Non-small Cell Lung Cancer
A Study of Abemaciclib (LY2835219) in Combination With Another Anti-cancer Drug in Participants With Stage IV Non-small Cell Lung Cancer (NSCLC)
The main purpose of this study is to evaluate the safety and tolerability of abemaciclib in combination with another anti-cancer drug in participants with NSCLC that is advanced or has spread to other parts of the body (stage IV). The study will also investigate how the body processes the combination treatment and how the study drug affects the body. The study will also collect disease-related symptoms and participant-reported pain related to NSCLC.
Depending on how you and your tumor respond to treatment, your study participation could last until your disease worsens or until you and your doctor decide to stop treatment.
Key Participation Requirements
All clinical trials have rules about who can participate. This section outlines some of those rules. Please contact a study center to discuss the full set of criteria
- Participant must have stage IV non-small cell lung cancer (NSCLC)
- Part D, US only participants (any subtype) must have received at least two, but not more than three prior therapies for advanced/metastatic NSCLC. The participant must not have received prior treatment with any phosphoinositide 3-kinase (PI3K) or mammalian target of rapamycin (mTOR) inhibitor
- Part E Participant (any subtype) must have received at least one but no more than three prior therapies for advanced/metastatic NSCLC
- Male and female participants of reproductive potential must agree to use medically approved contraceptive precautions during the trial and 3 to 4 months (as appropriate) following last dose of study drug
- Participant must be able to swallow oral medications
- Participant must not have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix or breast), unless in complete remission with no therapy for a minimum of 3 years
- Participant must not be pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial