Aumolertinib Adjuvant Therapy of Resectable Stage I EGFRm+ NSCLC With High-grade Patterns

NCT04922138 | Unknown Phase 2

• 1 other identifier: HSM-10296-A017
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 2

Brief Summary

Efficacy and safety of postoperative adjuvant treatment of NSCLC patients with Aumolertinib.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 2-year Disease free survival (DFS) rate

  Defined as the proportion of patients alive and disease free at 2 years,estimated from Kaplan Meier plots of the primary endpoint of DFS at the time of the primary analysis

  From date of treatment start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

Secondary Outcomes (3)

• 3-, 4-, and 5-year DFS rate

  From date of treatment start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months

• Overall Survival (OS)

  Start of study drug to Survival Endpoint through study completion, an average of 5 years, assessed up to 60 months

• Patient health-related quality of life and symptoms (HRQoL) by SF-36v2 Health Survey

  From date of treatment start until treatment completion or discontinuation, assessed up to 60 months

Other Outcomes (1)

• Incidence of Adverse Events (AEs)

  From date of treatment start until 28 days after treatment completion

Study Arms (2)

Arm A

EXPERIMENTAL

Orally 110 mg Aumolertinib tablets (55 mg/tablet, 2 tablets/day) once a day .

Drug: Aumolertinib

Arm B

NO INTERVENTION

Observation

Interventions

Aumolertinib DRUG

All subjects who meet the enrollment conditions will be included in the Aumolertinib monotherapy group: Orally 110 mg Aumolertinib tablets (55 mg/tablet, 2 tablets/day) once a day until recurrence or completion of treatment or reaching the standard of discontinuation.

Also known as: HS-10296

Arm A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, aged at least 18 years.
• Histologically confirmed diagnosis of primary non small lung cancer (NSCLC) on predominantly non-squamous histology.
• Brain examination must be done prior to surgery as it is considered standard of care.
• Patients are pathologically confirmed to be stage I after operation, containing solid, micropapillary, and/or complex gland components ≥10%.
• Confirmation by the central laboratory that the tumour harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations including T790M.
• Providing paraffin embedded section(10-15sheets),wax blocks or fresh frozen tissues.
• Complete surgical resection of the primary NSCLC is mandatory. All gross disease must have been removed at the end of surgery. All surgical margins of resection must be negative for tumour.
• World Health Organization Performance Status of 0 to 1.
• Women of childbearing age should take appropriate contraceptive measures from screening to 3 months after stopping the study treatment and should not breastfeed. Before starting the administration, the pregnancy test was negative.
• Male patients should be willing to use barrier contraception from screening to stopping study treatment for 3 months.(i.e., condoms).
• ≤10 weeks between surgery and treatment period

You may not qualify if:

• Treatment with any of the following:
• Pre-operative or post-operative or planned radiation therapy for the current lung cancer
• Pre-operative (neo-adjuvant) platinum based or other chemotherapy
• Prior treatment with neoadjuvant or adjuvant EGFR-TKI at any time
• Any other anti-tumor treatment for lung cancer(Including proprietary Chinese patent medicine with anti-tumor effects and anti-tumor immunotherapy, etc.)
• Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study drug.
• Treatment with an investigational drug within five half-lives of the compound or any of its related material.
• Medications that are predominantly CYP3A4 strong inhibitors or inducers or sensitive substrates of CYP3A4 with a narrow therapeutic range within 7 days of the first dose of study drug..
• Patients who have had only segmentectomies or wedge resections
• History of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer, or other solid tumours curatively treated with no evidence of disease for \> 5 years following the end of treatment.
• Any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study treatment with the exception of alopecia and Grade 2, prior platinum-therapy related neuropathy.
• Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses; or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV).
• Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of Aumolertinib.
• Any of the following cardiac criteria:
• Mean resting corrected QT interval (QTc) \> 470 ms obtained from 3 electrocardiograms (ECGs), using the screening clinic's ECG machine and Fridericia's formula for QT interval correction (QTcF).

Sponsors & Collaborators

• Baohui Han: lead
• Jiangsu Hansoh Pharmaceutical Co., Ltd.: collaborator

Study Sites (2)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

aumolertinib

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Baohui Han, doctor

CONTACT

18930858216; 18930858216@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: June 10, 2021
• Study Start: January 14, 2022
• Primary Completion: April 15, 2024
• Study Completion: October 15, 2025
• Last Updated: April 21, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)