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

Tianjin Medical University

Status: Not yet enrolling

Conditions: NSCLC

Treatments: Other: Not applicable- observational study

Study type: Observational

Funder types: Other

Identifiers

NCT07179445

LUAD-non-pCR-001

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No 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.

Trial design