Immunodynamics-Guided Optimization of Individualized Immunochemotherapy in Advanced Driver-Negative NSCLC: A Randomized Trial

PHASE1/PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

246

Participants

Timeline

Start Date

November 30, 2025

Primary Completion Date

November 30, 2025

Study Completion Date

November 30, 2028

Conditions
Advanced Non-Small Cell Lung Cancer (NSCLC)
Interventions
DRUG

Arm 1: Standard Synchronous Group

Arm 1: Concurrent PD-1 + Chemotherapy (Standard Synchronous Group) Participants in this group will receive PD-1 inhibitor and chemotherapy on the same day (D1) during each treatment cycle.

DRUG

Arm 2:Fixed Delay Group

Fixed Delay Arm Delayed PD-1 + Chemo PD-1 inhibitor (e.g., Sintilimab/Keytruda/Tislelizumab/Camrelizumab/Toripalimab/Nivolumab/Atezolizumab/Sugemalimab) Immune checkpoint inhibitor + Chemo (Day 3)

DRUG

Arm 3: Individualized Delay Group

"Arm 3: Individualized PD-1 Timing Based on Immune Window Score (IWS) (Individualized Group) Participants in this group will receive chemotherapy on D1 and undergo daily immune monitoring (CD8⁺PD-1⁺ T cells, Treg, IFN-γ, NLR, ALC, CRP).~Based on the immune window score (IWS):~If IWS ≥ 2, PD-1 inhibitor will be administered the same day. If IWS = 1-1.5, dosing may be delayed to D3-D5 depending on immune recovery. If IWS remains 0 by D5, PD-1 inhibitor will be administered on D6 as fallback."

All Listed Sponsors
lead

First Affiliated Hospital of Wenzhou Medical University

OTHER