Analysis of Deoxyribonucleic Acid and Ribonucleic Acid Next-Generation Sequencing in Non-Small Cell Lung Cancer Patients Without Pathological Complete Response Following Neoadjuvant Immunotherapy

NCT ID: NCT07179445

Last Updated: 2025-09-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-20
• Study Completion Date: 2026-05-31

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 response (non-pCR) upon postoperative pathological evaluation. Using Deoxyribonucleic Acid(DNA) and Ribonucleic Acid(RNA) next-generation sequencing (NGS), the investigators aim to detect driver genetic alterations to investigate the real-world frequency of driver gene positivity in postoperative samples from patients with lung adenocarcinoma-whose EGFR and ALK status had been previously excluded via pathological complete response(pCR) or DNA-based next-generation sequencing-yet still did not attain pathological complete response(pCR) after neoadjuvant immunotherapy. Additionally, the study will characterize the driver-positive patient subgroup and compare the efficacy of postoperative adjuvant immunotherapy between driver-positive and driver-negative populations.

Conditions

NSCLC

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

Not applicable- observational study

Not applicable- observational study

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dongsheng Yue

Chief Physician of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tianjin Medical University Cancer Institute and Hospital(Lead Center)

Tianjin, , China

Countries

China

Central Contacts

Dongsheng Yue Chief Physician of Surgery

Role: CONTACT

yuedongsheng_cg@163.com

+8602223109106

Facility Contacts

Dongsheng Yue Chief Physician of Surgery

Role: primary

yuedongsheng_cg@163.com

+8602223109106

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

LUAD-non-pCR-001

Identifier Type: -

Identifier Source: org_study_id