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

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.

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.

Study Overview

• Status: Unknown
• Conditions: ALK-positive NSCLC
• Intervention / Treatment: Drug: TQ-B3139

• Study Type: Interventional
• Enrollment (Anticipated): 135
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510050
      • Recruiting
      • SUN-YAT-SEN University Cancer Center
      • Contact: Li Zhang, Doctor; Phone Number: 020-87343088; Email: zhangli@sysucc.org.cn
      • Principal Investigator: Li Zhang, Doctor
  • Hunan
    • Changsha, Hunan, China, 410013
      • Not yet recruiting
      • Hunan Cancer Hospital
      • Principal Investigator: Nong Yang, Doctor
      • Contact: Nong Yang, Doctor; Phone Number: +86-731-88651900; Email: yangnong0217@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Overall survival (OS)	Time from date of randomization to date of death due to any cause.	up to 36 months

Collaborators and Investigators

• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2019
• Primary Completion (Anticipated): October 30, 2021
• Study Completion (Anticipated): April 30, 2022

Study Registration Dates

• First Submitted: August 12, 2019
• First Submitted That Met QC Criteria: August 12, 2019
• First Posted (Actual): August 14, 2019

Study Record Updates

• Last Update Posted (Actual): October 30, 2019
• Last Update Submitted That Met QC Criteria: October 29, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: TQ-B3139-II-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No