Clinical Trial: NCT04687241
Almonertinib Versus Placebo as Adjuvant Therapy in Resected Stage II-IIIB Non-Small Cell Lung Cancer With EGFR-sensitive 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: | 2024-11-07 |
Study Overview
Brief Summary
To assess the efficacy and safety of Almonertinib versus placebo in patients with epidermal growth factor receptor mutation-positive (EGFRm+) stage II-IIIB non-small cell lung cancer (NSCLC), following complete tumor resection with or without adjuvant chemotherapy.
Official Title
Efficacy and Safety of Almonertinib Versus Placebo as Adjuvant Therapy for Subjects With Resected Stage II-IIIB NSCLC Harboring EGFR-sensitive Mutations: A Randomized, Controlled, Double-blind, Phase 3 and Multicenter Clinical Study
Conditions
Non-small Cell Lung Cancer
Intervention / Treatment
- Drug: Almonertinib
- Drug: Placebo Almonertinib
Other Study ID Numbers
- HS-10296-302
Start Date (Actual)
2021-04-30
Primary Completion Date (Actual)
2024-07-08
Study Completion Date (Estimated)
2029-01-01
Enrollment (Estimated)
192
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | Jiangsu Hansoh Pharmaceutical Co., Ltd. |
| Information Provided By: | Jiangsu Hansoh Pharmaceutical Co., Ltd. |
| Last Update Posted: | 2024-11-07 |
Study Overview
Brief Summary
To assess the efficacy and safety of Almonertinib versus placebo in patients with epidermal growth factor receptor mutation-positive (EGFRm+) stage II-IIIB non-small cell lung cancer (NSCLC), following complete tumor resection with or without adjuvant chemotherapy.
Official Title
Efficacy and Safety of Almonertinib Versus Placebo as Adjuvant Therapy for Subjects With Resected Stage II-IIIB NSCLC Harboring EGFR-sensitive Mutations: A Randomized, Controlled, Double-blind, Phase 3 and Multicenter Clinical Study
Conditions
Non-small Cell Lung Cancer
Intervention / Treatment
- Drug: Almonertinib
- Drug: Placebo Almonertinib
Other Study ID Numbers
- HS-10296-302
Start Date (Actual)
2021-04-30
Primary Completion Date (Actual)
2024-07-08
Study Completion Date (Estimated)
2029-01-01
Enrollment (Estimated)
192
Study Type
Interventional
Phase
Phase 3