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
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No locations available
| 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
Investigators
Principal Investigator
Samir N. Khleif
International Coordinating Investigator
