Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
CTI BioPharma
See Summary
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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.
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.
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.
You may not be if
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.
Clareo Health | A Survival Study for Women With Advanced Lung Cancer Who Have Not Previously Received Chemotherapy.
