CompletedNot Applicable

Descriptive Observational Study ALK-2016-CPHG

France73 participantsStarted 2017-01-03

Plain-language 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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Age: Line of Treatment

Timeframe: Baseline

Body Weight: Line of Treatment and Gene Rearrangement

Timeframe: Baseline

Body Mass Index (BMI): Line of Treatment and Gene Rearrangement

Timeframe: Baseline

Gender: Line of Treatment

Timeframe: Baseline

Number of Participants Classified According to Smoking Status at Baseline: Line of Treatment and Gene Rearrangement

Timeframe: Baseline

Number of Pack Years: Line of Treatment and Gene Rearrangement

Timeframe: Baseline

Duration of Smoking and Duration of Quitting Smoke: Line of Treatment and Gene Rearrangement

Timeframe: Baseline

Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Assessment: Line of Treatment and Gene Rearrangement

Timeframe: Baseline

Trial details

NCT IDNCT03718117

SponsorPfizer

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2020-07-01

Results submitted2023-01-10

View on ClinicalTrials.gov More NSCLC trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Age: Line of Treatment

Timeframe: Baseline

Body Weight: Line of Treatment and Gene Rearrangement

Timeframe: Baseline

Body Mass Index (BMI): Line of Treatment and Gene Rearrangement

Timeframe: Baseline

Gender: Line of Treatment

Timeframe: Baseline

Number of Participants Classified According to Smoking Status at Baseline: Line of Treatment and Gene Rearrangement

Timeframe: Baseline

Number of Pack Years: Line of Treatment and Gene Rearrangement

Timeframe: Baseline

Duration of Smoking and Duration of Quitting Smoke: Line of Treatment and Gene Rearrangement

Timeframe: Baseline

Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Assessment: Line of Treatment and Gene Rearrangement

Timeframe: Baseline