Phase II Study of SY-3505 in Patients With ALK-positive NSCLC Who Have Failed Prior Second-Genera… (NCT05869162) | Clinical Trial Compass
UnknownPhase 2
Phase II Study of SY-3505 in Patients With ALK-positive NSCLC Who Have Failed Prior Second-Generation ALK TKI
China153 participantsStarted 2023-06-30
Plain-language summary
This is an open-label, single-arm, multicenter, phase II study to evaluate the efficacy and safety of SY-3505 capsule in patients with locally advanced or metastatic NSCLC who have progressed on or are intolerant to second-generation ALK tyrosine kinase inhibitor (TKI).
Who can participate
Age range
18 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 years at the time of signing the informed consent form (ICF).
. Histologically or cytologically confirmed locally advanced (tumor lesion could not be radically cued by surgery or radiation as asessed by the investigators) or metastatic NSCLC.
. Prior treated with at least one second-generation ALK TKI (including unmarketed investigational drugs) and imaging evidence of disease progression (PD) or intolerance to prior treatment toxicity.
. Agree to provide fresh tumor tissue samples to test positive for ALK fusion (ALK-positive) by the central laboratory:
. If the patient is indeed unable to provide fresh tumor tissue samples (e.g., repuncture has been assessed by the investigator as having a higher clinical risk) and cannot provide archived tissue samples within 2 years prior to initial administration, but can provide ALK-positive testing reports within 2 years prior to the first administration (detection methods include FISH, RT-PCR, IHC \[Ventana method\] or NGS, etc.), inclusion or not of the patient will be discussed and decided by the investigator and the sponsor;
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
Objective Response Rate (ORR) assessed by the independent review committee (IRC)
. If the patient is indeed unable to provide either fresh tumor tissue samples (e.g., repuncture has been assessed by the investigator as having a higher clinical risk) or ALK-positive testing reports within 2 years prior to the first administration, but can provide archived tissue samples within 2 years prior to the first administration and confirmed as ALK-positive by the central laboratory, inclusion or not of the patient will be discussed and decided by the investigator and the sponsor.
. Must have at least one extracranial target lesion that meets the RECIST 1.1 criteria; For a lesion that has previously received radiotherapy, it can be assessed as a target lesion only when it shows definite progression after radiotherapy.
. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
Exclusion criteria
. Patients with known driver alterations other than ALK, such as EGFR, MET, RET, ROS1, NTRK, etc. (If ALK co-mutation exists, the patient can discuss with the investigator for enrollment);
. Previous treated with any third-generation ALK TKI (including marketed drugs such as loratinib, and unmarketed investigational drugs);
. History of allergy to any component or excipient of SY-3505 capsules;
. With other primary malignancies, except those that have been cured and have not recurred within 2 years prior to screening, and those that have been cured of basal or squamous cell carcinoma of the skin, carcinoma in situ of cervix, or carcinoma in situ of breast;
. The presence of symptomatic primary CNS tumors, symptomatic CNS metastases, leptomeningeal carcinomatosis, or untreated spinal cord compression. Except: Patient had stable CNS disease (no evidence of progression identified by imaging for at least 4 weeks prior to initial administration, and all neurological symptoms had recovered to baseline), no evidence of new or progressive brain metastases, no CNS surgery or radiotherapy within 4 weeks prior to initial administration, and no stereotactic radiosurgery (SRS) within 2 weeks prior to initial administration. Steroid administration was stopped or the dose stabilized within 2 weeks prior to initial administration. (This exception does not include cancerous meningitis, which should be excluded regardless of clinically stable conditions).
. The following symptoms or diseases occurred prior to initial administration and remain poorly controlled after optimal treatment:
. Systemic bacterial, viral or fungal infection with uncontrolled activity;
. Poorly controlled (poorly control refers to the effusion increases significantly within 2 weeks after extraction, with obvious symptoms, requiring further puncture or other intervention) pleural effusion, abdominal effusion or pericardial effusion after intervention (such as drainage) ;