A Randomized Phase 2 Study of Abemaciclib (LY2835219) versus Docetaxel in Patients with Stage IV Squamous Non-Small Cell Lung Cancer Previously Treated with Platinum-based Chemotherapy

Eli Lilly and Company0 sites150 target enrollmentJuly 20, 2015

ConditionsStage IV squamous NSCLC patients who have progressed after platinum-based chemotherapy MedDRA version: 20.0Level: PTClassification code 10025125Term: Lung squamous cell carcinoma stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Stage IV squamous NSCLC patients who have progressed after platinum-based chemotherapy
Sponsor: Eli Lilly and Company
Enrollment: 150
Status: Active, not recruiting
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 20, 2015

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Eligibility Criteria

Inclusion Criteria

•\[1] Have confirmed diagnosis of stage IV NSCLC disease predominantly squamous histology according to the American Joint Committee on Cancer on Cancer Staging Handbook (Edge et al. 2009\). Squamous NSCLC diagnosis must be confirmed by histology or cytology local pathology report.
•\[2] Availability of adequate formalin\-fixed paraffin\-embedded (FFPE) tumor derived material (tumor blocks or 10 slides minimum) from a core needle biopsy or surgery for analysis of biomarkers. This sample should be the most recent available sample containing adequate material. Re\-biopsy after progression from prior therapy is not required.
•\[3]Have failed first line platinum\-based therapy and who have had no more than two prior therapies one of which may be an immune checkpoint inhibitor.Patients with recurrent disease after adjuvant or neoadjuvant therapy or patients who have received combined chemotherapy and radiation for locally advanced disease are eligible, if:
•\*The patient has progressed within 6 months after completion of adjuvant or neoadjuvant platinum\-based therapy (adjuvant therapy will be considered the patient’s one and only prior first\-line, platinum\-based chemotherapy). The time from completion of the last cycle of adjuvant or neoadjuvant therapy to progression must be less than 6 months. For radiotherapy for locally advanced disease with curative intent with chemotherapy (platinum based therapy), the time of completion of chemotherapy or radiotherapy, whichever finishes last, to progression must be less than 6 months to count as a line of therapy.
•May not have received docetaxel as monotherapy or in combination with platinum therapy in first\-line setting, or in the neoadjuvant/adjuvant setting
•a. Prior paclitaxel therapy as monotherapy or in combination is permitted in first line, or in neoadjuvant/adjuvant setting
•Prior immunotherapy is allowed and does not count as a line therapy.
•\[4]Have a performance status (PS) of \[0 to 1] on the Eastern Cooperative Oncology Group (ECOG) scale.
•\[5]Have the presence of measureable disease as defined by the Response Evaluation Criteria In Solid Tumors RECIST 1\.1 (Eisenhauer et al. 2009\)
•\[6]Have discontinued all previous treatments for cancer (including chemotherapy, radiotherapy, immunotherapy, and endocrine therapy) for at least 21 days for myelosuppressive agents; or 14 days for nonmyelosuppressive agents prior to receiving study drug, and recovered from the acute effects of therapy (treatment related toxicity resolved to baseline) except for residual alopecia

Exclusion Criteria

•\[14]Are currently enrolled in a clinical trial involving an investigational product or non\-approved use of a drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
•\[15]Have known or suspected allergy to docetaxel or any of its components
•\[16]Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of the initial dose of study drug of nonmyelosuppressive or myelosuppressive agent, respectively
•\[17]Have received prior treatment with any CDK4/6 inhibitor (or participated in any CDK4/6 inhibitor clinical trial for which treatment assignment is still blinded)
•\[18]Have had major surgery (excluding biopsy) \< 28 days of the initial dose of study drug and/or have not recovered from the acute effects of the surgery
•\[19]Have a personal history within the last 12 months of any of the following conditions: syncope of either unexplained or cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest.
•\[20]Have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study (for example, history of major surgical resection involving the stomach or small bowel)
•\[21]Have a history of any other cancer (except non\-melanoma skin cancer or carcinoma in\-situ of the cervix), unless in complete remission with no therapy for a minimum of 3 years
•\[22]Have the presence of unstable central nervous system (CNS) metastasis:
•History of CNS metastasis or stable CNS metastases are allowed (no longer requiring active therapy such as steroid medications). Patients with symptoms of CNS involvement or a history of CNS metastasis will have brain scan during baseline procedures to document stability. Patients having prior brain scan within 45 days of starting therapy and without symptoms of CNS metastases (stable or unstable) do not need to repeat scan at baseline (within 28 days of starting study treatment).