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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.

Select...

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

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My cancer has a ROS1 gene change.

Select...

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

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

Phlebitis

Visual impairment

Upper respiratory tract infection

Nasopharyngitis

Hypoalbuminaemia

Haemoptysis

Pruritus

Rash

Hypokalaemia

Lymphocyte count decreased

Blood bilirubin increased

Pain in extremity

Abdominal distension

Pain

Productive cough

Oedema peripheral

Musculoskeletal pain

Arthralgia

Vision blurred

Chest discomfort

Blood alkaline phosphatase increased

Gamma-glutamyltransferase increased

Paraesthesia

Hypocalcaemia

Abdominal pain

Protein total decreased

Abdominal pain upper

Hypoaesthesia

Pleural effusion

Disease progression

Death

Blood creatinine increased

Pneumonia

Oedema

Blood lactate dehydrogenase increased

Hypoproteinaemia

Hypertension

Pericardial effusion

Syncope

Transaminases increased

Cerebral infarction

100%

80%

60%

40%

20%

Study treatment Arm

Chemotherapy

Crizotinib

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

2,645 Previous Clinical Trials

4,130,769 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