population [ Time Frame: 4 years ]
- Proportion of patients alive at 18 months from randomization (OS18) [ Time Frame: 18 months ]
- Proportion of patients alive at 24 months from randomization (OS24) [ Time Frame: 24 months ]
- The Incidence of Treatment-Emergent Adverse Events assessed by Common Terminology Criteria for Adverse Event (CTCAE) v4.03 for subjects receiving Durvalumab therapy or SoC [ Time Frame: 4 years ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 130 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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]

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03003962

Study Director: | Parker Suzanne | AstraZeneca RDM, South San Francisco, USA |
Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT03003962 |
Other Study ID Numbers: |
D419AC00002 |
First Posted: | December 28, 2016 Key Record Dates |
Last Update Posted: | May 31, 2022 |
Last Verified: | May 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) |
Time Frame: | AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. |
Access Criteria: | When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. |
URL: | https://astrazenecagroup-dt.pharmacm.com/DT/Home |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
NSCLC PD-L1 Durvalumab (MEDI4736) OS |
Carcinoma, Non-Small-Cell Lung Carcinoma, Bronchogenic Bronchial Neoplasms Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Gemcitabine Paclitaxel Cisplatin Carboplatin Pemetrexed |
Durvalumab Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antimetabolites Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |