Study to Assess the Efficacy and Safety of Adjuvant Osimertinib in NSCLC With Uncommon EGFRm

NCT05546866 | Active Not Recruiting Phase 2

• 1 other identifier: D5161C00024
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 10

Brief Summary

This is an open-label, multi-centre, single-arm study assessing the efficacy and safety of osimertinib as adjuvant treatment in stage IB-IIIB (8th AJCC) NSCLC with uncommon EGFRm after receiving complete surgical resection with or without adjuvant chemotherapy.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 3-year disease-free survival (DFS) rate by investigator assessment

  DFS is defined as the time from the first dosing of study treatment until the date of disease recurrence by investigator assessment or death by any cause in the absence of disease recurrence. DFS rate at 3 years is defined as the proportion of patients alive and disease free at 3 years from the first dosing of study treatment as estimated by Kaplan-Meier method, respectively. Patients who are disease-free and alive at the time of analysis will be censored at the date of their latest follow-up assessment known to be disease-free

  Up to 3 years for each subject from the first dosing of study treatment.

Secondary Outcomes (8)

• DFS rate at 2 years

  Up to 2 years for each subject from the first dosing of study treatment.

• DFS rate at 5 years

  Up to 5 years for each subject from the first dosing of study treatment.

• OS rate at 2 years

  Up to 2 years for each subject from the first dosing of study treatment.

• OS rate at 3 years

  Up to 3 years for each subject from the first dosing of study treatment.

• OS rate at 4 years

  Up to 4 years for each subject from the first dosing of study treatment.

Study Arms (1)

Osimertinib

EXPERIMENTAL

Subjects successfully enrolled into the study will receive 80mg osimertinib QD p.o. until completion of planned treatment duration, recurrence of disease, or other treatment discontinuation criteria is met. The maximum treatment duration period is 3 years.

Drug: Osimertinib

Interventions

Osimertinib DRUG

Subjects successfully enrolled into the study will receive 80mg osimertinib QD p.o. until completion of planned treatment duration, recurrence of disease, or other treatment discontinuation criteria is met. The maximum treatment duration period is 3 years.

Osimertinib

Eligibility Criteria

• Age: 18 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of informed consent prior to any study specific procedures, sampling, and analyses.
• Male or female, aged at least 18 years.
• Histologically confirmed diagnosis of primary non-small cell lung cancer (NSCLC) on predominantly non-squamous histology.
• MRI or CT scan of the brain must be done prior to surgery as it is considered standard of care. Patients in whom this was not done prior to surgery may still be enrolled if appropriate imaging is performed prior to enrollment.
• Patients must be classified post-operatively as Stage IB, II, IIIA, or IIIB on the basis of pathologic criteria. Staging will be according to the 8th edition of AJCC Cancer Staging Manual.
• At least one documented uncommon EGFR mutation of G719X/L861Q/S768I/de novo T790M without EGFR Ex19del/L858R/exon 20 insertion as detected in tumour tissue, through real-time PCR or NGS analysis from accredited laboratories approved by the Chinese regulatory authority.
• 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. Resection may be accomplished by open or Video Associated Thoracic Surgery (VATS) techniques.
• Complete recovery from surgery and standard post-operative therapy (if applicable) at the time of enrollment. Treatment cannot commence within 4 weeks following surgery. No more than 10 weeks may have elapsed between surgery and the enrollment for patients who have not received adjuvant chemotherapy; no more than 26 weeks may have elapsed between surgery and enrollment for patients who received adjuvant chemotherapy.
• Complete post-operative wound healing must have occurred following any surgery.
• For patients who received post-operative adjuvant platinum-based chemotherapy, a minimum of 2 weeks must have elapsed (but no more than 10 weeks) from the last administered dose of chemotherapy to the date of enrollment.
• Patients must have recovered from all toxicities of 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.
• World Health Organization Performance Status of 0 to 1.
• Females must be using highly effective contraceptive measures, and must have a negative pregnancy test prior to start of dosing if of child-bearing potential, or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening:
• Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments.
• Women less than 50 years old would be consider postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels in the post-menopausal range for the institution.

You may not qualify if:

• Previous enrollment and treatment in the present study.
• Participation in another clinical study with a study intervention or investigational medicinal device administered in the last 8 weeks prior to enrollment, or concurrent enrollment and exposure in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
• 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.
• Any prior anticancer therapy, including investigational therapy, for treatment of NSCLC other than standard platinum based doublet post-operative adjuvant chemotherapy.
• Prior treatment with neoadjuvant or adjuvant EGFR-TKI.
• Major surgery (including primary tumour surgery, excluding placement of vascular access) within 4 weeks of the first dose of study drug.
• Patients currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inducers of CYP3A4 (at least 3 week prior) (Appendix F). All patients must try to avoid concomitant use of any medications, herbal supplements and/or ingestion of foods with known inducer effects on CYP3A4.
• Treatment with an investigational drug within five half-lives of the compound or any of its related material, if known.
• 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 and which, in the opinion of the treating physician, do not have a substantial risk of recurrence of the prior malignancy.
• Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the Investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardise compliance with the protocol; or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV).
• Screening for chronic conditions is not required.
• Active infection will include any patients receiving treatment for infection.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (10)

Research Site

Beijing, 100730, China

Location

Research Site

Chengdu, 610000, China

Location

Research Site

Chengdu, 610041, China

Location

Research Site

Fuzhou, 350011, China

Location

Research Site

Guangzhou, 510080, China

Location

Research Site

Kunming, 650118, China

Location

Research Site

Ningbo, 315010, China

Location

Research Site

Shijiazhuang, 050051, China

Location

Research Site

Suzhou, 215006, China

Location

Research Site

Tianjin, 300060, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

osimertinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: September 21, 2022
• Study Start: February 9, 2023
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2029
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Locations

CN (10)