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Nonsmall-cell Lung CancerPhase 1/2NCT05284994

TQ-B3525 Tablets Combined With Osimertinib Mesylate Tablets in the Treatment of Advanced Non-Small Cell Lung Cancer

A Phase 1/2 study testing TQ-B3525 Tablets, Osimertinib Mesylate Tablets in people with Nonsmall-cell Lung Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 9 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

TQ-B3525 tablet is a new α/δ dual inhibitor phosphatidylinositol 3-kinase inhibitor developed by Chia Tai Tianqing pharmaceutical Group Co., Ltd. It can overcome the drug resistance problem caused by the up-regulation of phosphatidylinositol 3-kinase α subunit activity caused by the single inhibition of… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Nonsmall-cell Lung Cancer
What is being tested?
TQ-B3525 Tablets, Osimertinib Mesylate Tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
9 sitesChina
Study dates
11 Mar 2022to Jun 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1 Aged 18 to 75 years old, and gender is not limited.
  • 2 The eastern cooperative oncology group（ECOG）score is 0 to 1, and the expected survival time is greater than or equal to 12 weeks.
  • 3 Subjects with histologically or cytologically confirmed non-small cell lung cancer (NSCLC) and stage IIIB-IV (according to the 8th edition of the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer Classification).
  • 4 The enrollment requirements for the dose escalation phase are as follows:
  • Patients who have failed previous standard therapy, including disease progression or toxicity intolerance, or who are clinically unsuitable or unacceptable, or who refuse to receive standard therapy.
  • The test report can reflect the presence of epidermal growth factor receptor (EGFR) sensitive mutations when the subjects were enrolled in this trial.
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  • Requirements for meeting the epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) treatment failure criteria:
  • Subjects without T790M mutation after receiving first- or second-generation epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) treatment resistance in the past; or subjects who have previously received third-generation epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) treatment resistance.
  • According to the definition of response evaluation criteria in solid tumors Recist version 1.1 (Recist 1.1) criteria, disease progression occurs after continuous epidermal growth factor receptor- -tyrosine kinase inhibitor treatment for at least 1 month.
  • No other systemic therapy between discontinuation of epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) and initiation of new therapy.
  • 5 The enrollment requirements for Cohort 1 in the dose expansion phase are as follows:
  • failure of previous standard therapy, including disease progression or toxicity intolerance, or clinical inappropriateness/inability to accept/refusal to receive standard therapy.
  • There is a sensitive epidermal growth factor receptor（EGFR） mutation, and previous reports have confirmed that it is accompanied by a gene abnormality in the PI3K signaling pathway.
  • Requirements for meeting the epidermal growth factor receptor-tyrosine kinase inhibitor（EGFR-TKI）treatment failure criteria:
  • Subjects without T790M mutation after receiving first- or second-generation epidermal growth factor receptor-tyrosine kinase inhibitor（EGFR-TKI） treatment resistance in the past; or subjects who have previously received third-generation epidermal growth factor receptor-tyrosine kinase inhibitor（EGFR-TKI）treatment resistance.
  • According to the definition of response evaluation criteria in solid tumors Recist version 1.1(Recist 1.1)criteria, disease progression occurs after continuous epidermal growth factor receptor-tyrosine kinase inhibitor(EGFR-TKI) treatment for at least 1 month.
  • No other systemic therapy between discontinuation of epidermal growth factor receptor-tyrosine kinase inhibitor（EGFR-TKI）and initiation of new therapy.
  • 6 Enrollment requirements for Cohort 2 in the dose expansion phase are as follows:
  • failure of previous standard therapy, including disease progression or toxicity intolerance, or clinically inappropriate, or unacceptable, or refusal to receive standard therapy.
  • There is a sensitive epidermal growth factor receptor（EGFR） mutation, and previous reports have confirmed that there is no abnormality in the PI3K signaling pathway, and the report can reflect the gene status of the subjects when they are enrolled in this trial.
  • Meet the following definitions for epidermal growth factor receptor-tyrosine kinase inhibitor（EGFR-TKI）treatment failure:
  • Subjects without T790M mutation after receiving first- or second-generation epidermal growth factor receptor-tyrosine kinase inhibitor（EGFR-TKI） treatment resistance in the past; or subjects who have previously received third-generation epidermal growth factor receptor-tyrosine kinase inhibitor（EGFR-TKI）treatment resistance.
  • According to the definition of response evaluation criteria in solid tumors Recist version 1.1（Recist 1.1）criteria, disease progression occurs after continuous epidermal growth factor receptor-tyrosine kinase inhibitor（EGFR-TKI） treatment for at least 1 month.
  • No other systemic therapy between discontinuation of epidermal growth factor receptor-tyrosine kinase inhibitor（EGFR-TKI）and initiation of new therapy.
  • 7 The enrollment requirements for Cohort 3 in the dose expansion phase are as follows.
  • Have not received any systemic therapy for locally advanced or metastatic NSCLC before.
  • There are epidermal growth factor receptor（EGFR） sensitive mutations, and the test report can reflect the gene status of the subjects when they are enrolled in this trial.
  • 8 At the time of screening, according to response evaluation criteria in solid tumors Recist version 1.1（Recist 1.1）criteria, the patient has at least one measurable target lesion.
  • 9 Inspections during the screening period shall meet the following conditions:
  • The absolute value of neutrophils (ANC) is greater than or equal to 1.5×109/L.
  • Platelet count (PLT) greater than or equal to 75×109/L.
  • Hemoglobin is greater than or equal to 90g/L.
  • The total blood bilirubin is less than or equal to 1.5 times the upper limit of normal（ULN）. If it is a subject with Gilbert syndrome, the total blood bilirubin is less than or equal to 3×upper limit of normal（ULN）.
  • Serum creatinine (Cr) is less than or equal to 1.5×upper limit of normal（ULN）, or creatinine clearance rate is greater than or equal to 60ml/min.
  • alanine aminotransferase（ALT）and aspartate aminotransferase（AST）are less than or equal to 2.5 times upper limit of normal（ULN）. If there is liver metastasis, alanine aminotransferase（ALT）and aspartate aminotransferase（AST）can be relaxed to the corresponding 5 times upper limit of normal（ULN）.
  • Coagulation function tests must meet the following criteria: prothrombin time (PT), activated partial thromboplastin time (APTT), and international normalized ratio (INR) are all less than or equal to 1.5 times the upper limit of normal (ULN) coagulation therapy) .
  • Doppler ultrasound: left ventricular ejection fraction (LVEF) greater than or equal to 50%.
  • 10 The subjects voluntarily participated in this study and signed the informed consent.

Who cannot join

  • 1 There are contraindications to Osimertinib Mesylate Tablets administration.
  • 2 Other malignant tumors that have occurred or are currently at the same time within 3 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumor.
  • 3 The subject has received PI3K inhibitor treatment in the past.
  • 4 Subjects who have received other systemic anti-tumor drugs within 3 weeks before the first dose, or who are still within the in 5 half-life period of the drug.
  • 5 Received any major surgical treatment within 4 weeks before the first dosage.
  • 6 Received any previous radiotherapy for curative purposes within 2 weeks before the first drug.
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  • 7 Unrelieved toxic reactions higher than common terminology criteria for adverse events （CTC AE）grade 1 due to any previous treatment, excluding alopecia.
  • 8 The subjects had active serious viral, or bacterial, or fungal infections within 4 weeks before the first administration.
  • 9 One of the following conditions of grade II or above occurred within 6 months before the first medication: myocardial infarction, severe or unstable angina pectoris, coronary or peripheral artery bypass grafting, cerebrovascular accident, including transient cerebral ischemia attack, as well as deep vein thrombosis or pulmonary embolism.
  • 10 Current uncontrolled congestive heart failure.
  • 11 Currently there is persistent arrhythmia greater than or equal to grade II, any degree of uncontrolled atrial fibrillation or QTc interval greater than 480 ms.
  • 12 Subjects with unsatisfactory blood pressure control, that is, subjects with systolic blood pressure greater than or equal to 150 mmHg and diastolic blood pressure greater than or equal to 100 mmHg.
  • 13 Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage.
  • 14 Type I and type II diabetes, in addition to only taking exercise and diet control, or only needing a single oral hypoglycemic drug to stably control blood sugar, and fasting blood sugar less than 7.0 mmol/L and glycosylated hemoglobin (HbA1c) less than 7.0 during the screening period % of subjects with type II diabetes.
  • 15 Presence of interstitial lung disease, severely impaired lung function, severe pulmonary fibrosis, radiation pneumonitis, history of drug-induced lung disease, and evidence of active pulmonary inflammation on chest computed tomography (CT) findings during screening.
  • 16 Subjects with a history of immunodeficiency, including but not limited to HIV-positive or other acquired, congenital immunodeficiency diseases, or subjects with active autoimmune diseases or a history of autoimmune diseases.
  • 17 There is currently a severe and unstable central nervous system metastasis. Note: Patients with no or mildly symptomatic central nervous system（CNS）metastases can be included. Whole brain radiation or gamma knife therapy received due to central nervous system（CNS）metastases must be completed 14 days before the first dose and clinically stable.
  • 18 When virological testing during the screening period shows any of the following:
  • hepatitis B surface antigen（HBsAg）positive and hepatitis B virus Deoxyribonucleic acid（HBV-DNA）exceeding the upper limit of normal or hepatitis B virus Deoxyribonucleic acid（HBV-DNA）exceeding 1000copies/ml.
  • Anti- hepatitis C virus（HCV）positive and hepatitis C virus（HCV）ribonucleic acid（RNA）positive or beyond the upper limit of normal.
  • 19 People with multiple factors that affect oral administration and drug absorption, such as inability to swallow, post gastrointestinal resection, ulcerative colitis, symptomatic or inflammatory bowel disease, chronic diarrhea and intestinal obstruction and other gastrointestinal diseases.
  • 20 Women of childbearing age have a positive pregnancy test before administration of the study drug, or who cannot guarantee to take effective contraceptive measures during the study period, and men cannot guarantee to take effective contraceptive measures during the study period.
  • 21 Any other circumstances that are judged by the investigator to be incapable of being included in the study.

Trial locations and contacts

9 sites in 1 country.

Li Zhang, Doctor contact

13902282893

zhangli6@mail.sysu.edu.cn

Wenfeng Fang, Doctor contact

15322302066

fangwf@sysucc.org.cn

9 sites in 1 country

China9 sites, 9 recruiting

  • Sun-Yat-Sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Li Zhang, Doctor, 13902282893, zhangli6@mail.sysu.edu.cn

    Recruiting

  • Sun Yat-Sen Memorial Hospital

    Guangzhou, Guangdong, 510120

    Minghui Wang, Doctor, 13826276868, wmingh@mail.sysu.edu.cn

    Recruiting

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510120

    Chengzhi Zhou, Doctor, 13560351186, doctorzcz@163.com

    Recruiting

  • Southern Hospital of Southern Medical University

    Guangzhou, Guangdong, 510515

    Laiyu Liu, Doctor, 13632102245, liulaiyu@126.com

    Recruiting

  • The First Affiliated Hospital of Guangdong Pharmaceutical University

    Guangzhou, Guangdong, 510699

    Xicheng Wang, Doctor, 13902400598, 139024005982@126.com

    Recruiting

  • The Second People's Hospital of Guangdong Province

    Guanzhou, Guangdong, 510310

    Ruilin Sun, Doctor, 13825167802, sunruilin213@126.com

    Recruiting

  • Jiangmen Central Hospital

    Jiangmen, Guangdong, 529099

    Daren Lin, Doctor, 13802607246, ldrdy@sina.com

    Min Ye, Doctor, 13902889916, yeminzhangcuiyan@126.com

    Recruiting

  • Meizhou People's Hospital

    Meizhou, Guangdong, 514001

    Guowu Wu, Doctor, 13823801920, wwwflay@126.com

    Recruiting

  • Affiliated Hospital Of Guangdong Medical University

    Zhanjiang, Guangdong, 510180

    Shujun Li, doctor, 13726913133, lishujun072@163.com

    Recruiting

Other trials in China

About this study

Official title: A Single-arm, Open-label, Multi-cohort, Multi-center Clinical Study on the Safety and Efficacy of TQ-B3525 Tablets Combined With Osimertinib in Subjects With Advanced Non-small Cell Lung Cancer

TQ-B3525 tablet is a new α/δ dual inhibitor phosphatidylinositol 3-kinase inhibitor developed by Chia Tai Tianqing pharmaceutical Group Co., Ltd. It can overcome the drug resistance problem caused by the up-regulation of phosphatidylinositol 3-kinase α subunit activity caused by the single inhibition of phosphatidylinositol 3-kinase δ subunit. This study is a single-arm, open-label, multi-cohort, multi-center clinical study of the safety and efficacy of TQ-B3525 tablets combined with osimertinib in subjects with advanced non-small cell lung cancer, aiming to evaluate TQ-B3525 tablets combined with osimertinib, the safety, tolerability, and efficacy of the treatment of patients with advanced non-small cell lung cancer who have failed epidermal growth factor receptor inhibitor therapy, while exploring the efficacy, resistance mechanism, and safety in the dose escalation phase biomarkers.

Being tested
TQ-B3525 Tablets, Osimertinib Mesylate Tablets
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TQ-B3525 Tablets, Osimertinib Mesylate TabletsDrug

    TQ-B3525 is a novel α/δ dual inhibitor PI3K kinase inhibitor. Osimertinib mesylate is a third-generation epidermal growth factor receptor inhibitor.

Study groups in NCT05284994
Study groupRoleWhat they receive
TQ-B3525 Tablets + Osimertinib Mesylate Tablets.OtherTQ-B3525 tablets combined with osimertinib mesylate tablets, 30 days as a treatment cycle.
Receives: Drug: TQ-B3525 Tablets, Osimertinib Mesylate Tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose limiting toxicity (DLT)

    Some major toxic and side effects of drugs are the main reasons for restricting the continued increase in the dose of chemotherapeutic drugs. These toxic and side effects are the dose-limiting toxicity of chemotherapeutic drugs.

    Measured: Baseline time to increase chemotherapy drug dose to toxicity intolerance, up to 5 weeks.

  2. Objective response rate (ORR)

    Objective response rate refers to the proportion of patients whose tumor shrinkage reaches a certain amount and maintains it for a certain period of time, including complete response (CR)+ partial response (PR) cases.

    Measured: From date of first medication until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.

Secondary outcomes (4)

  1. Progression-Free-Survival (PFS)

    Progression-free survival refers to the time span from the start of tumor treatment to the occurrence of secondary growth of the tumor. It means that the tumor basically does not progress at this stage.

    Measured: From date of first medication until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.

  2. Disease Control Rate (DCR)

    Disease control rate refers to the percentage of cases with remission and stable disease after treatment in the total number of evaluable cases.

    Measured: From date of first medication until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.

  3. Overall Survival (OS)

    Overall survival is the time from first medication to death from any cause.

    Measured: From date of first medication until the date of death from any cause，an average of 5 years.

  4. Duration of disease remission

    Duration of disease response refers to the time from the first tumor assessment as complete response (CR) or partial response (PR) to the first assessment as PD or death from any cause.

    Measured: Tumors were first assessed as complete response (CR) or partial response (PR) from the date of disease progression or death, whichever occurred first. Through study completion, an average of 1 year.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2022
  2. Study start11 Mar 2022
  3. Primary completionApr 2024 (estimated)
  4. Study completionJun 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05284994
Sponsor's protocol ID
TQ-B3525-Ib/II -01
Status last verified
Mar 2022
First submitted
3 Mar 2022
Last updated
17 Mar 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing TQ-B3525 Tablets, Osimertinib Mesylate Tablets in people with Nonsmall-cell Lung Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 9 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 38 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Li Zhang, Doctor (13902282893, zhangli6@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose limiting toxicity (DLT) (time frame: Baseline time to increase chemotherapy drug dose to toxicity intolerance, up to 5 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05284994.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2022; AzTrials last refreshed its copy on 7 Nov 2026.

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