Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Descriptive Observational Study ALK-2016-CPHG (ALK2016CPHG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03718117
Recruitment Status : Completed
First Posted : October 24, 2018
Last Update Posted : September 28, 2021
Sponsor:
Collaborator:
French College of General Hospital Pneumologists (CPHG)
Information provided by (Responsible Party):
Pfizer

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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


Condition or disease
NSCLC Crizotinib ALK Gene Rearrangement or ROS1 Gene Rearrangement

Detailed Description:
Describe the characteristics of patients treated with crizotinib Describe efficacy, safety, observance and QoL.
Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 71 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 18 Months
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.
Actual Study Start Date : January 3, 2017
Actual Primary Completion Date : July 1, 2020
Actual Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Demographical Characteristics of Participants [ Time Frame: Baseline up tp Month 18 ]

Secondary Outcome Measures :
  1. Number of subjects using the diagnostic method used to detect ALK (Anaplastic lymphoma kinase) gene rearrangement [ Time Frame: Baseline ]
  2. Number of Participants With Clinical Response through Month 18 [ Time Frame: Month 3, Month 6, Month 9, Month 12, Month 15, Month 18 ]
  3. Objective Tumor Response [ Time Frame: Baseline up to month 18 ]
  4. Progression-Free Survival (PFS) [ Time Frame: Baseline up to Month 18 ]
  5. 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 ]
  6. Change from baseline Morisky self-administered questionnaire [ Time Frame: Baseline through month 18 ]
  7. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerabitly] [ Time Frame: Time from first dose of study drug though month 18 ]
  8. Number of subjects using diagnostic method used to detect ROS1 gene rearrangement [ Time Frame: Baseline ]
  9. Overall Survival (OS) [ Time Frame: Baseline , Month 12, Month 18 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03718117


Locations
Show Show 26 study locations
Sponsors and Collaborators
Pfizer
French College of General Hospital Pneumologists (CPHG)
Investigators
Layout table for investigator information
Study Director: Pfizer CT.gov Call Center Pfizer
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03718117    
Other Study ID Numbers: A8081060
ALK-2016-CPHG ( Other Identifier: Alias Study Number )
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: September 28, 2021
Last Verified: September 2021
Individual Participant Data (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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
Non-Small Cell Lung Cancer (NSCLC)
crizotinib
ALK gene rearrangement or ROS1 gene rearrangement