TerminatedPhase 4

Long Term Safety Observation of Crizotinib in Chinese NSCLC Population

Stopped: The trial is terminated based on business decision, not due to safety concerns or regulatory requirements.

China41 participantsStarted 2019-01-28

Plain-language summary

This study is to allow access to crizotinib who were treated in previous Pfizer-sponsored studies in China.

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

. Patients who were enrolled and treated in Studies A8081005, A8081007, A8081014, A8081029, or A8081063 and are still receiving crizotinib treatment at the time of enrollment into this study. OR Patients randomized to the chemotherapy arm in Studies A8081014 or A8081029 who have experienced investigator assessed disease progression and have not yet crossed over to receive crizotinib treatment.
. No ongoing NCI CTCAE Grade 3 or intolerable Grade 2 adverse events considered to be related to crizotinib treatment
. Eastern Cooperative Oncology Group (ECOG) performance status 0-3
. Adequate organ function as defined by the following criteria

Exclusion criteria

. Use of any anticancer drug subsequent to crizotinib prior to study entry

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

Number of Participants With Grade 3 or 4 Adverse Events (AEs), Grade 5 AEs, AEs Lead to Treatment Discontinuation, Serious AEs (SAEs)- All Causality: Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03

Timeframe: From first dose of study treatment up to 28 days after last dose (maximum follow up approximately up to 52.3 months; maximum exposure to treatment was 51.3 months)

Number of Participants With Grade 3 or 4 AEs, Grade 5 AEs, AEs Leading to Treatment Discontinuation and SAEs- Treatment Related: Assessed by NCI CTCAE v4.03

Timeframe: From first dose of study treatment up to 28 days after last dose (maximum follow up approximately up to 52.3 months; maximum exposure to treatment was 51.3 months)

Trial details

NCT IDNCT03672643

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-09-28

Results submitted2024-09-04

View on ClinicalTrials.gov More ALK or ROS1-positive 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.

Inclusion criteria

. Patients who were enrolled and treated in Studies A8081005, A8081007, A8081014, A8081029, or A8081063 and are still receiving crizotinib treatment at the time of enrollment into this study. OR Patients randomized to the chemotherapy arm in Studies A8081014 or A8081029 who have experienced investigator assessed disease progression and have not yet crossed over to receive crizotinib treatment.
. No ongoing NCI CTCAE Grade 3 or intolerable Grade 2 adverse events considered to be related to crizotinib treatment
. Eastern Cooperative Oncology Group (ECOG) performance status 0-3
. Adequate organ function as defined by the following criteria

Exclusion criteria

. Use of any anticancer drug subsequent to crizotinib prior to study entry

What they're measuring

Timeframe: From first dose of study treatment up to 28 days after last dose (maximum follow up approximately up to 52.3 months; maximum exposure to treatment was 51.3 months)

Number of Participants With Grade 3 or 4 AEs, Grade 5 AEs, AEs Leading to Treatment Discontinuation and SAEs- Treatment Related: Assessed by NCI CTCAE v4.03

Timeframe: From first dose of study treatment up to 28 days after last dose (maximum follow up approximately up to 52.3 months; maximum exposure to treatment was 51.3 months)