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

ALK-positive NSCLC Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04056572
• Other study ID #: TQ-B3139-II-01
• Status: Recruiting
• Phase: Phase 2
• Start date: August 13, 2019
• Est. completion date: April 30, 2022

Study information

• Verified date: May 2019
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: Li Zhang, Doctor
• Phone: 020-87343088
• Email: zhangli[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 135
• Est. completion date: April 30, 2022
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• ALK-positive NSCLC
• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• TQ-B3139
TQ-B3139 is competitive multi-target protein kinase inhibitor of Met/ALK/ROS.

Locations

Country	Name	City	State
China	Hunan Cancer Hospital	Changsha	Hunan
China	Sun-Yat-Sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR)	The percentage of participants with a best overall response defined as complete response (CR) or partial response (PR).	up to 36 months
Secondary	Progression-free survival (PFS)	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.	up to 36 months
Secondary	Disease control rate (DCR)	Calculated as the percentage of participants with best overall response of CR, PR, stable disease (SD) and Non-CR/Non-progressive disease (PD).	up to 36 months
Secondary	Overall survival (OS)	Time from date of randomization to date of death due to any cause.	up to 36 months