Phase 2
N=159
A Study of Abemaciclib (LY2835219) in Participants With Stage IV Squamous Non-small Cell Lung Cancer
Non-Small Cell Lung Cancer Stage IV
Bottom Line
View on ClinicalTrials.gov: NCT02450539 ↗Enrolled (actual)
159
Serious AEs
29.1%
Results posted
Jun 2018
Primary outcome: Primary: Progression Free Survival (PFS) — 2.53; 4.21 months — p=0.0068
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Abemaciclib (Drug); Docetaxel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) |
2.53; 4.21 | 0.0068 sig |
| SECONDARY Pharmacokinetics (PK): Clearance of Abemaciclib |
21.3 | — |
| SECONDARY PK: Volume of Distribution of Abemaciclib |
769 | — |
| SECONDARY Overall Survival (OS) |
7; 12.39 | 0.1746 |
| SECONDARY Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR]) |
2.8; 20.8 | — |
| SECONDARY Percentage of Participants Who Exhibit Stable Disease (SD) or Confirmed Response (CR) or Partial Response (PR): Disease Control Rate (DCR) |
50.9; 64.2 | — |
| SECONDARY Time to Worsening of Eastern Cooperative Oncology Group (ECOG) Performance Status of >/=2 |
NA; 10.52 | 0.7039 |
| SECONDARY Change From Baseline in MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) Scores |
0.19; 0.01; 1.01; 0.15; 0.53; 0.00 | — |
| SECONDARY Change From Baseline in EuroQol 5-Dimensional 5-Level (EQ-5D-5L) Questionnaire EQ VAS Overall Self-rated Health Score |
-5.49; -2.36 | — |
| SECONDARY Change From Baseline in EuroQol 5-Dimensional 5-Level (EQ-5D-5L) Questionnaire Index Value |
-0.05; -0.01 | — |
Summary
The main purpose of this study is to evaluate the effectiveness of the study drug known as abemaciclib versus docetaxel in participants with stage IV squamous non-small cell lung cancer (NSCLC) previously treated with platinum-based chemotherapy.
Eligibility Criteria
Inclusion Criteria
- Confirmed diagnosis of stage IV NSCLC.
- Have progressed during or after platinum-based chemotherapy for advanced disease.
- Have not received prior treatment with docetaxel.
- Have availability of adequate formalin-fixed paraffin-embedded (FFPE) tumor derived material.
- Have adequate organ function including hematology, renal, and liver.
- Have good performance score (0-1).
- Have measurable disease per RECIST 1.1.
- Agree to use a reliable medically approved method of birth control.
Exclusion Criteria
- Have received prior treatment with any cyclin dependent kinase (CDK) 4 and 6 inhibitor or participated in a clinical trial with a CDK 4 and 6 inhibitor and the treatment administered is not known.
- Are currently receiving treatment in a clinical trial involving an investigational product or non-approved use of a drug or device.
- Have the presence of unstable central nervous system (CNS) metastasis.
- Have had major surgery (excluding biopsy) < 28 days of the initial dose of study drug.
Data sourced from ClinicalTrials.gov (NCT02450539). 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.