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Study of TQ-B3139 in Subjects With Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer (NSCLC) Previously Treated With Crizotinib

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ClinicalTrials.gov Identifier: NCT04056572
Recruitment Status : Not yet recruiting
First Posted : August 14, 2019
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Brief Summary:
To evaluate the efficacy and safety of TQ-B3139 in subjects with ALK-positive non-small cell lung cancer that have demonstrated progression during or after crizotinib treatment whether or not previously treated with cytotoxic chemotherapy.

Condition or disease Intervention/treatment Phase
ALK-positive NSCLC Drug: TQ-B3139 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 135 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of TQ-B3139 in Patients With Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer (NSCLC) Previously Treated With Crizotinib.
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : October 30, 2021
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Crizotinib

Arm Intervention/treatment
Experimental: TQ-B3139
TQ-B3139 tablet 600mg administered orally, twice daily.
Drug: TQ-B3139
TQ-B3139 is competitive multi-target protein kinase inhibitor of Met/ALK/ROS.




Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: up to 36 months ]
    The percentage of participants with a best overall response defined as complete response (CR) or partial response (PR).


Secondary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: up to 36 months ]
    The time from randomization to the date of the first documentation of objective progression of disease or death due to any cause, whichever occurs first.

  2. Disease control rate (DCR) [ Time Frame: up to 36 months ]
    Calculated as the percentage of participants with best overall response of CR, PR, stable disease (SD) and Non-CR/Non-progressive disease (PD).

  3. Overall survival (OS) [ Time Frame: up to 36 months ]
    Time from date of randomization to date of death due to any cause.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 diagnosis of advanced or metastatic NSCLC that is ALK-positive.
  5. Has progressive disease during or after crizotinib treatment.
  6. Has a measurable disease.
  7. Adequate organ system function.
  8. Understood and signed an informed consent form.

Exclusion Criteria:

  1. Diagnosed and/or treated additional malignancy within 5 years prior to randomization.
  2. Hypersensitivity to TQ-B3139 capsule.
  3. Has received ALK TKIs other than crizotinib.
  4. Has received any cancer therapy within 4 weeks or 5 times of t1/2.
  5. Has received major surgery within 4 weeks.
  6. Has received any radiotherapy or minor surgery within 2 weeks.
  7. Acute toxicity ≥ Grade 2 caused by previous cancer therapy.
  8. Has active viral, bacterial and fungal infections within 2 weeks.
  9. Has serious cardiovascular diseases.
  10. Has currently uncontrollable congestive heart failure.
  11. Has continuous arrhythmia ≥ Grade 2, any degree of poor controlled atrial fibrillation or QTc interval > 480ms.
  12. Has interstitial fibrosis or interstitial lung disease.
  13. Brain metastases with symptom or carcinomatous meningitis.
  14. Has active hepatitis B or hepatitis C.
  15. Has multiple factors affecting oral medication.
  16. Breastfeeding or pregnant women.
  17. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04056572


Contacts
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Contact: Li Zhang, Doctor 020-87343088 zhangli@sysucc.org.cn

Locations
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China, Guangdong
Sun-Yat-Sen University Cancer Center Not yet recruiting
Guangzhou, Guangdong, China, 510050
Contact: Li Zhang, Doctor    020-87343088    zhangli@sysucc.org.cn   
Principal Investigator: Li zhang, Doctor         
China, Hunan
Hunan Cancer Hospital Not yet recruiting
Changsha, Hunan, China, 410013
Contact: Nong Yang, Doctor    +86-731-88651900    yangnong0217@163.com   
Principal Investigator: Nong Yang, Doctor         
Sponsors and Collaborators
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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Responsible Party: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
ClinicalTrials.gov Identifier: NCT04056572     History of Changes
Other Study ID Numbers: TQ-B3139-II-01
First Posted: August 14, 2019    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Protein Kinase Inhibitors
Enzyme Inhibitors
Carcinoma, Non-Small-Cell Lung
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Crizotinib
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action