Status:
UNKNOWN
Study of TQ-B3139 in Subjects With Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer (NSCLC) Previously Treated With Crizotinib
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions:
ALK-positive NSCLC
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 previous...
Eligibility Criteria
Inclusion
- 18 and 75 years.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
- Life expectancy ≥12 weeks.
- Histologically or cytologically confirmed diagnosis of advanced or metastatic NSCLC that is ALK-positive.
- Has progressive disease during or after crizotinib treatment.
- Has a measurable disease.
- Adequate organ system function.
- Understood and signed an informed consent form.
Exclusion
- Diagnosed and/or treated additional malignancy within 5 years prior to randomization.
- Hypersensitivity to TQ-B3139 capsule.
- Has received ALK TKIs other than crizotinib.
- Has received any cancer therapy within 4 weeks or 5 times of t1/2.
- Has received major surgery within 4 weeks.
- Has received any radiotherapy or minor surgery within 2 weeks.
- Acute toxicity ≥ Grade 2 caused by previous cancer therapy.
- Has active viral, bacterial and fungal infections within 2 weeks.
- Has serious cardiovascular diseases.
- Has currently uncontrollable congestive heart failure.
- Has continuous arrhythmia ≥ Grade 2, any degree of poor controlled atrial fibrillation or QTc interval \> 480ms.
- Has interstitial fibrosis or interstitial lung disease.
- Brain metastases with symptom or carcinomatous meningitis.
- Has active hepatitis B or hepatitis C.
- Has multiple factors affecting oral medication.
- Breastfeeding or pregnant women.
- According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
Key Trial Info
Start Date :
August 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2022
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT04056572
Start Date
August 13 2019
End Date
April 30 2022
Last Update
October 30 2019
Active Locations (2)
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1
Sun-Yat-Sen University Cancer Center
Guangzhou, Guangdong, China, 510050
2
Hunan Cancer Hospital
Changsha, Hunan, China, 410013