Clinical trial · Interventional
Study of LY2181308 in Combination With Docetaxel Versus Docetaxel in Patients With Non-Small Cell Lung Cancer
A Randomized Phase 2 Study of LY2181308 in Combination With Docetaxel Versus Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Were Previously Treated With First Line Chemotherapy
NCT01107444CI-TRIAL-00040518completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| LY2181308 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- LY2181308 + Docetaxel
- 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.
- interventionNames
- Drug: Docetaxel
- Drug: LY2181308
- type
- ACTIVE_COMPARATOR
- label
- Docetaxel
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDNatale R, Blackhall F, Kowalski D, Ramlau R, Bepler G, Grossi F, Lerchenmuller C, Pinder-Schenck M, Mezger J, Danson S, Gadgeel SM, Summers Y, Callies S, Andre V, Das M, Lahn M, Talbot D. Evaluation of antitumor activity using change in tumor size of the survivin antisense oligonucleotide LY2181308 in combination with docetaxel for second-line treatment of patients with non-small-cell lung cancer: a randomized open-label phase II study. J Thorac Oncol. 2014 Nov;9(11):1704-8. doi: 10.1097/JTO.0000000000000285. PMID 25436803