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Clinical study of sPD-1 as a novel diagnostic and therapeutic marker for NSCLC immunotherapy with checkpoint inhibitors: a prospective observational cohort study

Clinical study of sPD-1 as a novel diagnostic and therapeutic marker for NSCLC immunotherapy with checkpoint inhibitors: a prospective observational cohort study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500114895
Enrollment
Unknown
Registered
2025-12-18
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with locally advanced or metastatic NSCLC

Interventions

NSCLC group:None

Sponsors

Nanjing Drum Tower Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age over 18 years; 2. Patients with locally advanced or metastatic non-small cell lung cancer confirmed by histology or cytology to be negative for driver gene mutations (negative for EGFR mutations and negative for ALK rearrangements); 3. Measurable lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST); 4. ECOG performance status of 0-2.

Exclusion criteria

Exclusion criteria: 1. patients who cannot be followed up; 2. patients who discontinued ICI treatment for reasons other than disease progression or death; 3. patients who have previously received ICI treatment; 4. expected survival time less than 3 months.

Design outcomes

Primary

MeasureTime frame
Progression-free survival (PFS) at 1-year follow-up;

Secondary

MeasureTime frame
6-month Objective Response Rate (ORR);1-year overall survival (OS);2-year PFS and OS;

Countries

China

Contacts

Public ContactChen Yuxin

Nanjing Drum Tower Hospital

yuxin.chen@nju.edu.cn+86 25 8310 6666

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026