Safety and Efficacy Study of TQ-B3101 in Patients With ROS1-positive Non-Small Cell Lung Cancer (NSCLC)

NCT03972189 | Unknown Phase 2

• 1 other identifier: TQ-B3101-II-01
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 22

Brief Summary

To assess efficacy and safety of oral TQ-B3101 administered to patients with Advanced Non-Small Cell Lung Cancer (NSCLC) that confirmed ROS1 positive gene mutation.

Conditions

ROS1-positive Non-Small Cell Lung Cancer (NSCLC)

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR)

  Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR).

  up to approximately 20 months

Secondary Outcomes (4)

• Duration of Response (DOR)

  up to approximately 20 months

• Disease control rate (DCR)

  up to approximately 20 months

• Progression-free survival (PFS)

  up to approximately 20 months

• Overall survival (OS)

  up to approximately 24 months

Study Arms (1)

TQ-B3101

EXPERIMENTAL

TQ-B3101 300 mg given orally in fasting conditions, twice daily in 28-day cycle.

Drug: TQ-B3101

Interventions

TQ-B3101 DRUG

TQ-B3101 300 mg given orally in fasting conditions, twice daily in 28-day cycle.

TQ-B3101

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and older. 2.Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1；Life expectancy ≥ 3 months.
• Understood and Signed an informed consent form. 4.Histologically or cytologically confirmed locally advanced or metastatic NSCLC .
• Subjects in the screening period should provide a written report of ROS1 positive, or tumor histological specimens obtained at the time of diagnosis/post before enrollment are sent to the central laboratory to confirm ROS1 positive.
• \. Had received no more than two chemotherapy regimens. 7.At least 1 measurable tumor lesion other than brain lesions within 28 days before first dose based on RECIST 1.1.
• The main organs function are normally, the following criteria are met:
• routine blood tests（no blood transfusion and blood products within 14 days）：hemoglobin（Hb）≥90g/L；absolute neutrophil count（ANC）≥1.5×109/L； platelets（PLT）≥100×109/L.
• Blood biochemical examination: alanine transaminase（ALT）and aspartate aminotransferase（AST）≤2.5×upper limit of normal (ULN)（when the liver is invaded, ALT, and AST ≤5× upper limit of normal (ULN) ）； total bilirubin (TBIL)≤1.5×upper limit of normal (ULN)；Serum creatinine ≤ 1.5 × upper limit of normal (ULN); or creatinine clearance calculated ≥ 50ml / min (calculated according to Cockcroft-Gault formula);
• left ventricular ejection fraction (LVEF) measured by the Cardiac echocardiography ≥ 50%.
• Women must meet one of the following conditions:has undergone surgical sterilization;have been menopausal at least 1 year;have fertility, the following conditions must be met;Serum pregnancy test results were negative; throughout the study period to 6 months after the last dose, agreed to adopt an approved method of contraception (for example: oral contraception, injection contraception or implanted, barrier-effect Contraceptive methods, spermicides and condoms, or intrauterine devices).Men must meet one of the following conditions:has surgical sterilization;an approved method of contraception must be used throughout the study period and 6 months after the last dose.

You may not qualify if:

• Has any known endothelial growth factor receptor (EGFR) positive mutation.
• Prior therapy with crizotinib, anti-programmed cell death (PD)-1, anti-PD-L1 or any other ROS1 inhibitor.
• Has multiple factors affecting oral medication, such as inability to swallow, post-gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.
• Has diagnosed and/or treated additional malignancy within 5 years prior to randomization with the exception of cured carcinoma in situ of the cervix、 non-melanoma skin cancers and superficial bladder tumors.
• Has a history of hypertensive crisis, hypertensive encephalopathy; or uncontrolled hypertension.
• Has clinically significant, uncontrolled cardio-cerebral vascular disease.
• Has major surgery and anti-tumor treatment before two weeks of treatment and participated in other drug clinical trials within four weeks.
• Has known central nervous system metastasis and/or spinal cord compression, cancerous meningitis, and pia mater disease.
• Has in screening period confirmed HCV positive, HIV positive, active syphilis positive, or HBsAg positive, HBV DNA titers \>500 copies/ml and stable time \<14 days after symptomatic treatment,or has a history of stem cells and organ transplantation.
• Has history of psychotropic substance abuse that unable to abstain from or mental disorder.
• According to the judgement of the researchers, there are other factors that may lead to the termination of the study.

Sponsors & Collaborators

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

Study Sites (22)

Anhui chest hospital

Hefei, Anhui, 230000, China

RECRUITING

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100000, China

NOT YET RECRUITING

Tumor hospital, Chinese academy of medical sciences

Beijing, Beijing Municipality, 100000, China

NOT YET RECRUITING

Beijing Cancer Hospital

Beijing, Beijing Municipality, 10000, China

RECRUITING

Fujian Tumor Hospital

Fuzhou, Fujian, 350000, China

NOT YET RECRUITING

Affiliated tumor hospital of sun yat-sen university

Guangzhou, Guangdong, 510000, China

RECRUITING

The first affiliated hospital of guangdong pharmaceutical university

Guangzhou, Guangdong, 510000, China

RECRUITING

The first affiliated hospital of guangzhou medical college

Guangzhou, Guangdong, 510000, China

RECRUITING

Affiliated tumor hospital of Harbin medical university

Harbin, Heilongjiang, 150000, China

RECRUITING

Henan Provincial People's Hospital

Zhengzhou, Henan, 450000, China

NOT YET RECRUITING

Henan Tumor Hospital

Zhengzhou, Henan, 450000, China

NOT YET RECRUITING

Hunan provincial tumor hospital

Changsha, Hunan, 410000, China

RECRUITING

Xiangya Hospital of Centre-south University

Changsha, Hunan, 410000, China

RECRUITING

Second hospital of jilin university

Changchun, Jilin, 130000, China

NOT YET RECRUITING

The second affiliated hospital of dalian medical university

Dalian, Liaoning, 116000, China

RECRUITING

Qilu Hospital of Shandong University

Jinan, Shandong, 250000, China

NOT YET RECRUITING

Linyi tumor hospital

Linyi, Shandong, 276000, China

NOT YET RECRUITING

Qingdao University Medical College Hospital

Qingdao, Shandong, 266000, China

NOT YET RECRUITING

Shanghai Jiaotong University Affiliated Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

The first affiliated hospital of xi 'an jiaotong university

Xi’an, Shanxi, 710000, China

RECRUITING

Tianjin tumor hospital

Tianjin, Tianjin Municipality, 300000, China

NOT YET RECRUITING

Sir Run Run Shaw Hospital School of Medical,Zhejiang University

Hangzhou, Zhejiang, 310016, China

RECRUITING

Related Publications (1)

• Lu S, Pan H, Wu L, Yao Y, He J, Wang Y, Wang X, Fang Y, Zhou Z, Wang X, Cai X, Yu Y, Ma Z, Min X, Yang Z, Cao L, Yang H, Shu Y, Zhuang W, Cang S, Fang J, Li K, Yu Z, Cui J, Zhang Y, Li M, Wen X, Zhang J, Li W, Shi J, Xu X, Zhong D, Wang T, Zhu J. Efficacy, safety and pharmacokinetics of Unecritinib (TQ-B3101) for patients with ROS1 positive advanced non-small cell lung cancer: a Phase I/II Trial. Signal Transduct Target Ther. 2023 Jun 30;8(1):249. doi: 10.1038/s41392-023-01454-z.

  PMID: 37385995 DERIVED

Central Study Contacts

Shun Lu, Doctor

CONTACT

021-22200000*3121; shun-lu@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2019
• First Posted: June 3, 2019
• Study Start: July 24, 2019
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: August 15, 2019

Record last verified: 2019-08

Locations

CN (22)