Status:
Recruiting
Disease Site:
Lung
Phase:
Official Title:
AVANZAR D926NC00001 Phase III , Randomized, open-labeled, Multicenter, global study of Datpoptamab and Carboplatin Vs Pembro in Combo w/ platinum-based Chemo for the First line tx of Pt’s w/ locally advanced or Metastatic NSCLC WITHOUT actionable Genomic Alterations
NCT ID:
NCT#05687266
Link to Full Details:
Description:
This is a Phase III, randomized, open-label, multicenter, global study to compare the efficacy and safety of Datopotamab Deruxtecan (Dato-DXd) in combination with durvalumab and carboplatin compared with pembrolizumab in combination with histology-specific platinum-based chemotherapy as first-line treatment of adults with stage IIIB, IIIC, or IV NSCLC without actionable genomic alterations (including sensitizing EGFR mutations, and ALK and ROS1 rearrangements).
Eligibility:
Male and Female – 18 years and older
Inclusion Criteria:
- No actionable Genomic Alterations
- ECOG 0-1
- Stg IIIB or IIIC disease not amenable to surgical resection or definitive chemoradiation, or Stg IV metastatic NSCLC at time of Rando.
- Not received prior chemo/systemic therapy for first-line Stg IIIB, IIIC or IV NSCLC
- Must have FFPE tumor sample (can use archival tissue) collected prior to Rando for Central lab PDL1 /TROP2 testing
- Measurable dx per RECIST 1.1
Exclusion Criteria:
- Mixed small-cell lung cancer and NSCLC histology: sacromatoid variant of NSCLC
- Active or prior documented autoimmune, connective tissue or inflammatory disorders
- Prior exposure to durvalumab, any agent including ADC containing a chemo targeting topoisomerase I, TROP2-targeted therapy