Evaluation of Circulating T Cells and Tumor Infiltrating Lymphocytes (TILs) During / After Pre-Surgery Chemotherapy in Non-Small Cell Lung Cancer (NSCLC)

PHASE2CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

March 31, 2013

Primary Completion Date

April 30, 2018

Study Completion Date

April 30, 2018

Conditions
Non Small Cell Lung Cancer
Interventions
DRUG

Ipilimumab

"Neoadjuvant (Pre-Surgery): Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes~Adjuvant (Post-Surgery): Ipilimumab 10 mg/kg IV every 3 weeks times 2 doses beginning 4 weeks postoperative ( up to 10 weeks if needed for recovery)~Maintenance: Ipilimumab 10 mg/kg/IV every 12 weeks times 2 doses"

DRUG

Paclitaxel, Cisplatin, Carboplatin

"Neoadjuvant (Pre-Surgery) Cycle 1: Paclitaxel 175 mg/m2 IV over 3 hours , followed by Cisplatin 75 mg/m2 IV over 60 minutes or carboplatin AUC 6 IV over 30-60 minutes on day 1(Every 21 days x 1 cycle)~Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes, Paclitaxel 175 mg/m2 IV over 3 hours , followed by Cisplatin 75 mg/m2 IV over 60 minutes or carboplatin AUC 6 IV over 30-60 minutes on day 1(Every 21 days x 2 cycles)"

Trial Locations (1)

27710

Duke University Medical Center, Durham

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Duke University

OTHER

NCT01820754 - Evaluation of Circulating T Cells and Tumor Infiltrating Lymphocytes (TILs) During / After Pre-Surgery Chemotherapy in Non-Small Cell Lung Cancer (NSCLC) | Biotech Hunter | Biotech Hunter