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 · tracked via the Priya Life Science China tracker

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Phase

Observational

Started

2025-09-20

Last updated

2025-09-17

Condition(s) studied

NSCLC

Investigational drug(s) / intervention(s)

Not applicable- observational study

Not applicable- observational study: Not applicable- observational study

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

100 Years

Healthy volunteers

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. Exclusion Criteria: * 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.

Primary outcome measure(s)

Proportion of driver-alteration-positive patients detected by combined DNA+RNA testing — through study completion, an average of 1 year
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.

Trial sites (1)

Facility	City	Region	Status
Tianjin Medical University Cancer Institute and Hospital(Lead Center)	Tianjin	China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07179445 on ClinicalTrials.gov ↗ ← All trials in China