Tyrosine Kinase Inhibitor

Crizotinib for Non-Small Cell Lung Cancer

Phase 3
Recruiting
Led By David Gerber
Research Sponsored by ECOG-ACRIN Cancer Research Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
NOTE: Patients taking low dose methotrexate for non-malignant conditions and other cytotoxic agents for non-malignant conditions are allowed to continue treatment while on study
NOTE: Neo-adjuvant chemotherapy or radiation therapy for the resected lung cancer is not permitted
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upup to 10 years
Awards & highlights
Pivotal Trial
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group

Study Summary

This trial studies crizotinib for patients with stage IB-IIIA NSCLC who have had surgery and have an ALK fusion mutation. Crizotinib may stop the growth of tumor cells by blocking the ALK protein from working.

Eligible Conditions
  • Stage IIB Non-small Cell Lung Cancer
  • Lung Cancer
  • Non-Small Cell Lung Cancer
  • ALK Gene Rearrangement

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Select...
If you are taking low-dose methotrexate or other cytotoxic agents to treat non-cancerous conditions, you can still participate in the study.
Select...
You cannot have received chemotherapy or radiation therapy before your lung cancer surgery.
Select...
You have not had advanced or spreading cancer that required treatment in the last 5 years, except for certain types of skin cancer. Also, you have not had lung cancer that was diagnosed at the same time as another cancer, or within the past 2 years.
Select...
You are not taking any medications or herbal products that can interfere with the way the study drug works in your body.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 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
Overall survival (OS)
Secondary outcome measures
Disease free survival (DFS)
Toxicity rates, determined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Side effects data

From 2020 Phase 3 trial • 207 Patients • NCT01639001
55%
White blood cell count decreased
50%
Nausea
49%
Anaemia
46%
Vomiting
45%
Alanine aminotransferase increased
37%
Neutropenia
35%
Aspartate aminotransferase increased
33%
Neutrophil count decreased
33%
Decreased appetite
27%
Constipation
27%
Platelet count decreased
24%
Cough
21%
Haemoglobin decreased
20%
Leukopenia
17%
Chest pain
17%
Fatigue
16%
Blood albumin decreased
16%
Hyponatraemia
15%
Pyrexia
13%
Back pain
11%
Dizziness
11%
Dyspnoea
11%
Alopecia
10%
Thrombocytopenia
10%
Asthenia
9%
Diarrhoea
9%
Headache
9%
Insomnia
9%
Red blood cell count decreased
8%
Visual impairment
8%
Upper respiratory tract infection
8%
Phlebitis
8%
Nasopharyngitis
8%
Hypoalbuminaemia
8%
Haemoptysis
8%
Pruritus
7%
Rash
7%
Hypokalaemia
6%
Abdominal distension
6%
Blood bilirubin increased
6%
Pain in extremity
6%
Lymphocyte count decreased
6%
Pain
6%
Productive cough
5%
Oedema peripheral
5%
Musculoskeletal pain
4%
Vision blurred
4%
Chest discomfort
4%
Blood alkaline phosphatase increased
4%
Gamma-glutamyltransferase increased
4%
Paraesthesia
4%
Arthralgia
4%
Hypocalcaemia
3%
Abdominal pain
3%
Protein total decreased
2%
Abdominal pain upper
2%
Hypoaesthesia
1%
Death
1%
Disease progression
1%
Pneumonia
1%
Pleural effusion
1%
Oedema
1%
Blood creatinine increased
1%
Blood lactate dehydrogenase increased
1%
Hypoproteinaemia
1%
Hypertension
1%
Pericardial effusion
1%
Syncope
1%
Transaminases increased
1%
Cerebral infarction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Chemotherapy
Crizotinib

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A (crizotinib)Experimental Treatment2 Interventions
Patients receive crizotinib PO BID on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Group II: Arm B (observation)Active Control2 Interventions
Patients undergo observation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tyrosine
FDA approved

Find a site

Who is running the clinical trial?

ECOG-ACRIN Cancer Research GroupLead Sponsor
111 Previous Clinical Trials
175,316 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,412 Previous Clinical Trials
41,238,898 Total Patients Enrolled
David GerberPrincipal Investigator
ECOG-ACRIN Cancer Research Group
1 Previous Clinical Trials
447 Total Patients Enrolled

Media Library

Crizotinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02201992 — Phase 3
Non-Small Cell Lung Cancer Research Study Groups: Arm A (crizotinib), Arm B (observation)
Non-Small Cell Lung Cancer Clinical Trial 2023: Crizotinib Highlights & Side Effects. Trial Name: NCT02201992 — Phase 3
Crizotinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02201992 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other efficacy studies have been done on Crizotinib?

"Crizotinib was first studied in 2007 at Surgical Intensive Care Unit Regional Hospital Jessa. As of now, there have been a total of 640 completed clinical trials. Out of these, 69 are active and ongoing, with a majority of these studies taking place in Canandaigua, New York."

Answered by AI

Could you please elucidate the risks associated with Crizotinib?

"Crizotinib has been deemed safe by our team at Power. This is due to the fact that it is a Phase 3 trial, which means that there is some data to support its efficacy and multiple rounds of data that support its safety."

Answered by AI

How many individuals are being included in this scientific research project?

"168 suitable patients are needed to fill the spots for this trial. Those who meet the requirements and live near one of the participating locations, such as Las Vegas Urology - Smoke Ranch in Canandaigua, New York or OptumCare Cancer Care at MountainView in Hendersonville, North Carolina, are encouraged to apply."

Answered by AI

Are people needed for this clinical trial right now?

"That is correct. The online information from clinicaltrials.gov indicates that this research is still looking for 168 individuals from 100 different locations. The trial was originally posted on August 18th, 2014 with the most recent update happening on July 26th, 2022."

Answered by AI

Does this clinical trial use any innovative or cutting-edge methods?

"As of now, there are 69 open clinical trials involving Crizotinib in 38 countries and 1221 cities. The very first trial was sponsored by Baxter Healthcare Corporation in 2007. That initial study had 4640 participants and successfully completed Phase 4 drug approval. Since that initial trial, there have been 640 more."

Answered by AI

What are the FDA-approved indications for crizotinib?

"Crizotinib is the standard course of treatment for amino acid supplementation therapy. However, this medication can also be used to help patients with renal dysfunction, amino acid supplementation, and kidney failure."

Answered by AI

Are there different hospitals in state conducting this research?

"Currently, patients are being enrolled at Las Vegas Urology - Smoke Ranch in Canandaigua, New York, OptumCare Cancer Care at MountainView in Hendersonville, North Carolina, and Sands Cancer Center in Belpre, Ohio. 100 other recruitment sites are also operational."

Answered by AI

Who else is applying?

What state do they live in?
Colorado
Maryland
How old are they?
65+
What site did they apply to?
Boulder Community Hospital
Anne Arundel Medical Center
Oakland Colon Rectal Associates
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
~100 spots leftby May 2036