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

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

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.

Study Overview

• Status: Unknown
• Conditions: NSCLC; Chemoradiotherapy; ctDNA

• Study Type: Observational
• Enrollment (Anticipated): 25

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Fudan University Shanghai Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with locally advanced NSCLC receiving radical concurrent chemoradiotherapy and subsequent immunoconsolidation therapy

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
PFS	Six months after consolidation treatment
OS	Six months after consolidation treatment

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: January 2, 2021
• First Submitted That Met QC Criteria: February 3, 2021
• First Posted (Actual): February 5, 2021

Study Record Updates

• Last Update Posted (Actual): February 5, 2021
• Last Update Submitted That Met QC Criteria: February 3, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: CID-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No