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

Last updated: June 6, 2023
Sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Overall Status: Active - Recruiting

Phase

N/A

Condition

Non-small Cell Lung Cancer

Cancer

Lung Cancer

Treatment

Observation

Clinical Study ID

NCT05857800
NAT-LungMate
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • The patients who failed to meet clinical trial screening criteria and those whodropped out of the clinical trial;
  • Any condition which in the Investigator's opinion makes it undesirable for the subjectto participate in the trial or which would jeopardize compliance with the protocol
  • The patient suffered from other cancers besides NSCLC (except cervical carcinoma insitu, 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.

Study Design

Total Participants: 2000
Treatment Group(s): 1
Primary Treatment: Observation
Phase:
Study Start date:
May 25, 2023
Estimated Completion Date:
May 25, 2033

Connect with a study center

  • Shanghai Pulmonary Hospital

    Shanghai, 200433
    China

    Active - Recruiting

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