NSCLC
Conditions
Interventions
None listed
Sponsors
Yokohama City University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Study selection Articles written in English that present a randomised controlled trial (RCT) evaluating neoadjuvant systemic immuno-therapy for NSCLC are eligible for inclusion. Conference abstracts are accepted. Patients Patients with operable NSCLC are evaluated, irrespective of pathological subtype or driver mutation, provided they are considered candidates for neoadjuvant systemic immuno-therapy by the original study authors. Treatment This study focuses on neoadjuvant ICI-based systemic immuno-therapy such as ICI monotherapy, dual ICI therapy, and chemoimmunotherapy. Systematic therapy without ICI is not allowed. Multimodal treatment combined with radiotherapy is excluded.
Exclusion criteria
Exclusion criteria: Non English articles.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Two surrogate endpoints are defined as the odds ratio (OR) of pathological complete response (pCR) and major pathological response (mPR). Two true endpoints are the HR of overall survival (OS) and event-free survival (EFS). Surrogacy is evaluated for four pairs: (i) pCR and EFS, (ii) pCR and OS, (iii) mPR and EFS, and (iv) mPR and OS. Various survival endpoints used in surgical trials--including RFS, PFS, and DFS--are collectively handled as EFS in this analysis to ensure consistency across neoadjuvant systemic immuno-therapy trials. | — |
Countries
Japan
Contacts
Public ContactNobuyuki Horita
Yokohama City University Hospital Chemotherapy Center
Outcome results
None listed