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

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If you are taking low-dose methotrexate or other cytotoxic agents to treat non-cancerous conditions, you can still participate in the study.

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You cannot have received chemotherapy or radiation therapy before your lung cancer surgery.

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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.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 years

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

Diarrhoea

Headache

Insomnia

Red blood cell count decreased

Visual impairment

Upper respiratory tract infection

Phlebitis

Nasopharyngitis

Hypoalbuminaemia

Haemoptysis

Pruritus

Rash

Hypokalaemia

Abdominal distension

Blood bilirubin increased

Pain in extremity

Lymphocyte count decreased

Pain

Productive cough

Oedema peripheral

Musculoskeletal pain

Vision blurred

Chest discomfort

Blood alkaline phosphatase increased

Gamma-glutamyltransferase increased

Paraesthesia

Arthralgia

Hypocalcaemia

Abdominal pain

Protein total decreased

Abdominal pain upper

Hypoaesthesia

Death

Disease progression

Pneumonia

Pleural effusion

Oedema

Blood creatinine increased

Blood lactate dehydrogenase increased

Hypoproteinaemia

Hypertension

Pericardial effusion

Syncope

Transaminases increased

Cerebral infarction

100%

80%

60%

40%

20%

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

0 / 4Eligibility criteria met

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