Evaluating the effects of relaxing eligibility criteria for lung cancer treatments
Quantitative Evaluation of the Impact of Relaxing Eligibility Criteria on the Risk-benefit Profile of Drugs for Lung Cancer Based on Real-world Data
This study is trying to see if making it easier for people with non-small cell lung cancer to join drug trials can improve their treatment options and outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50000 (estimated) |
| Sex | All |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06314542 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the impact of relaxing eligibility criteria for non-small cell lung cancer (NSCLC) drug trials using real-world data. By constructing a structured database through deep learning methods, the research will analyze how changes in eligibility criteria affect patient enrollment, clinical efficacy, and safety. The study will utilize Monte Carlo simulations and propensity matching to create randomized virtual cohorts for a comprehensive benefit-risk assessment. The goal is to provide evidence that could lead to more inclusive and effective lung cancer treatment protocols.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with stage IIIB, IIIC, or IV non-small cell lung cancer who have had at least two clinical visits since 2013.
Not a fit: Patients with early-stage NSCLC (stage I-IIIa) will not benefit from this study as they do not meet the inclusion criteria.
Why it matters
Potential benefit: If successful, this study could enhance patient access to lung cancer treatments and improve outcomes by ensuring a more diverse patient population in clinical trials.
How similar studies have performed: While the approach of relaxing eligibility criteria is gaining attention, this specific methodology using deep learning and real-world data for NSCLC is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients in the database were considered to be part of the real-world cohort if they were (1) diagnosed with NSCLC according to the tenth revision of the international classification of diseases (ICD-10) code; (2) diagnosed with stage IIIB, IIIC, IV NSCLC between 1 January 2013 and 31 December, 2022; (3) had at least two documented clinical visits on or after 1 January 2013. Exclusion Criteria: （1）NSCLC in stage I-IIIa
Where this trial is running
Beijing
- Cancer Hospital, Chinese Academy of Medical Sciences — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Ning Li, doctor
- Email: ncctrials@cicams.ac.cn
- Phone: 01087788713
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.