Clinical trial NCT05857800: Exploring the Neo-Adjuvant Therapy Effects on Lung Cancer Through Monitoring and Assessment of Tumor Environment
Official title: Exploring the Neo-Adjuvant Therapy Effects on Lung Cancer Through Monitoring and Assessment of Tumor Environment (NAT-LungMate)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Lead sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Sponsor class: OTHER
First posted: 2023-05-15
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with lung cancer who received neoadjuvant therapy and enrolled in the LungMate clinical trial series.

Brief 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 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.

Primary outcomes:
measure: Intratumour heterogeneity index
timeFrame: From trial activation until trial closure (approximately 15 May 2033)
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
Study officials:
affiliation: Shanghai Pulmonary Hospital, Shanghai, China
name: Peng Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
References: