a study of abemaciclib (ly2835219) in participants with non-small cell lung cancer or breast cancer

Conditions: Non Small Cell Lung Cancer; Breast Cancer

Summary: the main purpose of this study is to evaluate the safety and efficacy of abemaciclib in combination with pembrolizumab in participants with advanced non-small cell lung cancer (nsclc) or hormone receptor positive (hr+), human epidermal growth factor receptor negative (her2-) breast cancer.


Eligibility criteria:
inclusion criteria: * have a stage iv diagnosis of 1 of the following: part a: nsclc (kirsten rat sarcoma mutant \[kras mt\], pd-l1+); part b: nsclc (squamous histology); part c: metastatic breast cancer (hr+, her2-); or part d: locally advanced or metastatic breast cancer (hr+, her2-) * part a: must be chemotherapy naïve for metastatic nsclc * part b: must have received at least 1 prior therapy containing platinum-based chemotherapy for advanced/metastatic nsclc * part c: must have previously received prior treatment with at least 1 but no more than 2 chemotherapy regimens in the metastatic setting * part d: cannot have received endocrine therapy or chemotherapy as treatment in the locoregionally recurrent or metastatic breast cancer disease setting. note: participants may be enrolled if they received prior (neo)adjuvant chemotherapy or endocrine therapy for localized disease. * are amenable to provide tumor tissue prior to treatment and provide tumor tissue after treatment initiation (both mandatory). * have presence of measurable disease as defined by response evaluation criteria in solid tumors (recist 1.1). * have a performance status (ps) ≤1 on the eastern cooperative oncology group (ecog) scale. * have discontinued all previous treatments for cancer and recovered from the acute effects of therapy. * have an estimated life expectancy of ≥12 weeks. * for part d: have postmenopausal status due to surgical/natural menopause or chemical ovarian suppression (initiated 28 days prior to day 1 of cycle 1) with a gonadotropin-releasing hormone (gnrh) agonist such as goserelin or radiation-induced ovarian suppression. exclusion criteria: * have a personal history of any of the following conditions: syncope of either unexplained or cardiovascular etiology, ventricular arrhythmia (including but not limited to ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest. exception: subjects with controlled atrial fibrillation for \>30 days prior to study treatment are eligible. * have central nervous system (cns) metastasis with development of associated neurological changes 14 days prior to receiving study drug. * have corrected qt interval of \>470 milliseconds on screening electrocardiogram (ecg). * have history of interstitial lung disease or pneumonitis. * have history of or active autoimmune disease, or other syndrome that requires systemic steroids or autoimmune agents for the past 2 years. * have received a live vaccination within 30 days of study start. * have received prior treatment with an anti pd-1, anti-programmed death ligand 1 (pd-l1), or anti cytotoxic t-lymphocyte-associated protein 4 (ctla-4) agent. * for part d only: * have initiated bisphosphonates or approved rank ligand (rank-l) targeted agents (for example, denosumab) \<7 days prior to cycle 1 day 1. * are currently receiving or have previously received endocrine therapy for locoregionally recurrent or metastatic breast cancer. note: a participant may be enrolled if she received prior (neo)adjuvant endocrine therapy (including, but not limited to anti-estrogens or aromatase inhibitors) for localized disease. * are currently receiving or have previously received chemotherapy for locoregionally recurrent or metastatic breast cancer. note: participants may be enrolled if they received prior (neo)adjuvant chemotherapy for localized disease.