A Study of Durvalumab Versus Standard of Care in Advanced Non Small-Cell Lung Cancer
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ClinicalTrials.gov Identifier: NCT03003962 |
Recruitment Status
:
Recruiting
First Posted
: December 28, 2016
Last Update Posted
: April 2, 2018
|
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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 |
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 |

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
|
- The efficacy of Durvalumab therapy compared to SoC in terms of progression-free survival (PFS) in patients with NSCLC [ Time Frame: 3 years ]
- The efficacy of Durvalumab therapy compared to SoC in terms of Overall Survival (OS) in patients with NSCLC [ Time Frame: 3 years ]
- The efficacy of Durvalumab compared to SoC in terms of Objective response rate (ORR) [ Time Frame: 3 years ]
- The efficacy of Durvalumab compared to SoC in terms of Duration of response (DoR) [ Time Frame: 3 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: 3 years ]
- 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 ]
- 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 ]
- The immunogenicity of durvalumab by measuring the presence of Anti-drug Antibodies [ Time Frame: 3 years ]
- The Incidence of Treatment-Emergent Adverse Events assessed by CTCAE v4.03 for subjects receiving Durvalumab therapy or SoC [ Time Frame: 3 years ]

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Ages Eligible for Study: | 18 Years to 130 Years (Adult, Senior) |
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 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]

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

Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT03003962 History of Changes |
Other Study ID Numbers: |
D419AC00002 |
First Posted: | December 28, 2016 Key Record Dates |
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 |