At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed NSCLC stage III
- ✓At least 1 measurable lesion per RECIST 1.1
- ✓Feasible or anticipated feasible to undergo radical surgery after neoadjuvant therapy
- ✓Normal lung function adequate for surgery tolerance
- ✕Non-squamous NSCLC with EGFR mutations or ALK rearrangement
- ✕Prior systemic anti-cancer treatment including surgery, radiotherapy, chemotherapy, or targeted therapy
- ✕Any cancer within 5 years except cervical carcinoma in situ, cured basal cell carcinoma, or bladder epithelial tumor
- ✕Uncontrolled systemic disease including active infection, uncontrolled hypertension, unstable angina, heart failure ≥NYHA II, recent MI, severe arrhythmia, liver/kidney/metabolic disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT04728724Phase 2RecruitingUpdate OverdueUpdated 33mo ago · Completion was 33mo agoNeoadjuvant Sintilimab or Combined With Chemotherapy for Stage III Driven Gene Mutation Negative Non-small Cell Lung Cancer
In Brief
A Phase 2 clinical trial evaluating Sintilimab and Chemotherapy for Non-small Cell Lung Cancer Stage III. Currently recruiting, targeting 100 participants across 1 site.
Signals
Detailed Summary
This is a phase II, non-randomized, open-label, multi-center study to evaluate the efficacy of neoadjuvant Sintilimab (PD-1 antibody) or combined with chemotherapy as first-line treatment in patients with stage III non-small cell lung cancer (NSCLC).
Study Details
Timeline
Interventions
Neoadjuvant treatment stage: Sintilimab 200mg, q3w, i.v., 2-4 cycles, then receive chest CT evaluation. Surgery stage: the patients will receive radical surgery after the neoadjuvant treatment. Adjuvant treatment stage: according to the NCCN guidelines.
Neoadjuvant treatment stage: Sintilimab 200mg, q3w, i.v., 2-4 cycles; platinum-based chemotherapy (Non-squamus: Carboplatin AUC 5 + Pemetrexed 500mg/m2; Squamous: Carboplatin AUC 5 + Gemcitabine 1000mg/m2 or Paclitaxel 200mg/m2) q3w, i.v., 2-4 cycles, then receive chest CT evaluation. Surgery stage: the patients will receive radical surgery after the neoadjuvant treatment. Adjuvant treatment stage: according to the NCCN guidelines.