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A Multinational, Randomized, Open-Label Study of Custirsen In Patients With Advanced or Metastatic (Stage IV) Non-Small Cell Lung Cancer

Cancer Type
Lung Cancer
Trial Phase
Phase III
18 Years and older, Male and Female
Study Type
Protocol IDs
TV1011-LC-303 (primary)
Study Sponsor
Achieve Life Sciences


The primary objective of the study is to compare overall survival of patients randomized to receiving custirsen in combination with docetaxel (Arm A) with patients randomized to receive docetaxel alone (Arm B).


  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 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 performance status of 0 or 1 at screening.
  8. Have adequate values, bone marrow, renal and liver functions at screening as defined below:
  9. Absolute neutrophil count (ANC) = 1.5 x 109/L
  10. Platelet count = 100 x 109/L
  11. Hemoglobin = 9 g/dL
  12. Serum creatinine = 1.5 x upper limit of normal (ULN)
  13. Total Bilirubin = 1.0 x ULN (unless elevated secondary to benign conditions such as Gilbert's disease)
  14. AST and ALT = 1.5 x ULN
  15. 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).
  16. Females of child-bearing potential must have negative serum pregnancy test within 72 hours before randomization.
  17. 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. Men of reproductive potential who are not surgically sterile must agree to abstain from sexual activity or use medically accepted and highly effective method of contraception during and for 6 months after the chemotherapy/custirsen last dose.
  18. 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.
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
Georgia CORE


Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.