Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

Tubulin Modulators

Antimitotic Agents

200 milligram (mg) abemaciclib given orally every 12 hours (Q12H) on days 1 to 21 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

75 milligram per meter squared (mg/m²) docetaxel given intravenously (IV) on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Abemaciclib

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 effectiveness of the study drug known as abemaciclib versus docetaxel in participants with stage IV squamous non-small cell lung cancer (NSCLC) previously treated with platinum-based chemotherapy.

A Study of Abemaciclib (LY2835219) in Participants With Stage IV Squamous Non-small Cell Lung Cancer

A Randomized Phase 2 Study of Abemaciclib (LY2835219) Versus Docetaxel in Patients With Stage IV Squamous Non-Small Cell Lung Cancer Previously Treated With Platinum-Based Chemotherapy

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

PFS was defined as time from the date of randomization to the date of investigator-determined disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or death from any cause. Progressive disease (PD) was defined as at least a 20% increase in the sum of the longest diameters (LD) of target lesions, with reference the smallest sum on study and an absolute increase of at least 5mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant was not known to have died or have objective progression, PFS time will be censored at the day of their last radiographic tumor assessment (if available) or date of randomization if no post baseline radiographic assessment is available.

Pharmacokinetics (PK): Clearance of Abemaciclib

PK: Volume of Distribution of Abemaciclib

OS was defined as the time from randomization to the date of death due to any cause. For each participant who is not known to have died as the data inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive.

Overall response was defined as the percentage of randomized participants achieving a best overall response (BoR) of complete response (CR) or partial response (PR) using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. Participants with unevaluable or unknown response status are considered nonresponders. Complete response (CR) is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. Partial response (PR) is defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions and no appearance of new lesions.

DCR is the percentage of randomized participants who achieved a complete response, partial response or stable disease using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. Complete response (CR) is defined as the disappearance of all target and non-target lesions, and no appearance of new lesions. Partial response (PR) is defined as at least a 30% decrease in the sum of longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions and no appearance of new lesions. Stable disease was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions.

Worsening of ECOG performance status is the duration from randomization to ECOG PFS of \>/=2. Participants without an ECOG PFS \>/=2 are censored at last adequate post baseline ECOG Performance Status or randomization date (whichever is last).

The ECOG Performance Status:0 - Fully active, able to carry on all pre-disease performance without restriction,1 - Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, 2 - Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours,3 - Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours, 4 - Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair, 5 - Dead

MDASI-LC included 33 items:6 interference and 27 symptom(3 lung-cancer (LC),8 brain tumor (BT),and 3 study-specific(headache,diarrhea, and rash).Analyzed endpoints were 9 constructs:3 single-items (headache,diarrhea,and rash) and 6 composites(interference+core,LC,core+LC,BT, and core+LC worst 5 baseline).Data for all 9 constructs were collected by an 11-point numeric rating scale anchored at 0(not present or does not interfere) and 10(as bad as you can imagine or interfered completely).The measurement range was 10 (maximum score-minimum score). Between-group difference in regression-predicted change from baseline were estimated for each specified construct. MMRM models included independent variables treatment,visit, treatment\*visit,and baseline score. Group-level negative change from baseline indicated group improvement.

The EQ-5D-5L is a standardized instrument for use as a measure of self-reported health status. Overall self-rated health was measured with a vertical 20 cm visual analog scale (VAS) anchored at 0 (worst health) and ranged through 100 (best health). Between-group differences in regression-predicted change from baseline score were estimated for VAS scores. MMRM models included independent variables treatment, visit, treatment\*visit, and baseline score. Group-level negative change from baseline indicated group improvement.

There are 5 response levels on a good-to-bad continuum of 1-5 corresponding to none, slight, moderate, severe, and extreme/unable to.The EuroQol-developed crosswalk method was used to convert the EQ-5D-5L,using UK weights,health dimensions(mobility,self-care,usual activities,pain/discomfort, and anxiety/depression) into a single index value;the dimensions are not separately scored.The index is marked missing when ≥1 dimensions are missing.The index scores for the response patterns were anchored on full health to dead with negative values assigned to response patterns/health states considered worse than death.The best pattern is assigned the index value of 1.0; the worst pattern is assigned an index value of -0.594. Between-group differences in regression-predicted change from baseline score were estimated for the index .MMRM models included independent variables treatment, visit, treatment\*visit, and baseline score.Group-level negative change from baseline indicated group improvement.

Eli Lilly and Company

All randomized participants who received at least one dose of study drug.

200 milligram(mg) abemaciclib given orally every 12 hours (Q12H) on days 1 to 21 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

200 milligram(mg) Abemaciclib given orally every 12 hours (Q12H) on days 1 to 21 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

75 milligram per meter squared (mg/m²) Docetaxel given intravenously (IV) on day 1 of each 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)

Romania

Hungary

United States

Ukraine

Russia

Spain

South Korea

Taiwan

Poland

Italy

Australia

France

Germany

Region of Enrollment

Participants were stratified at randomization according to the following: Eastern Cooperative Oncology Group (ECOG) PS (0 vs. 1); number of prior therapies (received only platinum-based therapy vs. platinum-based therapy plus immune checkpoint inhibitor) and time since initiation of first line therapy (\<=9 months vs \>9 months). The ECOG Performance Status:0 - Fully active, able to carry on all pre-disease performance without restriction,1 - Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature.

Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)

Chief Medical Officer

Stratified by baseline ECOG performance status (0 vs 1), number of Prior Therapies (received only platinum-based therapy vs Received platinum-based Therapy plus Immune Checkpoint Inhibitor), and time since initiation of first line therapy (\<=9 months vs \>9 months).

All participants according to the treatment group to which they were randomized. Participants censored: Abemaciclib=19 and Docetaxel= 15.

Progression Free Survival (PFS)

200 milligram(mg) abemaciclib given orally every 12 hours (Q12H) on days 1 to 21 of each 21 day cycle.

All participants who received abemaciclib and had evaluable PK data.

All participants who received Abemaciclib and had evaluable PK data.

Stratified by baseline ECOG performance status (0 vs 1), number of Prior Therapies (received only platinum-based therapy vs Received platinum-based Therapy plus Immune Checkpoint Inhibitor), and time since initiation of first line therapy (\<=9 months vs \>9 months).\]

All participants according to the treatment group to which they were randomized. Participants censored: Abemaciclib=35 and Docetaxel= 17.

Overall Survival (OS)

Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])

Percentage of Participants Who Exhibit Stable Disease (SD) or Confirmed Response (CR) or Partial Response (PR): Disease Control Rate (DCR)

Stratification factors are baseline ECOG performance status (0 vs 1), Number of Prior Therapies (received only platinum-based therapy vs Received platinum-based Therapy plus Immune Checkpoint Inhibitor), and time since initiation of first line therapy (\<=9 months vs \>9 months).

All randomized participants. Participants censored: Abemaciclib =93 and Docetaxel= 43.

Time to Worsening of Eastern Cooperative Oncology Group (ECOG) Performance Status of >/=2

Mean core plus lung cancer symptom severity

Mean core plus lung worst 5 symptoms severity

Headache

Diarrhea

Mean core symptom severity

Mean interference

Mean lung cancer symptom severity

Mean brain tumor symptom severity

Rash

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 assessment after Cycle 1 (for example, a completed MDASI-LC questionnaire at Cycle 2 Day 1 or later)

Change From Baseline in MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) Scores

All randomized participants for cycles which at least 25% of participants in each arm have a score.The EQ-5D-5L population included all randomized participants who completed at least 1 baseline assessment followed by at least 1 EQ-5D-5L assessment after Cycle 1 (for example, a completed EQ-5D-5L questionnaire at Cycle 2 Day 1 or later).

Change From Baseline in EuroQol 5-Dimensional 5-Level (EQ-5D-5L) Questionnaire EQ VAS Overall Self-rated Health Score

Change From Baseline in EuroQol 5-Dimensional 5-Level (EQ-5D-5L) Questionnaire Index Value

Overall Study

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Immunoproliferative Disorders

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

The primary research outputs and measurements are the instruments/surveys, assessments, and video diaries to be completed by the patients, their caregivers and the healthcare providers during the time of the home transplantation care. Protocol-specific interventions during homebound care will continue until patient has achieved neutrophil engraftment. Post engraftment, standard of care practice will resume. Once discharged from homebound care, the patient will complete routine post-HSCT follow-up visits in the clinic setting.

A tablet will be provided to both the patient and the caregiver during the homecare portion of the study. The tablet will remain at the home, to be used by the patient and the caregiver during daily homecare visits to complete instruments/surveys and video diary recording sessions.

Home monitoring teleconsult visits

Distress Thermometer, MSK-Modified M.D. Anderson Symptom Inventory (MDASI) Instrument, FACT-G Instrument, FACT-BMT Instrument

Patient Reported Outcomes (PRO)

Distress Thermometer, Caregiver Reaction Assessment (CRA) Instrument, The Caregiver Quality of Life Index-Cancer (CQOLC) Scale, Satisfaction Questionnaire, Video Diary Entries

Caregiver Reported Outcomes instruments

Heather Landau, MD

Sergio Giralt, MD

In this study, the investigators plan to see what happens when a person receives care in the home setting. They want to find out if caring for a patient who has been treated with an ASCT in the home setting is feasible. They want to find out what effects good and/or bad this will have on the patient's recovery and treatment after ASCT. Studies in other institutions have shown that providing care in the home setting after ASCT is safe, increases patient satisfaction, and can decrease the risk of infection. It is our hope that this new approach of providing care in the home setting will prove to be a feasible and safe option for patients at Memorial Sloan Kettering Cancer Center (MSK).

This pilot trial will be the first attempt at developing a homebound hematopoietic stem cell transplant (HSCT) program at MSK.

Pilot Trial of Homebound Stem Cell Transplantation

the homebound procedure will be considered promising if no more than 10 patients are readmitted to the hospital within 21 days.

Memorial Sloan Kettering Cancer Center

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

The participant used the web and/or phone-based PRO reporting symptoms to enter symptoms twice a week at minimum.

The participants on this arm do not record their symptoms. They report symptoms as they would under usual care.

The participant reports their symptoms at least twice a week via the phone or web-based prototype system.

Report symptoms via web or phone-based system

DerShung Yang, PhD

VK Gadi, MD

Ana Maria Lopez, MD

Cancer symptoms due to disease progression or side effects caused by cancer treatment are prevalent. Most cancer patients are treated in outpatient settings. Patients may be provided with patient education materials and counseled on anticipated side effects while being provided with different self-management options and warnings regarding when medical care is required. Despite these efforts, many people feel set adrift in having to self-manage treatment and illness related symptoms at home resulting in a sense of burden for the patient and the caregiver.

When the patient does visit the doctor, they increasingly are asked questions to elicit information about symptoms and performance using structured questionnaires that are shown to give reproducible, meaningful, quantitative assessments of how patients feel and how they function-measures that are called patient reported outcomes or PROs. The questionnaires used to collect this information are called PRO instruments. The use of PRO instruments is part of a general movement toward the idea that the patient, properly queried, is the best source of information about how he or she feels. The goal of using PRO measures is to provide better information to doctors and patients so that the best treatment for patients can be determined.

PURPOSE: To reduce the isolation of patients/caregivers from the medical care team and to improve patient/provider communication and clinical decisions by keeping documented daily reports of patient symptoms online, having notifications sent to the medical team of moderate to severe symptoms and by reviewing these reports at clinic visits with the medical staff.

Comprehensive Patient Reported Outcomes (PRO) Management for Oncology Practice

Phase II Study of Comprehensive Patient Reported Outcomes (PRO) Management for Oncology Practice

Usability and effectiveness of BrightOutcome's web and phone-based symptom reporting and assessment software as it pertains to patient/provider communication

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Abemaciclib (LY2835219) in Participants With Stage IV Squamous Non-small Cell Lung Cancer	NCT02450539	Non-Small Cell ...	Abemaciclib Docetaxel	18 Years -	Eli Lilly and Company
A Study of Abemaciclib (LY2835219) in Participants With Stage IV Squamous Non-small Cell Lung Cancer	NCT02450539	Non-Small Cell ...	Abemaciclib Docetaxel	18 Years -	Eli Lilly and Company
Pilot Trial of Homebound Stem Cell Transplantation	NCT02671448	Plasma Cell Dys...	Home monitoring... Patient Reporte... Caregiver Repor...	18 Years - 80 Years	Memorial Sloan Kettering Cancer Center
Comprehensive Patient Reported Outcomes (PRO) Management for Oncology Practice	NCT01108315	Breast Cancer	Report symptoms...	18 Years -	BrightOutcome

Spots Global Cancer Trial Database for patient reported outcomes (pro)