Prediction Model of ICIs Combined With Chemotherapy in Advanced NSCLC

NCT05725915 | Unknown

• 1 other identifier: BJ-HDX-20220781
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The reliable predictive markers to identify which patients with advanced non-small cell lung cancer tumors will achieve durable clinical benefit for chemo-immunotherapy are needed. This study is a real world study, aiming to establish a multi-parameter model to predict the efficacy of immune checkpoint inhibitor(ICI) combined with chemotherapy, and to explore the correlation and predictive value of each single biomarker, so as to assist physician to select patients who may benefit for a long time as early as possible and guide clinical accurate treatment.

Conditions

Lung Cancer, Nonsmall Cell

Outcome Measures

Primary Outcomes (1)

• Progression-free survival（PFS）in days

  the time between the time a patient with tumor disease begins treatment and the time when disease progression is observed or death from any cause occurs.

  From date of enrollment until the date of first documented progression, assessed up to 2 years.

Secondary Outcomes (1)

• ctDNA in concentration

  The First treatment (month 1), the second treatment (month 2) and the time of progression (assessed up to 2 years)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with inoperable stage IIIB to IV NSCLS using immune checkpoint inhibitors in combination with chemotherapy.

You may qualify if:

• Male and female, ≥18 years old;
• Patients with a definite cytological or histopathological diagnosis of non-small cell lung cancer;
• Locally advanced (stage IIIB/IIIC) or metastatic (stage IV) NSCLC unable to receive radical surgery and/or radical radiotherapy (with or without concurrent chemotherapy) (AJCC cancer stage 8 clinical stage)
• There is no known ALK gene translocation
• For patients with EGFR-negative non-squamous cell carcinoma, or patients with EGFR-negative/unknown squamous cell carcinoma, it is required that they have not received systemic antitumor therapy for advanced NSCLC in the past (patients have received neoadjuvant chemotherapy, adjuvant chemotherapy, radiotherapy or chemoradiotherapy for curing non-metastatic disease in the past, A disease-free interval of ≥6 months was required between the last chemotherapy and/or radiotherapy).
• Patients with non-squamous cell carcinoma with EGFR-sensitive mutation and EGFR TKI progression could be enrolled if they met any of the following requirements:
• Progress in Treatment of 1/2 generation EGFR TKI, T790M-; EGFR TKI treatment progress of 1/2 generation, T790M+, after 3 generations of EGFR TKI treatment progress again; T790M status was not considered in patients who had progressed to the initial 3 generations of EGFR TKI therapy.
• At least 1 measurable lesion according to RECIST 1.1
• Receiving immune checkpoint inhibitor therapy for more than 2 cycles
• ECOG PS 0-1 score
• Be able to understand and abide by the requirements of the agreement, and voluntarily participate in the study.

You may not qualify if:

• Patients participating in other clinical studies;
• Patients with serious lack of diagnosis and treatment data;
• Patients could not understand the purpose of the study or disagreed with the requirements of the study;
• A history of other tumors within 5 years;

Sponsors & Collaborators

• Beijing Red Clove Public Welfare Development Center: lead

Study Sites (1)

Shuhua Han

Nanjing, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Shuhua Han, docter

  Southeast University Zhongda Hospital

  STUDY CHAIR

Central Study Contacts

Shuhua Han, docter

CONTACT

13585148267; hanshuhua0922@126.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: February 13, 2023
• Study Start: December 1, 2022
• Primary Completion: September 1, 2024
• Study Completion: March 1, 2025
• Last Updated: February 13, 2023

Record last verified: 2023-01

Locations

CN (1)