Clinical Trials List
Protocol NumberTB-AB030103
NCT Number(ClinicalTrials.gov Identfier)NCT02629848
2012-05-31 - 2018-05-30
Phase III
Study ended9
ICD-10C34.90
Malignant neoplasm of unspecified part of unspecified bronchus or lung
ICD-10C34.91
Malignant neoplasm of unspecified part of right bronchus or lung
ICD-10C34.92
Malignant neoplasm of unspecified part of left bronchus or lung
ICD-10C7A.090
Malignant carcinoid tumor of the bronchus and lung
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9162.9
Malignant neoplasm of bronchus and lung, unspecified
A Global Phase 3, Randomized, Placebo-Controlled, Double-Blind Trial of AMG 706 in Combination With Paclitaxel and Carboplatin for Advanced Non-Squamous Non-Small Cell Lung Cancer (Asian Phase 3 Study)
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Sponsor
Takeda Bio Development Center Limited
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/19
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Study ended
Co-Principal Investigator
- JENG-SEN TSENG Division of Thoracic Medicine
- 陳焜結 Division of Thoracic Medicine
- KUO-HSUAN HSU Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Study ended
The Actual Total Number of Participants Enrolled
0 Study ended
Co-Principal Investigator
- 張竣期 Division of Thoracic Medicine
- 林炫聿 Division of Hematology & Oncology
- 鍾智淵 Division of Hematology & Oncology
- 張正雄 Division of General Internal Medicine
- 林慶雄 Division of Thoracic Medicine
- 紀炳銓 Division of Thoracic Medicine
- 施穎銘 Division of Thoracic Medicine
- 林聖皓 Division of Thoracic Medicine
- 王全正 Division of Hematology & Oncology
- 林正純 Division of Hematology & Oncology
- 葉金水 Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Study ended
The Actual Total Number of Participants Enrolled
0 Study ended
Co-Principal Investigator
- Chong-Jen Yu Division of Thoracic Medicine
- 廖唯昱 Division of Thoracic Medicine
- 林育麟 Division of Hematology & Oncology
- 陳冠宇 Division of Thoracic Medicine
- Chia-Chi Lin Division of Hematology & Oncology
- JIN-YUAN SHIH Division of Thoracic Medicine
- Jih-Hsiang Lee Division of Hematology & Oncology
- CHAO-CHI HO CHAO-CHI HO Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Study ended
Co-Principal Investigator
- 林明賢 Division of Hematology & Oncology
- Shang-Wen Chen Division of Hematology & Oncology
- 曹朝榮 Division of Hematology & Oncology
- 陳昭勳 Division of Hematology & Oncology
- 林正耀 Division of Hematology & Oncology
- 陳威宇 Division of Hematology & Oncology
- 陳彥勳 Division of Hematology & Oncology
- 黃文聰 Division of Hematology & Oncology
- 林建良 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Study ended
Co-Principal Investigator
- Wen-Cheng Chang Division of Hematology & Oncology
- 張志豪 Division of Infectious Disease
- 吳振德 Division of Radiology
- 洪禎佑 Division of Infectious Disease
- Chih-Liang Wang Division of Hematology & Oncology
- 李立夫 Division of Infectious Disease
- Chien-Ying Liu Division of Hematology & Oncology
- Chih-Hung Chen Division of Hematology & Oncology
- Po-Hao Feng Division of Thoracic Medicine
- Chih-Hung Chen Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Study ended
Co-Principal Investigator
- Han-Lin Hsu Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Study ended
Condition/Disease
Advanced Non-Squamous Non Small Cell Lung Cancer
Objectives
Primary Objective: To determine if AMG 706 in combination with paclitaxel and carboplatin
improves progression-free survival (PFS) compared to placebo in combination with paclitaxel and
carboplatin.
Key Secondary Objective: To determine if AMG 706 in combination with paclitaxel and
carboplatin improves overall survival (OS) compared to placebo in combination with paclitaxel
and carboplatin.
Other Secondary Objectives:
• To evaluate the objective response rate (ORR) and duration of response of AMG 706 in
combination with paclitaxel and carboplatin compared to placebo in combination with
paclitaxel and carboplatin
• To evaluate the safety of AMG 706 in combination with paclitaxel and carboplatin compared to
placebo in combination with paclitaxel and carboplatin
• To evaluate the pharmacokinetics of AMG 706 and its metabolites when AMG 706 is
administered with paclitaxel and carboplatin
Test Drug
AMG 706
Active Ingredient
Motesanib
Dosage Form
Tablet
Dosage
25 mg
Endpoints
Primary Efficacy Endpoint:
• Progression-free survival (PFS)
Key Secondary Efficacy Endpoint:
• Overall survival (OS)
Other Secondary Efficacy Endpoints:
• Objective response rate (ORR)
• Duration of response
• Incidence of adverse events and abnormalities in clinical laboratory data
• Pharmacokinetics of AMG 706 and its metabolites when AMG 706 is administered in
combination with paclitaxel and carboplatin.
• Progression-free survival (PFS)
Key Secondary Efficacy Endpoint:
• Overall survival (OS)
Other Secondary Efficacy Endpoints:
• Objective response rate (ORR)
• Duration of response
• Incidence of adverse events and abnormalities in clinical laboratory data
• Pharmacokinetics of AMG 706 and its metabolites when AMG 706 is administered in
combination with paclitaxel and carboplatin.
Inclution Criteria
• Histologically or cytologically confirmed, stage IV or recurrent non-squamous NSCLC (except
diagnosis by sputum cytology only). Adenosquamous histology or an unclear histology
subtype containing more than 10% squamous cells is NOT allowed.
• No prior chemotherapy, molecularly-targeted therapy, or immunotherapy. Neoadjuvant and
post-operative adjuvant therapy except chemotherapy with platinum agent completed 1 year
prior to randomization is permitted.
• Measurable or non-measurable lesion per RECIST version 1.1 (except malignant
effusion only).
• ECOG performance status of 0 or 1
• Life expectancy of ≥ 3 months as documented by the investigator
• Patients must be 18 years of age or older at the time informed consent is obtained.
• Hematological function, as follows:
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- Platelet count ≥ 100 x 109/L and ≤ 850 x 109/L
- Hemoglobin ≥ 9 g/dL
• Renal function, as follows:
- Creatinine clearance (GFR) > 40 mL/min (calculated by Cockcroft-Gault formula)
- Urinary protein quantitative value of ≤ 30 mg in urinalysis or ≤ 1+ on dipstick unless
quantitative protein is < 500 mg in a 24-hour urine sample
• Hepatic function, as follows:
- Aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal (ULN) or AST < 5 x ULN if
liver metastases are present
- Alanine aminotransferase (ALT) ≤ 2.5 x ULN or ALT < 5 x ULN if liver metastases are
present
- ALP ≤ 2.0 x ULN or ALP < 5 x ULN if liver or bone metastases are present
- Total bilirubin < 1.5 x ULN
• Blood coagulation function, as follows:
- Partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1 x ULN
- International normalized ratio (INR) ≤ 1.5 x ULN
• Competency to give written informed consent
• Ability to take oral medications
• Able to start protocol-directed therapy within 7 days from date of randomization
diagnosis by sputum cytology only). Adenosquamous histology or an unclear histology
subtype containing more than 10% squamous cells is NOT allowed.
• No prior chemotherapy, molecularly-targeted therapy, or immunotherapy. Neoadjuvant and
post-operative adjuvant therapy except chemotherapy with platinum agent completed 1 year
prior to randomization is permitted.
• Measurable or non-measurable lesion per RECIST version 1.1 (except malignant
effusion only).
• ECOG performance status of 0 or 1
• Life expectancy of ≥ 3 months as documented by the investigator
• Patients must be 18 years of age or older at the time informed consent is obtained.
• Hematological function, as follows:
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- Platelet count ≥ 100 x 109/L and ≤ 850 x 109/L
- Hemoglobin ≥ 9 g/dL
• Renal function, as follows:
- Creatinine clearance (GFR) > 40 mL/min (calculated by Cockcroft-Gault formula)
- Urinary protein quantitative value of ≤ 30 mg in urinalysis or ≤ 1+ on dipstick unless
quantitative protein is < 500 mg in a 24-hour urine sample
• Hepatic function, as follows:
- Aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal (ULN) or AST < 5 x ULN if
liver metastases are present
- Alanine aminotransferase (ALT) ≤ 2.5 x ULN or ALT < 5 x ULN if liver metastases are
present
- ALP ≤ 2.0 x ULN or ALP < 5 x ULN if liver or bone metastases are present
- Total bilirubin < 1.5 x ULN
• Blood coagulation function, as follows:
- Partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1 x ULN
- International normalized ratio (INR) ≤ 1.5 x ULN
• Competency to give written informed consent
• Ability to take oral medications
• Able to start protocol-directed therapy within 7 days from date of randomization
Exclusion Criteria
• Untreated or symptomatic central nervous system metastases. Subjects with a history of brain
metastases are eligible if definitive therapy has been administered (surgery and/or radiation
therapy), there is no planned treatment for brain metastases, and the subject is clinically
stable and off corticosteroids for at least 2 weeks prior to randomization.
• Palliative radiation therapy:
- Radiation therapy within 28 days prior to randomization for Central (chest)
- Radiation therapy within 14 days prior to randomization for distant metastatic foci
• History of pulmonary hemorrhage or gross hemoptysis (approximately 3 mL or more of bright
red blood) within 6 months prior to randomization
• Prior targeted therapies, including but not limited to:
- AMG 706, inhibitors of VEGF (eg, SU5416, SU6668, ZD6474, SU11248, PTK787,
AZD2171, AEE-788, sorafenib, bevacizumab), or EGFR (eg, panitumumab, cetuximab,
gefitinib, erlotinib)
• Any anticoagulation therapy within 7 days prior to randomization. The use of low-dose warfarin
(≤ 2 mg daily) or low molecular weight heparin or heparin flushes for prophylaxis against
central venous catheter thrombosis is allowed.
• Known history of allergy or hypersensitivity reaction to paclitaxel or carboplatin
• History of arterial or venous thrombosis within 12 months prior to randomization
• History of bleeding diathesis or bleeding within 14 days prior to randomization
• Peripheral neuropathy ≥ grade 2 per Common Terminology Criteria for Adverse Events
(CTCAE) Version 3.0
• Clinically significant cardiovascular disease within 12 months of randomization, including
myocardial infarction, unstable angina, ≥ grade 2 peripheral vascular disease, cerebrovascular
accident, transient ischemic attack, percutaneous transluminal coronary angioplasty/stent,
congestive heart failure, or ongoing arrhythmias requiring medication
• Any kind of disorder that compromises the ability of the subject to comply with the study
procedures
• Open wound, ulcer or fracture
• Active or any uncontrolled, infection or inflammatory disease requiring systemic treatment
≤ 14 days prior to randomization
• Uncontrolled hypertension (resting blood pressure > 150/90 mm Hg) despite the use of an
antihypertensive.
• History (past/current) of other primary cancer unless:
- Curatively resected non-melanomatous skin cancer
- Curatively treated cervical carcinoma in situ
- Other primary solid tumor curatively treated with no known active disease present and no
curative treatment administered for the last 3 years
• Surgery:
- Major surgical procedures within 28 days prior to randomization
- Minor surgical procedures within 14 days prior to randomization
- Failure to recover from prior surgery
- Placement of a central venous access device (including ports and tunneled or nontunneled
catheters) within 7 days prior to randomization
- Core needle biopsy within 7 days prior to randomization
• Planned elective surgery while on study treatment
• Not recovered from all previous therapies (ie, radiation, surgery and medications). Adverse
events related to previous therapies must be CTCAE grade ≤ 1 at screening or must have
resolved to the subject’s baseline level prior to the most recent previous therapy
• Participation in therapeutic clinical trials or currently receiving other investigational
treatment(s) within 30 days prior to randomization
• Pregnant (eg, positive HCG test-serum or urine) or breast feeding woman
• Any subject not consenting to use adequate contraceptive precautions, from informed consent
until 6 months after the last treatment
• Known to be human immunodeficiency virus (HIV), hepatitis B surface antigen or hepatitis C
positive. Subjects may be HBs antigen (-) and HBc antibody (+) and/or HBs antibody (+) with
HBV DNA (-).
• Known chronic hepatitis
• History of any medical or psychiatric condition or laboratory abnormality that, in the opinion of
the investigator, may increase the risks associated with participation in the study or
administration of investigational product(s), or may interfere with the interpretation of the
results
• Previously randomized to this study
• Not available for follow-up assessments or unable to comply with study requirements
metastases are eligible if definitive therapy has been administered (surgery and/or radiation
therapy), there is no planned treatment for brain metastases, and the subject is clinically
stable and off corticosteroids for at least 2 weeks prior to randomization.
• Palliative radiation therapy:
- Radiation therapy within 28 days prior to randomization for Central (chest)
- Radiation therapy within 14 days prior to randomization for distant metastatic foci
• History of pulmonary hemorrhage or gross hemoptysis (approximately 3 mL or more of bright
red blood) within 6 months prior to randomization
• Prior targeted therapies, including but not limited to:
- AMG 706, inhibitors of VEGF (eg, SU5416, SU6668, ZD6474, SU11248, PTK787,
AZD2171, AEE-788, sorafenib, bevacizumab), or EGFR (eg, panitumumab, cetuximab,
gefitinib, erlotinib)
• Any anticoagulation therapy within 7 days prior to randomization. The use of low-dose warfarin
(≤ 2 mg daily) or low molecular weight heparin or heparin flushes for prophylaxis against
central venous catheter thrombosis is allowed.
• Known history of allergy or hypersensitivity reaction to paclitaxel or carboplatin
• History of arterial or venous thrombosis within 12 months prior to randomization
• History of bleeding diathesis or bleeding within 14 days prior to randomization
• Peripheral neuropathy ≥ grade 2 per Common Terminology Criteria for Adverse Events
(CTCAE) Version 3.0
• Clinically significant cardiovascular disease within 12 months of randomization, including
myocardial infarction, unstable angina, ≥ grade 2 peripheral vascular disease, cerebrovascular
accident, transient ischemic attack, percutaneous transluminal coronary angioplasty/stent,
congestive heart failure, or ongoing arrhythmias requiring medication
• Any kind of disorder that compromises the ability of the subject to comply with the study
procedures
• Open wound, ulcer or fracture
• Active or any uncontrolled, infection or inflammatory disease requiring systemic treatment
≤ 14 days prior to randomization
• Uncontrolled hypertension (resting blood pressure > 150/90 mm Hg) despite the use of an
antihypertensive.
• History (past/current) of other primary cancer unless:
- Curatively resected non-melanomatous skin cancer
- Curatively treated cervical carcinoma in situ
- Other primary solid tumor curatively treated with no known active disease present and no
curative treatment administered for the last 3 years
• Surgery:
- Major surgical procedures within 28 days prior to randomization
- Minor surgical procedures within 14 days prior to randomization
- Failure to recover from prior surgery
- Placement of a central venous access device (including ports and tunneled or nontunneled
catheters) within 7 days prior to randomization
- Core needle biopsy within 7 days prior to randomization
• Planned elective surgery while on study treatment
• Not recovered from all previous therapies (ie, radiation, surgery and medications). Adverse
events related to previous therapies must be CTCAE grade ≤ 1 at screening or must have
resolved to the subject’s baseline level prior to the most recent previous therapy
• Participation in therapeutic clinical trials or currently receiving other investigational
treatment(s) within 30 days prior to randomization
• Pregnant (eg, positive HCG test-serum or urine) or breast feeding woman
• Any subject not consenting to use adequate contraceptive precautions, from informed consent
until 6 months after the last treatment
• Known to be human immunodeficiency virus (HIV), hepatitis B surface antigen or hepatitis C
positive. Subjects may be HBs antigen (-) and HBc antibody (+) and/or HBs antibody (+) with
HBV DNA (-).
• Known chronic hepatitis
• History of any medical or psychiatric condition or laboratory abnormality that, in the opinion of
the investigator, may increase the risks associated with participation in the study or
administration of investigational product(s), or may interfere with the interpretation of the
results
• Previously randomized to this study
• Not available for follow-up assessments or unable to comply with study requirements
The Estimated Number of Participants
-
Taiwan
100 participants
-
Global
400 participants
