First-line Treatment With Dacomitinib Plus Anlotinib for Patients With Advanced NSCLC With EGFR 21L858R Mutations

This is a multicenter, open label, Phase I/IIB study investigating the efficacy and safety of treatment with dacomitinib plus anlotinib as first-line therapy for patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) 21-L858R mutations. This study comprises two parts: 1. A dose escalation Phase I study to determine the recommended phase II dose. 2. a multi-center, open label, randomized controlled, Phase IIB study.

Trial Details

NCT ID
NCT05271916
Phase
PHASE1 / PHASE2
Sponsor
Shanghai Chest Hospital
Status
RECRUITING
Cancer Type
Non-Small Cell (NSCLC) Lung Cancer
Interventions
  • Dacomitinib+Anlotinib
  • Dacomitinib
Locations (sample)
  • Shanghai, Shanghai Municipality, China|31.22222,121.45806

Key Eligibility Criteria

  • ≥18 years of age and ≤75 years;
  • Provision of a voluntarily given, personally signed and dated, written informed consent document;
  • Histologically documented, unresectable, inoperable, locally advanced, recurrent or metastatic stage IIIB or IV non-small cell lung cancer (NSCLC);
  • It is acceptable for subjects with the presence of EGFR activating mutation (exon 19 deletion and the L858R mutation in exon 21) to be included in …

For full eligibility, visit ClinicalTrials.gov.

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