Multi Dimensional Precise Exploration of Immunoconsolidation Therapy for Locally Advanced NSCLC After Chemo-radiotherapy

NSCLC Clinical Trial

— NSCLC  

Official title:

Multi Dimensional Precise Exploration of Immunoconsolidation Therapy for Locally Advanced Non-small Cell Lung Cancer After Chemo-radiotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04741633
• Other study ID #: CID-001
• Status: Recruiting
• Start date: April 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2021
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to carry out a prospective observational study in patients with locally advanced NSCLC receiving radical concurrent chemoradiotherapy and follow-up immune consolidation therapy. By detecting ctDNA and TILs of the patients, we explored the value of blood dynamic monitoring of ctDNA in patients with prognosis stratification and treatment effect, and explored the patients before and after concurrent chemoradiotherapy and immune consolidation therapy The characteristics of DNA, RNA, T cells and other biomarkers were correlated with the efficacy and prognosis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Non small cell lung cancer patients confirmed by pathology;

2. They were 18-80 years old;

3. The tumor could not be resected or could not tolerate surgery;

4. Planed to receive chemoradiotherapy and subsequent immunoconsolidation therapy;

5. Clinical stage III (AJCC, 8th Edition, 2017);

6. After systematic detection of non-small cell lung cancer core indicators including EGFR, ALK, ros1, KRAS, ntrk, TMB, etc;

7. Patient informed consent.

Exclusion Criteria:

1. After radiotherapy and chemotherapy, the disease progressed and immune maintenance therapy could not be carried out

2. It can not cooperate with the completion of baseline mutation screening and subsequent sample detection

3. Factors judged by other researchers not suitable for further study

Related Conditions & MeSH terms

• Chemoradiotherapy
• ctDNA
• NSCLC

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between ctDNA dynamic detection and 1-year PFS rate after chemoradiotherapy	The ctDNA dynamic detection will contain NGS test including mutations(both somatic and germline), copy number variations, gene fusions along with genetic interpretation for each and every mutation identified in each test(both blood and tissue) during the whole therapeutic process	Six months after consolidation treatment
Secondary	PFS		Six months after consolidation treatment
Secondary	OS		Six months after consolidation treatment