A Double-blind Study Evaluating IPI-504 and Docetaxel in Patients With Non-Small Cell Lung Cancer

This is a Phase 2, double-blind, randomized, placebo-controlled study in patients with previously treated, locally advanced or metastatic Stage IIIb or IV NSCLC designed to compare IPI-504 plus docetaxel versus placebo plus docetaxel. All patients will have at least a 15 pack year smoking history. Tumor samples will be assessed by a central pathology reviewer to confirm pathology that is documented at baseline; this review need not occur in advance of randomization.

Inclusion criteria

• Patients must be ≥18 years of age
• Voluntarily signed an informed consent
• Confirmed NSCLC and Stage IIIB or IV disease.
• At least a ≥15 pack year smoking history and must have been an active smoker within 20 years of diagnosis.
• Must have archival NSCLC tissue available to provide for analysis or have a lesion that is accessible for biopsy
• Must have experienced disease progression during or after receiving at least 1 prior platinum-containing chemotherapy regimen.
• Must have received no more than 2 prior chemotherapy regimens
• Measurable disease by RECIST 1.1 criteria.
• ECOG performance status of 0 or 1 (Refer to scale in Appendix 1).
• Women of child-bearing potential (WCBP), all sexually active male patients, and partners of patients must agree to use adequate methods of birth control.

Exclusion criteria

• Prior docetaxel, IPI-504 or other Hsp90 inhibitor treatment
• Known hypersensitivity to drugs formulated with polysorbate-80.
• Not recovered from any toxicities related to prior treatment
• Use of a medication or food that is a clinically relevant CYP3A inhibitor or inducer
• Inadequate hematologic function
• Inadequate hepatic function
• Inadequate renal function
• Symptomatic keratitis or keratoconjunctivitis.
• Uncontrolled systemic fungal, bacterial, viral or other infection
• Patients with clinically active brain metastases
• Patients with clinically stable brain metastases (previously treated or untreated) are eligible.
• Sinus bradycardia (resting heart rate <50 bpm).
• Significant cardiac disease
• Previous or current malignancies at other sites within the last 2 years
• Prior hepatic resections or hepatic-directed therapy
• Known HIV-positive patients receiving combination antiretroviral therapy.
• Women who are pregnant or lactating.