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Immune-Modulated Study of Selected Small Molecules (Gefitinib, AZD9291, or Selumetinib + Docetaxel) or a 1st Immune-Mediated Therapy (IMT; Tremelimumab) with a Sequential Switch to a 2nd IMT (MEDI4736) in Patients with Locally Advanced or Metastatic Non-Small-Cell Lung Cancer
Study identifier:D4191C00011
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase IIa, Open-Label, Multi-Center, Multi-Cohort, Immune-Modulated Study of Selected Small Molecules (Gefitinib, AZD9291, or Selumetinib + Docetaxel) or a 1st Immune-Mediated Therapy (IMT; Tremelimumab) with a Sequential Switch to a 2nd IMT (MEDI4736) in Patients with Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (Stage IIIB-IV)
Medical condition
Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (Stage IIIB-IV)
Phase
Phase 2
Healthy volunteers
No
Study drug
Gefitinib, AZD9291, Selumetinib+Docetaxel, Tremelimumab
Sex
All
Actual Enrollment
32
Study type
Interventional
Age
18 Years - 130 Years
Date
Study Start Date: 25 Jul 2014
Primary Completion Date: 11 Jun 2016
Study Completion Date: 11 Jun 2016
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Aug 2019 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
Quintiles
Inclusion and exclusion criteria
Location
Research Site
Spokane, WA, United States, 99208-1129
Location
Research Site
Augusta, GA, United States, 30912
Location
Research Site
St Louis, MO, United States, 63110
Location
Research Site
Tacoma, WA, United States, 98405
Location
Research Site
Mineola, NY, United States, 11501
Location
Research Site
Washington, DC, United States, 20007
Location
Research Site
Marietta, GA, United States, 30060
Location
Research Site
Ashland, KY, United States, 41101
| Arms | Assigned Interventions |
|---|---|
| Experimental: Gefitinib with a Seq. Switch to a MEDI4736 Gefitinib once daily followed by MEDI4736 | Drug: Gefitinib Gefitinib once daily followed by MEDI4736 |
| Experimental: AZD9291 with a Seq. Switch to a MEDI4736 AZD9291 once daily followed by MEDI4736 | Drug: AZD9291 AZD9291 once daily followed by MEDI4736 |
| Experimental: Selumetinib+Docetaxel with a Seq. Switch to a MEDI4736 Selumetinib twice daily + docetaxel, followed by MEDI4736 | Drug: Selumetinib+Docetaxel Selumetinib twice daily + docetaxel, followed by MEDI4736 |
| Experimental: Tremelimumab with a Seq. Switch to a MEDI4736 Tremelimumab every 4 weeks followed by MEDI4736 | Drug: Tremelimumab Tremelimumab every 4 weeks followed by MEDI4736 |
Contacts
Contact
AstraZeneca Clinical Study Information Center
Investigators
Principal Investigator
Samir N. Khleif
International Coordinating Investigator
