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

NCT07190027 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 246

Last updated 2025-09-24

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate whether individualized sequencing of immunotherapy and chemotherapy based on immune dynamics can improve treatment outcomes in adults with advanced non-small cell lung cancer (NSCLC) without driver gene mutations. This study will also assess the safety and feasibility of different infusion strategies.

The main questions it aims to answer are:

Does optimizing the timing of PD-1 inhibitor infusion relative to chemotherapy improve the objective response rate (ORR)?

Does individualized infusion sequencing enhance progression-free survival (PFS) compared to standard or fixed-delay administration?

What safety concerns or immune-related adverse events occur with different infusion timing strategies?

Researchers will compare three treatment strategies:

Group A (Standard Concurrent Group): Immunotherapy and chemotherapy administered on the same day (D1).

Group B (Fixed Delay Group): Chemotherapy on D1, followed by PD-1 inhibitor infusion on Day 3.

Group C (Individualized Delay Group): Chemotherapy on D1, and PD-1 inhibitor infusion scheduled on D2-D6 based on daily immune monitoring.

Participants will:

Receive a PD-1 inhibitor (e.g., sintilimab, pembrolizumab, camrelizumab) combined with platinum-based chemotherapy.

Attend clinic visits for regular immune monitoring, imaging assessments, and safety checks during each treatment cycle.

Undergo blood tests to evaluate immune biomarkers (e.g., CD8⁺PD-1⁺ T cells, MDSC, Treg、IFN-γ、NLR、ALC、CRP) to guide individualized treatment decisions.

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.

Sponsors & Collaborators

  • First Affiliated Hospital of Wenzhou Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-30
Primary Completion
2025-11-30
Completion
2028-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07190027 on ClinicalTrials.gov