A Study of Durvalumab Versus Standard of Care in Advanced Non Small-Cell Lung Cancer

Study Description

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Brief 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

Condition or disease	Intervention/treatment	Phase
Non Small Cell Lung Carcinoma NSCLC	Biological: Durvalumab (MEDI4736); Drug: Paclitaxel + carboplatin; Drug: Gemcitabine + cisplatin; Drug: Gemcitabine + carboplatin; Drug: Pemetrexed + cisplatin; Drug: Pemetrexed + carboplatin	Phase 3

Detailed Description:

Patients will be randomized in a 1:1 ratio to 2 treatment arms (durvalumab or SOC therapy). The Co-primary objectives of this study are to assess the efficacy of durvalumab compared to SoC in terms of PFS (Progression Free Survival) and OS (Overall Survival) in patients with NSCLC

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	440 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 22, 2018
Estimated Study Completion Date :	June 12, 2020

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Durvalumab; PD-L1 monoclonal Antibody monotherapy	Biological: Durvalumab (MEDI4736); PD-L1 monoclonal Antibody
Active Comparator: 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

Outcome Measures

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Primary Outcome Measures :

1. The efficacy of Durvalumab therapy compared to SoC in terms of progression-free survival (PFS) in patients with NSCLC [ Time Frame: 3 years ]
2. The efficacy of Durvalumab therapy compared to SoC in terms of Overall Survival (OS) in patients with NSCLC [ Time Frame: 3 years ]

Secondary Outcome Measures :

1. The efficacy of Durvalumab compared to SoC in terms of Objective response rate (ORR) [ Time Frame: 3 years ]
2. The efficacy of Durvalumab compared to SoC in terms of Duration of response (DoR) [ Time Frame: 3 years ]
3. 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 ]
4. The efficacy of Durvalumab compared to SoC in terms of Progression-free survival after subsequent anticancer therapy (PFS2) [ Time Frame: 3 years ]
5. Disease-related symptoms in subjects treated with durvalumab compared to SoC using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-LC13) [ Time Frame: 3 years ]
6. 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 (EORTC QLQ-C30) [ Time Frame: 3 years ]
7. The immunogenicity of durvalumab by measuring the presence of Anti-drug Antibodies [ Time Frame: 3 years ]

Other Outcome Measures:

1. The Incidence of Treatment-Emergent Adverse Events assessed by CTCAE v4.03 for subjects receiving Durvalumab therapy or SoC [ Time Frame: 3 years ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 130 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

• Aged at least 18 years
• Documented evidence of Stage IV NSCLC
• No sensitizing EGFR mutation and ALK rearrangement
• PD-L1 expression at least 25%
• 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]

Contacts and Locations

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Contacts

Contact: AstraZeneca Clinical Study Information Center	1-877-240-9479	information.center@astrazeneca.com

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Sponsors and Collaborators

AstraZeneca

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT03003962 History of Changes
Other Study ID Numbers:	D419AC00002
First Posted:	December 28, 2016
Last Update Posted:	April 2, 2018
Last Verified:	March 2018

Keywords provided by AstraZeneca:

NSCLC; PD-L1; Durvalumab	MEDI4736; PFS; OS

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Gemcitabine; Cisplatin; Carboplatin; Pemetrexed	Antibodies, Monoclonal; Antineoplastic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Antiviral Agents; Anti-Infective Agents; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Folic Acid Antagonists; Nucleic Acid Synthesis Inhibitors