RecistTM Criteria in Evaluating the Efficacy of Targeted Therapy for NSCLC

NSCLC Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06142058
• Other study ID #: RecistTM-1
• Status: Recruiting
• Start date: November 13, 2023
• Est. completion date: December 31, 2028

Study information

• Verified date: November 2023
• Source: Third Military Medical University
• Contact: Xueqin Yang, PhD
• Phone: 15923366936
• Email: yangxueqin[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2026
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Evaluation
• NSCLC
• Targeted Therapy

Intervention

Diagnostic Test:
• RecistTM criteria
RecistTM criteria and RECIST criteria were used to evaluate the efficacy of targeted therapy for NSCLC with positive driving gene.

Locations

Country	Name	City	State
China	Cancer Center, Dapping Hospital, Army Medical Center of PLA	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Xueqin Yang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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