Clinical Trial: NCT04923906
Aumolertinib with or Without Chemotherapy As 1st Line Treatment in Locally Advanced or Metastatic Non-Small Cell Lung Cancer with Sensitizing EGFR Mutations
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 3| Lead Sponsor: | Jiangsu Hansoh Pharmaceutical Co., Ltd. |
| Information Provided By: | Jiangsu Hansoh Pharmaceutical Co., Ltd. |
| Last Update Posted: | 2024-11-25 |
Study Overview
Brief Summary
To assess the efficacy and safety of Aumolertinib plus chemotherapy versus Aumolertinib alone as first-line treatment in locally advanced or metastatic non-small cell lung cancer (NSCLC) with sensitizing epidermal growth factor receptor mutations (EGFRm+).
Official Title
Efficacy and Safety of Aumolertinib with or Without Chemotherapy As First-line Treatment in Locally Advanced or Metastatic Non-Small Cell Lung Cancer with Sensitizing Epidermal Growth Factor Receptor Mutations: a Randomized, Controlled, Open-label, Phase 3 and Multicenter Clinical Study
Conditions
Non-small Cell Lung Cancer
Intervention / Treatment
- Drug: Aumolertinib
- Drug: Placebo Aumolertinib
Other Study ID Numbers
- HS-10296-306
Start Date (Actual)
2021-08-11
Primary Completion Date (Actual)
2024-06-18
Study Completion Date (Estimated)
2026-01-31
Enrollment (Estimated)
624
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | Jiangsu Hansoh Pharmaceutical Co., Ltd. |
| Information Provided By: | Jiangsu Hansoh Pharmaceutical Co., Ltd. |
| Last Update Posted: | 2024-11-25 |
Study Overview
Brief Summary
To assess the efficacy and safety of Aumolertinib plus chemotherapy versus Aumolertinib alone as first-line treatment in locally advanced or metastatic non-small cell lung cancer (NSCLC) with sensitizing epidermal growth factor receptor mutations (EGFRm+).
Official Title
Efficacy and Safety of Aumolertinib with or Without Chemotherapy As First-line Treatment in Locally Advanced or Metastatic Non-Small Cell Lung Cancer with Sensitizing Epidermal Growth Factor Receptor Mutations: a Randomized, Controlled, Open-label, Phase 3 and Multicenter Clinical Study
Conditions
Non-small Cell Lung Cancer
Intervention / Treatment
- Drug: Aumolertinib
- Drug: Placebo Aumolertinib
Other Study ID Numbers
- HS-10296-306
Start Date (Actual)
2021-08-11
Primary Completion Date (Actual)
2024-06-18
Study Completion Date (Estimated)
2026-01-31
Enrollment (Estimated)
624
Study Type
Interventional
Phase
Phase 3