Patients With Non-Small Cell Lung Cancer(NSCLC)
Conditions
Interventions
investigational material(s)
Generic name etc : Gefitinib, MEDI4736
INN of investigational material : -
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigatio
Sponsors
AstraZeneca KK
MedImmune LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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.
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety - | — |
Secondary
| Measure | Time frame |
|---|---|
| pharmacokinetics pharmacodynamics efficacy - | — |
Countries
Asia except Japan, Japan, North America
Outcome results
None listed