Clinical trial NCT06142058: RecistTM Criteria in Evaluating the Efficacy of Targeted Therapy for NSCLC
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Evaluation
NSCLC
Targeted Therapy
Keywords: tumor marker
NSCLC
RECIST
RecistTM
positive driving gene
Lead sponsor: Third Military Medical University
Sponsor class: OTHER
First posted: 2023-11-21
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
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,

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation consistency
timeFrame: efficacy evaluation at the 1st, 3rd, 6th month after treatment, and every 3 months thereafter up to 1 year
Secondary outcomes:
measure: progression-free survival （PFS）
timeFrame: 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 outcomes:
measure: The correlation between the efficacy evaluation results of the RecistTM criteria and the results of ctDNA testing
timeFrame: At the 1st, 3rd, 6th month after treatment, and at the time of disease progression, up to 2 years
Locations:
city: Chongqing
country: China
facility: Cancer Center, Dapping Hospital, Army Medical Center of PLA
state: Chongqing
Study officials:
References: