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Trial Title:
Exploring the Neo-Adjuvant Therapy Effects on Lung Cancer Through Monitoring and Assessment of Tumor Environment
NCT ID:
NCT05857800
Condition:
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Observation
Description:
Analysis of dynamic changes of lung cancer microenvironment in neoadjuvant therapy using
bio-omics information collected in clinical trials.
Arm group label:
Lung cancer patients
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.
Criteria for eligibility:
Study pop:
Patients with lung cancer who received neoadjuvant therapy and enrolled in the LungMate
clinical trial series.
Sampling method:
Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Pulmonary Hospital
Address:
City:
Shanghai
Zip:
200433
Country:
China
Status:
Recruiting
Contact:
Last name:
Peng Zhang, PhD
Phone:
021-55672180
Email:
zhangpeng1121@tongji.edu.cn
Start date:
May 25, 2023
Completion date:
May 25, 2033
Lead sponsor:
Agency:
Shanghai Pulmonary Hospital, Shanghai, China
Agency class:
Other
Source:
Shanghai Pulmonary Hospital, Shanghai, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05857800
