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

NCT07179445 | Not Yet Recruiting

• 1 other identifier: LUAD-non-pCR-001
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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

Keywords

NSCLC; Neoadjuvant; NGS

Outcome Measures

Primary Outcomes (1)

• Proportion of driver-alteration-positive patients detected by combined DNA+RNA testing

  We selected patients with lung adenocarcinoma who had received preoperative neoadjuvant immunotherapy, did not achieve pathological complete response (pCR) after surgery, and had pre-treatment biopsy samples testing negative for EGFR and ALK alterations. Subsequent combined DNA/RNA next-generation sequencing (NGS) was performed using the 3DMed Onco™ Core Tissue Detection Kit. The proportion of patients with identified driver genomic alterations served as the primary endpoint of the study.

  through study completion, an average of 1 year

Secondary Outcomes (2)

• Comparative Analysis of Adjuvant Immunotherapy Efficacy Between Driver-Alteration-Positive and Negative Cohorts

  through study completion, an average of 1 year

• Stratified Analysis of EGFR/ALK-Positive Versus Other Driver-Alteration-Positive Subgroups

  through study completion, an average of 1 year

Interventions

Not applicable- observational study OTHER

Not applicable- observational study

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This multicenter, retrospective cohort study plans to enroll patients with non-small cell lung cancer (NSCLC). Cases meeting the eligibility criteria between January 2022 and December 2024 will first be identified through the hospital pathology information management system. The screening process consists of two stages: Initial Screening: Extraction of data from electronic medical records for patients aged ≥18 years, with pathologically confirmed NSCLC, and who underwent genetic testing prior to surgery. Collection of Neoadjuvant Immunotherapy Information: 1. Received preoperative neoadjuvant immunotherapy, including regimens such as immune monotherapy, immune combination chemotherapy, or immune combination with antiangiogenic agents, with available postoperative pathological assessment results; 2. Exclusion of EGFR and ALK positivity in pre-treatment biopsy samples; 3. Availability of qualifying surgical tissue samples. Estimating a requirement of 300 cases.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital(Lead Center)

Tianjin, China

Location

Central Study Contacts

Dongsheng Yue Chief Physician of Surgery

CONTACT

+8602223109106; yuedongsheng_cg@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician of Surgery

Study Record Dates

• First Submitted: September 7, 2025
• First Posted: September 17, 2025
• Study Start: September 20, 2025
• Primary Completion: January 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)