Clinical Trials List
Protocol NumberTV1011-LC-303
NCT Number(ClinicalTrials.gov Identfier)NCT01630733
2013-02-01 - 2018-06-30
Phase III
Terminated6
ICD-10C34.90
Malignant neoplasm of unspecified part of unspecified bronchus or lung
A Multinational, Randomized, Open-Label Phase III Study of Custirsen (TV-1011/OGX/011) In Combination With Docetaxel Versus Docetaxel As A Second-Line Treatment In Patients With Advanced or Metastatic (Stage IV) Non-Small Cell Lung Cancer
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Trial Applicant
PPD DEVELOPMENT (HK) LIMITED
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Sponsor
Teva Pharmaceutical Industries, Ltd
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- JENG-SEN TSENG Division of Thoracic Medicine
- TSUNG -YING YANG 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 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Shang-Yin Wu Division of Hematology & Oncology
- Yu-Min Yeh Division of Hematology & Oncology
- Chia-Jui Yen Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Wei-Chun Chen Division of Thoracic Medicine
- Chih-Yen Tu Division of Thoracic Medicine
- 陳鴻仁 Division of Thoracic Medicine
- Chen Chia-Hung Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- CHAO-CHI HO CHAO-CHI HO Division of Thoracic Medicine
- 陳冠宇 Division of Thoracic Medicine
- Chia-Chi Lin Division of Hematology & Oncology
- 廖唯昱 Division of Thoracic Medicine
- James Chih-Hsin Yang Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Advanced or metastatic (Stage IV) non-small cell lung cancer (NSCLC)
Objectives
To evaluate if the combination regimen of custirsen and docetaxel improves the Overall Survival (OS) of patients with advanced or metastatic (Stage IV) NSCLC who have received one prior line of platinum-based systemic anticancer therapy.
Test Drug
Custirsen
Active Ingredient
Custirsen
Dosage Form
injection
Dosage
20mg/mL, 160mg/vial
Endpoints
Efficacy:
1. To compare Progression Free Survival (PFS) between patients receiving docetaxel with or without custirsen.
2. To compare Objective Response Rate (ORR) between patients receiving docetaxel with or without custirsen.
3. To compare Duration of Objective Response (complete response [CR] or partial response [PR]) between patients receiving docetaxel with or without custirsen.
4. To compare Disease Control Rate (DCR) between patients receiving docetaxel with or without custirsen
5. To compare Duration of Disease Control (DC) (ie, CR, PR, or stable disease [SD]), between patients receiving docetaxel with or without custirsen.
Safety:
To assess the safety profile of custirsen in combination with docetaxel.
1. To compare Progression Free Survival (PFS) between patients receiving docetaxel with or without custirsen.
2. To compare Objective Response Rate (ORR) between patients receiving docetaxel with or without custirsen.
3. To compare Duration of Objective Response (complete response [CR] or partial response [PR]) between patients receiving docetaxel with or without custirsen.
4. To compare Disease Control Rate (DCR) between patients receiving docetaxel with or without custirsen
5. To compare Duration of Disease Control (DC) (ie, CR, PR, or stable disease [SD]), between patients receiving docetaxel with or without custirsen.
Safety:
To assess the safety profile of custirsen in combination with docetaxel.
Inclution Criteria
Inclusion Criteria:
1. Patients must have a histologically or cytologically confirmed,
unresectable, advanced or metastatic (Stage IV per American
Joint Committee on Cancer [AJCC] 7th edition of tumor, nodes
and metastases classification of malignant tumors [TNM] staging) NSCLC.
2. Males or females ≥ 18 years of age at screening.
3. Life expectancy of > 12 weeks from screening, according to the
Investigator's assessment.
4. Patients must have received one prior line of platinum-based
systemic anticancer therapy for advanced or metastatic NSCLC.
Prior maintenance therapy is allowed and will be considered as
the same line of therapy when continued at the end of a treatment regimen.
5 Patients must have documented radiological disease progression either during or after the first-line therapy.
6. Patients must have at least one measurable lesion per RECIST 1.1 criteria.
7. ECOG PS of 0 or 1 at screening.
8. Have adequate bone marrow, renal and liver functions.
9. Resolution of any toxic effects of prior therapy to Grade ≤1
according to the National Cancer Institute Common Terminology
Criteria for Adverse Events (NCI CTCAE), version 4.0
(exception of alopecia and ≤ Grade 2 peripheral neuropathy).
10. Females of child-bearing potential must have negative serum
pregnancy test within 72 hours before randomization.
11. Women of child-bearing potential will practice a highly effective method of birth control during and for 3 months after the
chemotherapy/custirsen last dose. Male partners of women of
child-bearing potential can be either surgically sterile, or will ensure that their female partner utilizes a highly effective contraceptive method during and for 3 months after chemotherapy/custirsen last dose.
12. Patients must be willing and able to give written informed
consent prior to any protocol-specific procedures being performed and comply with the protocol requirements for the duration of the study.
1. Patients must have a histologically or cytologically confirmed,
unresectable, advanced or metastatic (Stage IV per American
Joint Committee on Cancer [AJCC] 7th edition of tumor, nodes
and metastases classification of malignant tumors [TNM] staging) NSCLC.
2. Males or females ≥ 18 years of age at screening.
3. Life expectancy of > 12 weeks from screening, according to the
Investigator's assessment.
4. Patients must have received one prior line of platinum-based
systemic anticancer therapy for advanced or metastatic NSCLC.
Prior maintenance therapy is allowed and will be considered as
the same line of therapy when continued at the end of a treatment regimen.
5 Patients must have documented radiological disease progression either during or after the first-line therapy.
6. Patients must have at least one measurable lesion per RECIST 1.1 criteria.
7. ECOG PS of 0 or 1 at screening.
8. Have adequate bone marrow, renal and liver functions.
9. Resolution of any toxic effects of prior therapy to Grade ≤1
according to the National Cancer Institute Common Terminology
Criteria for Adverse Events (NCI CTCAE), version 4.0
(exception of alopecia and ≤ Grade 2 peripheral neuropathy).
10. Females of child-bearing potential must have negative serum
pregnancy test within 72 hours before randomization.
11. Women of child-bearing potential will practice a highly effective method of birth control during and for 3 months after the
chemotherapy/custirsen last dose. Male partners of women of
child-bearing potential can be either surgically sterile, or will ensure that their female partner utilizes a highly effective contraceptive method during and for 3 months after chemotherapy/custirsen last dose.
12. Patients must be willing and able to give written informed
consent prior to any protocol-specific procedures being performed and comply with the protocol requirements for the duration of the study.
Exclusion Criteria
Exclusion Criteria:
1. Patients treated with any systemic anti-cancer therapy for NSCLC
within 21 days prior to randomization (6 weeks for bevacizumab).
2. Radiotherapy ≤ 2 weeks prior to randomization. Patients must
have recovered from all radiotherapy-related toxicities.
3. Major surgical procedure within 4 weeks prior to randomization.
Patient must have recovered from all surgery-related complications.
4. Patients with known central nervous system (CNS) metastases
(Patients with any clinical signs of CNS metastases must have a CT or MRI of the brain to rule out CNS metastases in order to be eligible for participation in the study. Patients who have had brain
metastases treated with radiotherapy or surgically removed with
no residual disease confirmed by imaging should be clinically stable and off corticosteroid treatment at least 3 weeks prior to
randomization).
5. Patients with current diagnosis or a history of another active
primary malignancy (except in situ carcinoma of the cervix, adequately treated non-melanomatous skin cancers, clinically
localized prostate cancer, superficial bladder cancer or other
malignancy treated at least 5 years previously with no evidence
of recurrence).
6. Severe or unstable medical conditions such as heart failure, ischemic heart disease, uncontrolled hypertension, uncontrolled
diabetes mellitus, psychiatric condition, as well as an ongoing cardiac arrhythmia requiring medication (≥ Grade 2, according to
NCI CTCAE v4.0) or any other significant or unstable concurrent
medical illness that in the opinion of the Investigator would preclude protocol therapy.
7. A history of events such as myocardial infarction, cerebrovascular accident (CVA) or acute hepatitis within 3 months of randomization or treatment of a major active infection within one month of randomization, or any other significant event that in the opinion of the Investigator would preclude protocol therapy.
8. Planned concomitant participation in another clinical trial of an
experimental agent, vaccine, or device. Concomitant participation
in observational studies is acceptable.
9. Female patients who are breastfeeding.
10. Patients previously treated with docetaxel for NSCLC or with
known severe hypersensitivity to taxane therapies.
1. Patients treated with any systemic anti-cancer therapy for NSCLC
within 21 days prior to randomization (6 weeks for bevacizumab).
2. Radiotherapy ≤ 2 weeks prior to randomization. Patients must
have recovered from all radiotherapy-related toxicities.
3. Major surgical procedure within 4 weeks prior to randomization.
Patient must have recovered from all surgery-related complications.
4. Patients with known central nervous system (CNS) metastases
(Patients with any clinical signs of CNS metastases must have a CT or MRI of the brain to rule out CNS metastases in order to be eligible for participation in the study. Patients who have had brain
metastases treated with radiotherapy or surgically removed with
no residual disease confirmed by imaging should be clinically stable and off corticosteroid treatment at least 3 weeks prior to
randomization).
5. Patients with current diagnosis or a history of another active
primary malignancy (except in situ carcinoma of the cervix, adequately treated non-melanomatous skin cancers, clinically
localized prostate cancer, superficial bladder cancer or other
malignancy treated at least 5 years previously with no evidence
of recurrence).
6. Severe or unstable medical conditions such as heart failure, ischemic heart disease, uncontrolled hypertension, uncontrolled
diabetes mellitus, psychiatric condition, as well as an ongoing cardiac arrhythmia requiring medication (≥ Grade 2, according to
NCI CTCAE v4.0) or any other significant or unstable concurrent
medical illness that in the opinion of the Investigator would preclude protocol therapy.
7. A history of events such as myocardial infarction, cerebrovascular accident (CVA) or acute hepatitis within 3 months of randomization or treatment of a major active infection within one month of randomization, or any other significant event that in the opinion of the Investigator would preclude protocol therapy.
8. Planned concomitant participation in another clinical trial of an
experimental agent, vaccine, or device. Concomitant participation
in observational studies is acceptable.
9. Female patients who are breastfeeding.
10. Patients previously treated with docetaxel for NSCLC or with
known severe hypersensitivity to taxane therapies.
The Estimated Number of Participants
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Taiwan
48 participants
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Global
1100 participants
