A Trial of Injectable SHR-A1811 in Combination With Pyrotinib or SHR-1316 in Subjects With Advanc… (NCT05482568) | Clinical Trial Compass
RecruitingPhase 1/2
A Trial of Injectable SHR-A1811 in Combination With Pyrotinib or SHR-1316 in Subjects With Advanced Non-small Cell Lung Cancer
China324 participantsStarted 2022-09-15
Plain-language summary
This study was an open, multicenter, dose-increasing/investigational Phase IB/II clinical trial to evaluate the efficacy of SHR-A1811 in combination with other antitumor therapies in subjects with advanced non-small cell lung cancer with HER2 . It can be divided into two parts, Part A is the dose escalation and efficacy exploration study of SHR-A1811 combined with Pyrotinib, and Part B is the dose escalation and efficacy exploration study of SHR-A1811 combined with SHR-1316.
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
. Ability to give informed consent, signed and dated IRB/EC approved informed consent, willing and able to comply with treatment planning visits, tests and other procedural requirements
. When signing the informed consent, the age is 18-75 years old (including both ends), and there is no gender limitation
. The ECOG score is 0 or 1
. The expected survival is ≥12 weeks
. Subjects with advanced or metastatic non-small cell lung cancer
. Formalin fixed, paraffin-embedded tumor tissue blocks or sections of unstained tumor specimens are provided
. Subjects who have failed prior standard care or are intolerant to standard care
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
DLT(Phase I (dose exploration phase) main study endpoint)
Timeframe: 21 days after the first administration of each subject
2
AE(Phase I (dose exploration phase) main study endpoint)
Timeframe: Two years after the last subject was enrolled in the group
3
Incidence and severity of serious adverse events (SAE)(Phase I (dose exploration phase) main study endpoint)
Timeframe: Two years after the last subject was enrolled in the group
4
Objective response rate(The main end points of the second stage (efficacy expansion stage))
Timeframe: Two years after the last subject was enrolled in the group
. There are untreated or active central nervous system (CNS) tumor metastases
. Pleural, ascites, or pericardial effusion requiring intervention occurred within 7 days prior to initial administration
. Systemic antitumor therapy was performed 4 weeks prior to study initiation
. Prior treatment with antibody-conjugated drugs
. Received \>30 Gy chest radiation within 6 months prior to initial administration
. Palliative radiotherapy was completed within 7 days prior to initial administration
. Failure to recover from toxicity and/or complications of previous interventions to nCI-CTCAE ≤1
. The half-life of CYP3A4 suppressor, moderate inhibitor or strong inducer or moderate inducer is less than 3 or less than 14 days from the date of first drug use, and the shorter is selected