A Phase 1, 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)
- Conditions
- Patients With Non-Small Cell Lung Cancer(NSCLC)
- Registration Number
- JPRN-jRCT2080222721
- Lead Sponsor
- AstraZeneca KK
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 9
Provision of signed and dated, written informed consent
- 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
- a.For Escalation Phase: At least one lesion (measurable and/or non-measurable) b. For Expansion Phase: At least one measurable lesion.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment.
- Any investigational agent, chemotherapy, immunotherapy, biologic, hormonal within 28 days of the first dose of study treatment
- Inadequate bone marrow reserve or organ function
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>-
- Secondary Outcome Measures
Name Time Method pharmacokinetics<br>pharmacodynamics<br>efficacy<br>-