Status:
NOT_YET_RECRUITING
Analysis of Deoxyribonucleic Acid and Ribonucleic Acid Next-Generation Sequencing in Non-Small Cell Lung Cancer Patients Without Pathological Complete Response Following Neoadjuvant Immunotherapy
Lead Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Conditions:
NSCLC
Eligibility:
All Genders
18-100 years
Brief Summary
This multicenter, retrospective cohort study plans to enroll patients with lung adenocarcinoma who received neoadjuvant immunotherapy prior to surgery and did not achieve pathological complete respons...
Eligibility Criteria
Inclusion
- Aged 18 years or older, regardless of sex.
- Pathologically confirmed, resectable non-small cell lung cancer (NSCLC); having received neoadjuvant therapy containing immune checkpoint inhibitors prior to surgery; without achieving pathological complete response (non-pCR) upon postoperative pathological assessment.
- Molecular characteristics: Pre-treatment biopsy specimens tested negative for EGFR mutations and ALK fusions by DNA-based NGS or PCR methods.
- Sample requirements: Availability of 5-10 formalin-fixed, paraffin-embedded (FFPE) sections prepared from surgical tissue specimens, with ≥5% tumor cell content confirmed by H\&E staining.
Exclusion
- Failure to meet any one of the requisite eligibility criteria specified in the inclusion criteria.
- History of a concurrent or prior malignancy at other sites.
- Failure to complete the planned cycles of neoadjuvant immunotherapy due to treatment-related toxicities.
- Any other condition that, in the judgment of the investigator, renders the patient unsuitable for participation in this study.
Key Trial Info
Start Date :
September 20 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT07179445
Start Date
September 20 2025
End Date
May 31 2026
Last Update
September 17 2025
Active Locations (1)
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1
Tianjin Medical University Cancer Institute and Hospital(Lead Center)
Tianjin, China