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Tyrosine Kinase Inhibitor

Repotrectinib vs Crizotinib for Non-Small Cell Lung Cancer

Q: How many medical centers are overseeing this clinical exploration?

<p>According to the study, Augusta University in <a href="https://www.withpower.com/clinical-trials/georgia">Georgia</a>, Laura and Isaac Perlmutter <a href="https://www.withpower.com/clinical-trials/cancer">Cancer</a> Center in São José do Rio Preto (São Paulo), Local Institution - 0037 (Quebec) are amongst the 37 sites that are currently enrolling patients.</p>

Phase 3

Recruiting

Research Sponsored by Bristol-Myers Squibb

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Up to 1 prior line of systemic treatment for NSCLC is permitted

ECOG Performance Status ≤ 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 87 months

Awards & highlights

Study Summary

This trial tests a new drug for people with lung cancer caused by a genetic mutation. It evaluates safety and effectiveness.

Who is the study for?

This trial is for adults with advanced or metastatic non-small cell lung cancer (NSCLC) that haven't been treated with TKIs but may have had one other treatment. They need to have a specific gene change called ROS1 and be in good enough health to do their daily activities (ECOG ≤ 2). People can't join if they've got certain brain issues, heart disease, other cancers treated within the last 2 years, or specific genetic changes.Check my eligibility

What is being tested?

The study compares Repotrectinib and Crizotinib's effectiveness and safety in treating NSCLC patients who are new to TKI treatments. Participants will receive either drug to see which works better at controlling lung cancer growth.See study design

What are the potential side effects?

Possible side effects of both Repotrectinib and Crizotinib include liver problems, vision issues, nausea, diarrhea, edema (swelling), heart issues like slow heartbeat or QT prolongation on an EKG. Each person might react differently.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had only one treatment for my lung cancer.

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I can take care of myself and am up and about more than half of my waking hours.

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My lung cancer is advanced or has spread to other areas.

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My cancer has a ROS1 gene change.

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I have not taken any TKI medications for ROS1-positive lung cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 87 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 87 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 87 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-free Survival (PFS) as per Blinded Independent Central Review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Secondary outcome measures

DOR as per Investigator according to RECIST v1.1

Duration of Response (DOR) as per BICR according to RECIST v1.1

Number of deaths

+9 more

Side effects data

From 2020 Phase 3 trial • 207 Patients • NCT01639001

66%

Alanine aminotransferase increased

61%

Diarrhoea

60%

Aspartate aminotransferase increased

59%

Vomiting

54%

Nausea

41%

White blood cell count decreased

40%

Visual impairment

38%

Neutrophil count decreased

36%

Constipation

32%

Cough

28%

Headache

27%

Dizziness

26%

Oedema peripheral

26%

Decreased appetite

25%

Blood albumin decreased

21%

Pain in extremity

21%

Nasopharyngitis

20%

Neutropenia

19%

Anaemia

18%

Pyrexia

18%

Hypoalbuminaemia

17%

Upper respiratory tract infection

15%

Chest pain

15%

Dyspnoea

14%

Disease progression

14%

Blood lactate dehydrogenase increased

13%

Blood creatine phosphokinase increased

13%

Sinus bradycardia

13%

Vision blurred

13%

Gamma-glutamyltransferase increased

13%

Back pain

13%

Insomnia

13%

Protein total decreased

13%

Hypocalcaemia

12%

Leukopenia

12%

Rash

12%

Hypokalaemia

11%

Abdominal distension

10%

Abdominal pain

10%

Blood alkaline phosphatase increased

10%

Pain

10%

Alopecia

Blood creatinine increased

Chest discomfort

Fatigue

Oedema

Hypoaesthesia

Lymphocyte count decreased

Arthralgia

Asthenia

Abdominal pain upper

Platelet count decreased

Hypertension

Haemoptysis

Face oedema

Photopsia

Toothache

Haemoglobin decreased

Paraesthesia

Muscular weakness

Bradycardia

Taste disorder

Blood creatine phosphokinase MB increased

Pneumonia

Hyponatraemia

Hypoproteinaemia

Musculoskeletal pain

Red blood cell count decreased

Productive cough

Blood bilirubin increased

Pruritus

Thrombocytopenia

Pulmonary embolism

Dysphagia

Pleural effusion

Death

Interstitial lung disease

Pneumothorax

Anaphylactic shock

Hepatic function abnormal

Intestinal obstruction

Subcutaneous emphysema

Phlebitis

Abdominal discomfort

Impaired healing

Pancreatitis

Pancreatitis acute

Drug-induced liver injury

Gastrointestinal viral infection

Lower respiratory tract infection

Goitre

Ocular hypertension

Post procedural infection

Deep vein thrombosis

Cellulitis

Hyperuricaemia

Colon adenoma

Adenomyosis

Circulatory collapse

Fracture

Altered state of consciousness

100%

80%

60%

40%

20%

Study treatment Arm

Crizotinib

Chemotherapy

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm AExperimental Treatment1 Intervention

Group II: Arm BActive Control1 Intervention

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor

2,641 Previous Clinical Trials

4,129,834 Total Patients Enrolled

Zai Lab (Shanghai) Co., Ltd.Industry Sponsor

28 Previous Clinical Trials

3,451 Total Patients Enrolled

Frequently Asked Questions

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

Are new participants welcomed to join the trial at this time?

"According to the clinicaltrials.gov platform, this trial does not have an open call for participants at present; while it was initially posted on January 15th 2024 and last edited November 15th 2023, there are 1977 other studies with active recruitment campaigns ongoing."

Answered by AI

What potential perils are associated with Arm A for individuals?

"Power's internal evaluation of Arm A gave it a score of 3 due to the availablity of multiple rounds and efficacy data collected during Phase 3 clinical trials."

Answered by AI

How many medical centers are overseeing this clinical exploration?

"According to the study, Augusta University in Georgia, Laura and Isaac Perlmutter Cancer Center in São José do Rio Preto (São Paulo), Local Institution - 0037 (Quebec) are amongst the 37 sites that are currently enrolling patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Repotrectinib Versus Crizotinib in Participants With Locally Advanced or Metastatic Tyrosine Kinase Inhibitor (TKI)-naïve ROS1-positive Non-Small Cell Lung Cancer (NSCLC) (TRIDENT-3)

2023. "A Study of Repotrectinib Versus Crizotinib in Participants With Locally Advanced or Metastatic Tyrosine Kinase Inhibitor (TKI)-naïve ROS1-positive Non-Small Cell Lung Cancer (NSCLC) (TRIDENT-3)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06140836.

All > Non Small Cell Lung Cancer