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
1. Patients must have a histologically or cytologically confirmed, unresectable,
advanced or metastatic (Stage IV per AJCC 7th edition 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
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
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 performance status of 0 or 1 at screening.
8. Have adequate values, bone marrow, renal and liver functions at screening as defined
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- Platelet count ≥ 100 x 109/L
- Hemoglobin ≥ 9 g/dL
- Serum creatinine ≤ 1.5 x upper limit of normal (ULN)
- Total Bilirubin ≤ 1.0 x ULN (unless elevated secondary to benign conditions such
as Gilbert's disease)
- AST and ALT ≤ 1.5 x ULN
9. Resolution of any toxic effects of prior therapy to Grade ≤1 according to 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 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
3. Major surgical procedure within 4 weeks prior to randomization. Patient must have
recovered from all surgery-related complications.
4. Patients with known 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; patients 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 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.