Study identifier:D791PC00001
ClinicalTrials.gov identifier:NCT02088112
EudraCT identifier:N/A
CTIS identifier:N/A
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)
Carcinoma, Non-Small-Cell Lung
Phase 1
No
Gefitinib, MEDI4736
All
56
Interventional
18 Years - 130 Years
Allocation: Non-randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Mar 2022 by MedImmune, LLC
MedImmune, LLC
AstraZeneca
This 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). The study consists of two phases: Escalation phase and an expansion phase to be conducted in locally advanced or metastatic NSCLC subjects
In Escalation phase: MEDI4736 and gefitinib in NSCLC subjects In Expansion phase: Subjects with EGFR mutation positive locally advanced or metastatic NSCLC will be enrolled in expansion arms. Initiation of expansion arms with the recommended dose of MEDI4736 in combination with gefitinib will be based on an adequate safety and tolerability profile of the combination from the escalation phase.
Location
Location
Tampa, FL, United States, 33612
Location
Houston, TX, United States, 77030
Location
Seattle, WA, United States, 98109
Location
Seoul, Republic of Korea, 03080
Location
Seoul, Republic of Korea, 05505
Location
Chuo-ku, Japan, 104-0045
Location
Matsuyama-shi, Japan, 791-0280
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 |
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