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Recruiting NCT05857800

Exploring the Neo-Adjuvant Therapy Effects on Lung Cancer Through Monitoring and Assessment of Tumor Environment

— Observational Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Observation.
Who it may be relevant to
Registry conditions: Lung Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Exploring the Neo-Adjuvant Therapy Effects on Lung Cancer Through Monitoring and Assessment of Tumor Environment (NAT-LungMate)

Overview

This translational study aims to investigate how neoadjuvant therapy affects lung cancer patients by monitoring dynamic changes in the tumor environment. The study focuses on patients with histologically confirmed lung cancer, including non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), who are eligible for neoadjuvant therapy in the LungMate clinical trial series. By analyzing intra-tumour genetic and functional heterogeneity following neoadjuvant therapy through multi-omic analysis (including genomics, transcriptomics, metabolomics and proteomics), this study could potentially identify new biomarkers or therapeutic targets that could improve lung cancer patient outcomes.

Interventions

  • Other Observation
    Analysis of dynamic changes of lung cancer microenvironment in neoadjuvant therapy using bio-omics information collected in clinical trials.

Primary outcome measures

  • Intratumour heterogeneity index [Time frame: From trial activation until trial closure (approximately 15 May 2033)]

Eligibility criteria

Inclusion criteria

  • Patients enrolled in LungMate clinical trial series, including:
  • LungMate-001: Clinical study for neoadjuvant anti-PD-1 inhibitor, sintilimab, chemotherapy combined with surgery in treating phase IB - IIIA non-small cell lung cancer
  • LungMate-002: Clinical study for neoadjuvant therapy of anti-PD-1 drug combined with radical surgery in treating phase IIb - III non-small cell lung cancer patients
  • LungMate-003: Neoadjuvant PD-1 Antibody Plus Apatinib or Chemotherapy for Non-small Cell Lung Cancer
  • LungMate-004: Neoadjuvant Afatinib Therapy for Potentially Resectable Stage III EGFR Mutation-Positive Lung Adenocarcinoma
  • LungMate-005: Clinical Study of PD-L1 Antibody (TQB2450) Plus Chemotherapy (Cisplatin and Etoposide) for Previously Untreated Small Cell Lung Cancer
  • LungMate-006: Clinical Study of PD-1 Antibody (BGB-A317) Plus Chemotherapy (Cisplatin and Etoposide) for Limited Stage Small Cell Lung Cancer
  • LungMate-007: Neoadjuvant HS-10296 (Almonertinib) Therapy for Potential Resectable Stage III EGFR Mutation-Positive Lung Adenocarcinoma
  • LungMate-009: Neoadjuvant Immunotherapy for Stage III Non-small Cell Lung Cancer
  • LungMate-012: Neoadjuvant Furmonertinib Plus Bevacizumab or Furmonertinib Monotherapy for Resectable and Potentially Resectable Stage III-IVA EGFR Mutation-Positive Lung Adenocarcinoma
  • LungMate-013: Induction Therapy With PD-1 Antibody Combined With Platinum-based Doublet Chemotherapy for Locally-advanced Non-small Cell Lung Cancer;
  • LungMate-015: The Efficiency of Surgery and Radiotherapy After SHR-1316 (Adebrelimab) and Platinum-containing Doublet Induction Therapy for Limited-stage Small Cell Lung Cancer;
  • Patients enrolled in the LungMate series of neoadjuvant therapy lung cancer clinical trials in the future;
  • Age 18- years or older;
  • Histopathologically confirmed with NSCLC or SCLC;
  • Written Informed consent

Exclusion criteria

  • The patients who failed to meet clinical trial screening criteria and those who dropped out of the clinical trial;
  • Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol
  • The patient suffered from other cancers besides NSCLC (except cervical carcinoma in situ, cured basal cell carcinoma, and bladder epithelial tumor \[including Ta and Tis\]) within 5 years before the trial;
  • The patient is a carrier of active hepatitis B, hepatitis C or HIV.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Shanghai Pulmonary Hospital — Shanghai

Identifiers

NCT: NCT05857800 · NAT-LungMate

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗