Evaluating targeted therapy effectiveness in advanced lung cancer using RecistTM criteria
Application of the RecistTM Criteria in Evaluating the Efficacy of Targeted Therapy for Advanced Non-small Cell Lung Cancer With Positive Driving Genes
This study is testing if a new way to measure how well targeted therapy works can help people with advanced lung cancer who have specific gene changes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 44 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Third Military Medical University Academic / other |
| Locations | 1 site (Chongqing, Chongqing Municipality) |
| Trial ID | NCT06142058 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the efficacy of the RecistTM criteria in evaluating targeted therapy for patients with advanced non-small cell lung cancer (NSCLC) who have positive driving genes. The study will analyze the correlation between tumor marker abnormalities and treatment outcomes, focusing on patients receiving first-line targeted therapy. Investigators will use statistical methods to compare the RecistTM criteria with traditional RECIST criteria and explore the relationship between treatment efficacy and circulating tumor DNA levels. The goal is to refine the evaluation rules of RecistTM to enhance its reliability in clinical settings.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with stage IIIB-IV NSCLC who have positive driving genes and measurable lesions.
Not a fit: Patients with dysphagia or those unable to adhere to medication schedules may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate assessments of treatment efficacy for patients with advanced NSCLC, potentially improving patient outcomes.
How similar studies have performed: While the use of RECIST criteria is well-established, the application of RecistTM criteria in this specific context is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chongqing, Chongqing Municipality
- Cancer Center, Dapping Hospital, Army Medical Center of PLA — Chongqing, Chongqing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Xueqin Yang, PhD
- Email: yangxueqin@hotmail.com
- Phone: 15923366936
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.