Clinical trial NCT06314542: Quantitative Evaluation of the Impact of Relaxing Eligibility Criteria for Lung Cancer Based on Real-world Data
Official title: Quantitative Evaluation of the Impact of Relaxing Eligibility Criteria on the Risk-benefit Profile of Drugs for Lung Cancer Based on Real-world Data
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2024-03-18
Enrollment: 50000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Those patients diagnosed with primary NSCLC in stage IIIb-IV, are the study population.

Brief summary: Eligibility criteria for cancer drug trials are generally too stringent, leading to key issues such as low enrolment rates and lack of population diversity. In order to evaluate the REC of NSCLC drug trials, this study will use deep learning methods to construct a structured real-world database of NSCLC across dimensions, and quantitatively assess the independent contribution of changes in each eligibility criterion to patient numbers, clinical efficacy and safety.

Detailed description: Restrictive eligibility criteria in cancer drug trials result in low enrollment rates and limited population diversity. Relaxed eligibility criteria (REC) based on solid evidence is becoming necessary for stakeholders worldwide. However, the absence of high-quality, favorable evidence remains a major challenge. This study presents a protocol to quantitatively evaluate the impact of relaxing eligibility criteria in common non-small cell lung cancer (NSCLC) protocols in China, on the risk-benefit profile. This involves a detailed explanation of the rationale, framework, and design of REC.

To evaluate our REC in NSCLC drug trials, we will first construct a structured, cross-dimensional real-world NSCLC database using deep learning methods. We will then establish randomized virtual cohorts and perform benefit-risk assessment using Monte Carlo simulation and propensity matching. Shapley value will be utilized to quantitatively measure the effect of the change of each eligibility criterion on patient volume, clinical efficacy and safety.

Eligibility 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

Primary outcomes:
measure: Scale of eligibility criteria
timeFrame: 2024.12.31
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Sciences
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Ning Li, doctor
role: STUDY_DIRECTOR
References: