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Simulation of Randomized Controlled Clinical Trial: Comparative Study on the Efficacy of EGFR-TKI as First-line Treatment for Advanced or Recurrent Metastatic Non-small Cell Lung Cancer

Simulation of Randomized Controlled Clinical Trial: Comparative Study on the Efficacy of EGFR-TKI as First-line Treatment for Advanced or Recurrent Metastatic Non-small Cell Lung Cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500111748
Enrollment
Unknown
Registered
2025-11-05
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

Interventions

Observational group:None

Sponsors

Center for Drug Evaluation, National Medical Products Administration
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Step 1: Inclusion Criteria: 1. Pathologically diagnosed with locally advanced or recurrent/metastatic (Stage IIIB-IV) non-small cell lung cancer; 2. Age >= 18 years; 3. Has at least one record of drug administration (or prescription) after diagnosis of locally advanced or recurrent/metastatic non-small cell lung cancer, or with an interval of more than one month between two visits; 4. Carries one of the two common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R); 5. Has received EGFR-TKI therapy; 6. Has not undergone curative surgery or radiotherapy after diagnosis of locally advanced or recurrent/metastatic non-small cell lung cancer. Step 2: Inclusion and Exclusion Criteria: Based on the outcomes of Step 1, four sub-cohorts will be established respectively, each with detailed inclusion and exclusion criteria for matched RCTs.

Exclusion criteria

Exclusion criteria: Patients complicated with other types of solid tumors

Design outcomes

Primary

MeasureTime frame
Demographic characteristics;Clinical Characteristics;Treatment Patterns;Therapeutic outcome and prognosis;

Countries

China

Contacts

Public ContactXin Xiaona

Center for Drug Evaluation, National Medical Products Administration

xinxn@cde.org.cn+86 10 6858 5566

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026