A Global Study to Assess the Effects of MEDI4736 (Durvalumab), Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer
Public ClinicalTrials.gov record NCT02352948. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III, Open Label, Randomised, Multi-centre, International Study of MEDI4736, Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB-IV) Who Have Received at Least Two Prior Systemic Treatment Regimens Including One Platinum Based Chemotherapy Regimen and Do Not Have Known EGFR TK Activating Mutations or ALK Rearrangements (ARCTIC).
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is a Phase III, randomised, open label, multi-centre study assessing the efficacy and safety of MEDI4736 (durvalumab) versus Standard of Care in NSCLC patients with PD-L1 positive tumours and the combination of MEDI4736 (durvalumab) plus tremelimumab (MEDI4736+treme) versus Standard of Care in NSCLC patients with PD-L1-negative tumours in the treatment of male and female patients with locally advanced or metastatic NSCLC (Stage IIIB-IV), who have received at least 2 prior systemic treatment regimens including 1 platinum-based chemotherapy regimen for NSCLC. Patients with known EGFR (Epidermal growth factor receptor) tyrosine kinase (TK) activating mutations and anaplastic lymphoma kinase (ALK) rearrangements are not eligible for the study (prospective testing is not planned within this study). The Standard of Care options are: an EGFR tyrosine kinase inhibitor (erlotinib \[TARCEVA®\]), gemcitabine or vinorelbine (NAVELBINE®)
Study identification
- NCT ID
- NCT02352948
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 597 participants
Conditions and interventions
Conditions
Interventions
- MEDI4736 (durvalumab) Drug
- Vinorelbine Drug
- Gemcitabine Drug
- Erlotinib Drug
- MEDI4736 (durvalumab) in combination with tremelimumab (anti-CTLA4) Drug
- tremelimumab (anti-CTLA4) Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 130 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 13, 2015 (Actual)
- Primary completion
- Feb 9, 2018 (Actual)
- Completion
- Aug 30, 2023 (Actual)
- Last update posted
- Jul 26, 2024
2015 – 2023
United States locations
- U.S. sites
- 33
- U.S. states
- 18
- U.S. cities
- 32
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Chandler | Arizona | 85224 | — |
| Research Site | Anaheim | California | 92801 | — |
| Research Site | Duarte | California | 91010 | — |
| Research Site | La Jolla | California | 92093 | — |
| Research Site | San Diego | California | 92123 | — |
| Research Site | Aurora | Colorado | 80045 | — |
| Research Site | Fort Myers | Florida | 33901 | — |
| Research Site | Orlando | Florida | 32804 | — |
| Research Site | Port Saint Lucie | Florida | 34952 | — |
| Research Site | St. Petersburg | Florida | 33705 | — |
| Research Site | Athens | Georgia | 30607 | — |
| Research Site | Atlanta | Georgia | 30322 | — |
| Research Site | Lawrenceville | Georgia | 30046 | — |
| Research Site | Chicago | Illinois | 60612 | — |
| Research Site | Waterloo | Iowa | 50701 | — |
| Research Site | Ashland | Kentucky | 41101 | — |
| Research Site | Rockville | Maryland | 20850 | — |
| Research Site | Battle Creek | Michigan | 49017 | — |
| Research Site | St Louis | Missouri | 63156 | — |
| Research Site | Lincoln | Nebraska | 68506 | — |
| Research Site | Mineola | New York | 11501 | — |
| Research Site | New York | New York | 10011 | — |
| Research Site | New York | New York | 10029 | — |
| Research Site | The Bronx | New York | 10461-2375 | — |
| Research Site | Charlotte | North Carolina | 28204 | — |
| Research Site | Pinehurst | North Carolina | 28374 | — |
| Research Site | Cincinnati | Ohio | 45242 | — |
| Research Site | West Chester | Ohio | 45069 | — |
| Research Site | Chattanooga | Tennessee | 37404 | — |
| Research Site | Germantown | Tennessee | 38138 | — |
| Research Site | Nashville | Tennessee | 37203 | — |
| Research Site | Salt Lake City | Utah | 84106 | — |
| Research Site | Spokane | Washington | 99208 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 168 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02352948, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 26, 2024 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02352948 live on ClinicalTrials.gov.