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

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.