Small Cell Lung CancerPhase 1/2NCT04890795
A Phase Ib / IIA Study of AL8326 in Small Cell Lung Cancer
A Phase 1/2 study testing AL8326 tablets in people with Small Cell Lung Cancer, run by Advenchen Laboratories Nanjing Ltd. at 9 sites in China.
Trial summary
Based on indicators such as 24 week progression free survival (24 weeks PFS) in small cell lung cancer (SCLC) patients without disease progression after first-line platinum containing chemotherapy, objective response rate (ORR) in SCLC patients with recurrence or progression after first-line platinum containing… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- AL8326 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 237 participants
- Where
- 9 sitesChina
- Study dates
- 19 Oct 2020to Sep 2021
- Phase
- Phase 1/2
- 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
- All subjects or legal surrogates were required to give written, ethics committee approved informed consent prior to initiation of any screening procedures;
- Age ≥ 18 years, both genders, patients with histologically confirmed SCLC, and fulfilling the following criteria:
- Group A: Patients with small-cell lung cancer without disease progression (in remission [PR or Cr] or stable disease [SD] status according to RECIST 1.1 criteria) after first-line platinum containing chemotherapy, including extensive stage and limited stage who were not eligible for radical radiotherapy, received four to six cycles of platinum containing chemotherapy previously; Group B: Patients with small-cell lung cancer who have relapsed or progressed after first-line platinum containing chemotherapy regimens; Group C: Patients with small cell lung cancer who have relapsed or progressed after at least one line of therapy (including first-line platinum containing therapy, second-line single agent therapy, or other);Notes: platinum containing chemotherapy regimens included etoposide + cisplatin, etoposide + carboplatin, irinotecan + cisplatin, irinotecan + carboplatin, etoposide + lobaplatin;Second line monotherapy regimens include topotecan, irinotecan, paclitaxel, docetaxel, gemcitabine, oral etoposide, vinorelbine, temozolomide, ifosfamide;Second line and beyond other treatments include small molecule targeted agents, monoclonal antibodies, etc.
- ECOG (PS) score was 0,1;
- Life expectancy ≥ 12 weeks;
- Subjects in arm B / C had at least one measurable tumor lesion according to response evaluation criteria in solid tumors (RECIST 1.1;
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- The subject had adequate organ and bone marrow function meeting the following laboratory test criteria:
- Bone marrow function: absolute neutrophil count (ANC) ≥ 1.5×10^9 / L (1500 / mm^3), platelets ≥ 80×10^9/L;
- Hemoglobin ≥ 9.0 g / dl;Liver function: serum total bilirubin ≤ 1.5 times the upper limit of normal (ULN), with the exception of patients with Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that manifests as elevated unconjugated bilirubin in the absence of evidence of hemolysis or liver pathology);
- Those without liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN, those with liver metastases, ALT and AST ≤ 5×ULN;
- Renal function: serum creatinine ≤ 1.5×ULN and a standard endogenous creatinine clearance ≥ 60 ml / min estimated by the Cockcroft Gault formula, CCR (ml / min) = [(140 - age)×Weight (kg)] / [72× SCR (mg / dl)], females as calculated×0.85;
- Coagulopathy: international normalized ratio (INR) ≤ 1.5;
- Hemodynamically stable and left ventricular ejection fraction (LVEF) ≥ 50% as determined by echocardiography;
- Previous treatment with cytotoxic chemotherapy, traditional Chinese medicine, ending at least 4 weeks apart from first dose, receipt of nitroso or mitomycin at least 6 weeks apart, and TKI class molecularly targeted agents at least 4 weeks apart and having recovered to grade ≤ 1 from the toxic effects of previous chemotherapy, with the following exceptions: a.alopecia;b. Long term toxicity caused by radiotherapy, which could not be recovered after the judgment of the investigator;c. Platinum induced grade 2 and the following neurotoxicity such as hearing impairment (according to common terminology criteria for adverse events CTCAE V5.0);
- Women of childbearing age and all male subjects must agree to use highly effective methods of contraception (condoms, contraceptive sponges, contraceptive gels, contraceptive membranes, IUDs, oral or injectable contraceptives, subcutaneous implants, etc.) for the duration of the study and for 3 months after discontinuation.
Who cannot join
- Patients who had used AL8326 tablets in the past;
- Allergic to AL8326 or its analogues, or to any component in the prescription of AL8326;
- The patients with leptomeningeal history or leptomeningeal metastasis or central nervous system (CNS) metastasis at the time of screening had uncontrollable brain metastasis, spinal cord compression and cancerous meningitis within 8 weeks after the first medication, Patients with CNS metastasis or spinal cord compression whose clinical status is stable and does not need corticosteroid treatment and whose screening time is more than 4 weeks before treatment (including radiotherapy or surgery) are excluded;
- Patients with current or previous second tumor (except for fully treated basal cell carcinoma of skin or squamous cell carcinoma, cervical carcinoma in situ), unless radical treatment has been carried out and there is no evidence of recurrence and metastasis in the past 5 years;
- Those who have obvious gastrointestinal history or current diseases, such as inability to swallow, severe peptic ulcer, uncontrollable nausea and vomiting, chronic diarrhea, intestinal obstruction or other chronic gastrointestinal diseases that are difficult to control in recent 3 months, inability to swallow drugs or may affect the intake, transportation or absorption of drugs, or who have undergone total gastrectomy before;
- Patients with other important primary diseases, such as single drug uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and / or diastolic blood pressure ≥ 100 mmHg), arrhythmias that need clinical intervention (such as long QT syndrome, unmeasurable bazetts corrected QTc or male > 450 ms, female > 470 MS), abnormally prolonged arrhythmias caused by unstable coronary artery disease Patients with decompensated congestive heart failure (NYHA grade III or IV) or myocardial infarction, grade 2 or above thyroid disease, ascites or uncontrolled pleural effusion (CTCAE 5.0 ≥ 2), history of thrombosis or stroke, autoimmune disease, and mental illness within 6 months before administration of the test drug;
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- The patients with arteriovenous thrombotic events such as cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism in the first 6 months were screened;
- The tumor had invaded the important blood vessels or the researchers judged that the tumor was likely to invade the important blood vessels during the follow-up study and cause fatal massive hemorrhage;
- Uncontrolled infection (within 2 weeks before the administration of the test drug);
- Urine routine examination showed that urine protein was ≥ + +, and 24-hour urine protein was more than 1.0 G;
- The patients with grade 1 or more bleeding events (according to CTCAE 5.0 > grade 1), including gastrointestinal tract, respiratory system, tumor, urinary tract and cerebral hemorrhage, were screened;
- Patients treated with anticoagulants or vitamin K antagonists (such as warfarin, heparin or their analogues); Under the premise of prothrombin time international normalized ratio (INR) ≤ 1.5, it is allowed to use low-dose anticoagulants for preventive purposes, such as warfarin (not more than 1 mg daily, oral), low-dose heparin (not more than 12000 u daily) or low-dose aspirin (not more than 100 mg daily);
- Hepatitis C virus (HCV) antibody, Treponema pallidum antibody or human immunodeficiency virus (HIV) antibody test results of any one or more positive, or active hepatitis B patients (defined as HBV DNA ≥ 2000 IU / ml or HBV DNA ≥ 104 copies);
- Patients who received any trial drug treatment within 30 days before signing the informed consent form;
- Patients who received red blood cell or platelet transfusion within 14 days before the first administration;
- Received major surgical treatment within 4 weeks before signing the informed consent (the patient must fully recover and stabilize before the start of treatment);
- Patients with previous organ transplantation history or preparing for organ transplantation;
- Pregnant or lactating female patients;
- According to the judgment of the investigator, there are other reasons that are not suitable to participate in this study.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites, 9 recruiting
- Recruiting
The first affiliated hospital of bengbu medical college
Bengbu, Anhui, 233000
Lisha Duan, 0552-3086046, byyfyll@163.com
- Recruiting
Sichuan Cancer Hospital
Chengdu, Sichuan, 610000
Weijia Zhou, 028-85420681, SCCHEC@163.com
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310000
Lihong Wang, 0571-88122564, zjzliec@163.com
- Recruiting
General Hospital of Eastern Theater Command
Nanjing, Jiangsu, 210000
Pingping Dong, 025-80860225, dongpingpingabc@163.com
- Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000
Xiaolei Zhang, 0532-82912611, qingyilunli@126.com
- Recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200000
Tao Gui, 021-65115006-1019, fkyygcp@163.com
- Recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000
Xiaomei Wang, 0516-85802291, xyfyll2297@163.com
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450000
Jing Ding, 0371-65588251, dingjing201305@163.com
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
Li Tian, 0371-65150792, tianli_llzl@163.com
About this study
Official title: A Single Arm, Open, Non Randomized, Phase Ib / IIA Study to Evaluate the Safety and Preliminary Efficacy of AL8326 in the Treatment of Small Cell Lung Cancer
Based on indicators such as 24 week progression free survival (24 weeks PFS) in small cell lung cancer (SCLC) patients without disease progression after first-line platinum containing chemotherapy, objective response rate (ORR) in SCLC patients with recurrence or progression after first-line platinum containing chemotherapy, and orr in SCLC patients with recurrence or progression after second-line and above treatment,Evaluation of the effectiveness of al8326 monotherapy in small cell lung cancer.
Read the detailed description
This trial is a multicenter, single arm, open label, nonrandomized, phase Ib / IIA trial that will evaluate the preliminary efficacy and safety of AL8326 in patients with small cell lung cancer (SCLC).Three treatment groups were used in this trial, and the study population, sample size, and basic design of each group were as follows:
Group A: Patients with small-cell lung cancer without disease progression (in remission [PR or Cr] or stable disease [SD] status) after first-line platinum containing chemotherapy were included, with a total sample size expected to be 79 patients.
Group B: Patients who relapsed or progressed after first-line platinum containing chemotherapy regimens, with a total sample size expected to be 79 patients.
Group C: Patients with small cell lung cancer who have relapsed or progressed after at least one line of treatment (including first-line platinum containing therapy, second-line single agent or other) with a total sample size expected to be 79 patients.
- Conditions
- Small Cell Lung Cancer
- Being tested
- AL8326 tablets
- 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.
| Study group | Role | What they receive |
|---|---|---|
| AL8326 | Experimental | Subject will received AL8326 once daily for 28-days cycle until intolerable toxicity or disease progression or death or voluntary withdrawal the end of this study.During treatment, subjects will be evaluated for anti-tumor efficacy and corresponding safety examinations every 2 cycles, and tumor disease status will be according to RECIST 1.1. Receives: Drug: AL8326 tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
(Group A) 24 weeks progression free survival (24 weeks PFS)
Objective to evaluate the 24 week progression free survival (24 weeks PFS) of AL8326 in patients with small cell lung cancer (SCLC) without disease progression (PR or CR or SD) after first-line platinum based chemotherapy.
Measured: Every 2 cycles(each cycle is 28--days)
(Group B and C) Objective response rate (ORR)
Objective response rate (ORR) of SCLC patients with recurrence or progression after first-line platinum chemotherapy, and objective response rate (ORR) of SCLC patients with recurrence or progression after second-line or above treatment.
Measured: Every 2 cycles(each cycle is 28--days)
Secondary outcomes (1)
Safety and tolerance(Number of participants with treatment-related adverse events as assessed by CTCAE v5.0)
Objective to evaluate the safety and tolerability of al8326 monotherapy in patients with small cell lung cancer (SCLC) without disease progression (PR or CR or SD) after first-line platinum based chemotherapy; Safety and tolerability in patients with small cell lung cancer who relapsed or progressed after first-line platinum based chemotherapy; Safety and tolerability in patients with small cell lung cancer who relapse or progress after at least second-line treatment (including first-line platinum containing therapy, second-line monotherapy or other treatments).
Measured: Every 2 cycles(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 posted18 May 2021
- Study start19 Oct 2020
- Primary completionSep 2021 (estimated)
- Study completionSep 2021 (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 CancerStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 237 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Advenchen Laboratories Nanjing Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- xiaochun Zhang, Principal investigator, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04890795
- Sponsor's protocol ID
- AL8326-CN-004
- Status last verified
- May 2021
- First submitted
- 26 Apr 2021
- Last updated
- 18 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Open, Non Randomized, Phase Ib / IIA Study to Evaluate the Safety and Preliminary Efficacy of AL8326 in the Treatment of Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04890795
- Acronym / sponsor ID
- AL8326-CN-004
- Conditions
- Small Cell Lung Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 237 participants (estimated)
- Lead sponsor
- Advenchen Laboratories Nanjing Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 18 May 2021 (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.
Based on indicators such as 24 week progression free survival (24 weeks PFS) in small cell lung cancer (SCLC) patients without disease progression after first-line platinum containing chemotherapy, objective response rate (ORR) in SCLC patients with recurrence or progression after first-line platinum containing chemotherapy, and orr in SCLC patients with recurrence or progression after second-line and above treatment,Evaluation of the effectiveness of al8326 monotherapy in small cell lung cancer.
Detailed description
This trial is a multicenter, single arm, open label, nonrandomized, phase Ib / IIA trial that will evaluate the preliminary efficacy and safety of AL8326 in patients with small cell lung cancer (SCLC).Three treatment groups were used in this trial, and the study population, sample size, and basic design of each group were as follows:
Group A: Patients with small-cell lung cancer without disease progression (in remission [PR or Cr] or stable disease [SD] status) after first-line platinum containing chemotherapy were included, with a total sample size expected to be 79 patients.
Group B: Patients who relapsed or progressed after first-line platinum containing chemotherapy regimens, with a total sample size expected to be 79 patients.
Group C: Patients with small cell lung cancer who have relapsed or progressed after at least one line of treatment (including first-line platinum containing therapy, second-line single agent or other) with a total sample size expected to be 79 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AL8326 | Experimental | Drug: AL8326 tabletsSubject will received AL8326 once daily for 28-days cycle until intolerable toxicity or disease progression or death or voluntary withdrawal the end of this study.During treatment, subjects will be evaluated for anti-tumor efficacy and corresponding safety examinations every 2 cycles, and tumor disease status will be according to RECIST 1.1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- All subjects or legal surrogates were required to give written, ethics committee approved informed consent prior to initiation of any screening procedures;
- Age ≥ 18 years, both genders, patients with histologically confirmed SCLC, and fulfilling the following criteria:
- Group A: Patients with small-cell lung cancer without disease progression (in remission [PR or Cr] or stable disease [SD] status according to RECIST 1.1 criteria) after first-line platinum containing chemotherapy, including extensive stage and limited stage who were not eligible for radical radiotherapy, received four to six cycles of platinum containing chemotherapy previously; Group B: Patients with small-cell lung cancer who have relapsed or progressed after first-line platinum containing chemotherapy regimens; Group C: Patients with small cell lung cancer who have relapsed or progressed after at least one line of therapy (including first-line platinum containing therapy, second-line single agent therapy, or other);Notes: platinum containing chemotherapy regimens included etoposide + cisplatin, etoposide + carboplatin, irinotecan + cisplatin, irinotecan + carboplatin, etoposide + lobaplatin;Second line monotherapy regimens include topotecan, irinotecan, paclitaxel, docetaxel, gemcitabine, oral etoposide, vinorelbine, temozolomide, ifosfamide;Second line and beyond other treatments include small molecule targeted agents, monoclonal antibodies, etc.
- ECOG (PS) score was 0,1;
- Life expectancy ≥ 12 weeks;
Key exclusion criteria (19 listed)
- Patients who had used AL8326 tablets in the past;
- Allergic to AL8326 or its analogues, or to any component in the prescription of AL8326;
- The patients with leptomeningeal history or leptomeningeal metastasis or central nervous system (CNS) metastasis at the time of screening had uncontrollable brain metastasis, spinal cord compression and cancerous meningitis within 8 weeks after the first medication, Patients with CNS metastasis or spinal cord compression whose clinical status is stable and does not need corticosteroid treatment and whose screening time is more than 4 weeks before treatment (including radiotherapy or surgery) are excluded;
- Patients with current or previous second tumor (except for fully treated basal cell carcinoma of skin or squamous cell carcinoma, cervical carcinoma in situ), unless radical treatment has been carried out and there is no evidence of recurrence and metastasis in the past 5 years;
- Those who have obvious gastrointestinal history or current diseases, such as inability to swallow, severe peptic ulcer, uncontrollable nausea and vomiting, chronic diarrhea, intestinal obstruction or other chronic gastrointestinal diseases that are difficult to control in recent 3 months, inability to swallow drugs or may affect the intake, transportation or absorption of drugs, or who have undergone total gastrectomy before;
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 | AL8326 |
Primary outcome
(Group A) 24 weeks progression free survival (24 weeks PFS)
Time frame: Every 2 cycles(each cycle is 28--days)
Objective to evaluate the 24 week progression free survival (24 weeks PFS) of AL8326 in patients with small cell lung cancer (SCLC) without disease progression (PR or CR or SD) after first-line platinum based chemotherapy.
(Group B and C) Objective response rate (ORR)
Time frame: Every 2 cycles(each cycle is 28--days)
Objective response rate (ORR) of SCLC patients with recurrence or progression after first-line platinum chemotherapy, and objective response rate (ORR) of SCLC patients with recurrence or progression after second-line or above treatment.
1 secondary outcome
Safety and tolerance(Number of participants with treatment-related adverse events as assessed by CTCAE v5.0)
Time frame: Every 2 cycles(each cycle is 28--days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
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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.
xiaochun Zhang principal investigator
The Affiliated Hospital of Qingdao University
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AL8326 tablets in people with Small Cell Lung Cancer, run by Advenchen Laboratories Nanjing Ltd. at 9 sites 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 15 inclusion and 19 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 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 yingyin Li (+8657188683590, annel@advenchen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(Group A) 24 weeks progression free survival (24 weeks PFS) (time frame: Every 2 cycles(each cycle is 28--days)). The study lists 2 primary outcomes in all. 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 18 May 2021.