RecistTM Criteria in Evaluating the Efficacy of Targeted Therapy for NSCLC

Application of the RecistTM Criteria in Evaluating the Efficacy of Targeted Therapy for Advanced Non-small Cell Lung Cancer With Positive Driving Genes

Investigators established the efficacy evaluation criteria for tumor markers (RecistTM) in the preliminary research. Among patients with advanced non-small cell lung cancer, patients with positive driving genes are more likely to exhibit abnormalities in tumor markers, which suggests that this criteria may be more suitable for evaluating the efficacy of targeted therapy in driving gene positive patients. Moreover, The judgment rules of the prelimary criteria still need further improvement. Therefore, in order to broaden the application scope of the RecistTM criteria, further improve the evaluation rules of RecistTM criteria, and multi-dimensionally confirm the reliability of RecistTM criteria on efficacy evaluation, investigators plan to conduct research on the application of RecistTM criteria in evaluating the efficacy of targeted therapy for advanced non-small cell lung cancer with positive driving genes.

Study Overview

• Status: Recruiting
• Conditions: NSCLC; Targeted Therapy; Evaluation
• Intervention / Treatment: Diagnostic test: RecistTM criteria

Detailed Description

Investigators established the efficacy evaluation criteria for tumor markers (RecistTM) in the preliminary research. The establishment of this criteria makes the application of tumor markers in clinical efficacy evaluation more objective and solves the problem of consistency in clinical efficacy evaluation. Among patients with advanced non-small cell lung cancer, patients with positive driving genes are more likely to exhibit abnormalities in tumor markers, which suggests that this criteria may be more suitable for evaluating the efficacy of targeted therapy in driving gene positive patients. Moreover, The judgment rules of the preliminary criteria still need further improvement. . Therefore, in order to broaden the application scope of the RecistTM criteria, further improve the evaluation rules of RecistTM criteria, and multi-dimensionally confirm the reliability of RecistTM criteria on efficacy evaluation, investigators plan to conduct research on the application of RecistTM criteria in evaluating the efficacy of targeted therapy for advanced non-small cell lung cancer with positive driving genes. Investigators used statistical analysis to assess the consistency of efficacy evaluation between the RecistTM criteria and the RECIST criteria, the correlation between different efficacy and progression free survival (PFS) under the RecistTM, and the correlation between the efficacy of RecistTM criteria and ctDNA level.

• Study Type: Observational
• Enrollment (Estimated): 44

Contacts and Locations

• Study Contact: Name: Xueqin Yang, PhD; Phone Number: 15923366936; Email: yangxueqin@hotmail.com

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400042
      • Recruiting
      • Cancer Center, Dapping Hospital, Army Medical Center of PLA
      • Contact: Xueqin Yang, PH.D.; Phone Number: 86-23-68757151; Email: yangxueqin@hotmail.com
      • Principal Investigator: Xueqin Yang, PH.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

NSCLC patients with stage IIIB-IV，Driver gene positive， and any one of the tumor markers is more than three times higher than the normal level,

Description

Inclusion Criteria:

• NSCLC patients with stage IIIB-IV
• Driver gene positive (EGFR,ALK,C-MET, ROS,RET, HER2);
• First line targeted therapy.
• Performance status of 0-2 on the ECOG criteria.
• Any one of the tumor markers is more than three times higher than the normal level, and the tumor markers include: CEA>15ng/ml,CA-199>105U/ml,CA-125>105 U/ml, NSE>60 ng/ml, SCCAg>7.5 ng/ml, CYFRA21-1>21 ng/ml, et al.
• Measurable lesions present
• Age>=18
• Adequate hematologic (neutrophil count >= 1,500/uL, platelets >= 60,000/uL,hemoglobin≥70g/L), hepatic (transaminase =< upper normal limit(UNL)x2.5, bilirubin level =< UNLx1.5), and renal (creatinine =< UNL) function.
• Informed consent from patient or patient's relative.

Exclusion Criteria:

• Patients with dysphagia;
• Unable to taking medication on time;
• Patients with a history of abuse of psychotropic substances who are unable to quit or have mental disorders

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation consistency	The ratio of the number of patients with the same efficacy evaluated both by RecistTM and Recist criteria to the total number of the patients.	efficacy evaluation at the 1st, 3rd, 6th month after treatment, and every 3 months thereafter up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
progression-free survival （PFS）	The correlation between the efficacy evaluation results of the RecistTM criteria and the RECIST criteria and PFS	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The correlation between the efficacy evaluation results of the RecistTM criteria and the results of ctDNA testing	The correlation between the efficacy evaluated by the RecistTM criteria and the ctDNA amounts detected by NGS	At the 1st, 3rd, 6th month after treatment, and at the time of disease progression, up to 2 years

Collaborators and Investigators

• Sponsor: Xueqin Yang

Study record dates

Study Major Dates

• Study Start (Estimated): November 13, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: October 31, 2023
• First Submitted That Met QC Criteria: November 15, 2023
• First Posted (Actual): November 21, 2023

Study Record Updates

• Last Update Posted (Actual): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: NSCLC; RECIST; tumor marker; RecistTM; positive driving gene
• Other Study ID Numbers: RecistTM-1

Drug and device information, study documents

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