Non-small-cell Lung CarcinomaPhase 2NCT05869162

Phase II Study of SY-3505 in Patients With ALK-positive NSCLC Who Have Failed Prior Second-Generation ALK TKI

A Phase 2 study testing SY-3505 in people with Non-small-cell Lung Carcinoma, run by Shouyao Holdings (Beijing) Co. LTD at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-small-cell Lung Carcinoma
What is being tested?: SY-3505
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 153 participants
Where: 1 siteChina
Study dates: 30 Jun 2023to 10 Jun 2025
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients must meet all of the following criteria to be eligible to participate in this study:
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;

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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.
Estimated Life expectancy ≥ 3 months.
Prior antitumor treatment-related AE had recovered to ≤ Grade 1 as defined by NCI-CTCAE v 5.0 prior to initial administration (except for toxicities without safety risk as determined by the investigator, such as alopecia, Grade 2 peripheral neurotoxicity associated with prior platinum therapy, etc.).
Organ function shall meet the following requirements:
No blood products, hematopoietic cell growth factors (e.g., granulocyte colony stimulating factor, erythropoietin), or other medication received to correct abnormal blood routine at least 2 weeks before initial administration, and blood routine: Absolute neutrophil count (ANC) ≥1.5×109/L, Platelets (PLT) ≥100×109/L, Platelets (Hb) ≥90g/L;
Pancreatic function: Serum total amylase ≤1.5× upper limit of normal (ULN); Serum lipase ≤1.5×ULN (it is allowed to be included if serum total amylase>1.5× ULN, but the pancreatic amylase is in the ULN range);
Hepatic function: Total serum bilirubin (TBIL) ≤ 1.5×ULN, Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5×ULN if no liver metastases, or otherwise TBIL ≤ 3×ULN, AST and ALT ≤ 5×ULN.
Renal function: Creatinine clearance ≥ 50 mL/min (according to Cockcroft-Gault Equation).
Coagulation function: International normalized ratio (INR) and prothrombin time (PT)≤ 1.5×ULN (except for patients receiving anticoagulant therapy).
Be able to swallow medication, follow protocol procedures, and comply with follow-up visit requirements.
Female patients with reproductive potential agreed to use effective method of contraception throughout the entire study duration and for at least 3 months after the last dose of study medication.

Who cannot join

Patients who meet any of the following criteria are not eligible to participate in this study:
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).

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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) ;
Poorly controlled diabetes (fasting blood glucose ≥11.1 mmol/L and/or HbA1c ≥ 8%);
Uncontrolled symptomatic hyperthyroidism or hypothyroidism as assessed by the investigator;
Uncontrolled electrolyte disturbances (e.g., hypocalcemia, hypomagnesium, hypokalemia) as assessed by the investigator;
Clinically significant gastrointestinal disorders included active ulcerative colitis, Crohn's disease, gastrointestinal ulcers, or prior surgical procedures that could significantly affect drug absorption as assessed by the investigator.
Presence with severe cardiovascular diseases/abnormalities, meeting any of the following criteria:
Patients with corrected QT interval for heart rate according to Fridericia's formula > 470 msec (females) and > 450 msec (males) during the screening period (If prolonged QTcF suspected to be caused by medication and was assessed as safe and controllable by the investigator, the patient can be enrolled after drug correction);
Left ventricular ejection fraction (LVEF) < 50%;
Myocardial infarction or unstable angina or clinically significant uncontrolled arrhythmias, including bradyarrhythmia (such as type II second degree heart block or third degree heart block) that may lead to prolonged QTcF within 6 months prior to initial administration;
Class III or IV congestive heart failure according to New York Heart Association (NYHA) classification;
History of poorly controlled hypertension, unstable hypertension, or poor compliance with antihypertensive therapy as assessed by the investigator.
Presence or with histiory of the following active viral infection:
Active hepatitis B (HBsAg positive and HBV-DNA ≥2×103 IU/mL, patients could be included if the HBV-DNA value decreased to below 2×103 IU/mL after regular antiviral therapy) or active hepatitis C virus infection (HCV-RNA >ULN on central test) at screening;
HIV positive at the time of screening or have a known history of other immunodeficiency diseases;
History of organ transplantation, hematopoietic stem cell or bone marrow transplantation.
Presence of other lung diseases that require systematic therapy or are severe, such as active tuberculosis, interstitial lung disease, etc., that may affect the interpretation of the study results or put patients at high risk according to the judgment of the investigator;
Have used CYP3A4 potent inhibitors (atazanavir, clarithromycin, Indinavir, Itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telomycin, troleandomycin, voriconazole, grapefruit [juice]) or inducers (carbamazepine, phenobarbital, phenytoin, rifabutin, St. John's Wort, Rifampicin) within 2 weeks prior to initial administration or cannot be stopped during the study;
The following antitumor treatments were administered prior to initial administration: More than 30% of bone marrow radiation or extensive radiotherapy (within 4 weeks prior to initial administration); Palliative radiotherapy (within 7 days prior to initial administration); Other antitumor agents treatment (within 2 weeks prior to initial administration or within 5 half-life times of the agent, whichever is longer), such as chemotherapy, targeted therapy (immunotherapy or other antibody-based therapies).
Major surgery (defined as Grade ≥3 surgery, excluding central venous catheter placement, tumor punch biopsy, and gastric tube placement) or significant trauma within 4 weeks prior to initial administration, and did not fully recover.
Have participated in other clinical studies within 4 weeks prior to initial administration (Note: Patients who did not use the investigational drug or investigational medical device or who had discontinued treatment from other clinical studies and only followed up for survival were excluded) or plan to participate in other clinical studies during the study.
History of severe arteriovenous thrombosis (such as cerebrovascular accident [including transient ischemic attack], deep vein thrombosis, and pulmonary embolism) within 1 year prior to initial administration and has the potential to increase the risk in the study as assessed by the investigators, or a tendency to bleed within 30 days prior to initial administration, or a risk of major gastrointestinal bleeding as determined by the investigators.
Pregnant or lactating woman.
Other conditions assessed unsuitable for participation in this study, such as other serious acute or chronic diseases, or laboratory abnormalities that may increase the risk for the patient, or may interfere with interpretation of the study results.

Trial locations and contacts

1 site in 1 country.

Yinghui Sun contact

86-10-88858616

yhsun@centaurusbio.com

China1 site, 1 recruiting

Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, 100021
Yuankai Shi, MD, 86-10-87788293, syuankai@cicams.ac.cn
Recruiting

Other trials in China

About this study

Official title: A Phase II, Open-Label, Single-Arm, Multicenter Study of Efficacy and Safety of SY-3505 in Patients With ALK-Positive Advanced Non-Small Cell Lung Cancer Who Have Progressed On or Are Intolerant to Second-Generation ALK TKI

Read the detailed description

SY-3505 is a potent, brain-penetrant, third-generation ALK tyrosine kinase inhibitor (TKI) with preclinical activity against both wild-type and most known resistance mutations of ALK occurring in first-generation and second-generation ALK TKI-resistant patients.

In this phase 2 study, patients with locally advanced or metastatic NSCLC who have progressed on or are intolerant to second-generation ALK TKI will be treated with SY-3505 capsules at 600 mg once daily (QD) orally until disease progression, refusal or unacceptable toxicity. Cycles of treatment are every 21 days with continuous dosing of SY-3505. During the study, patients will be followed-up for safety and efficacy evaluation at study protocol defined time points.

Conditions: Non-small-cell Lung Carcinoma
Being tested: SY-3505
Keywords: SY-3505, Anaplastic lymphoma kinase, Non-small cell lung carcinoma, Third-generation ALK tyrosine kinase inhibitor
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SY-3505Drug
Also called CT-3505
A Third-generation ALK TKI

Study groups in NCT05869162
Study group	Role	What they receive
SY-3505-Phase II	Experimental	SY-3505 single agent, 600 mg oral capsules, QD, continuously Receives: Drug: SY-3505

What is being measured

The primary outcome is the main question the study is designed to answer.

Objective Response Rate (ORR) assessed by the independent review committee (IRC)
ORR is defined as the proportion of patients achieving an objective response (complete response [CR] or partial response [PR]) according to Response Evaluation Criteria in Solid Tumors (RECIST), v.1.1 (RECIST 1.1).
Measured: Up to 2 years

Secondary outcomes (10)

ORR assessed by the investigator
ORR is defined as the proportion of patients achieving an objective response (CR or PR) according to RECIST 1.1.
Measured: Up to 2 years
Disease Control Rate (DCR) assessed by the investigator and IRC
DCR is defined as the proportion of patients achieving an objective response (CR or PR) or stable disease (SD) according to RECIST 1.1.
Measured: Up to 2 years
Progression-Free Survival (PFS) assessed by the investigator and IRC
PFS is defined as the time interval from the date of the first dose of the study treatment until the first date at which disease progression is objectively documented, or death due to any cause, whichever occurs first. PFS will be censored for participants without documented disease progression or death.
Measured: Up to 2 years
Time to Tumor Response (TTR) assessed by the investigator and IRC
TTR is defined as the time from the first dose and the first occurrence of an objective response (CR or PR) based on RECIST 1.1.
Measured: Up to 2 years
Duration of Response (DoR) assessed by the investigator and IRC
DoR is defined as the time from the first occurrence of an objective response (CR or PR), based on RECIST 1.1 to first documented disease progression or death.
Measured: Up to 2 years
Intracranial Objective Response Rate (IC-ORR) assessed by the investigator and IRC
IC-ORR is defined as the proportion of patients with intracranial target lesions that are measurable at baseline who achieve an objective response (CR or PR) according to RECIST 1.1 and Revised Assessment in Neuro Oncology (RANO) criteria.
Measured: Up to 2 years
Intracranial Disease Control Rate (IC-DCR) assessed by the investigator and IRC
IC-DCR is defined as the proportion of patients with intracranial target lesions that are measurable at baseline who achieve an objective response (CR or PR) or SD according to RECIST 1.1 and Revised Assessment in Neuro Oncology (RANO) criteria.
Measured: Up to 2 years
Intracranial Duration of Response (IC-DoR) assessed by the investigator and IRC
IC-DoR was defined as time from documentation of intracranial response (CR or PR) to intracranial disease progression or death.
Measured: Up to 2 years
Overall Survival
OS is defined as the time interval from the date of the first dose of the study treatment until death due to any cause. It will be censored on the date of last contact for those participants who are alive.
Measured: Up to 2 years
Incidence of Treatment-emergent adverse events (AEs) and serious adverse events (SAEs) as characterized and graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event [CTCAE] v5
To evaluate safety and tolerability of the study treatment.
Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jun 202310 Jun 2025

First posted22 May 2023
Study start30 Jun 2023
Primary completion10 Jun 2025 (estimated)
Study completion10 Jun 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Non-small-cell Lung CarcinomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 153 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05869162
Sponsor's protocol ID: CT-3505-II-01
Status last verified: May 2023
First submitted: 11 May 2023
Last updated: 25 Aug 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II, Open-Label, Single-Arm, Multicenter Study of Efficacy and Safety of SY-3505 in Patients With ALK-Positive Advanced Non-Small Cell Lung Cancer Who Have Progressed On or Are Intolerant to Second-Generation ALK TKI
ClinicalTrials.gov ID: NCT05869162
Acronym / sponsor ID: CT-3505-II-01
Conditions: Non-small-cell Lung Carcinoma
Keywords: SY-3505, Anaplastic lymphoma kinase, Non-small cell lung carcinoma, Third-generation ALK tyrosine kinase inhibitor
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 153 participants (estimated)
Lead sponsor: Shouyao Holdings (Beijing) Co. LTDUniversity, hospital or other
Study start: 30 Jun 2023 (actual)
Primary completion: 10 Jun 2025 (estimated)
Study completion: 10 Jun 2025 (estimated)
First posted: 22 May 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
SY-3505-Phase II	Experimental	Drug: SY-3505SY-3505 single agent, 600 mg oral capsules, QD, continuously

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (19 listed)

Patients must meet all of the following criteria to be eligible to participate in this study:
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:

Key exclusion criteria (31 listed)

Patients who meet any of the following criteria are not eligible to participate in this study:
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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SY-3505Also: CT-3505A Third-generation ALK TKI	Drug	SY-3505-Phase II

Primary outcome

Objective Response Rate (ORR) assessed by the independent review committee (IRC)
Time frame: Up to 2 years
ORR is defined as the proportion of patients achieving an objective response (complete response [CR] or partial response [PR]) according to Response Evaluation Criteria in Solid Tumors (RECIST), v.1.1 (RECIST 1.1).

10 secondary outcomes

ORR assessed by the investigator
Time frame: Up to 2 years
Disease Control Rate (DCR) assessed by the investigator and IRC
Time frame: Up to 2 years
Progression-Free Survival (PFS) assessed by the investigator and IRC
Time frame: Up to 2 years
Time to Tumor Response (TTR) assessed by the investigator and IRC
Time frame: Up to 2 years
Duration of Response (DoR) assessed by the investigator and IRC
Time frame: Up to 2 years
Intracranial Objective Response Rate (IC-ORR) assessed by the investigator and IRC
Time frame: Up to 2 years
Intracranial Disease Control Rate (IC-DCR) assessed by the investigator and IRC
Time frame: Up to 2 years
Intracranial Duration of Response (IC-DoR) assessed by the investigator and IRC
Time frame: Up to 2 years
Overall Survival
Time frame: Up to 2 years
Incidence of Treatment-emergent adverse events (AEs) and serious adverse events (SAEs) as characterized and graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event [CTCAE] v5
Time frame: Up to 2 years

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yinghui Sun contact

86-10-88858616

yhsun@centaurusbio.com

Yinghui Sun study director

Shouyao Holdings (Beijing) Co. LTD

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SY-3505 in people with Non-small-cell Lung Carcinoma, run by Shouyao Holdings (Beijing) Co. LTD at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yinghui Sun (86-10-88858616, yhsun@centaurusbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) assessed by the independent review committee (IRC) (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05869162.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2023.