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 range

18 Years

Sex

ALL

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

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 range

18 Years

Sex

ALL

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