Study to Assess the Efficacy and Safety of Adjuvant Osimertinib in NSCLC With Uncommon EGFRm (NCT05546866) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Study to Assess the Efficacy and Safety of Adjuvant Osimertinib in NSCLC With Uncommon EGFRm
China51 participantsStarted 2023-02-09
Plain-language 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.
Who can participate
Age range
18 Years – 130 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
3-year disease-free survival (DFS) rate by investigator assessment
Timeframe: Up to 3 years for each subject from the first dosing of study treatment.
. 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:
. 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).
. Negative for HBsAg and positive for hepatitis B core antibody \[anti-HBc IgG\] or
. Positive for HBsAg, negative for HBeAg but for \> 6 months have had transaminases levels below ULN and HBV DNA levels ≤ 100 IU/mL (i.e., are in an inactive carrier state). Refer to Restrictions, Section 5.3.