The purpose of CTO-IUSCC-0730 study is to assess the clinical efficacy of LY3214996 in combination with abemaciclib at the recommended phase 2 dose of LY3214996 200 mg orally daily and abemaciclib 150 mg orally twice daily. Patients will be treated until evidence of disease progression, non-compliance with study protocol, unacceptable major toxicity, at subject's own request for withdrawal, or if the study closes for any reason.
Name: Abemaciclib
Name: LY3214996
Description: the number of patients who achieve a best overall response of complete response (CR) or partial response (PR) divided by the total number of patients treated (safety population)
Measure: Overall response rate Time: from cycle 1 day 1 until safety follow up visit (up to 1 year)Description: CTCAE Version 5.0 will be used to summarize adverse events in the assessment of safety for incorporating LY3214996 in combination with abemaciclib. Summaries of treatment related adverse events in the population will be tabulated. All adverse events (AEs) will be presented in incidence tables coded by CTC term.
Measure: Incidence of Adverse Events Time: baseline until safety follow up visit (up to 1 year)Description: measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented
Measure: Duration of Overall Response Rate Time: up to 1 yearDescription: the time from the date of start of treatment to the first date of the observed clinical or radiologically documented PD or death due to any cause, whichever occurs first. For patients who are not known to have died or progressed as of the data-inclusion cut-off date, PFS time will be censored at the date of the last objective progression-free disease assessment prior to the date of any subsequent systematic anticancer therapy.
Measure: Duration of Progression free survival Time: up to 1 yearAllocation: N/A
Single Group Assignment
There is one SNP
i. Patients with NSCLC that harbor BRAF V600E treated with prior RAF and/or MEK inhibition therapy will be excluded. --- V600E ---
Patients with tumor types other than NSCLC that harbor BRAF V600E mutations who have been treated and progressed on prior BRAF and/or MEK inhibition will be included. --- V600E ---
Cancer Cancer Metastatic BRAF V600E MEK1 Gene Mutation MEK2 Gene Mutation ERK Mutation RAF1 Gene Mutation null --- V600E ---