Ignite Creation Date:
2025-12-24 @ 2:47 PM
Ignite Modification Date:
2025-12-26 @ 4:14 PM
Study NCT ID:
NCT04762459
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2022-02-24
First Post:
2021-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Almonertinib Combined With or Without Chemotherapy as an Adjuvant Treatment for Stage II-IIIA Non-small Cell Lung Carcinoma Following Complete Tumour Resection
Sponsor:
Chinese Academy of Medical Sciences
Organization:
Study Overview
Official Title:
Efficacy and Safety of Almonertinib Combined With or Without Chemotherapy as an Adjuvant Treatment for EGFR Mutation Positive Stage II-IIIA Non-small Cell Lung Carcinoma Following Complete Tumour Resection: A Multicenter, Randomized Controlled, Open-label Clinical Study
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
APEX
Brief Summary:
This is a multicenter, randomized, open label, phase III study.
Detailed Description:
This is a multicenter, randomized, open label, phase III study assessing the efficacy and safety of Almonertinib combined with or without chemotherapy as an adjuvant treatment in patients with epidermal growth factor receptor (EGFR) mutation positive stage II-IIIA non-squamous NSCLC following complete tumour resection: Eligible patients will be randomized to receive either Almonertinib alone (110mg, po, once daily) or Almonertinib (110mg, po, once daily) plus pemetrexed (500mg/m2, iv) and cisplatin (500mg/m2, iv) or pemetrexed (500mg/m2, iv) plus cisplatin (500mg/m2, iv) in a 3:2:1 ratio.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: