Study of LY2181308 in Combination With Docetaxel Versus Docetaxel in Patients With Non-Small Cell Lung Cancer

Lilly

Status and phase: Completed; Phase 2

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: LY2181308; Drug: Docetaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT01107444

2009-017591-24 (EudraCT Number)

11766

H8Z-MC-JACW (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the anti-tumor activity of LY2181308 in combination with docetaxel compared to docetaxel alone in participants with non-small cell lung cancer who were previously treated with first line chemotherapy.

Enrollment: 180 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants with non-small cell lung cancer with locally or advanced metastatic disease(Stage IIIB or IV at entry) not amenable to curative therapy and who have progressed after 1 line of chemotherapy
• Measureable disease as defined by response evaluation criteria in solid tumors (RECIST) version 1.1
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
• Must make available any existing tumor tissue from the primary biopsy
• Participants with prior radiation may be eligible if they meet certain criteria
• Adequate bone marrow reserve and organ functioning
• Women must have a negative pregnancy test and must comply with a highly reliable contraceptive method during and for 6 months after the treatment period and must not be breastfeeding
• Men must comply with a contraceptive regimen during and for 6 months after the treatment period

Exclusion criteria

• Currently enrolled in or discontinued a clinical trial involving an investigational drug/device within the last 30 days. Participants may be permitted to enter treatment before the 30 day waiting period in special circumstances
• Pregnant or breastfeeding
• Serious concomitant systemic disorders that would compromise the safety of the participant or the participant's ability to complete the study
• Second primary malignancy that could affect compliance with the protocol or interpretation of the study results
• Known allergy or hypersensitivity to docetaxel, taxanes, LY2181308, oligonucleotides, or any component of the formulations
• Participants with documented central nervous system or brain metastasis at the time of study entry
• Pre-existing neuropathy equivalent to a common terminology criteria for adverse events(CTCAE)code greater than or equal to 2

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

LY2181308 + Docetaxel

Experimental group

Description:

LY2181308: 750 milligrams (mg), intravenous (IV), on Day -2 and Day -1 of a 2 day lead-in period; on Day 1, Day 6, and Day 14 for Cycle 1 (1 cycle = 21 days); and once weekly for Days 1 through 21 for Cycles 2 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met. Docetaxel: 75 milligrams/square meter (mg/m\^2), intravenous (IV), on Day 1 of Cycle 1 (1 cycle = 21 days) and on Day 1 of Cycles 2 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.

Treatment:

Drug: LY2181308

Drug: Docetaxel

Docetaxel

Active Comparator group

Description:

Docetaxel: 75 milligrams/square meter (mg/m\^2), intravenous (IV) on Day 1 of Cycles 1 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.

Treatment:

Drug: Docetaxel