search
Back to results

Study of TQ-B3139 Versus Crizotinib in the First Line Treatment of Subjects With Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer (NSCLC)

Primary Purpose

ALK-positive NSCLC

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
TQ-B3139
Crizotinib
Sponsored by
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ALK-positive NSCLC

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 1.18 and 75 years. 2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.

    3. Life expectancy ≥12 weeks. 4. Histologically or cytologically confirmed advanced or metastatic NSCLC with ALK-positive.

    5. Has not received ALK tyrosine kinase inhibitor (TKI). 6. Has received one chemotherapy regimen for stage IIIB-IV NSCLC. 7. At least one measurable lesion. 8. Adequate organ system function. 9. Understood and signed an informed consent form.

Exclusion Criteria:

  • 1. Has diagnosed and/or treated additional malignancy within 5 years prior to randomization. Exceptions include cured cancer carcinoma in situ of the cervix, intramucosal carcinoma of gastrointestinal tract, breast and melanoma skin cancers and superficial bladder tumors.

    2. Hypersensitivity to TQ-B3139 or crizotinib. 3. Has received any cancer therapy within 4 weeks or 5 times of t1/2. 4. Has received any major surgery within 4 weeks. 5. Has received any radiotherapy or minor surgery aimed to cure cancer within 2 weeks.

    6. Acute toxicity that is ≥ Grade 2 caused by previous cancer therapy. 7. Has active viral, bacterial and fungal infections within 2 weeks before the first dose.

    8. Has serious cardiovascular disease within 3 months before the first dose. 9. Has currently uncontrollable congestive heart failure. 10. Has continuous arrhythmia ≥ Grade 2, uncontrollable atrial fibrillation or QTc interval > 480ms.

    11. Has interstitial fibrosis or interstitial lung disease ≥ Grade 3. 12. Brain metastases with symptom. 13. HBsAg positive and HBV DNA positive (≥ULN);HCV antibody and HCV-RNA positive (≥ULN); HIV positive or ≥HIV ULN.

    14. Has multiple factors affecting oral medication. 15. Has received a strong CYP3A inhibitors within 7days before the first dose. 16. Has received a strong CYP3A inducers. 17. Breastfeeding or pregnant women.; Men unwilling to use adequate contraceptive measures during the study.

    18. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.

Sites / Locations

  • Sun Yat-Sen University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TQ-B3139

Crizotinib

Arm Description

TQ-B3139 tablet 600mg administered orally , twice daily in 28-day cycle.

Crizotinib tablet 250mg administered orally, twice daily in 28-day cycle.

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS)
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.

Secondary Outcome Measures

Objective Response Rate (ORR)
Percentage of subjects achieving complete response (CR) and partial response (PR).
Disease Control rate (DCR)
Percentage of subjects achieving CR, PR, stable disease (SD) and Non-CR/Non-progressive disease (PD)
Overall Survival (OS)
OS defined as the time from randomization to death from any cause. Subjects who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.

Full Information

First Posted
July 2, 2019
Last Updated
October 29, 2019
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT04009317
Brief Title
Study of TQ-B3139 Versus Crizotinib in the First Line Treatment of Subjects With Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer (NSCLC)
Official Title
A Multicenter, Randomized, Open-label Study to Evaluate the Efficacy and Safety of TQ-B3139 Versus Crizotinib in the First Line Treatment of Subjects With Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer (NSCLC)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 13, 2019 (Actual)
Primary Completion Date
October 30, 2021 (Anticipated)
Study Completion Date
April 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
To evaluate the efficacy and safety of TQ-B3139 versus crizotinib in subjects with ALK-positive NSCLC that have received one chemotherapy regimen and have not received ALK inhibitor.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ALK-positive NSCLC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
260 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TQ-B3139
Arm Type
Experimental
Arm Description
TQ-B3139 tablet 600mg administered orally , twice daily in 28-day cycle.
Arm Title
Crizotinib
Arm Type
Active Comparator
Arm Description
Crizotinib tablet 250mg administered orally, twice daily in 28-day cycle.
Intervention Type
Drug
Intervention Name(s)
TQ-B3139
Intervention Description
a multi-target protein kinase inhibitor.
Intervention Type
Drug
Intervention Name(s)
Crizotinib
Intervention Description
a multi-target protein kinase inhibitor.
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.
Time Frame
up to 36 months
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
Percentage of subjects achieving complete response (CR) and partial response (PR).
Time Frame
up to 36 months
Title
Disease Control rate (DCR)
Description
Percentage of subjects achieving CR, PR, stable disease (SD) and Non-CR/Non-progressive disease (PD)
Time Frame
up to 36 months
Title
Overall Survival (OS)
Description
OS defined as the time from randomization to death from any cause. Subjects who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.
Time Frame
up to 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1.18 and 75 years. 2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1. 3. Life expectancy ≥12 weeks. 4. Histologically or cytologically confirmed advanced or metastatic NSCLC with ALK-positive. 5. Has not received ALK tyrosine kinase inhibitor (TKI). 6. Has received one chemotherapy regimen for stage IIIB-IV NSCLC. 7. At least one measurable lesion. 8. Adequate organ system function. 9. Understood and signed an informed consent form. Exclusion Criteria: 1. Has diagnosed and/or treated additional malignancy within 5 years prior to randomization. Exceptions include cured cancer carcinoma in situ of the cervix, intramucosal carcinoma of gastrointestinal tract, breast and melanoma skin cancers and superficial bladder tumors. 2. Hypersensitivity to TQ-B3139 or crizotinib. 3. Has received any cancer therapy within 4 weeks or 5 times of t1/2. 4. Has received any major surgery within 4 weeks. 5. Has received any radiotherapy or minor surgery aimed to cure cancer within 2 weeks. 6. Acute toxicity that is ≥ Grade 2 caused by previous cancer therapy. 7. Has active viral, bacterial and fungal infections within 2 weeks before the first dose. 8. Has serious cardiovascular disease within 3 months before the first dose. 9. Has currently uncontrollable congestive heart failure. 10. Has continuous arrhythmia ≥ Grade 2, uncontrollable atrial fibrillation or QTc interval > 480ms. 11. Has interstitial fibrosis or interstitial lung disease ≥ Grade 3. 12. Brain metastases with symptom. 13. HBsAg positive and HBV DNA positive (≥ULN);HCV antibody and HCV-RNA positive (≥ULN); HIV positive or ≥HIV ULN. 14. Has multiple factors affecting oral medication. 15. Has received a strong CYP3A inhibitors within 7days before the first dose. 16. Has received a strong CYP3A inducers. 17. Breastfeeding or pregnant women.; Men unwilling to use adequate contraceptive measures during the study. 18. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Zhang, Doctor
Phone
020-87343088
Email
zhangli@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Zhang, Doctor
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-Sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510050
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Zhang, Doctor
Phone
020-87343088
Email
zhangli@sysucc.org.cn
First Name & Middle Initial & Last Name & Degree
Li Zhang, Doctor

12. IPD Sharing Statement

Learn more about this trial

Study of TQ-B3139 Versus Crizotinib in the First Line Treatment of Subjects With Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer (NSCLC)

We'll reach out to this number within 24 hrs