A Study of abemaciclib in Participants With Previously Treated Lung Cancer

Phase 1

• Conditions: on Small Cell Lung Cancer; MedDRA version: 19.1Level: LLTClassification code 10025055Term: Lung cancer non-small cell stage IVSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-004662-33-DE
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-07
• Last Update Posted: 11 June 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• The participants must have confirmed diagnosis of stage IV non-small
cell lung cancer (NSCLC) according to the American Joint Committee on
Cancer Staging Handbook.
• Determined to have detectable mutations in codons 12 or 13 of the
KRAS oncogene by an investigational assay at the Study JPBK central
laboratory. A KRAS positive mutation result in codons 12 or 13 of the
KRAS oncogene from tumor tissue per local laboratory will be permitted
in no more than 10%
of the randomized patients;
• The participant must have progressed after platinum-based
chemotherapy (with or without maintenance therapy) AND have
received one additional therapy which may include an immune
checkpoint inhibitor or other anti-cancer therapy for advanced and/or
metastatic disease OR is judged by the physician as ineligible for further
standard second-line chemotherapy. Prior adjuvant or neoadjuvant
therapy for an earlier stage of NSCLC counts as an
appropriate line of therapy in case the patient progressed within 6
months of completing the platinum-based adjuvant or neoadjuvant
therapy.
• Have measureable disease as defined by the Response Evaluation
Criteria in Solid Tumors (RECIST 1.1).
• Have a performance status (PS) of 0 to 1 on the Eastern Cooperative
Oncology Group (ECOG) scale.
• Have discontinued all previous therapies for cancer (including
chemotherapy, radiotherapy, immunotherapy, and investigational
therapy) for at least 21 days for myelosuppressive agents or 14 days for
nonmyelosuppressive agents prior to receiving study drug.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 270
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 180

Exclusion Criteria

• 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 for a nonmyelosuppressive or myelosuppressive agent, respectively.
• Have a personal history of any of the following conditions: presyncope or syncope of either unexplained or cardiovascular etiology, ventricular arrhythmia (including but not limited to ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.
• Have the presence of unstable central nervous system (CNS) metastasis. History of CNS metastasis or stable CNS metastases is allowed (no longer requiring active therapy such as steroid medications). Participants with a history of CNS metastases must have a brain scan (for example, magnetic resonance imaging) within 28 days of randomization to document stability, even if there have been no changes in symptoms.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified