MEDI4736 (anti PD-L1) Combined with Gefitinib in Subjects with Non-Small Cell Lung Cancer(NSCLC).
Study identifier:D791PC00001
ClinicalTrials.gov identifier:NCT02088112
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of gefitinib in Combination with MEDI4736 (anti PD-L1) in Subjects with Non-Small Cell Lung Cancer(NSCLC)
Medical condition
Carcinoma, Non-Small-Cell Lung
Phase
Phase 1
Healthy volunteers
No
Study drug
Gefitinib, MEDI4736
Sex
All
Actual Enrollment
56
Study type
Interventional
Age
18 Years - 130 Years
Date
Study Start Date: 24 Mar 2014
Primary Completion Date: 09 Mar 2021
Study Completion Date: 09 Mar 2021
Study design
Allocation: Non-randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Mar 2022 by MedImmune, LLC
Sponsors
MedImmune, LLC
Collaborators
AstraZeneca
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Escalation MEDI4736 will be combined with gefitinib to assess safety and tolerability | Drug: Gefitinib Gefitinib QD Drug: MEDI4736 MEDI4736 IV Q2W |
| Experimental: Expansion Arm MEDI4736 will be combined with gefitinib | Drug: Gefitinib Gefitinib QD Drug: MEDI4736 MEDI4736 IV Q2W |
Contacts
Investigators
Principal Investigator
Ben Creelan
Moffit Cancer Center
