Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Carcinoma

Lung Neoplasms

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Gemcitabine

Pemetrexed

Pembrolizumab

Ramucirumab

Antimetabolites

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Angiogenesis Inhibitors

Growth Inhibitors

Folinic Acid

Folate

Vitamin B9

150 milligram (mg) or 200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 500 milligrams/square meter (mg/m\^2) pemetrexed given intravenously (IV) over approximately 10 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

150 mg or 200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 1250 milligram/square meter (mg/m\^2) gemcitabine given intravenously over approximately 30 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

150 mg or 200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Day 1 or 8 to 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

100 mg or 150 mg or 200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 100, 150, or 200 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

100 mg or 150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 200 mg pembrolizumab given intravenously over approximately 30 minutes on day 1 of a 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Abemaciclib

LY3023414

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

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.

A Study of Abemaciclib (LY2835219) in Combination With Another Anti-cancer Drug in Participants With Lung Cancer (NSCLC)

A Phase 1b Study of LY2835219 in Combination With Multiple Single Agent Options for Patients With Stage IV NSCLC

A DLT defined as adverse event(AE) occurring between Day 1 and Day 21 of Cycle 1 that was considered at least possibly related to either abemaciclib or the combination therapy and fulfilled a criteria selected (using the National Cancer Institute Common Terminology Criteria for Adverse Events,version 4.0 \[NCI-CTCAE v 4.0\] \[NCI 2009\]):Grade(Gr)≥3 nonhematological toxicity,Gr4 thrombocytopenia lasting at least 5 days and/or complicated with bleeding,Gr≥3 febrile neutropenia(ntr) and for Part D participants (pts): Gr3 hyperglycemia (fasting) of \<5 days, Gr3 hypertriglyceridemia or hyperlipidemia without optimal treatment.A DLT-equivalent defined as AE that would have met the criteria for DLT if it had occurred during Cycle 1 for pts enrolled in dose-escalation phase,but that occurs between 1)Day 1 and Day 21 of Cycle 2 and beyond for a participant enrolled in dose-escalation phase 2) at any time for a participant in dose-expansion phase.

ORR is the best response of CR or PR as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of not-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with at least 1 measurable lesion, multiplied by 100.

Progression free survival (PFS) defined as the time from the date of randomization to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of randomization, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date. PFS time was summarized using Kaplan-Meier estimates.

The MDASI-LC is a self-reported lung cancer instrument included 22 items covered by one of the following dimensions: Mean core symptom severity (Core items 1-13: pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, remembering things, lack of appetite, drowsy, dry mouth, sad, vomiting, numbness/tingling), Lung cancer symptoms (3 items: coughing, constipation, sore throat), Mean symptom severity (13 core items plus 3 lung items) and Interference with mood or functional status (6 items: general activity, mood, work, relations with other people, walking, enjoyment of life). The mean of all symptom subscale items was calculated where 0 equals "not present" and 10 equals "as bad as you can imagine." A change from baseline with negative values indicate improvement, positive values indicate worsening.

Cmax of Abemaciclib on day 1 and at steady State (Cycle 2 Day 1) Part A , B, C, D and E was evaluated.

Cmax of pemetrexed at steady state in Part A was evaluated.

Cmax of active gemcitabine metabolite (dFdU) on day 1 and at steady state (Cycle 2 Day 1) dose-normalized to 1250 mg/m\^2 in Part B was evaluated.

Cmax of ramucirumab at 1 hour post-end-of-Infusion in Part C was evaluated.

Cmax of LY3023414 in Part D was evaluated.

Area under the concentration time curve from zero to 8 hours AUC(0-8h) of abemaciclib in Part A, B, C, D and E was evaluated.

Area under the plasma concentration versus time curve from time zero to infinity (AUC\[0-∞\]) of Pemetrexed in Part A was evaluated.

Area under the plasma concentration time curve from time zero to 12 hours (AUC\[0-12h\]) of active gemcitabine metabolite (dFdU) in Part B was evaluated

Area under the plasma concentration versus time curve from time zero to infinity (AUC) of LY3023414 in Part D was evaluated. For Day 1, AUC is defined as AUC from time zero to infinity (AUC\[0-∞\]), for steady state, AUC is defined as AUC from time zero to the end of the dosing interval, tau (AUC\[0-tau \])

Merck Sharp & Dohme LLC

Eli Lilly and Company

All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.

150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 500 mg/m\^2 pemetrexed given IV over approximately 10 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Part A:150 mg Abemaciclib + 500 mg/m^2 Pemetrexed

200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 500 mg/m\^2 pemetrexed given IV over approximately 10 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Part A: 200 mg Abemaciclib + 500 mg/m^2 Pemetrexed

150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 1250 mg/m\^2 gemcitabine given intravenously over approximately 30 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Part B:150 mg Abemaciclib + 1250 mg/m^2 Gemcitabine

200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 1250 mg/m\^2 gemcitabine given intravenously over approximately 30 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Part B: 200 mg Abemaciclib + 1250 mg/m^2 Gemcitabine

150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 mg/kg ramucirumab given intravenously over approximately 60 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Part C: 150 mg Abemaciclib + 10 mg/kg Ramucirumab Day1

200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 mg/kg ramucirumab given intravenously over approximately 60 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Part C: 200 mg Abemaciclib + 10 mg/kg Ramucirumab Day1

150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 8 mg/kg ramucirumab given intravenously over approximately 60 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Part C: 150 mg Abemaciclib + 8 mg/kg Ramucirumab Days 1 and 8

150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 mg/kg ramucirumab given intravenously over approximately 60 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Part C: 150 mg Abemaciclib + 10 mg/kg Ramucirumab Days 1 and 8

100 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 100 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Part D: 100 mg Abemaciclib + 100 mg LY3023414

150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 100 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Part D: 150 mg Abemaciclib + 100 mg LY3023414

150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 150 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Part D: 150 mg Abemaciclib + 150 mg LY3023414

200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 150 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Part D: 200 mg Abemaciclib + 150 mg LY3023414

150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 200 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Part D: 150 mg Abemaciclib + 200 mg LY3023414

100 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 200 mg pembrolizumab given intravenously over approximately 30 minutes on day 1 of a 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Part E: 100 mg Abemaciclib + 200 mg Pembrolizumab

150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 200 mg pembrolizumab given intravenously over approximately 30 minutes on day 1 of a 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Part E: 150 mg Abemaciclib + 200 mg Pembrolizumab

150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 500 milligrams/square meter (mg/m\^2) pemetrexed given intravenously (IV) over approximately 10 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Part A:150 Milligram(mg) Abemaciclib + 500 mg/m^2 Pemetrexed

200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 500 mg/m\^2 pemetrexed given intravenously (IV) over approximately 10 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Part B: 150 mg Abemaciclib + 1250 mg/m^2 Gemcitabine

150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Part C:150 mg Abemaciclib+10mg/kg Ramucirumab Day1

200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Part C: 200 mg Abemaciclib + 10mg/kg Ramucirumab Day1

150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 mg/kg ramucirumab given intravenously over approximately 60 minutes on on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

100 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 100 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

150 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 100 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

150 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 150 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

200 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 150 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

150 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 200 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Spain

Region of Enrollment

All randomized participants who received at least one dose of study drug in Part A, B, C, D and E.

Chief Medical Officer

150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Day of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Part C:150 mg Abemaciclib+10 mg/kg Ramucirumab Day 1

200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Day of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Part C: 200 mg Abemaciclib + 10 mg/kg Ramucirumab Day 1

Number of Participants With Dose-Limiting Toxicities (DLT) or DLT-equivalent in Part A, B, C, D and E

150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Day 1 or 8 to 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 8 mg/kg ramucirumab given intravenously over approximately 60 minutes on Day 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Number of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR]) in Part A, B, C, D and E

150/200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 500 milligrams/square meter (mg/m\^2) pemetrexed given intravenously (IV) over approximately 10 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Part A:Abemaciclib + 500 mg/m^2 Pemetrexed

150/200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 1250 mg/m\^2 gemcitabine given intravenously over approximately 30 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Part B: Abemaciclib + 1250 mg/m^2 Gemcitabine

150 /200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 8 mg/kg /10 mg/kg ramucirumab / given intravenously over approximately 60 minutes on Day 1 or 8 to 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Part C:Abemaciclib+ 8/10mg/kg Ramucirumab Day1/8

100 mg/ 150 mg / 200 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 100 mg / 150 mg/ 200 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Part D: Abemaciclib + 100 mg/150 mg/ 200 mg LY3023414

100 mg / 150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 200 mg pembrolizumab given intravenously over approximately 30 minutes on day 1 of a 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Part E: 100 mg/150 mg Abemaciclib + 200 mg Pembrolizumab

All randomized participants in Part A, B, C, D and E. Censored participants: Part A= 13, Part B = 7, Part C = 17, Part D = 19, Part E = 10.

Progression Free Survival Time in Part A, B, C, D and E

Mean core symptom severity

Mean symptom severity

Mean lung cancer symptom

Mean interference severity

200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Day 1 or 8 to 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 8 mg/kg ramucirumab given intravenously over approximately 60 minutes on Day 1 or 8 to 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 mg/kg ramucirumab given intravenously over approximately 60 minutes on Day 1 or 8 to 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

All randomized participants for cycles which at least 25% of participants in each arm have a score. MDASI-LC population included all randomized participants who completed at least 1 baseline assessment followed by at least 1 MDASI-LC result in Part A, B, C, D and E.

Change From Baseline in MD Anderson Symptom Inventory Scale-Lung Cancer (MDASI-LC) in Part A, B, C, D and E

Day 1

Steady State

150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Day 1, or 8 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Days 1 and 8, or 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Part C: 150 mg Abemaciclib + 8 mg/kg or 10 mg/kg Ramucirumab

Part C: 200 mg Abemaciclib + 10mg/kg Ramucirumab Day 1

150 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 100 or 150 or 200 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Part D: 150 mg Abemaciclib + 100 or 150 or 200 mg LY3023414

All randomized participants who received at least one dose of study drug with evaluable PK data in Part A , B, C, D and E.

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Abemaciclib on Day 1 and at Steady State (Cycle 2 Day 1) in Part A , B, C, D and E

All randomized participants who received at least one dose of study drug with evaluable PK data in Part A.

Pharmacokinetics: Maximum Concentration (Cmax) of Pemetrexed at Steady State in Part A

200 mg abemaciclib or maximum tolerated dose (MTD) under the combination treatment abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 1250 mg/m\^2 gemcitabine given intravenously over approximately 30 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Part B: 200 mg or MTD Abemaciclib + 1250 mg/m^2 Gemcitabine

All randomized participants who received at least one dose of study drug with evaluable PK data in Part B.

PK: Dose-normalized Maximum Concentration (Cmax) of Active Gemcitabine Metabolite: 2',2'-Difluorodeoxyuridine (dFdU) on Day 1 and at Steady State (Cycle 2 Day 1) in Part B

C1D1

C2D1

150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 8 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Part C: 150 mg Abemaciclib + 10 mg/kg Ramucirumab Day 1

150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

All randomized participants who received at least one dose of study drug with evaluable PK data in Part C.

PK: Maximum Concentration (Cmax) of Ramucirumab at 1 Hour Post-End-of-Infusion in Part C

100 or 150 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 100 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Part D: 100 or 150 mg Abemaciclib + 100 mg LY3023414

150 or 200 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 150 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Part D: 150 or 200 mg Abemaciclib + 150 mg LY3023414

All randomized participants who received at least one dose of study drug with evaluable PK data in Part D.

PK: Maximum Concentration (Cmax) of LY3023414 in Part D

All randomized participants who received at least one dose of study drug with evaluable PK data in Part A, B, C, D and E.

PK: Area Under the Concentration Curve (AUC) of Abemaciclib in Part A, B, C, D and E

150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 500 mg/m\^2 pemetrexed given IV over approximately 10 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met

PK: Area Under the Concentration Curve (AUC) of Pemetrexed at Steady State in Part A

200 mg or MTD Abemaciclib + 1250 mg/m^2 Gemcitabine

PK: Area Under the Concentration Curve (AUC) of Active Gemcitabine Metabolite: 2',2'-Difluorodeoxyuridine (dFdU) on Day 1 and at Steady State (Cycle 2 Day 1) in Part B

150 or 200 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 100 mg or 150 mg or 150 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

PK: Area Under the Concentration Curve (AUC) of LY3023414 in Part D

150 mg abemaciclib given orally every 12 hours (Q12H) on Days 1 through 21 of a 21-day cycle in combination with 500 milligrams/square meter (mg/m\^2) pemetrexed given intravenously (IV) over approximately 10 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Spots Global Cancer Trial Database for A Study of Abemaciclib (LY2835219) in Combination With Another Anti-cancer Drug in Participants With Lung Cancer (NSCLC)

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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