A Study of SHR-A2009 Versus Platinum-based Chemotherapy in EGFR-mutated, Advanced or Metastatic N… (NCT06671379) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Study of SHR-A2009 Versus Platinum-based Chemotherapy in EGFR-mutated, Advanced or Metastatic NSCLC
China498 participantsStarted 2024-11-29
Plain-language summary
This study was a randomized, controlled, open-label, multicenter phase III clinical study to compare the efficacy and safety of SHR-A2009 with platinum-based dual-agent chemotherapy in patients with EGFR-mutated advanced or metastatic non-small cell lung cancer who failed EGFR TKI treatment.
Who can participate
Age range
18 Years – 75 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
. Age 18 to 75 years old (inclusive), Female or male
. Subjects with unresectable locally advanced or metastatic non-squamous non-small cell lung cancer confirmed by histology or cytology
. Previously treated by EGFR-TKI；
. At least one measurable tumor lesion according to RECIST v1.1
. ECOG performance score of 0-1;
. Expected survival time ≥ 12 weeks;
. Adequate bone marrow and organ function
. Subjects are required to give informed consent for this study prior to the trial and voluntarily sign a written informed consent form.
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
Progression-free survival (PFS) assessed by BICR according to RECIST v1.1
. Subjects with active central nervous system (CNS) metastases.
. Received antitumor therapy such as chemotherapy within 4 weeks prior to the first dose of study drug;
. Received \>30 Gy of non-thoracic radical radiation therapy within 4 weeks prior to the first administration of study drug;
. Major organ surgery or significant trauma within 4 weeks prior to first use of study drug;
. Concomitant other malignancies ≤ 5 years prior to first dose of study drug;
. Subjects with a history of interstitial pneumonitis or imaging at screening suggestive of suspected interstitial pneumonitis; or other moderate-to-severe lung disease that severely affects lung function
. Serious cardiovascular disease
. Presence of severe infection within 4 weeks prior to first dose of study drug