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NCT Number: NCT07179445

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

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.

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Key information

Conditions

NSCLC

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tianjin Medical University Cancer Institute and Hospital(Lead Center)

Tianjin, China

Location contact

Dongsheng Yue Chief Physician of Surgery

CONTACT

[email protected]

+8602223109106

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Not applicable- observational study

Other

Not applicable- observational study

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

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

    Time frame: through study completion, an average of 1 year

    For the comparison between driver gene-positive and negative populations:

    Disease-Free Survival (DFS) will be compared between patients who received adjuvant immunotherapy and were driver gene-positive versus those who were driver gene-negative. DFS is defined as the time from surgery to the first occurrence of disease recurrence, distant metastasis, or death from any cause.

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

    Time frame: through study completion, an average of 1 year

    For the stratified analysis among positive populations:

    Among the driver gene-positive patients who received adjuvant immunotherapy, a stratified analysis will be performed comparing patients with EGFR or ALK mutations versus those with mutations in other driver genes (e.g., ROS1, BRAF V600E, MET, RET, etc.).

Study contacts

Contact information is provided by the study sponsor or research team.

Dongsheng Yue Chief Physician of Surgery

CONTACT

[email protected]

+8602223109106

Sponsors and collaborators

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital

Other

Registry information

Official study title

A Retrospective Study of Deoxyribonucleic Acid and Ribonucleic Acid Next-Generation Sequencing in Non-Small Cell Lung Cancer Patients With Non-Pathologic Complete Response Following Neoadjuvant Immunotherapy

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 17, 2025
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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