A Study of SHR-A2009 Versus Platinum-based Chemotherapy in EGFR-mutated, Advanced or Metastatic N… (NCT06671379) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Study of SHR-A2009 Versus Platinum-based Chemotherapy in EGFR-mutated, Advanced or Metastatic NSCLC
China498 participantsStarted 2024-11-29
Plain-language summary
This study was a randomized, controlled, open-label, multicenter phase III clinical study to compare the efficacy and safety of SHR-A2009 with platinum-based dual-agent chemotherapy in patients with EGFR-mutated advanced or metastatic non-small cell lung cancer who failed EGFR TKI treatment.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Age 18 to 75 years old (inclusive), Female or male
✓. Subjects with unresectable locally advanced or metastatic non-squamous non-small cell lung cancer confirmed by histology or cytology
✓. Previously treated by EGFR-TKI；
✓. At least one measurable tumor lesion according to RECIST v1.1
✓. ECOG performance score of 0-1;
✓. Expected survival time ≥ 12 weeks;
✓. Adequate bone marrow and organ function
✓. Subjects are required to give informed consent for this study prior to the trial and voluntarily sign a written informed consent form.
Exclusion criteria
✕. Subjects with active central nervous system (CNS) metastases.
✕. Received antitumor therapy such as chemotherapy within 4 weeks prior to the first dose of study drug;
✕. Received \>30 Gy of non-thoracic radical radiation therapy within 4 weeks prior to the first administration of study drug;
✕. Major organ surgery or significant trauma within 4 weeks prior to first use of study drug;
✕. Concomitant other malignancies ≤ 5 years prior to first dose of study drug;
What they're measuring
1
Progression-free survival (PFS) assessed by BICR according to RECIST v1.1
✕. Subjects with a history of interstitial pneumonitis or imaging at screening suggestive of suspected interstitial pneumonitis; or other moderate-to-severe lung disease that severely affects lung function
✕. Serious cardiovascular disease
✕. Presence of severe infection within 4 weeks prior to first dose of study drug