NSCLC
Conditions
Keywords
Non-small cell lung cancer, NSCLC, PS 2, female, chemotherapy
Brief summary
This is a randomized, open-label, multinational, phase III study in women with histologically- or cytologically-confirmed advanced NSCLC who are chemotherapy naïve and have PS 2. Study drug will be administered on day 1 of each 21 day cycle
Detailed description
See Summary
Interventions
DRUGpaclitaxel
Sponsors
CTI BioPharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Female. 2. Histologically- or cytologically-confirmed diagnosis of NSCLC. 3. ECOG performance score of 2. 4. Patients who meet one of the following criteria: * Stage IIIB who are not candidates for combined modality therapy (primary radiation therapy or surgery), or * Stage IV. 5. Age greater than or equal to 18 years. 6. Adequate bone marrow function 7. Adequate renal function 8. Adequate hepatic function 9. Patients with known brain metastases must have received standard antitumor treatment for their CNS metastases as defined by the site's institutional standards. 10. Patients who have had major surgery must be fully recovered from the surgery. 11. Ability to comply with the visit schedule and assessments required by the protocol. 12. For patients of reproductive potential, commitment to use adequate contraception. 13. Signed approved informed consent, with understanding of study procedures. 14. Agreement to begin study therapy within 8 calendar days after randomization.
Exclusion criteria
1. Any intolerance to poly-L-glutamic acid, Poloxamer 188, dibasic sodium phosphate, monobasic sodium phosphate (the excipients of CT-2103). 2. Evidence of small cell carcinoma, carcinoid, or mixed small cell/non-small cell histology. 3. Any prior systemic chemotherapy for the treatment of lung cancer. This includes systemic radiosensitizers used to treat brain metastases and any biologic agent. 4. Concurrent primary malignancies except for carcinoma in situ or non-melanoma skin cancer. 5. Grade 2 or greater neuropathy. 6. Evidence of significant unstable neurological symptoms within the 4 weeks before study randomization. (If unstable neurologic symptoms resulted from brain metastases, patient must meet inclusion criteria number 9). 7. Clinically significant active infection for which active therapy is underway. 8. Investigational therapy within 4 weeks before randomization, unless local requirements are more stringent. 9. Unstable medical conditions including unstable angina or myocardial infarction within the past 6 months before randomization. Patients with evidence of cardiac conduction abnormalities are eligible if their cardiac status is stable. 10. Pregnant women or nursing mothers. 11. Any circumstance at the time of study entry that would preclude completion of the study or the required follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to compare the overall survival of female patients randomized to CT-2103 to that of female patients randomized to paclitaxel. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives are to compare the progression-free survival, response rate, disease control, clinical benefit, quality of life, and the safety and tolerability of the treatment arms. | — |
Countries
Argentina, Bulgaria, Canada, Hungary, Mexico, Poland, Romania, Russia, Ukraine, United Kingdom, United States
Outcome results
None listed