- Advanced Non-Small Cell Lung Cancer (NSCLC).
- For Cohort I and Cohort II, advanced NSCLC patients must have received at least one
prior regimen of systemic therapy which includes at least one standard chemotherapy
for advanced NSCLC and who have failed (ie, progressed or intolerant due to toxicity
which precludes further treatment) standard therapy for advanced or metastatic
disease. To be considered intolerant to treatment, a patient must have received at
least two cycles to be considered previously treated.
- For Cohort III, advanced NSCLC patients must not have received prior systemic
treatment for their advanced disease and require a known EGFR (HER-1) mutation, HER-2
mutation or HER-2 amplification. Cohort III patients could have received prior
adjuvant chemotherapy for Stage I-III disease or combined modality
chemotherapy-radiation for Stage IIIA disease is allowed if treatment completed>12
months prior to enrollment.
- All cohorts, patients must have evidence of disease; however, measurable disease is
not required to enroll.
- Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
- Estimated creatinine clearance ≥15 mL/min.
- Prior treatment with an EGFR-targeted or HER-targeted agent (all cohorts).
- Chemotherapy, radiotherapy, biological or investigational agents within 2 weeks of
baseline disease assessments (all cohorts).
- Patients with known diffuse interstitial lung disease (all cohorts).
- Investigational therapy as only treatment for advanced NSCLC without administration
of an approved chemotherapy for advanced NSCLC (for Cohort I and Cohort II)