Prediction Model of ICIs Combined With Chemotherapy in Advanced NSCLC

Multiparameter Prediction Model of Immune Checkpoint Inhibitors Combined With Chemotherapy in Advanced Non-small Cell Lung Cancer: a Real-world Study

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer, Nonsmall Cell

• Study Type: Observational
• Enrollment (Anticipated): 56

Contacts and Locations

• Study Contact: Name: Shuhua Han, docter; Phone Number: 13585148267; Email: hanshuhua0922@126.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Recruiting
      • Shuhua Han
      • Contact: Shuhua Han, docter; Phone Number: 13585148267; Email: hanshuhua0922@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

1. Male and female, ≥18 years old;
2. Patients with a definite cytological or histopathological diagnosis of non-small cell lung cancer;
3. 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)
4. There is no known ALK gene translocation
5. 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).

6. 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.

7. At least 1 measurable lesion according to RECIST 1.1
8. Receiving immune checkpoint inhibitor therapy for more than 2 cycles
9. ECOG PS 0-1 score
10. Be able to understand and abide by the requirements of the agreement, and voluntarily participate in the study.

Exclusion Criteria:

1. Patients participating in other clinical studies;
2. Patients with serious lack of diagnosis and treatment data;
3. Patients could not understand the purpose of the study or disagreed with the requirements of the study;
4. A history of other tumors within 5 years;
5. Patients judged by the researchers as not suitable for inclusion in this study

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
ctDNA in concentration	The best predictive value of ctDNA concentration change threshold and the best collection time.	The First treatment (month 1), the second treatment (month 2) and the time of progression (assessed up to 2 years)

Collaborators and Investigators

• Sponsor: Beijing Red Clove Public Welfare Development Center
• Investigators: Study Chair: Shuhua Han, docter, Southeast University Zhongda Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2022
• Primary Completion (ANTICIPATED): September 1, 2024
• Study Completion (ANTICIPATED): March 1, 2025

Study Registration Dates

• First Submitted: January 16, 2023
• First Submitted That Met QC Criteria: February 10, 2023
• First Posted (ACTUAL): February 13, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 13, 2023
• Last Update Submitted That Met QC Criteria: February 10, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: BJ-HDX-20220781

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: This is the initial stage of the study, and the data sets generated and analyzed in the later stage of the study can be obtained from corresponding authors according to reasonable requirements.

Drug and device information, study documents

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