A Perioperative Comprehensive Diagnosis and Treatment System for Lung Cancer in the Era of Neoadjuvant Immunotherapy

NCT07119190 | Not Yet Recruiting

• 1 other identifier: BRWEP2024W034080200
• Study Type: observational
• Target: 350
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this study is to develop and refine an integrated minimally invasive care pathway for resectable lung cancer in the immunotherapy era, establishing a novel precision perioperative immunotherapy paradigm encompassing original techniques and clinical applications.

Conditions

Non-Small Cell Lung Cancer

Keywords

Non-Small Cell Lung Cancer; Multiomics analysis; Tumor immune microenvironment; Radiomics; Pathological response; Immune-related adverse event; Nursing prehabilitation

Outcome Measures

Primary Outcomes (1)

• Pathological Complete Response (pCR)

  Pathologic Complete Response (pCR) is defined as the absence of residual tumor in both the primary lung tumor site and all sampled regional lymph nodes after neoadjuvant immunotherapy, confirmed through systematic pathological examination of the surgical specimen.

  At surgery (typically 3-6 months post-treatment initiation)

Secondary Outcomes (8)

• Major Pathological Response (MPR)

  At surgery (typically 3-6 months post-treatment initiation)

• Objective Response Rate (ORR)

  After two cycles or four cycles of neoadjuvant therapy (each cycle is 21 days).

• Recurrence-free Survival (RFS)

  Through study completion, an average of 2 years

• Overall Survival (OS)

  Through study completion, an average of 2 years

• MRD (minimal residual disease) dynamics after neoadjuvant immunotherapy

  Periprocedural and every three to six months post-treatment (up to three years)

Study Arms (1)

Prospective cohort

Non-small cell Lung cancer patients receiving neoadjuvant immunotherapy and surgery

Eligibility Criteria

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

Study Population

Patients who meet the eligibility criteria will be included consecutively

You may qualify if:

• Age ≥ 18 years old;
• NSCLC patients underwent radical surgical resection;
• Adequate clinical-pathologic data, imaging data and follow-up data obtainable for multi-omics analysis;
• Scheduled for or currently receiving neoadjuvant/perioperative immunotherapy.

You may not qualify if:

• Histology of other malignant tumors, including concurrent malignant tumors of other organ systems;
• Unresectable advanced disease (Stage IV) or locally advanced unresectable (Stage IIIC);
• Pregnancy or lactation;
• Insufficient sample quality;
• Severe organ dysfunction (e.g. cardiac or renal insufficiency);
• Other judgments by the Investigator that the patient should not participate in the study.

Sponsors & Collaborators

• Peking University People's Hospital: lead
• Beijing Municipal Health Commission: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

biopsy tissues and blood samples

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Fan Yang, MD

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hao Li, MD

CONTACT

+86 13051713494; lihao_pkuhsc@163.com

Tianxiao Han, MD

CONTACT

+86 18811411496; hantianxiao00@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: August 12, 2025
• Study Start: August 6, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): October 30, 2027
• Last Updated: August 12, 2025

Record last verified: 2025-08