MEDI4736 (Anti PD-L1) Combined With Gefitinib in Subjects With Non-Small Cell Lung Cancer(NSCLC).
NCT ID: NCT02088112
Last Updated: 2022-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
56 participants
INTERVENTIONAL
2014-03-24
2021-03-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Escalation
MEDI4736 will be combined with gefitinib to assess safety and tolerability
Gefitinib
Gefitinib QD
MEDI4736
MEDI4736 IV Q2W
Expansion Arm
MEDI4736 will be combined with gefitinib
Gefitinib
Gefitinib QD
MEDI4736
MEDI4736 IV Q2W
Interventions
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Gefitinib
Gefitinib QD
MEDI4736
MEDI4736 IV Q2W
Eligibility Criteria
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Inclusion Criteria
2. Male or female aged 18 years and older.
3. Subjects must have a. In the escalation phase, locally advanced or metastatic NSCLC subjects who have either failed to respond or relapsed following any line of standard treatment, were unable to tolerate, or were not eligible for standard treatment b. In the expansion phase, histologically or cytologically confirmed locally advanced or metastatic NSCLC that is EGFR mutation positive, naïve to EGFR TKI therapy, and sensitive to EGFR TKIs therapy
4. a.For Escalation Phase: At least one lesion (measurable and/or non-measurable) b.For Expansion Phase: At least one measurable lesion.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* For Japan Escalation - the same as the global escalation I/E criteria except patients must be EGFR mutation positive
Exclusion Criteria
2. Any investigational agent, chemotherapy, immunotherapy, biologic, hormonal within 28 days of the first dose of study treatment
3. Inadequate bone marrow reserve or organ function
18 Years
130 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
MedImmune LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Ben Creelan, MD
Role: PRINCIPAL_INVESTIGATOR
Moffit Cancer Center
Don Gibbons, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Laura Chow, MD
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Sang-We Kim, MD
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Dong-Wan Kim, MD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Shinitaro Kanda, MD
Role: PRINCIPAL_INVESTIGATOR
National Cancer Center
Naoyuki Nogami
Role: PRINCIPAL_INVESTIGATOR
Shikoku Cancer Center
Locations
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Research Site
Tampa, Florida, United States
Research Site
Houston, Texas, United States
Research Site
Seattle, Washington, United States
Research Site
Chūōku, , Japan
Research Site
Matsuyama, , Japan
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Countries
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References
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Creelan BC, Yeh TC, Kim SW, Nogami N, Kim DW, Chow LQM, Kanda S, Taylor R, Tang W, Tang M, Angell HK, Roudier MP, Marotti M, Gibbons DL. A Phase 1 study of gefitinib combined with durvalumab in EGFR TKI-naive patients with EGFR mutation-positive locally advanced/metastatic non-small-cell lung cancer. Br J Cancer. 2021 Jan;124(2):383-390. doi: 10.1038/s41416-020-01099-7. Epub 2020 Oct 5.
Related Links
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Results of this clinical trial are available on www.astrazenecaclinicaltrials.com
Other Identifiers
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D791PC00001
Identifier Type: -
Identifier Source: org_study_id
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