Descriptive Observational Study ALK-2016-CPHG (ALK2016CPHG)

• Sponsor: Pfizer
• Collaborator: French College of General Hospital Pneumologists (CPHG)
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: March 5, 2018
• First Posted Date: October 24, 2018
• Last Update Posted Date: May 31, 2019
• Actual Study Start Date: January 3, 2017
• Estimated Primary Completion Date: December 6, 2019 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 29, 2019): Demographical Characteristics of Participants [ Time Frame: Baseline up tp Month 18 ]

Original Primary Outcome Measures (submitted: October 22, 2018)

• Number of Participants With Change From Baseline in Eastern Co-operative Oncology Group Performance Status (ECOG-PS)ECOG [ Time Frame: Baseline though month 15 ]
  ECOG-PS measures on-therapy assessed participant's performance status on 5 point scale: 0=Fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (>50% of waking hrs), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair >50% of waking hrs; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead.
• Demographical Characteristics of Participants [ Time Frame: Baseline ]

• Change History: Complete list of historical versions of study NCT03718117 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: May 29, 2019)

• Number of subjects using the diagnostic method used to detect ALK (Anaplastic lymphoma kinase) gene rearrangement [ Time Frame: Baseline ]
• Number of Participants With Clinical Response through Month 18 [ Time Frame: Month 3, Month 6, Month 9, Month 12, Month 15, Month 18 ]
• Objective Tumor Response [ Time Frame: Baseline up to month 18 ]
• Progression-Free Survival (PFS) [ Time Frame: Baseline up to Month 18 ]
• Number of participants with a change from baseline in (QLQ-LC 13) Quality of life Questionnaire for Lung Cancer [ Time Frame: Baseline through Month 18 ]
• Change from baseline Morisky self-administered questionnaire [ Time Frame: Baseline through month 18 ]
• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerabitly] [ Time Frame: Time from first dose of study drug though month 18 ]
• Number of subjects using diagnostic method used to detect ROS1 gene rearrangement [ Time Frame: Baseline ]
• Overall Survival (OS) [ Time Frame: Baseline , Month 12, Month 18 ]

Original Secondary Outcome Measures (submitted: October 22, 2018)

• Number of subjects using the diagnostic method used to detect ALK (Anaplastic lymphoma kinase) gene rearrangement [ Time Frame: Baseline ]
• Number of Participants With Clinical Response through Month 18 [ Time Frame: Month 3, Month 6, Month 9, Month 12, Month 15, Month 18 ]
• Objective Tumor Response [ Time Frame: Baseline up to month 15 ]
• Progression-Free Survival (PFS) [ Time Frame: Baseline up to Month 15 ]
• Number of participants with a change from baseline in (QLQ-LC 13) Quality of life Questionnaire for Lung Cancer [ Time Frame: Baseline through Month 18 ]
• Change from baseline Morisky self-administered questionnaire [ Time Frame: Baseline through month 18 ]
• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerabitly] [ Time Frame: Time from first dose of study drug though month 18 ]
• Number of subjects using diagnostic method used to detect (ROS1 Proto-oncogene 1, receptor tyrosine kinase) gene rearrangement [ Time Frame: Baseline ]
• Overall Survival (OS) [ Time Frame: Baseline up to Month 15 ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Descriptive Observational Study ALK-2016-CPHG
• Official Title: CHARACTERISTICS OF ADULT PATIENTS TREATED WITH CRIZOTINIB FOR ADVANCED NON-SMALL-CELL LUNG CANCER (NSCLC) WITH ALK GENE REARRANGEMENT OR ROS1 GENE REARRANGEMENT IN GENERAL HOSPITALS.

Brief Summary

Descriptive Observational Study.

Characteristics Of ALK-positive and ROS1-positive Adults Patients Non-Small Cell Lung Cancer (NSCLC) Treated With Crizotinib Within General Hospitals

• Detailed Description: Describe the characteristics of patients treated with crizotinib Describe efficacy, safety, observance and QoL.
• Study Type: Observational [Patient Registry]
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: 18 Months
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Participants with ALK positive or ROS1-positive Locally advanced or metastatic non-small cell lung cancer NSCLC, initiated in the previous 3 months or participants initiating crizotinib treatment regardless of the line of treatment

Condition

• NSCLC
• Crizotinib
• ALK Gene Rearrangement or ROS1 Gene Rearrangement

• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: October 22, 2018): 70
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 6, 2019
• Estimated Primary Completion Date: December 6, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion criteria

• Age ≥ 18 years
• Locally advanced or metastatic NSCLC
• Patient ALK gene rearrangement or ROS1 gene rearrangement
• Patient having initiated in the previous 3 months or patient initiating crizotinib treatment regardless of the line of treatment
• Patient followed up by a physician in a hospital pulmonary medicine department
• Subject of reproductive age, using an effective method of contraception
• Patient informed verbally and in writing on the study and having consented to his/her personal data being collected within the scope of the study.

Non-inclusion criteria

• Patient included within the scope of an interventional therapeutic trial
• Patient not presenting with ALK gene rearrangement or ROS1 gene rearrangement
• Patient not available for follow-up throughout the duration of the study
• Patient deemed to be incapable of responding to the study questions for linguistic, cognitive or organisational reasons.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT03718117
• Other Study ID Numbers: A8081060; ALK-2016-CPHG ( Other Identifier: Alias Study Number )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

• Responsible Party: Pfizer
• Study Sponsor: Pfizer
• Collaborators: French College of General Hospital Pneumologists (CPHG)

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: May 2019