Lung Cancer Clinical Trial: PGT307

Now Enrolling

OPAXIO™ (paclitaxel poliglumex, CT-2103; formerly known as XYOTAX) in combination with carboplatin for the treatment of chemotherapy-naïve advanced non-small cell lung cancer (NSCLC) in women with estradiol greater than 25 pg/mL.

How Is this Lung Cancer Clinical Trial Conducted?

This is a multinational, phase III open-label study of patients randomized to one of two arms. The primary objective of this study is to compare the overall survival of patients randomized to the CT-2103/carboplatin arm to that of patients randomized to the comparator arm, paclitaxel/carboplatin. Secondary objectives are to compare the progression-free survival, disease control, clinical benefit, response rate, quality of life, and the safety and tolerability of the treatment arms.

Who Can Participate in this Lung Cancer Clinical Trial?

The following criteria (along with other technical criteria) must be evaluated by the study physician:

• Adult women with histologically- or cytologically-confirmed diagnosis of advanced NSCLC with measurable or nonmeasurable disease
• Baseline estradiol greater than 25 pg/mL (women on hormone replacement therapy are allowed)
• Performance status 0, 1, or 2
• No prior chemotherapy for NSCLC
• Patients must have either recurrent disease following radiation or surgery, stage IIIB disease in patients who are not candidates for combined modality therapy, or stage IV disease
• Those patients with known brain metastases must have recovered from therapy for their CNS metastases and must have stable neurologic function for at least 2 weeks before randomization.
• Adequate bone marrow, renal, hepatic, and cardiac function
• Other criteria that the study physician will evaluate