NCT02276560

Cisplatin and Nab-paclitaxel for (N2) Defined NSCLC

Phase II Multicenter Trial of Neoadjuvant Cisplatin and Nab-paclitaxel for (N2) Defined Stage IIIA Non-Small Cell Lung Cancer (NSCLC)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to determine whether giving cisplatin and nab-paclitaxel before surgery will reduce the presence of disease in certain areas of the lung at the time of surgery.

Detailed description

Objectives To estimate the rate of N2 nodal clearance at time of surgery in patients with NSCLC undergoing treatment with neoadjuvant nab-paclitaxel plus cisplatin and surgery. Estimate response rate and complete response rate in non-small cell lung cancer (NSCLC) after 3 cycles of neoadjuvant nab-paclitaxel plus cisplatin Estimate complete pathological response of primary tumor and lymph nodes at the time of surgery in patients with NSCLC undergoing treatment with neoadjuvant nab-paclitaxel plus cisplatin Estimate disease free survival for all patients who undergo surgery and also stratified by nodal clearance Patients will be assigned to receive three (3) cycles of cisplatin (mg/m2) and nab-paclitaxel (125 mg/m2). Surgery will then be conducted per standard of care. Approximately 4-12 weeks after the surgical resection, patients will receive one of three available treatment regimens based on the results of the surgical reports, which include: Two four week cycles of therapy of Cisplatin and Nab-paclitaxel; Four three-week cycles of Cisplatin and Pemetrexed, or four three-week cycles of Cisplatin and Gemcitabine Thirty (30) days after treatment ends, subjects will be followed for any ongoing serious adverse events, if necessary, and every 3-6 months thereafter for two years. After the two years of follow-up, subjects will be followed for survival and disease status Estimate overall survival for entire group and stratified by nodal clearance To estimate event free survival (EFS) Estimate time to distant recurrence and time to local recurrence following total study procedures

Conditions

• Stage IIIA Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Neoadjuvant Cisplatin, nab-paclitaxel	Cisplatin (75mg/m2) D1, nab-paclitaxel 125 mg/m2) D1, 8, 15; repeat each 28 D cycle x 2 then surgery
DRUG	Adjuvant Cisplatin,nab-paclitaxel	Cisplatin 75mg/m2 D1,nab-paclitaxel 125mg/m2 D1, 8, 15, repeat each 28D cycle x 2
DRUG	Adjuvant cisplatin+pemetrexed or cisplatin+gemcitabine	Cisplatin 75mg/m2 D1 + pemetrexed 500mg/m2 D1 or Gemcitabine 1000 mg/m2 D1, 8 (if SqCC) repeat each 21 D Cycle x 4

Timeline

• Start date: 2015-01-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2014-10-28
• Last updated: 2017-05-11
• Results posted: 2017-05-11

Locations

9 sites across 1 country: United States