Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung
Conditions
Interventions
Intervention1: Nivolumab: Low-dose nivolumab (40 mg flat dose)
Comparator/Control:
Historical cohort of patients with resectable NSCLC treated with neoadjuvant chemotherapy alone from 2014 2024.
Cont
Sponsors
Lung cancer education society
Eligibility
Inclusion criteria
Inclusion criteria: Pathological diagnosis of NSCLC Stage IB to IIIB T3N2 irrespective of PDL1 status Being considered for neoadjuvant treatment followed by surgery after evaluation by MDT Complete surgical removal should be deemed achievable including surgical fitness ECOG PS 0 to 1 Able to understand the PIS (patient information sheet) and give informed consent Adequate organ function Provided informed consent
Exclusion criteria
Exclusion criteria: Pregnancy or Lactation autoimmune conditions requiring systemic immunosuppression HIV prior malignancy transplant recipients or those receiving prior anticancer therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)Radiological response rate 2)Major pathological response (mPR) rateTimepoint: 1)At the Week 9 2)At the Week 12 13 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) % of patients undergoing surgical resection (R0 resection rates) 2)Pathological complete response (pCR) rate 3)Event-free survival (EFS) rate 4)Safety and tolerabilityTimepoint: 1)Week 12 13 2)At the time of surgery (Week 12 13) 3)At 3 months and 6 months post-surgery 4)Continuously monitored until 6 months post-surgery | — |
Countries
India
Contacts
Public ContactJayabharathi Palanivel
Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh
Outcome results
None listed