Phase 2
Completed N=180
Study of LY2181308 in Combination With Docetaxel Versus Docetaxel in Patients With Non-Small Cell Lung Cancer
Source: ClinicalTrials.gov NCT01107444 ↗Enrolled (actual)
180
Serious AEs
49.4%
Results posted
May 2019
Primary outcomePrimary: Change From Baseline in Tumor Size to the End of Cycle 2 — 1.06; 1.01 Log Ratio of Tumor Size — p=0.284
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Tumor Size to the End of Cycle 2 |
1.06; 1.01 | 0.284 |
| SECONDARY Number of Participants With Characterization of Toxicities as Defined by Common Terminology Criteria for Adverse Events (CTCAE) Coding |
98; 42; 76; 34; 24; 11 | — |
| SECONDARY Progression Free Survival (PFS) |
2.83; 3.35 | — |
| SECONDARY Pharmacokinetics: Area Under the Concentration Curve From Zero to 4 Hours (AUC[0-4]) for LY2181309 and Docetaxel |
1642; 1195 | — |
| SECONDARY Pharmacokinetics: Area Under the Drug Concentration-Time Curve From Zero to Infinity (AUC[0 ∞]) of LY2181309 and Docetaxel |
1905; 1778 | — |
| SECONDARY Overall Survival (OS) |
7.9; 8.8 | — |
| SECONDARY Time to Worsening of Symptoms as Defined by Lung Cancer Symptom Score (LCSS) Questionnaire |
1.0; 0.8 | — |
| SECONDARY Time to Objective Tumor Response of Partial Response (PR) or Complete Response (CR) |
NA; NA | — |
| SECONDARY Time to Documented Disease Progression |
2.9; 3.4 | — |
| SECONDARY Percent of Participants Having a Partial Response (PR) or a Complete Response (CR) |
6.1; 2.1 | — |
| SECONDARY Duration of Response |
2.8; 5.4 | — |
| SECONDARY Lung Cancer Symptom Scale (LCSS) Average Symptom Burden Index (ASBI) on Cycle 2 Day 1 |
22; 24 | — |
| SECONDARY Lung Cancer Symptom Scale (LCSS) Average Total Score at Cycle 2 Day 1 |
27; 30 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01107444). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.