ClinicalTrials.gg
CompletedNCT03375242Updated Aug 28, 2026

Safety and Efficacy of Xalkori ROS1

An observational study in Non-small Cell Lung Cancer, sponsored by Pfizer. Completed at 1 site in Japan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-28.

Sponsored by Pfizer · Observational

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
97
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 158 studies in Carcinoma, Non-Small-Cell Lung by Pfizer — 15 open to participants now, 26 under way, 5 of them phase 3. Carcinoma, Non-Small-Cell Lung · Pfizer.

Enrollment
9th of 17
97 · median 97
Started
2017
with 7 others
Observational
17 of 158
1 open now
Registered
82nd of 158
by date

Among the 158 studies in Carcinoma, Non-Small-Cell Lung by Pfizer, this one is the 9th largest by enrollment of the 17 observational ones that give a count, is one of 8 that started in 2017, is one of 17 observational ones, and was the 82nd registered.

Carcinoma, Non-Small-Cell Lung

7,621 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,837 are open to participants now.

Browse Carcinoma, Non-Small-Cell Lung studies →

Open to participants now

15 of the 158 studies in Carcinoma, Non-Small-Cell Lung by Pfizer are open now, in 12 countries. Recruiting first, the newest first:

10 more — sign in →

By country, each count listing its studies:

All 15 open studies →

Who these studies take

Of the 1,326 Carcinoma, Non-Small-Cell Lung studies recruiting now, 988 (75%) set no upper age limit and 225 (17%) stop at 75 or younger; 34 take children under 18; 40 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 158 studies in Carcinoma, Non-Small-Cell Lung by Pfizer, or all of them as a file.
02

Study summary

The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

03

Conditions studied

  • Non-small Cell Lung Cancer
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

100 patients

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients with unresectable progressive/recurrent NSCLC who are naive to XALKORI and whose tumor is ROS1 gene positive

Exclusion criteria

Exclusion Criteria:

  • Patients with past history of to any of the ingredients of XALKORI
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
97 participants (actual)
Patient registry
No

Groups and cohorts

  • crizotinib

    Drug: crizotinib

Interventions

  • XALKORI® Capsule 200 mg/XALKORI® Capsule 250 mg Frequency and duration are according to Package Insert as follows. " The recommended dose schedule of crizotinib is 250 mg taken orally twice daily. Dosing interruption and/or dose reduction may be required based on patients' clinical status. "

    Also known as: XALKORI® Capsule 200 mg/XALKORI® Capsule 250 mg

06

What researchers measure

Primary outcomes

  1. The incidence of adverse drug reactions in this surveillance.

    Time frame: 52 weeks

Secondary outcomes

  1. Objective Response Rate (ORR)

    Time frame: 12, 24, 52 weeks

07

Study locations

1 site
  • Pfizer
    Tokyo, Japan
08

References and documents

Individual participant data

Plan to share: No — 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.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2017 to primary completion in Aug 2026, 105 months.

Of 142 industry-sponsored observational studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 64. This study's 105 months is above that.

Counting every sponsor, half of 498 studies reached it within 55 months; a quarter within 35 and three quarters within 83.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 12, 2017
First posted
Dec 18, 2017
StartActual
Oct 25, 2017
Primary completionActual
Aug 10, 2026
CompletionActual
Aug 10, 2026
Last update
Aug 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03375242
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Dec 18, 2017
Start date
Oct 25, 2017
Primary completion
Aug 10, 2026
Completion
Aug 10, 2026
Last update
Aug 28, 2026

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion