Small Cell Lung CarcinomaPhase 3NCT06247605
A Phase IIII Study of AL8326 in Small Cell Lung Cancer
A Phase 3 study testing AL8326 tablets in people with Small Cell Lung Carcinoma, run by Advenchen Laboratories Nanjing Ltd. at 1 site in China.
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled, phase III study to evaluate the efficacy and safety of AL8326 tablets in small cell lung cancer (SCLC) patients with disease progression or recurrence after receiving at least second-line treatment regimens. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Carcinoma
- What is being tested?
- AL8326 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 243 participants
- Where
- 1 siteChina
- Study dates
- 26 Oct 2023to Jul 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- All subjects or legal representatives must sign the informed consent form approved by the Ethics Committee in writing prior to the start of any screening procedures;
- Age ≥ 18 years, male or female;
- Histologically or cytologically confirmed small cell lung cancer patients who have recurrent or advanced disease after at least two lines of systemic regimen (including first-line platinum-based therapy, second-line monotherapy or other therapies *);
- At least one measurable tumor lesion according to RECIST 1.1 **;
- Expected survival time of at least 12 weeks;
- ECOG (PS) score of 0 to 2;
Show all 13Show fewer
- Subject has adequate organ and bone marrow function and meets the following laboratory criteria:
- Blood routine test (without red blood cell or platelet transfusion or hematopoietic factor drug correction within 14 days before screening): absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L (1500/mm3), platelets ≥ 80 × 10^9/L; hemoglobin ≥ 9.0 g/dL;
- Liver function: serum total bilirubin ≤ 1.5 × ULN (upper limit of normal), except for patients with Gilbert 's syndrome (persistent or recurrent hyperbilirubinemia, manifested as unconjugated bilirubin elevation in the absence of hemolysis or pathological evidence of liver); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN for patients without liver metastasis, and ALT and AST ≤ 5 × ULN for patients with liver metastasis;
- Renal function: Serum creatinine ≤ 1.5 × ULN and estimated standard cendogenous creatinine clearance rate ≥ 60 ml/min by Cockcroft-Gault formula, Ccr (ml/min) = [(140-age) × body weight (kg)]/[72 × Scr (mg/dl)], calculated for females × 0.85;
- Coagulation function: international normalized ratio (INR) ≤ 1.5;
- Left ventricular ejection fraction (LVEF) > 50% at screening. 8.1) Female: For female subjects of childbearing potential, they must have a negative serum pregnancy test within 7 days prior to enrollment and agree to use a medically approved method of contraception (condom, sponge, gel, diaphragm, IUD, oral or injectable contraceptive, subcutaneous implant, etc.) during and for 3 months after treatment; they must be non-pregnant and lactating. Female subjects are considered fertile if they are menopausal but have not reached post-menopausal status (menopause of 12 consecutive months or more, with no cause other than menopause) and have not undergone sterilization (removal of ovaries and/or uterus). Their sexual partner agrees to use a medically licensed method of contraception during the subject's treatment and for 3 months after completion; 2) Males: surgical sterilization or agreement to use medically licensed contraception during and for 3 months after the end of treatment; their sexual partners agree to use medically licensed contraception during and for 3 months after the end of the subject's treatment;
- 9. Capable and willing to comply with protocol requirements during the study and subsequent procedures.
Who cannot join
- Known uncontrollable hypersensitivity to AL8326 similar compounds;
- Having previously used AL8326 tablets;
- Having or had a history of leptomeningeal disease or leptomeningeal metastases at screening, or confirmed CNS metastases presenting with symptoms of uncontrolled brain metastases, spinal cord compression, or cancerous meningitis within 8 weeks of first dose, except for CNS metastases or spinal cord compression that are clinically stable and do not require corticosteroids and have an interval of greater than 2 weeks between screening and previous treatment (including radiation therapy or surgery);
- Having or had other neoplasms unless radically treated and with no evidence of recurrence or metastasis within the past 2 years;
- Having significant gastrointestinal history or current illness, such as inability to swallow, severe peptic ulcer, uncontrollable nausea and vomiting, and clinical difficulty in controlling chronic diarrhea, intestinal obstruction or other chronic gastrointestinal diseases in the past 3 months, which may affect the intake, transport or absorption of drugs as judged by the investigator, or who have previously undergone total gastrectomy;
- Having other important primary diseases, such as single agent uncontrolled hypertension (systolic blood pressure ≥ 150 mmHg and/or diastolic blood pressure ≥ 95 mmHg), arrhythmia requiring clinical intervention (such as long QT syndrome, QTcF > 470 ms), abnormally prolonged arrhythmia caused by unstable coronary artery disease, decompensated congestive heart failure (New York Heart Association(NYHA) class III or IV) or myocardial infarction, unstable angina pectoris, ascites or pleural effusion with uncontrolled within 6 months before the administration of the investigational product (CTCAE 5.0 ≥ 2), active autoimmune diseases, mental illness, symptomatic or interstitial lung disease requiring treatment, thyroid disease that may seriously affect the trial evaluation;
Show all 21Show fewer
- Previously received cytotoxic chemotherapy and/or immunotherapy, and the end of the last dose is at least 4 weeks apart from the first dose of study drug; the end of anti- tumor herb medicine is at least 14 days apart; the end of nitroso or mitomycin was at least 6 weeks apart, and tyrosine kinase inhibitors (TKIs) class molecular targeted drugs were at least 4 weeks apart; the treatment of brain metastases/bone metastases had to be at least 2 weeks apart; and had recovered to ≤ Grade 1 from the toxicity of previous treatment [except for the following: a. alopecia; b. long-term toxicity caused by radiotherapy, which could not be recovered in the judgment of the investigator; c. platinum-induced Grade 2 and the following neurotoxicity such as hearing impairment (according to the Common Terminology Criteria for Adverse Events CTCAE V5.0)];
- Had arterial thrombosis or severe venous thromboembolic events within 6 months before screening, such as cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism;
- Having imaging findings indicating that the tumor has invaded around important vessels at screening or the tumor is likely to invade important vessels and cause fatal massive hemorrhage during the subsequent study period as judged by the investigator;
- Uncontrolled infection within 14 days prior to first dose;
- Screening urine routine showed urine protein ≥ + +, and 24-hour urine protein > 1.0 g;
- Having active bleeding within 3 months before screening or at high risk of bleeding as judged by the investigator;
- Been receiving anticoagulants or vitamin K antagonists (e.g., warfarin, heparin, or their analogues) during the screening period [low-dose anticoagulants such as warfarin (no more than 1 mg daily orally), low-dose heparin (no more than 12,000 U daily), or low-dose aspirin (no more than 100 mg daily) were permitted for prophylactic purposes provided INR was ≤ 1.5];
- Having positive test results for hepatitis C virus (HCV) antibody, treponema pallidum antibody, or human immunodeficiency virus (HIV) antibody, or active hepatitis B (defined as hepatitis B virus HBV DNA ≥ 2000 IU/mL or HBV DNA ≥ 10 ^ 4 copies);
- Participated in other clinical trials (excluding observational or vitamin studies) within 4 weeks before informed consent;
- Having received major surgical treatment within 6 weeks prior to screening (patients must be fully recovered and stable before the start of treatment) or serious unhealed wounds, ulcers or fractures at screening;
- Having a history of organ transplantation or being prepared to undergo organ transplantation;
- Other reasons that, in the discretion of the investigator, would make participation in this study inappropriate.
- Notes:
- 1 new line of therapy refers to a change in treatment regimen due to disease progression rather than toxicity or other reasons; after progression on the first treatment, reuse of the same treatment regimen is also a new line of therapy;
- Lesions treated with radiotherapy or locoregional therapy must have radiographic evidence of disease progression to be considered target lesions. If there is only one measurable lesion, the lesion cannot be brain lesion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
JILIN Cancer Hospital
Changchun, Jilin, 130000
Ning Zhang, 0431-80596067, JPCHIRB@163.com
About this study
Official title: Phase III Clinical Study of AL8326 Tablets in Patients With Advanced or Recurrent Small Cell Lung Cancer After at Least Prior Second-line Treatment
This is a multicenter, randomized, double-blind, placebo-controlled, phase III study to evaluate the efficacy and safety of AL8326 tablets in small cell lung cancer (SCLC) patients with disease progression or recurrence after receiving at least second-line treatment regimens.
Read the detailed description
There are 2 treatment groups in this trial, and the study population, sample size and basic design of each group are:
Patients with pathologically confirmed small cell lung cancer at baseline and need = or >3rd line treatment : the sample size was expected to be 243 cases, 162 in the active group and 81 in the control group.
Subjects will be randomized in a 2:1 ratio under double-blind conditions into two groups, with the active group receiving the trial drug AL8326 tablets and the control group receiving placebo. AL8326 tablets and placebo are administered as follows: oral administration, once daily for 28 days per cycle until intolerable toxicity or established disease progression or death or voluntary withdrawal or up to 12 months ( approximately 13 cycles) of treatment. Subjects will have a final visit, followed by a long-term follow-up period, and the tumor disease status will be determined according to RECIST 1.1.
- Conditions
- Small Cell Lung Carcinoma
- Being tested
- AL8326 tablets, placebo
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AL8326 tabletsDrug
Also called AL8326
10mg/tablet, Oral administration, once daily.
placeboDrug
Oral administration, once daily.
| Study group | Role | What they receive |
|---|---|---|
| active group（AL8326） | Experimental | Oral AL8326 (28-day cycle, once daily) until confirmation of disease progression, intolerable toxicity or death, voluntary withdrawal from the study, for a total of no more than 12 months (approximately 13 cycles). Receives: Drug: AL8326 tablets |
| Control group（Placebo) | Placebo comparator | Oral placebo (28-day cycle, once daily) until confirmation of disease progression, intolerable toxicity or death, voluntary withdrawal from the study, for a total of no more than 12 months (approximately 13 cycles). Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
The time between the date of randomization and the death of the subject from any cause.
Measured: Cycle 1 Day 1 up to 3 years (each cycle is 28 days)
Secondary outcomes (6)
Progression-free survival (PFS)
The period of time between the start of the subject's date of randomization and the first observation of disease progression (based on RECIST 1.1 criteria) or the occurrence of death due to any cause (the earlier of the two occurrences).
Measured: Cycle 1 Day 1 up to 12 months(each cycle is 28 days)
Objective remission rate (ORR)
Proportion of subjects achieving CR and PR according to RECIST 1.1.
Measured: 12 months
Duration of remission (DOR)
Time from the start of the first assessment of the tumor as CR or PR to the first assessment of PD or death from any cause.
Measured: 12 months
Disease Control Rate (DCR)
Proportion of subjects achieving CR, PR, and SD.
Measured: 12 months
Adverse Events (AEs)
According to CTCAE V5.0, AES and abnormal indicators of laboratory tests need to be reported according to treatment group, category and worst grade.
Measured: Cycle 1 Day 1 up to 12 months(each cycle is 28 days)
Plasma Concentration
Sparse PK samples (plasma concentration time data) of all subjects treated with study drug (AL8326 tablets / placebo) were collected for population pharmacokinetic analysis.
Measured: Cycle 1 Day 1，Cycle 2 Day1（±3days），Cycle 4 Day 14（±3days）(each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start26 Oct 2023
- Primary completionJul 2028 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 243 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Advenchen Laboratories Nanjing Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ying Cheng, Principal investigator, Jilin Provincial Tumor Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06247605
- Sponsor's protocol ID
- AL8326-GB-010
- Status last verified
- Jan 2024
- First submitted
- 9 Oct 2023
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Clinical Study of AL8326 Tablets in Patients With Advanced or Recurrent Small Cell Lung Cancer After at Least Prior Second-line Treatment
- ClinicalTrials.gov ID
- NCT06247605
- Acronym / sponsor ID
- AL8326-GB-010
- Conditions
- Small Cell Lung Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 243 participants (estimated)
- Lead sponsor
- Advenchen Laboratories Nanjing Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Oct 2023 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 8 Feb 2024 (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.
This is a multicenter, randomized, double-blind, placebo-controlled, phase III study to evaluate the efficacy and safety of AL8326 tablets in small cell lung cancer (SCLC) patients with disease progression or recurrence after receiving at least second-line treatment regimens.
Detailed description
There are 2 treatment groups in this trial, and the study population, sample size and basic design of each group are:
Patients with pathologically confirmed small cell lung cancer at baseline and need = or >3rd line treatment : the sample size was expected to be 243 cases, 162 in the active group and 81 in the control group.
Subjects will be randomized in a 2:1 ratio under double-blind conditions into two groups, with the active group receiving the trial drug AL8326 tablets and the control group receiving placebo. AL8326 tablets and placebo are administered as follows: oral administration, once daily for 28 days per cycle until intolerable toxicity or established disease progression or death or voluntary withdrawal or up to 12 months ( approximately 13 cycles) of treatment. Subjects will have a final visit, followed by a long-term follow-up period, and the tumor disease status will be determined according to RECIST 1.1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active group（AL8326） | Experimental | Drug: AL8326 tabletsOral AL8326 (28-day cycle, once daily) until confirmation of disease progression, intolerable toxicity or death, voluntary withdrawal from the study, for a total of no more than 12 months (approximately 13 cycles). |
| Control group（Placebo) | Placebo comparator | Drug: placeboOral placebo (28-day cycle, once daily) until confirmation of disease progression, intolerable toxicity or death, voluntary withdrawal from the study, for a total of no more than 12 months (approximately 13 cycles). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- All subjects or legal representatives must sign the informed consent form approved by the Ethics Committee in writing prior to the start of any screening procedures;
- Age ≥ 18 years, male or female;
- Histologically or cytologically confirmed small cell lung cancer patients who have recurrent or advanced disease after at least two lines of systemic regimen (including first-line platinum-based therapy, second-line monotherapy or other therapies *);
- At least one measurable tumor lesion according to RECIST 1.1 **;
- Expected survival time of at least 12 weeks;
Key exclusion criteria (21 listed)
- Known uncontrollable hypersensitivity to AL8326 similar compounds;
- Having previously used AL8326 tablets;
- Having or had a history of leptomeningeal disease or leptomeningeal metastases at screening, or confirmed CNS metastases presenting with symptoms of uncontrolled brain metastases, spinal cord compression, or cancerous meningitis within 8 weeks of first dose, except for CNS metastases or spinal cord compression that are clinically stable and do not require corticosteroids and have an interval of greater than 2 weeks between screening and previous treatment (including radiation therapy or surgery);
- Having or had other neoplasms unless radically treated and with no evidence of recurrence or metastasis within the past 2 years;
- Having significant gastrointestinal history or current illness, such as inability to swallow, severe peptic ulcer, uncontrollable nausea and vomiting, and clinical difficulty in controlling chronic diarrhea, intestinal obstruction or other chronic gastrointestinal diseases in the past 3 months, which may affect the intake, transport or absorption of drugs as judged by the investigator, or who have previously undergone total gastrectomy;
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 |
|---|---|---|
| AL8326 tabletsAlso: AL832610mg/tablet, Oral administration, once daily. | Drug | active group（AL8326） |
| placeboOral administration, once daily. | Drug | Control group（Placebo) |
Primary outcome
Overall survival (OS)
Time frame: Cycle 1 Day 1 up to 3 years (each cycle is 28 days)
The time between the date of randomization and the death of the subject from any cause.
6 secondary outcomes
Progression-free survival (PFS)
Time frame: Cycle 1 Day 1 up to 12 months(each cycle is 28 days)
Objective remission rate (ORR)
Time frame: 12 months
Duration of remission (DOR)
Time frame: 12 months
Disease Control Rate (DCR)
Time frame: 12 months
Adverse Events (AEs)
Time frame: Cycle 1 Day 1 up to 12 months(each cycle is 28 days)
Plasma Concentration
Time frame: Cycle 1 Day 1，Cycle 2 Day1（±3days），Cycle 4 Day 14（±3days）(each cycle is 28 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
Related trials for Small Cell Lung Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
RecruitingPhase 2
A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity
Carcinoma, Neuroendocrine, Tumor, Neuroendocrine
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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.
Ying Cheng principal investigator
Jilin Provincial Tumor Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AL8326 tablets in people with Small Cell Lung Carcinoma, run by Advenchen Laboratories Nanjing 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 13 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 8 Feb 2024. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact yingyin Li (+8657188683590, anne@advenchen.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: Cycle 1 Day 1 up to 3 years (each cycle is 28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Feb 2024.