CT-2103/Carboplatin vs Paclitaxel/Carboplatin for NSCLC in Women With Estradiol > 25 pg/mL

Study Overview
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Brief Summary
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This study is designed to test whether CT-2103/carboplatin provides improved overall survival compared to paclitaxel/carboplatin in women with NSCLC who have estradiol levels >30 pg/ml.

Official Title
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Paclitaxel Poliglumex (CT-2103)/Carboplatin vs Paclitaxel/Carboplatin for the Treatment of Chemotherapy-Naïve Advanced Non-Small Cell Lung Cancer (NSCLC) in Women With Estradiol > 25 pg/mL

Conditions
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NSCLC

Intervention / Treatment
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* Drug: CT-2103/carboplatin
* Drug: paclitaxel/carboplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with baseline estradiol >25 pg/mL Histologically- or cytologically-confirmed diagnosis of NSCLC. ECOG performance score (PS) of 0, 1, or 2. Patients must meet one of the following criteria have either (1) Recurrent disease following completion of radiation or surgery, (2) Stage IIIB disease and not be a candidate for combined modality therapy (primary radiation therapy or surgery), or (3) Stage IV disease. At least 18 years of age. Adequate bone marrow function Adequate renal function Adequate hepatic function Life expectancy ≥12 weeks Exclusion Criteria: Known hypersensitivity to the excipients or the study drug (either CT-2103, paclitaxel, or carboplatin that the patient will receive. Evidence of small cell carcinoma, carcinoid, or mixed small cell/non-small cell histology. Weight loss >10% in previous 6 months LDH > 2.5X IULN Both LDH > 1.5X IULN and ≥ 5% weight loss in previous 6 months BMI >35 Any prior systemic chemotherapy for the treatment of lung cancer. This includes systemic radiosensitizers used to treat brain metastases and any biologic agent. Local palliative radiotherapy < 7 days before randomization. Radiation with curative intent < 30 days before randomization. Concurrent primary malignancies except for carcinoma in situ or non-melanoma skin cancer. Grade 2 or greater neuropathy. Evidence of significant unstable neurological symptoms within the 4 weeks before study randomization. Clinically significant active infection for which active therapy is underway. Investigational therapy within 4 weeks before randomization, unless local requirements are more stringent. Unstable medical conditions including unstable angina or myocardial infarction within the past 6 months before randomization. Pregnant women or nursing mothers.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br> | Drug: CT-2103/carboplatin<br>* CT-2103 (175 mg/m2 10 min IV infusion) and carboplatin (AUC 6, 30 min IV infusion) on day 1 of each 21-day cycle for up to 6 cycles.<br>|
| Active Comparator: Control<br> | Drug: paclitaxel/carboplatin<br>* Paclitaxel (175 mg/m2, 3 hr IV infusion) and carboplatin (AUC 6) (30 minute IV infusion) on day 1 of each 21-day cycle for up to 6 cycles.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | up to 3 years post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival, disease control, clinical benefit, response rate, quality of life, and the safety |  | up to 3 years post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSCLC, women, CT-2103, paclitaxel, carboplatin