Clinical Trials List
Protocol NumberD933IC00001
NCT Number(ClinicalTrials.gov Identfier)NCT03819465
2018-12-01 - 2024-06-21
Phase I
Recruiting8
ICD-10C34
Malignant neoplasm of bronchus and lung
ICD-9162.8
Malignant neoplasm of other parts of bronchus or lung
A Phase IB, Open-Label, Multi-Center Study to Determine the Efficacy and Safety of Durvalumab in Combination With Novel Oncology Therapies, With or Without Chemotherapy, for First-Line Stage IV Non Small Cell Lung Cancer (NSCLC) (MAGELLAN)
-
Trial Applicant
-
Sponsor
AZ
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/20
Investigators and Locations
Principal Investigator
Co-Principal Investigator
- JENG-SEN TSENG Division of Thoracic Medicine
- TSUNG -YING YANG Division of Thoracic Medicine
- KUO-HSUAN HSU Division of Thoracic Medicine
- Gee-chen Chang Division of Thoracic Medicine
- YEN-HSIANG HUANG Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Co-Principal Investigator
- Yu-Min Yeh Division of General Internal Medicine
- Jui-Hung Tsai Division of General Internal Medicine
- Wu-Chou Su Division of General Internal Medicine
- Wei-Pang Chung Division of General Internal Medicine
- Wen-Pin Su Division of General Internal Medicine
- Chien-Chung Lin Division of General Internal Medicine
- Shang-Yin Wu Division of General Internal Medicine
- Po-Lan Su Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Audit
None
Co-Principal Investigator
- Chi-Lu Chiang Division of Hematology & Oncology
- Hsu-ching Huang Division of Thoracic Medicine
- Chao-Hua Chiu Division of Hematology & Oncology
- Heng-Sheng Chao Division of Hematology & Oncology
- 楊朝能 Division of Hematology & Oncology
- 蕭慈慧 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
1 Recruiting
Audit
None
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- YEN-HAN TSENG Division of Thoracic Medicine
- Tzu-Tao Chen Division of Thoracic Medicine
- Ching-Shan Luo Division of Thoracic Medicine
- Po-Hao Feng Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
10 Recruiting
Audit
CRO
Linkou Chang Gung Medical Foundation
Taiwan National PI
楊政達
Co-Principal Investigator
- Wen-Cheng Chang Division of Hematology & Oncology
- 柯皓文 Division of Hematology & Oncology
- 黃振洋 Division of Hematology & Oncology
- Chih-Hsi Kuo Division of Hematology & Oncology
- 枋岳甫 Division of Hematology & Oncology
- Chien-Ying Liu Division of Hematology & Oncology
- Chih-Liang Wang Division of Hematology & Oncology
- Shih-Hong Li Division of Hematology & Oncology
- Chih-Hung Chen Division of Hematology & Oncology
- Ping-Chih Hsu Division of Hematology & Oncology
- Chih-Hung Chen Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
4 Recruiting
Audit
None
Co-Principal Investigator
Audit
CRO
Co-Principal Investigator
- Chia-Chi Lin Division of Hematology & Oncology
- 徐偉勛 Division of Hematology & Oncology
- CHAO-CHI HO CHAO-CHI HO Division of General Internal Medicine
- 楊景堯 Division of General Internal Medicine
- Jih-Hsiang Lee Division of Hematology & Oncology
- JIN-YUAN SHIH Division of General Internal Medicine
- 許嘉林 Division of General Internal Medicine
- 吳尚俊 Division of General Internal Medicine
- 廖斌志 Division of Hematology & Oncology
- 陳冠宇 Division of General Internal Medicine
- 蔡子修 Division of General Internal Medicine
- 林育麟 Division of Hematology & Oncology
- Chong-Jen Yu Division of General Internal Medicine
- 廖唯昱 Division of General Internal Medicine
- YEN-TING LIN Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Audit
None
Co-Principal Investigator
- Jui-Ying Lee Division of Thoracic Medicine
- Inn-Wen Chong Division of Thoracic Medicine
- 郭家佑 Division of Thoracic Medicine
- 李玫萱 Division of Thoracic Medicine
- Ying-Ming Tsai Tsai Division of Thoracic Medicine
- Chih-Jen Yang Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
NSCLC
Objectives
A Phase 1B, open-label, multi-center trial to evaluate the efficacy and safety of Durvalumab combined with new tumor therapies (with or without chemotherapy) as the first-line treatment for stage 4 non-small cell lung cancer (NSCLC)
Test Drug
Durvalumab
Active Ingredient
Danvatirsen (STAT3 antisense oligonucleotide)
Durvalumab (Humanized anti-PD-1 mAb)
Durvalumab (Humanized anti-PD-1 mAb)
Dosage Form
IV
Dosage
50
50
50
50
50
Endpoints
main indicators
To evaluate the safety and tolerability of the following treatment combinations: durvalumab monotherapy, durvalumab combined with new tumor therapies, durvalumab combined with chemotherapy, durvalumab combined with new tumor therapies and chemotherapy.
To evaluate the safety and tolerability of the following treatment combinations: durvalumab monotherapy, durvalumab combined with new tumor therapies, durvalumab combined with chemotherapy, durvalumab combined with new tumor therapies and chemotherapy.
Inclution Criteria
The informed consent procedure can sign the subject’s consent form and comply with the requirements and restrictions listed in this trial plan and the subject’s consent form (ICF).
2 Provide a signed and dated written consent form for the subject before conducting any necessary test specific procedures, sample collection and analysis.
3 Before collecting genetic specimens for analysis (this is a voluntary assessment project), sign and date this subject consent form, indicating consent to specimen collection and genetic analysis.
Please refer to Appendix A 3 of the plan for the informed consent procedure.
age
4 At the time of screening, the age must be≥18 years old (the legal adult in Taiwan is 20 years old or above).
Subject type and disease characteristics
5 Histological or cytological examination confirmed the diagnosis of stage 4 non-small cell lung cancer, and is not suitable for curative surgery or radiotherapy (according to the International Association for the Study of Lung Cancer [IASLC] Thoracic Tumor Staging Manual [IASLC Thoracic Tumor Staging Manual, 8th Edition] )
6 The patient's tumor cells did not have activated EGFR mutations (such as exon 19 deletion, or exon 21 L858R, exon 21 L861Q, exon 18 G719X, exon 20 S768I mutations), and no ALK fusion gene. Patients with non-small cell lung cancer who are not sure whether they have ALK and/or EGFR mutations must provide tumor specimens (can be stock (<3 years) tumor specimens or newly collected primary or metastatic tumor specimens ) Perform detection of EGFR mutations and ALK fusion genes. If the patient has had a histological pattern of squamous cell carcinoma, or the tumor is known to have a mutation in the KRAS oncogene, it is not necessary to test for EGFR and ALK genes.
7 When recruiting and assigning treatment groups, the patient's fitness status must be 0 or 1 according to the World Health Organization (WHO)/ECOG.
8 The patient has not received chemotherapy or other systemic treatments for stage IV non-small cell lung cancer. If the patient previously received platinum-containing adjuvant, lead, or definitive chemoradiation therapy for the treatment of non-fourth stage non-small cell lung cancer, and the disease worsened more than 12 months after the last treatment, it is eligible for inclusion Eligibility (see exclusion condition 17).
9 Have not previously received immune vector therapy, including but not limited to other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-(PD-L2) antibodies, except for anti-cancer vaccine therapy.
10 In the baseline period, there is at least one lesion that meets the definition of RECIST version 1.1 and has not received radiotherapy and must be assessed by computed tomography or MRI within 28 days before being assigned to the treatment group.
11 The verified Ventana SP263 PD-L1 immunohistochemical staining method (IHC assay) was used to confirm the expression of tumor cells PD-L1 through the central reference laboratory. All patients must provide tumor specimens collected within 3 years before being included in the trial. Newly collected tumor tissue sections are better; but if clinical implementation is not easy, they can be used for inventory specimens collected within 3 years. screening. If there are both stock specimens and newly collected tumor tissue sections, both types of specimens must be analyzed. The newly collected tissue section should not be the same as the target lesion defined in RECIST version 1.1, unless there is no other lesion suitable for tissue section; in this case, only coarse needle section collection (non-resectable/incisional specimen) is allowed. For patients with only a single target lesion, the collection of tissue slices for baseline tumor assessment should be separated from subsequent imaging screening by 2 weeks. Specimens with limited tumor content and fine-needle aspiration specimens are not accepted. Specimens with metastatic bone lesions are generally not accepted unless the specimen contains a large amount of soft tissue. Tumor specimens submitted to confirm the eligibility of the test must have sufficient volume for immunohistochemical staining (IHC) to detect PD-L1 expression and other exploratory biomarker analysis, and be stored in paraffin embedding (FFPE) The sample is better (see section 8.8.1 and other relevant details of the laboratory operation manual).
-Note: PD-L1 positive is defined as ≥50% of tumor cells in the specimen have PD-L1 staining signal (any staining intensity) in the cell membrane. PD-L1 negative is defined as the cell membrane of <50% tumor cells in the specimen with PD-L1 staining signal.
12 With good organs and bone marrow, the function is defined as follows, but blood transfusion is not allowed to increase the following values of patients in order to qualify for inclusion:
-Heme ≥9 g/dL
-Absolute neutrophil count &≥1.5 x 109/L
-Platelet count≥100 x 109/L
-Serum bilirubin≤1.5 times the upper limit of normal (ULN), and patients with Gilbert’s syndrome must be excluded. If you have consulted a physician and AstraZeneca, you can join the trial.
-Alanine transamidation enzyme(ALT) and aspartic acid transamidation enzyme(AST)≤ 2.5 times the upper limit of normal (ULN); patients with lung cancer liver metastasis, alanine transamidation enzyme(AST)≤ enzyme (ALT) and aspartic acid transamidation (AST) is ≤5 times the upper limit of normal (ULN)
-Creatinine clearance rate calculated by Cockroft-Gault formula (using actual body weight) or by collecting and testing 24-hour urine is ≥60 mL/min.
male:
Creatinine clearance (mL/min) = weight (kg)*(140-age)/72*serum creatinine (mg/dL)
female:
Creatinine clearance (mL/min) = weight (kg)*(140-age)*0.85/72*serum creatinine (mg/dL)
-Albumin≥3 g/dL
13 Life expectancy at least 12 weeks
body weight
14 Weight >35 kg
gender
15 male or female
2 Provide a signed and dated written consent form for the subject before conducting any necessary test specific procedures, sample collection and analysis.
3 Before collecting genetic specimens for analysis (this is a voluntary assessment project), sign and date this subject consent form, indicating consent to specimen collection and genetic analysis.
Please refer to Appendix A 3 of the plan for the informed consent procedure.
age
4 At the time of screening, the age must be≥18 years old (the legal adult in Taiwan is 20 years old or above).
Subject type and disease characteristics
5 Histological or cytological examination confirmed the diagnosis of stage 4 non-small cell lung cancer, and is not suitable for curative surgery or radiotherapy (according to the International Association for the Study of Lung Cancer [IASLC] Thoracic Tumor Staging Manual [IASLC Thoracic Tumor Staging Manual, 8th Edition] )
6 The patient's tumor cells did not have activated EGFR mutations (such as exon 19 deletion, or exon 21 L858R, exon 21 L861Q, exon 18 G719X, exon 20 S768I mutations), and no ALK fusion gene. Patients with non-small cell lung cancer who are not sure whether they have ALK and/or EGFR mutations must provide tumor specimens (can be stock (<3 years) tumor specimens or newly collected primary or metastatic tumor specimens ) Perform detection of EGFR mutations and ALK fusion genes. If the patient has had a histological pattern of squamous cell carcinoma, or the tumor is known to have a mutation in the KRAS oncogene, it is not necessary to test for EGFR and ALK genes.
7 When recruiting and assigning treatment groups, the patient's fitness status must be 0 or 1 according to the World Health Organization (WHO)/ECOG.
8 The patient has not received chemotherapy or other systemic treatments for stage IV non-small cell lung cancer. If the patient previously received platinum-containing adjuvant, lead, or definitive chemoradiation therapy for the treatment of non-fourth stage non-small cell lung cancer, and the disease worsened more than 12 months after the last treatment, it is eligible for inclusion Eligibility (see exclusion condition 17).
9 Have not previously received immune vector therapy, including but not limited to other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-(PD-L2) antibodies, except for anti-cancer vaccine therapy.
10 In the baseline period, there is at least one lesion that meets the definition of RECIST version 1.1 and has not received radiotherapy and must be assessed by computed tomography or MRI within 28 days before being assigned to the treatment group.
11 The verified Ventana SP263 PD-L1 immunohistochemical staining method (IHC assay) was used to confirm the expression of tumor cells PD-L1 through the central reference laboratory. All patients must provide tumor specimens collected within 3 years before being included in the trial. Newly collected tumor tissue sections are better; but if clinical implementation is not easy, they can be used for inventory specimens collected within 3 years. screening. If there are both stock specimens and newly collected tumor tissue sections, both types of specimens must be analyzed. The newly collected tissue section should not be the same as the target lesion defined in RECIST version 1.1, unless there is no other lesion suitable for tissue section; in this case, only coarse needle section collection (non-resectable/incisional specimen) is allowed. For patients with only a single target lesion, the collection of tissue slices for baseline tumor assessment should be separated from subsequent imaging screening by 2 weeks. Specimens with limited tumor content and fine-needle aspiration specimens are not accepted. Specimens with metastatic bone lesions are generally not accepted unless the specimen contains a large amount of soft tissue. Tumor specimens submitted to confirm the eligibility of the test must have sufficient volume for immunohistochemical staining (IHC) to detect PD-L1 expression and other exploratory biomarker analysis, and be stored in paraffin embedding (FFPE) The sample is better (see section 8.8.1 and other relevant details of the laboratory operation manual).
-Note: PD-L1 positive is defined as ≥50% of tumor cells in the specimen have PD-L1 staining signal (any staining intensity) in the cell membrane. PD-L1 negative is defined as the cell membrane of <50% tumor cells in the specimen with PD-L1 staining signal.
12 With good organs and bone marrow, the function is defined as follows, but blood transfusion is not allowed to increase the following values of patients in order to qualify for inclusion:
-Heme ≥9 g/dL
-Absolute neutrophil count &≥1.5 x 109/L
-Platelet count≥100 x 109/L
-Serum bilirubin≤1.5 times the upper limit of normal (ULN), and patients with Gilbert’s syndrome must be excluded. If you have consulted a physician and AstraZeneca, you can join the trial.
-Alanine transamidation enzyme(ALT) and aspartic acid transamidation enzyme(AST)≤ 2.5 times the upper limit of normal (ULN); patients with lung cancer liver metastasis, alanine transamidation enzyme(AST)≤ enzyme (ALT) and aspartic acid transamidation (AST) is ≤5 times the upper limit of normal (ULN)
-Creatinine clearance rate calculated by Cockroft-Gault formula (using actual body weight) or by collecting and testing 24-hour urine is ≥60 mL/min.
male:
Creatinine clearance (mL/min) = weight (kg)*(140-age)/72*serum creatinine (mg/dL)
female:
Creatinine clearance (mL/min) = weight (kg)*(140-age)*0.85/72*serum creatinine (mg/dL)
-Albumin≥3 g/dL
13 Life expectancy at least 12 weeks
body weight
14 Weight >35 kg
gender
15 male or female
Exclusion Criteria
1 Have received allogeneic organ transplantation
2 Suffer from active or previously diagnosed autoimmune or inflammatory diseases (including inflammatory bowel disease [such as colitis or Crohn’s disease], diverticulitis [except diverticulosis], systemic lupus erythematosus, sarcomatoid syndrome , Wegener syndrome [granulomatosis with multiple vasculitis, Graves' disease, rheumatoid arthritis, pituitary gland, uveitis, etc.]. However, the following conditions are excluded:
-Patients with leukoplakia or baldness
-Patients with hypothyroidism who have received stable hormone replacement therapy (such as Hashimoto's syndrome follow-up)
-Any chronic skin disease that does not require systemic therapy
-Patients with no active disease in the last 5 years can be included after consulting the trial physician
-Patients with celiac disease controlled by diet only
3 Suffer from uncontrolled concurrent diseases, including but not limited to persistent or active infections, symptoms of congestive heart failure, uncontrolled hypertension, unstable angina, uncontrolled arrhythmia, active interstitial Intrinsic lung disease (ILD), severe chronic gastrointestinal disease accompanied by diarrhea, or mental illness/social condition that may prevent patients from complying with trial requirements, greatly increase the risk of adverse events, or hinder the patient’s ability to sign the subject’s consent.
4 Patients with a history of myocardial infarction, stroke or transient cerebral ischemia in the last 6 months
5 Patients with a history of venous thromboembolism in the last 3 months
6 There is a history of other primary malignant tumors, except for the following:
-Malignant tumors that have received radical treatment, lasted ≥5 years before the first trial drug, and have no active disease and have a low risk of recurrence
-Non-melanoma skin cancers or malignant moles that have been properly treated and have no evidence of disease
-Carcinoma in situ that has been properly treated and has no signs of disease
7 have a history of papilloma
8 There is a history of active primary immune insufficiency
9 Active infections include pulmonary tuberculosis (after clinical evaluation, including clinical history, physical examination, and radiographic results of pulmonary tuberculosis test performed in accordance with local regulations), hepatitis B (hepatitis B virus; known test results are HBV surface Antigen (HBsAg) positive), hepatitis C (HCV) or human immunodeficiency virus (HIV type 1/2 antibody is positive). If the patient has been infected with HBV virus or has remission after infection (defined as having hepatitis B core antibody [anti-HBc] but no HBsAg), it can be included. If the patient is positive for hepatitis C virus (HCV) but negative for HCV RNA by polymerisation enzyme chain reaction, it can be included.
10 It was discovered through brain imaging during the screening period (for imaging mode, see Appendix F of the plan [RECIST Version 1.1]), or it was discovered that the patient had untreated central nervous system cancer metastasis before signing the subject's consent. Patients who have received brain metastasis therapy can participate in the trial, but the results of radiology imaging must be stable (2 brain images after receiving brain metastasis therapy, the two contrast scans should be separated by 4 weeks, and there is no sign of intracranial deterioration). In addition, at least 14 days before the start of treatment, whether it is brain metastasis or the neurological symptoms caused by the treatment must be relieved or stabilized, no steroids and antiepileptic drugs, or stable use of steroids (prednisone ≤10 mg/day or equivalent dose ). Brain metastases will not be recorded as the fiducial target lesions defined in RECIST version 1.1.
11 Patients who are known to be allergic or highly sensitive to the test drug or its excipients.
12 The average QT interval (QTcF) ≥470 ms after 3 ECG detections (within 15 minutes, each interval of 5 minutes) and Fridericia formula for heart rate correction.
13 There are clinically significant abnormalities in the heart rhythm, conduction or pattern of the static ECG (such as complete left bundle branch block, third-degree heart block, etc.).
14 Any factor that increases the risk of QTc prolongation or the risk of arrhythmia events, such as heart failure, hypokalemia, potential torsade de pointes ventricular tachycardia, congenital prolonged QT syndrome, family history with prolonged QT syndrome Or sudden death of unknown cause before the age of 40, or combined use of drugs known to prolong the QT interval.
Previous/concomitant drugs
15 Have received chemotherapy or other systemic treatments for the treatment of stage 4 non-small cell lung cancer
16 Currently receiving any chemotherapy, experimental drugs, biologics or hormone therapy for the treatment of cancer, but if the hormone therapy used is for the treatment of non-cancer related diseases (such as hormone replacement therapy), it can be accepted.
17 Radiation therapy, unless (1) decisive radiation therapy is at least 12 months away from the progression of non-small cell lung cancer to the fourth stage (see inclusion criteria 8); (2) brain palliative radiation therapy, at least 4 months away from the first dose of trial drug Weeks ago, and related conditions were stable or asymptomatic (see exclusion criteria 10); (3) Painful bone lesion relief radiotherapy (must be less than 30% bone marrow radiotherapy), and at least 4 weeks away from the first dose of the test drug.
18 Vaccine live attenuated vaccine within 30 days before the first dose of test drug. Note: After the patient is included in the trial, no live vaccine is allowed during the trial treatment period to 30 days after the last dose of the trial treatment drug.
19 Major surgery (as defined by the trial host) was performed within 28 days before receiving the first dose of the test drug, or the patient has not fully recovered from the previous surgery, but the patient is allowed to perform local surgery (such as placing the drug) within 24 hours before the first dose of the test drug. Systemic injection seat, thick needle section and prostate tissue section).
20 Have used or are currently using immunosuppressive drugs in the 28 days before the first dose of durvalumab. Except in the following cases:
-Intranasal, inhaled, topical steroids or local injections of steroids (e.g. intra-articular injection)
-The physiological dose of systemic corticosteroids does not exceed the daily dose of prednisone 10 mg (or equivalent dose)
-Allergic reaction pretreatment steroid medication (e.g. CT scan pretreatment medication)
Previous/concurrent clinical trial experience
21 Participated in clinical trials of other experimental treatment drugs in the last 12 months
22 = Have accepted the trial drug distribution of this trial
23 Participate in other clinical trials at the same time, unless the trial is an observational (non-interventional) clinical study or the follow-up period of an interventional trial.
24 Previously received random assignment or received durvalumab clinical trial treatment, regardless of whether it was assigned to the treatment group
Diagnostic evaluation
25 Histological types of mixed small cell lung cancer and non-small cell lung cancer, sarcoma variants
Other exclusions
26 Pregnant or breast-feeding female patients, or fertile but from screening to durvalumab + new tumor therapy ± within 180 days after the last dose of chemotherapy treatment, or within 90 days after the last dose of durvalumab monotherapy (the latest Standard), male or female patients who are unwilling to use effective contraceptive methods.
27 If the trial leader determines that the patient is unable to comply with the trial procedures, restrictions and requirements, the patient should not participate in the trial.
28 Patients with low expression of PD-L1 tumor cells should not be used for platinum-containing dual chemotherapy
29 Genetic research test (optional):
30 The exclusion conditions for the selectivity (DNA) gene research part of this test include:
-Allogeneic bone marrow transplantation has been done before.
-Have received whole blood transfusion without removing white blood cells within 120 days before the collection of genetic samples
2 Suffer from active or previously diagnosed autoimmune or inflammatory diseases (including inflammatory bowel disease [such as colitis or Crohn’s disease], diverticulitis [except diverticulosis], systemic lupus erythematosus, sarcomatoid syndrome , Wegener syndrome [granulomatosis with multiple vasculitis, Graves' disease, rheumatoid arthritis, pituitary gland, uveitis, etc.]. However, the following conditions are excluded:
-Patients with leukoplakia or baldness
-Patients with hypothyroidism who have received stable hormone replacement therapy (such as Hashimoto's syndrome follow-up)
-Any chronic skin disease that does not require systemic therapy
-Patients with no active disease in the last 5 years can be included after consulting the trial physician
-Patients with celiac disease controlled by diet only
3 Suffer from uncontrolled concurrent diseases, including but not limited to persistent or active infections, symptoms of congestive heart failure, uncontrolled hypertension, unstable angina, uncontrolled arrhythmia, active interstitial Intrinsic lung disease (ILD), severe chronic gastrointestinal disease accompanied by diarrhea, or mental illness/social condition that may prevent patients from complying with trial requirements, greatly increase the risk of adverse events, or hinder the patient’s ability to sign the subject’s consent.
4 Patients with a history of myocardial infarction, stroke or transient cerebral ischemia in the last 6 months
5 Patients with a history of venous thromboembolism in the last 3 months
6 There is a history of other primary malignant tumors, except for the following:
-Malignant tumors that have received radical treatment, lasted ≥5 years before the first trial drug, and have no active disease and have a low risk of recurrence
-Non-melanoma skin cancers or malignant moles that have been properly treated and have no evidence of disease
-Carcinoma in situ that has been properly treated and has no signs of disease
7 have a history of papilloma
8 There is a history of active primary immune insufficiency
9 Active infections include pulmonary tuberculosis (after clinical evaluation, including clinical history, physical examination, and radiographic results of pulmonary tuberculosis test performed in accordance with local regulations), hepatitis B (hepatitis B virus; known test results are HBV surface Antigen (HBsAg) positive), hepatitis C (HCV) or human immunodeficiency virus (HIV type 1/2 antibody is positive). If the patient has been infected with HBV virus or has remission after infection (defined as having hepatitis B core antibody [anti-HBc] but no HBsAg), it can be included. If the patient is positive for hepatitis C virus (HCV) but negative for HCV RNA by polymerisation enzyme chain reaction, it can be included.
10 It was discovered through brain imaging during the screening period (for imaging mode, see Appendix F of the plan [RECIST Version 1.1]), or it was discovered that the patient had untreated central nervous system cancer metastasis before signing the subject's consent. Patients who have received brain metastasis therapy can participate in the trial, but the results of radiology imaging must be stable (2 brain images after receiving brain metastasis therapy, the two contrast scans should be separated by 4 weeks, and there is no sign of intracranial deterioration). In addition, at least 14 days before the start of treatment, whether it is brain metastasis or the neurological symptoms caused by the treatment must be relieved or stabilized, no steroids and antiepileptic drugs, or stable use of steroids (prednisone ≤10 mg/day or equivalent dose ). Brain metastases will not be recorded as the fiducial target lesions defined in RECIST version 1.1.
11 Patients who are known to be allergic or highly sensitive to the test drug or its excipients.
12 The average QT interval (QTcF) ≥470 ms after 3 ECG detections (within 15 minutes, each interval of 5 minutes) and Fridericia formula for heart rate correction.
13 There are clinically significant abnormalities in the heart rhythm, conduction or pattern of the static ECG (such as complete left bundle branch block, third-degree heart block, etc.).
14 Any factor that increases the risk of QTc prolongation or the risk of arrhythmia events, such as heart failure, hypokalemia, potential torsade de pointes ventricular tachycardia, congenital prolonged QT syndrome, family history with prolonged QT syndrome Or sudden death of unknown cause before the age of 40, or combined use of drugs known to prolong the QT interval.
Previous/concomitant drugs
15 Have received chemotherapy or other systemic treatments for the treatment of stage 4 non-small cell lung cancer
16 Currently receiving any chemotherapy, experimental drugs, biologics or hormone therapy for the treatment of cancer, but if the hormone therapy used is for the treatment of non-cancer related diseases (such as hormone replacement therapy), it can be accepted.
17 Radiation therapy, unless (1) decisive radiation therapy is at least 12 months away from the progression of non-small cell lung cancer to the fourth stage (see inclusion criteria 8); (2) brain palliative radiation therapy, at least 4 months away from the first dose of trial drug Weeks ago, and related conditions were stable or asymptomatic (see exclusion criteria 10); (3) Painful bone lesion relief radiotherapy (must be less than 30% bone marrow radiotherapy), and at least 4 weeks away from the first dose of the test drug.
18 Vaccine live attenuated vaccine within 30 days before the first dose of test drug. Note: After the patient is included in the trial, no live vaccine is allowed during the trial treatment period to 30 days after the last dose of the trial treatment drug.
19 Major surgery (as defined by the trial host) was performed within 28 days before receiving the first dose of the test drug, or the patient has not fully recovered from the previous surgery, but the patient is allowed to perform local surgery (such as placing the drug) within 24 hours before the first dose of the test drug. Systemic injection seat, thick needle section and prostate tissue section).
20 Have used or are currently using immunosuppressive drugs in the 28 days before the first dose of durvalumab. Except in the following cases:
-Intranasal, inhaled, topical steroids or local injections of steroids (e.g. intra-articular injection)
-The physiological dose of systemic corticosteroids does not exceed the daily dose of prednisone 10 mg (or equivalent dose)
-Allergic reaction pretreatment steroid medication (e.g. CT scan pretreatment medication)
Previous/concurrent clinical trial experience
21 Participated in clinical trials of other experimental treatment drugs in the last 12 months
22 = Have accepted the trial drug distribution of this trial
23 Participate in other clinical trials at the same time, unless the trial is an observational (non-interventional) clinical study or the follow-up period of an interventional trial.
24 Previously received random assignment or received durvalumab clinical trial treatment, regardless of whether it was assigned to the treatment group
Diagnostic evaluation
25 Histological types of mixed small cell lung cancer and non-small cell lung cancer, sarcoma variants
Other exclusions
26 Pregnant or breast-feeding female patients, or fertile but from screening to durvalumab + new tumor therapy ± within 180 days after the last dose of chemotherapy treatment, or within 90 days after the last dose of durvalumab monotherapy (the latest Standard), male or female patients who are unwilling to use effective contraceptive methods.
27 If the trial leader determines that the patient is unable to comply with the trial procedures, restrictions and requirements, the patient should not participate in the trial.
28 Patients with low expression of PD-L1 tumor cells should not be used for platinum-containing dual chemotherapy
29 Genetic research test (optional):
30 The exclusion conditions for the selectivity (DNA) gene research part of this test include:
-Allogeneic bone marrow transplantation has been done before.
-Have received whole blood transfusion without removing white blood cells within 120 days before the collection of genetic samples
The Estimated Number of Participants
-
Taiwan
50 participants
-
Global
200 participants
