NCT05857800 Exploring the Neo-Adjuvant Therapy Effects on Lung Cancer Through Monitoring and Assessment of Tumor Environment
| NCT ID | NCT05857800 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai Pulmonary Hospital, Shanghai, China |
| Condition | Lung Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2023-05-25 |
| Primary Completion | 2033-05-25 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,000 participants in total. It began in 2023-05-25 with a primary completion date of 2033-05-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Peng Zhang, PhD
PRINCIPAL INVESTIGATOR
Shanghai Pulmonary Hospital, Shanghai, China
Frequently Asked Questions
Who can join the NCT05857800 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05857800 currently recruiting?
Yes, NCT05857800 is actively recruiting participants. Contact the research team at zhangpeng1121@tongji.edu.cn for enrollment information.
Where is the NCT05857800 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT05857800 clinical trial?
NCT05857800 is sponsored by Shanghai Pulmonary Hospital, Shanghai, China. The principal investigator is Peng Zhang, PhD at Shanghai Pulmonary Hospital, Shanghai, China. The trial plans to enroll 2,000 participants.
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