At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically documented NSCLC, stage IIIA disease, considered resectable
- ✓Tumor must be resectable before study entry
- ✓ECOG Performance Status 0 or 1
- ✓FEV1 ≥ 1.2 liters
- ✕EGFR-sensitizing mutations (TK domain) or ALK alterations
- ✕Active, known, or suspected autoimmune disease
- ✕Systemic corticosteroids (>10 mg daily prednisone equivalent) or immunosuppressants within 14 days of enrollment
- ✕Symptomatic interstitial lung disease (Grade 3-4)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Neo - Adjuvant Chemo / Immunotherapy for the Treatment of Resectable Stage IIIA Non Small Cell Lung Cancer (NSCLC): A Phase II Multicenter Exploratory Study
In Brief
A Phase 2 clinical trial evaluating Nivolumab 360 mg, Paclitaxel 200mg/m2, and 1 other intervention for Non Small Cell Lung Cancer. Completed, enrolled 46 participants across 24 sites.
Detailed Summary
Phase II, single-arm, open-label multicenter study that assesses feasibility, safety and efficacy of combined neoadjuvant chemotherapy and immunotherapy with Nivolumab 360 mg IV Q3W + Paclitaxel 200mg/m2 + Carboplatin AUC 6 IV Q3W in resectable stage IIIA N2-NSCLC adult patients followed by adjuvant treatment for 1 year with Nivolumab 240 mg IV Q2W for 4 months and Nivolumab 480mg Q4W for 8 months.
Study Details
Timeline
Interventions
Nivolumab 360 mg IV Q3W + Followed by adjuvant treatment for 1 year with Nivolumab 240 mg IV Q2W for 4 months and Nivolumab 480mg Q4W for 8 months
Paclitaxel 200mg/m2 IV Q3W
Carboplatin AUC 6 IV Q3W