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Clinical Trials List

Protocol NumberBGB-A317-NSCL-001
NCT Number(ClinicalTrials.gov Identfier)NCT03745222

2019-09-01 - 2019-08-06

Phase III

Recruiting3

Terminated5

ICD-10 C34.10

Malignant neoplasm of upper lobe, unspecified bronchus or lung

Regarding tislelizumab (BGB-A317) combined with chemotherapy and radiotherapy followed by tislelizumab monotherapy for use in newly diagnosed, locally advanced, unresectable stage III non-small cell lung cancer subjects for a phase 3, random assignment, double blind, Placebo controlled trial.

  • Trial Applicant

    PPD DEVELOPMENT (HK) LIMITED

  • Sponsor

    PPD

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Gee-chen Chang Division of Thoracic Medicine
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 賴俊良 Division of Thoracic Medicine
Dalin Tzu Chi Hospital Buddhist Tzu Chi Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator CHIN-CHOU WANG Division of Thoracic Medicine
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Jen-Yu Hung Division of Thoracic Medicine
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 魏裕峰 Division of Thoracic Medicine
E-DA Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator James Chih-Hsin Yang Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 何景良 Division of Hematology & Oncology
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Chih-Hsi Kuo Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Condition/Disease

NSCLC

Objectives

main purpose The main purpose is to compare tislelizumab with concurrent chemoradiotherapy (cCRT) followed by tislelizumab monotherapy in subjects newly diagnosed with locally advanced, unresectable stage III non-small cell lung cancer (NSCLC) Group 1) Compared with the progression free survival (PFS) of cCRT alone (Group 3); in addition, cCRT will be followed by tislelizumab (Group 2) and cCRT alone (Group 3). Group) to compare.

Test Drug

Tislelizumab

Active Ingredient

Tislelizumab

Dosage Form

IV

Dosage

100 mg/vial

Endpoints

Overview of important efficacy evaluations
The tumor response and deterioration of all subjects will be evaluated. According to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, the trial host will be screened and randomly assigned every 6 weeks for the first 36 weeks (± 7 days) and every 9 weeks (± 7 days) from the 36th week to evaluate the treatment decision until it is recorded that the disease is worsening, the follow-up anti-cancer therapy is started, or the consent is withdrawn.
Response assessment will include computed tomography (CT) or magnetic resonance imaging (MRI).
The main indicator PFS is a response assessment based on a blind independent central review.
The follow-up period will follow the follow-up anti-cancer treatment after the last dose of investigational product (IP) every 3 months (± 14 days) until death, withdrawal of consent, or loss of contact during follow-up, whichever is the earliest Or until the end of the test.

Overview of important safety assessments
From the time the subject signs the informed consent form (ICF) to 30 days after the last dose of the trial treatment (tislelizumab/placebo, chemotherapy, or RT), all subjects will be monitored for adverse events. And the trial host will learn about SAEs that are suspected to be related to the trial treatment at any time thereafter. From the time the subject signs the ICF, to 90 days after the last dose of tislelizumab or placebo, the subject will also be monitored for immune-related adverse events (serious or non-serious), regardless of whether the subject has started receiving new anti-cancer therapy . All AEs and SAEs determined to be related to RT at any time after the first RT are collected, including delayed radiotoxicity. During the screening period, the physical condition will be fully assessed, including analysis of lung function, left ventricular ejection fraction (LVEF), C-reactive protein (C-reactive protein), and hepatitis B virus (HBV) ) And hepatitis C virus (HCV). Regular monitoring of physical examination (PE), vital signs, laboratory assessments (for example: serum chemistry, hematology, coagulation, thyroid function), electrocardiogram (12-lead electrocardiogram, ECG), eye examination, urinalysis, HBV And HCV (if the result is positive during the screening period) and ECOG performance status records. Contraceptive measures will be used to prevent the subject or her partner from becoming pregnant, and fertile women will undergo pregnancy tests during the screening period and the trial period.

Inclution Criteria

Inclusion conditions
Subjects must meet the following conditions before they can be included in the trial:
1. Subjects are ≥ 18 years old when they sign the Informed consent form (ICF). (Participants in this trial in Taiwan must be 20 years of age or older.)
2. Before conducting any trial-related evaluations/procedures, subjects must understand and voluntarily sign the subject consent form.
3. The subject has newly diagnosed, locally advanced, unresectable stage III non-small cell lung cancer confirmed by histology.
a. The stage will be confirmed by positron emission tomography (PET)/computed tomography (CT) and brain magnetic resonance imaging (MRI) or computed tomography using imaging agent during screening.
b. Fluorodeoxyglucose (FDG)-positron tomography/computerized tomography that is sufficient to exclude distant metastasis (for example, from the base of the skull to the knee) will be performed to rule out the distal disease and confirm the test It is the third phase. If the computer tomography part uses a developer and is of high enough quality, there is no need to perform additional computer tomography during screening.
c. Although we encourage the trial center to obtain tissue confirmation of lymph node metastasis for N2 or N3 disease, this procedure can be exempted for tumor committee/interdisciplinary team cases.
4. Before random assignment, subjects must have epidermal growth factor receptor (EGFR) mutations and anaplastic lymphoma kinase (ALK) gene translocation status (only tumor tissues are used) To test):
a. If the results of EGFR mutation and ALK gene translocation cannot be obtained, the subject will be tested for EGFR sensitive mutation or ALK translocation (only tumor tissues are used). The test results used to confirm the presence or absence of EGFR mutations and ALK gene translocations must be provided to the trial client for evaluation before random assignment.
b. Subjects with EGFR mutations or ALK gene translocations will account for about 10% of the total number of random assignments. After reaching this value, subjects with EGFR mutations or ALK gene translocations will be excluded.
5. Subjects must be able to provide fresh or sealed tumor tissue (formalin-fixed paraffin embedded [formalin-fixed paraffin embedded, FFPE] tissue block, or at least 15 to 20 freshly sectioned unstained FFPE slides), and attached The relevant pathology report (squamous or non-squamous). If the sealed tumor tissue cannot be obtained, a fresh section (at least 2 to 3 copies) of the tumor must be taken at the base stage. If only less than 15 unstained glass slides can be provided, the subjects can be included on a case-by-case basis after discussing with the medical monitor of the trial client.
6. Subject’s physical status of the Eastern Cooperative Oncology Group (ECOG) ≤ 1.
7. Subjects with appropriate blood and peripheral organ functions are defined as meeting the following experimental test results (obtained within 2 weeks before random assignment):
a. Absolute neutrophil count (ANC) ≥ 1.5 × 109/L
b. Platelet count ≥ 100 x 109/L
c. Heme ≥ 9 g/dL or ≥ 5.6 mmol/L (after giving growth factor support or blood transfusion ≥ 28 days)
d. Subjects receiving cisplatin/etoposide (creatinine clearance, CrCl) calculated value ≥ 60 mL/min (Cockcroft-Gault formula), receive Jiaplatin (carboplatin)/paclitaxel (paclitaxel) subjects are ≥ 45 mL/min (Cockcroft-Gault formula).
e. Serum total bilirubin ≤ 1.5 times the upper limit of normal (ULN) (if you have Gilbert's syndrome [Gilbert's syndrome], or the indirect bilirubin concentration shows extrahepatic increase Source, then≤ 3 times the upper limit of normal)
f. Aspartate aminotransferase (Aspartate aminotransferase, AST) and alanine aminotransferase (alanine aminotransferase, ALT)≤ 3 times the upper limit of normal
8. Female of childbearing potential (FCBP) is defined as follows: 1) have had first menstruation, 2) have not removed the uterus or bilateral ovaries, or 3) after natural menopause (no menstruation after cancer treatment The cycle cannot be ruled out as having fertility) If you have not been at least 24 consecutive months (that is, you have had menstruation at any time during the previous 24 consecutive months), you must:
a. Before starting the trial treatment, the trial host will confirm that the results of the 2 pregnancy tests are negative. You must agree to undergo a pregnancy test during the trial period and after the trial treatment ends. Even if the subject completely prohibits sexual intercourse between the opposite sex, he must meet this condition.
b. Agree to use 2 reliable contraceptive methods at the same time during the following periods related to this trial, or completely prohibit sexual intercourse between opposite sexes: 1) At least 28 days before the start of the trial treatment; 2) During the trial treatment; 3) During the interruption of the treatment , And 4) At least 120 days after the subject received the last dose of tislelizumab or placebo, and within 180 days after the subject received the last dose of chemotherapy. The 2 reliable contraceptive methods must include a highly effective contraceptive method and an additional effective contraceptive method (barrier method). The following are examples of highly effective and extra effective contraceptive methods:
• Examples of highly effective contraceptive methods:
-Intrauterine contraceptive device
-Compounds related to ovulation inhibition (including estrogen and progestogen) hormonal contraceptives (oral, intravaginal, or transdermal)
-Hormonal contraceptives containing only progesterone (oral, injectable, intrauterine, or implanted) related to the suppression of ovulation
-Fallopian tube ligation
-The male partner has undergone a vasectomy, provided that the partner of the vasectomy is the only sexual partner of the trial participant, and the partner of the vasectomy has been medically evaluated for the success of the operation.
• Examples of additional effective contraceptive methods:
-Male condom or female condom (with or without spermicide)
-Uterine cap
-Cervical cap, contraceptive membrane or sponge containing spermicide
-The main effect is a hormonal contraceptive containing only progesterone, non-ovulation suppression
9. Male subjects must:
a. During the trial period, during treatment interruption, at least 120 days after the subject received the last dose of tislelizumab or placebo and 180 days after the subject received the last dose of chemotherapy, or a longer period required by local regulations , Must be completely abstinent* (must be evaluated monthly), or agree to use a condom when having sex with a pregnant or fertile woman, even if a vasectomy has been successfully completed.
b. Agree not to donate sperm
10. The subject is willing and able to follow the trial return schedule and other plan requirements.

Exclusion Criteria

Exclude conditions
Subjects will not be included in the trial if they meet any of the following conditions:
1. The subject has received treatment targeting PD-1 or programmed cell death protein-ligand 1 (PD-L1).
2. The subject has received chemotherapy, radiotherapy, targeted therapy, biological therapy, immunotherapy or experimental drugs for the control of non-small cell lung cancer.
3. The subject has had a severe allergic reaction to other monoclonal antibodies.
4. The subject has a history of interstitial lung disease, or data shows that they currently suffer from interstitial lung disease, or a history of pneumonia requiring oral or intravenous steroids.
5. The subject’s radiotherapy plan may cause the total lung volume (V20) receiving ≥ 20 Gy to exceed 38% of the lung volume.
6. The subject has clinically significant pericardial effusion.
7. The subject has clinically uncontrolled pleural effusion or ascites, and requires thoracentesis or abdominal puncture drainage within 2 weeks before random assignment.
8. Subjects had undergone major surgical procedures, open sectioning, or had obvious trauma within 14 days before random assignment, or were expected to undergo major surgical procedures during the trial period. Note: Patients eligible for this trial must have locally advanced, stage III non-small cell lung cancer and be deemed unresectable. After the completion of chemoradiation therapy, a decline in the stage of the disease is observed, and any patient who considers surgery as a treatment option in accordance with the institution's diagnosis and treatment should be considered as ineligible.
a. The placement of vascular access devices is not considered a major operation.
9. Subjects had any active malignant tumors within 2 years before random assignment, but excluding non-small cell lung cancer and cured locally recurrent cancers (for example: resected basal or squamous cell skin cancer, epidermal cancer) Superficial bladder cancer, carcinoma in situ of the cervix or breast).
10. The subject has a severe chronic or active infection that requires systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection.
11. The subject is known to be infected with Human Immunodeficiency Virus (HIV).
12. The subject has untreated chronic hepatitis B, or is a carrier of chronic hepatitis B virus (HBV) and HBV deoxyribonucleic acid (DNA)> 500 IU/mL ( 2500 copies/mL), or have active hepatitis C.
a. Subjects are inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B (HBV DNA <500 IU/mL), and cured C type Patients with hepatitis can be included in the trial.
13. The subject has an active autoimmune disease, or a history of autoimmune disease that may recur. Subjects with the following diseases can be included after further screening: Type I diabetes, hypothyroidism controlled only by hormone replacement therapy, skin diseases that do not require systemic treatment (such as leukoplakia, psoriasis, or baldness), or A disease that is not expected to recur in the absence of external stimuli.
14. The subject had a condition requiring systemic treatment with corticosteroids (equivalent to cortisol [prednisone] daily> 10 mg or equivalent dose) or other immunosuppressive agents within 14 days before random assignment.
a. Allow short-term (≤ 7 days) corticosteroids to be given as preventive treatment (for example: imaging agent allergy) or to treat non-autoimmune conditions (for example: delayed allergic reactions caused by contact allergens) .
b. In the absence of active autoimmune diseases, adrenal replacement steroids at a dose equivalent to cortisol 10 mg per day or equivalent doses are allowed.
c. Local, ocular, intra-articular, intranasal and inhaled corticosteroids are allowed (with minimal systemic absorption).
15. The subject meets any of the following cardiovascular conditions:
a. There is evidence of acute or persistent cardiac ischemia
b. Currently suffering from symptomatic pulmonary embolism
c. Acute myocardial infarction occurred within 6 months before random assignment
d. Heart failure classified as grade III or IV by the New York Heart Association occurred within 6 months before random assignment.
e. A ≥ Grade 2 ventricular arrhythmia occurred within 6 months before random assignment
f. Cerebrovascular accident or temporary cerebral ischemia occurred within 6 months before random assignment
16. The subject has received allogeneic stem cell transplantation or organ transplantation.
17. The subjects have used any live vaccine against infectious diseases (such as chickenpox, shingles, etc.) within 4 weeks (28 days) after random assignment. However, seasonal influenza vaccines that do not contain live viruses are allowed.
18. The subject had used any herbal or patent medicine to control cancer or improve immunity within 14 days before receiving the first trial treatment.
19. Subjects have any major medical conditions, abnormal laboratory test results or mental illness that would prevent them from participating in the trial.
20. The subject has any condition, including abnormal laboratory test results, which puts him/her at an unacceptable risk if he/she participates in the test.
21. The subject has any condition that would confuse the ability to interpret the test data.
22. The subject has contraindications to the course of chemotherapy to be administered in the trial.

The Estimated Number of Participants

  • Taiwan

    30 participants

  • Global

    840 participants

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