Investigating the effects of neoadjuvant therapy on lung cancer

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

This study is testing how neoadjuvant therapy affects lung cancer patients by looking at changes in their tumors before surgery to see if it can help improve their treatment outcomes.

Quick facts

• Study type: Observational
• Enrollment: 2000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China (Academic / other)
• Drugs / interventions: sintilimab, Bevacizumab, Adebrelimab, Apatinib, Afatinib, Almonertinib, Furmonertinib, chemotherapy, Immunotherapy
• Locations: 1 site (Shanghai)
• Trial ID: NCT05857800 on ClinicalTrials.gov

What this trial studies

This observational study aims to explore the impact of neoadjuvant therapy on lung cancer patients by monitoring changes in the tumor environment. It focuses on individuals with histologically confirmed lung cancer, including both non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), who are participating in the LungMate clinical trial series. The study employs multi-omic analysis to assess intra-tumor genetic and functional heterogeneity following neoadjuvant therapy, potentially identifying new biomarkers or therapeutic targets to enhance patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are patients with confirmed lung cancer who are enrolled in the LungMate clinical trial series and eligible for neoadjuvant therapy.

Not a fit: Patients not enrolled in the LungMate clinical trial series or those with lung cancer types not included in the study may not benefit.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies and outcomes for lung cancer patients.

How similar studies have performed: Other studies exploring neoadjuvant therapies in lung cancer have shown promising results, indicating potential for success in this approach.

Eligibility criteria

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 cell lung cancer
  2. 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
  3. LungMate-003: Neoadjuvant PD-1 Antibody Plus Apatinib or Chemotherapy for Non-small Cell Lung Cancer
  4. LungMate-004: Neoadjuvant Afatinib Therapy for Potentially Resectable Stage III EGFR 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 Potential Resectable 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 Furmonertinib Monotherapy for Resectable and Potentially Resectable Stage III-IVA EGFR Mutation-Positive Lung Adenocarcinoma
  10. LungMate-013: Induction Therapy With PD-1 Antibody Combined With Platinum-based Doublet 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-stage Small Cell Lung Cancer;
  12. 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.

Where this trial is running

Shanghai

• Shanghai Pulmonary Hospital — Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Peng Zhang, PhD — Shanghai Pulmonary Hospital, Shanghai, China
• Study coordinator: Peng Zhang, PhD

Conditions Lung Cancer