← Back to Search

ALK/ROS1 Inhibitor

PF-06463922 for Non-small Cell Lung Cancer (NSCLC)

Phase 1 & 2
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Study Summary

This trialwill study the safety and effectiveness of a new drug to treat advanced lung cancer in people with ALK or ROS1 mutations.

Eligible Conditions
  • Non-small Cell Lung Cancer (NSCLC)

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Cycle 1 Dose-Limiting Toxicities (DLTs) in Phase 1
Percentage of Participants With Overall and Intracranial Objective Response (Phase 2)
Secondary outcome measures
Apparent Oral Clearance (CL/F) of Midazolam (Phase 1)
Apparent Oral Clearance (CL/F) of PF-06463922 (Phase 2)
Apparent Oral Clearance (CL/F) of PF-06463922 Following Multiple Oral Doses (Phase 1)
+66 more

Side effects data

From 2023 Phase 1 & 2 trial • 334 Patients • NCT01970865
67%
Hypertriglyceridaemia
47%
Hypercholesterolaemia
43%
Blood cholesterol increased
40%
Oedema peripheral
30%
Cough
27%
Fatigue
27%
Constipation
23%
Diarrhoea
23%
Aspartate aminotransferase increased
23%
Dyspnoea
20%
Dizziness
17%
Neuropathy peripheral
17%
Headache
17%
Rash
17%
Arthralgia
17%
Anaemia
17%
Upper respiratory tract infection
17%
Alanine aminotransferase increased
13%
Vomiting
13%
Weight increased
13%
Decreased appetite
13%
Musculoskeletal pain
13%
Nausea
13%
Oedema
13%
Insomnia
10%
Mucosal inflammation
10%
Vision blurred
10%
Irritability
10%
Asthenia
10%
Pyrexia
10%
Hypoalbuminaemia
10%
Hyperglycaemia
10%
Myalgia
10%
Peripheral sensory neuropathy
10%
Paraesthesia
10%
Dry skin
10%
Lipase increased
7%
Pain
7%
Hypomagnesaemia
7%
Memory impairment
7%
Alopecia
7%
Hypertension
7%
Face oedema
7%
Influenza
7%
Haematuria
7%
Pericardial effusion
7%
Eye irritation
7%
Toothache
7%
Mood swings
7%
Hyperlipidaemia
7%
Abdominal distension
7%
Tinnitus
7%
Blood triglycerides increased
7%
Hyperuricaemia
7%
Back pain
7%
Hypokalaemia
7%
Muscular weakness
7%
Dysgeusia
7%
Pain in extremity
7%
Haemoptysis
3%
Confusional state
3%
Musculoskeletal stiffness
3%
Respiratory tract infection
3%
Lower respiratory tract infection
3%
Glossitis
3%
Gastric volvulus
3%
Bronchitis
3%
Gastrooesophageal reflux disease
3%
Blood creatine phosphokinase increased
3%
Dysphonia
3%
Pleural effusion
3%
Cognitive disorder
3%
Dyspnoea exertional
3%
Stomatitis
3%
Epistaxis
3%
Viral upper respiratory tract infection
3%
Wheezing
3%
Depression
3%
Pneumonia
3%
Vertigo
3%
Intestinal obstruction
3%
Dyspepsia
3%
Amylase increased
3%
Bone pain
3%
Asthma
100%
80%
60%
40%
20%
0%
Study treatment Arm
EXP-1 (Phase 2)
EXP-6 (Phase 2)
Japan Lead-In Cohort (LIC)
EXP-2 (Phase 2)
EXP-3 (Phase 2)
EXP-5 (Phase 2)
75 mg QD (Phase 1)
100 mg QD (Phase 1)
150 mg QD (Phase 1)
200 mg QD (Phase 1)
35 mg BID (Phase 1)
75 mg BID (Phase 1)
100 mg BID (Phase 1)
10 mg QD (Phase 1)
25 mg QD (Phase 1)
50 mg QD (Phase 1)
EXP-4 (Phase 2)

Trial Design

2Treatment groups
Experimental Treatment
Group I: PF-06463922Experimental Treatment1 Intervention
Group II: CrizotinibExperimental Treatment1 Intervention
ALK+ NSCLC patients who are treatment naïve may be eligible to receive crizotinib following PF-06463922 as a substudy to the main study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PF-06463922
2016
Completed Phase 2
~390
Crizotinib
2014
Completed Phase 3
~2370

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,567 Previous Clinical Trials
10,911,539 Total Patients Enrolled
2 Trials studying Non-small Cell Lung Cancer (NSCLC)
65 Patients Enrolled for Non-small Cell Lung Cancer (NSCLC)
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,474 Previous Clinical Trials
8,092,707 Total Patients Enrolled
1 Trials studying Non-small Cell Lung Cancer (NSCLC)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
The Lancet OncologyJournal
Lorlatinib in Non-small-cell Lung Cancer with ALK or ROS1 Rearrangement: An International, Multicentre, Open-label, Single-arm First-in-man Phase 1 Trial
Shaw, Alice T, Enriqueta Felip, Todd M Bauer, Benjamin Besse, Alejandro Navarro, Sophie Postel-Vinay, Justin F Gainor, et al.. 2017. “Lorlatinib in Non-small-cell Lung Cancer with ALK or ROS1 Rearrangement: An International, Multicentre, Open-label, Single-arm First-in-man Phase 1 Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(17)30680-0.
clinicaltrials.govStudy
A Study Of PF-06463922 An ALK/ROS1 Inhibitor In Patients With Advanced Non Small Cell Lung Cancer With Specific Molecular Alterations
2014. "A Study Of PF-06463922 An ALK/ROS1 Inhibitor In Patients With Advanced Non Small Cell Lung Cancer With Specific Molecular Alterations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01970865.
~30 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top