Extensive Stage Small Cell Lung CancerPhase 2NCT05896059
A Study to Investigate the Efficacy and Safety of Tislelizumab Combined With Anlotinib as Maintenance Therapy for ES-SCLC
A Phase 2 study testing Tislelizumab and Anlotinib in people with Extensive Stage Small Cell Lung Cancer, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
This is an open-label, single-arm, prospective phase 2 study, evaluating the efficacy and safety of tislelizumab combined with Anlotinib as maintenance therapy following tislelizumab and chemotherapy for treatment naïve extensive stage small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Extensive Stage Small Cell Lung Cancer
- What is being tested?
- Tislelizumab and Anlotinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2023to 31 Dec 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed ES-SCLC, defined by the American Joint Committee on Cancer (AJCC) 8th edition or the Veterans Administration Lung Study Group (VALG) staging system.
- No prior treatment for ES-SCLC. (Patients who have received prior chemoradiotherapy for limited-stage SCLC must have been treated with curative intent and experienced a treatment-free interval of ≥ 6 months between the completion of chemotherapy, radiotherapy, or chemoradiotherapy and diagnosis of ES-SCLC).
- ECOG performance status ≤ 1.
- Life expectancy ≥ 3 months.
- Adequate organ function as indicated by the following laboratory values (obtained ≤ 7 days before first dose):
- Absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelets ≥ 100 × 109/L，hemoglobin ≥ 90 g/L.
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- International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 x upper limit of normal (ULN).
- Activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN.
- Serum total bilirubin ≤ 1.5 x ULN.
- Aspartate and alanine aminotransferase (AST and ALT) ≤ 2.5 x ULN, or AST and ALT ≤ 5 x ULN for patients with liver metastases.
- Serum albumin (ALB) ≥ 25g/L.
- Serum creatinine ≤ 1.5 x ULN or estimated glomerular filtration rate (GFR) ≥ 60 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
- Able to provide written informed consent by the patient or by the patient's legally acceptable representative and can understand and agree to comply with the requirements of the study.
- 18 to 75 years old on the day of signing the informed consent form (ICF).
- Fertile patients must be willing to use highly effective contraception during the study period and for 120 days after the last dose of tislelizumab.
Who cannot join
- Active leptomeningeal disease or uncontrolled, untreated brain metastasis:
- Patients with a history of treated and, at the time of screening, asymptomatic central nervous system (CNS) metastases are eligible if they meet all the following:
- only supratentorial metastases allowed.
- No radiotherapy for the central nervous system within 14 days prior to screening.
- Untreated and Asymptomatic patients with brain metastasis brain metastases can be included in the study after judgment by the investigators, but regular brain imaging examinations of the disease site are required.
- Received prior therapies targeting PD-1, PD-L1, CTLA-4 or other immune checkpoints.
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- Received prior anti-VEGF or VEGFR TKI agents including but not limited to Anlotinib.
- Treatment with any approved systemic anti-cancer therapy or systemic immune-stimulatory agents (including but not limited to interferons, interleukin IL-2, and tumor necrosis factor) within 28 days prior to initiation of study treatment.
- Clinically uncontrolled pleural effusion, ascites, pericardial effusion that requires treatment and may affect study treatment estimated by investigator.
- History of allergic reactions to any study drugs or any component of the preparation or any component of the container.
- Patients with untreated chronic hepatitis B (HBV) or chronic HBV carriers whose HBV DNA ≥ 500 IU/mL (2500 copies/mL), patients with active hepatitis C (HCV).
- Active autoimmune diseases that require treatment and may affect study treatment estimated by investigator.
- Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or any other immunosuppressive medication≤ 14 days before first dose of study drugs that may affect study treatment estimated by investigator.
- Severe chronic or active infections requiring systemic antibacterial, antifungal, or antiviral therapy, within 14 days prior to first dose of study drug(s). Note: antiviral therapy is permitted for patients with viral hepatitis.
- Prior allogeneic stem cell transplantation or organ transplantation.
- Any of the following cardiovascular risk criteria:
- Cardiac chest pain, defined as moderate pain that limits instrumental activities of daily living, ≤ 28 days before first dose of study drugs.
- Symptomatic pulmonary embolism ≤ 28 days before first dose of study drugs.
- Any history of acute myocardial infarction ≤ 6 months before first dose of study drugs.
- Any history of heart failure meeting New York Heart Association Classification III or IV ≤ 6 months before first dose of study drugs.
- Any event of ventricular arrhythmia ≥ Grade 2 in severity ≤ 6 months before first dose of study drugs.
- Any history of cerebrovascular accident ≤ 6 months before first dose of study drugs.
- QTc interval (corrected by Fridericia's method) > 450 msec (for males)/ > 470 msec (for females).
- Note: If QTc interval is > ULN on initial ECG, a follow up ECG will be performed to exclude result.
- Current left ventricular ejection fraction (LVEF) < institutional LLN as assessed by echocardiography (ECHO).
- Any episode of syncope or seizure ≤ 28 days before the first dose of study drug(s).
- Inadequately controlled hypertension (defined as systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg).
- Bleeding or thrombotic disorders or use of anticoagulants such as warfarin or similar agents requiring therapeutic INR monitoring within 6 months before first dose of study drugs, that may affect study treatment estimated by investigator.
- Regardless of the severity, patients with any signs or medical history of bleeding; within 4 weeks prior to allocation, patients with any bleeding events ≥ CTCAE level 3, unhealed wounds, ulcers, or fractures.
- Hemoptysis>50ml/d.
- Inability to swallow capsules or disease significantly affecting gastrointestinal function, such as malabsorption syndrome, resection of the stomach or small bowel, bariatric surgery procedures, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.
- History of interstitial lung disease, noninfectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases, etc, that may affect study treatment estimated by investigator.
- Significant history or clinical manifestation of any organ systems disorder, as determined by the investigator, that may affect study treatment estimated by investigator.
- Any major surgical procedure requiring general anesthesia ≤ 28 days before initiation of study treatment.
- Underlying medical conditions (including laboratory abnormalities) or alcohol or drug abuse or dependence that would be unfavorable for the administration of study drug or affect the explanation of drug toxicity or AEs or result in insufficient or might impair compliance with study conduct.
- Was administered a live vaccine ≤ 4 weeks before screening.
- A known history of HIV infection.
- Any active malignancy ≤ 2 years before first dose of study drugs except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (e.g., resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast).
- Pregnant or breastfeeding woman.
- Concurrent participation in another clinical study unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang
Fan Yun
Fan Yun
About this study
Official title: A Phase II, Open-Label, Single-Arm, Prospective Clinical Study to Investigate the Efficacy and Safety of Tislelizumab Combined With Anlotinib as Maintenance Therapy Following Tislelizumab and Chemotherapy for Treatment Naïve Extensive Stage Small Cell Lung Cancer
This is an open-label, single-arm, prospective phase 2 study, evaluating the efficacy and safety of tislelizumab combined with Anlotinib as maintenance therapy following tislelizumab and chemotherapy for treatment naïve extensive stage small cell lung cancer.
Read the detailed description
The study included screening period, treatment period (including induction and maintenance), safety follow-up and survival follow-up periods.
Induction treatment will be administered on a Q3W cycle for 4 cycles. Following induction treatment, patients who have received 4 cycles of tislelizumab and platinum-based chemotherapy and meet the following criteria will enter a maintenance treatment phase with tislelizumab and Anlotinib.
Patients have an ongoing response per RECIST v1.1 criteria of SD or better assessed by the investigator according to RECIST v1.1（Patients will be eligible to enter maintenance phase if chemotherapy interruption due to toxicity, but at least 3 cycles of tislelizumab combined with chemotherapy are completed and assessed as CR, PR or SD according to RECISTv1.1 criteria）.
Excluded patients with central cavitary ES-SCLC, or tumor invading or adjacent to large vessels as shown by imaging, and likely to invade large vessels and cause fatal bleeding assessed by the investigator.
During the maintenance treatment period prophylactic cranial irradiation (PCI) is permitted as per local standard of care.
Treatment may continue until 1) disease progression as assessed by the investigator per RECIST v1.1, 2) loss of clinical benefit as assessed by the investigator, 3) unacceptable toxicity, or 4) withdrawal of informed consent, whichever occurs first, 5) study treatment duration reached 2 years (including induction and maintenance period).
Per investigator's discretion, patients who may continue to benefit from study treatment after progressive disease must meet the following criteria in order to be treated and documented in the study records:
Absence of symptoms and signs indicating clinically significant progression of disease and absence of worsening of laboratory values indicating disease progression.
Stable ECOG performance status ≤ 1 Absence of rapid progression of disease or of progressive tumor at critical anatomical sites (eg,cord compression) that requires urgent alternative medical intervention Investigators must obtain written informed consent for treatment beyond radiologic disease.
Study treatment will be administered for up to 2 years (including induction and mantenance period).
- Conditions
- Extensive Stage Small Cell Lung Cancer
- Being tested
- Tislelizumab, Anlotinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TislelizumabDrug
Tislelizumab，200mg，D1, intravenous，Q3W；
AnlotinibDrug
Anlotinib，12mg，oral administration，QD.
| Study group | Role | What they receive |
|---|---|---|
| Tislelizumab combined with Anlotinib | Experimental | Not described Receives: Drug: Tislelizumab; Drug: Anlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year PFS rate assessed by investigator in maintenance phase-patient analysis set per RECIST v1.1.
PFS is defined as the time from the first dose of study drug(s) in maintenance phase to the first occurrence of disease progression as determined by investigator using RECIST v1.1 or death from any cause, whichever occurs first.
Measured: Start of maintenance therapy until 1-year follow-up
Secondary outcomes (6)
PFS
PFS assessed by investigators per RECIST v1.1 in maintenance phase-patient analysis set and induction phase-patient analysis set, respectively.
Measured: up to 2 year
OS
OS, defined as the time from first dose of study drug(s) to death from any cause, in maintenance phase-patient analysis set and induction phase-patient analysis set, respectively.
Measured: up to 2 year
ORR
ORR, defined as the proportion of patients with partial response or complete response as determined by the investigators based on RECIST v1.1 in maintenance phase-patient analysis set and induction phase-patient analysis set, respectively.
Measured: up to 2 year
DCR
DCR, defined as the proportion of patients achieving complete response (CR), partial response (PR), or stable disease (SD) as determined by the investigators based on RECIST v1.1 in maintenance phase-patient analysis set and induction phase-patient analysis set, respectively.
Measured: up to 2 year
DOR
DOR is defined as the duration from the date of patients achieve CR or PR to the date of PD or death, which occurs first, for patients with an objective response in maintenance phase-patient analysis set and induction phase-patient analysis set, respectively.
Measured: up to 2 year
TEAE
Incidence and severity of treatment-emergent adverse events (TEAEs) graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0, and relevant physical examinations, electrocardiograms (ECGs), and laboratory assessments as needed. The safety and tolerability will be evaluated in maintenance phase and induction phase population respectively.
Measured: up to 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start15 May 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extensive Stage Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe sponsor's other registered studies.
- 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
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fan Yun, MD, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05896059
- Sponsor's protocol ID
- [2022]-12-23
- Status last verified
- Jun 2023
- First submitted
- 24 May 2023
- Last updated
- 9 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-Label, Single-Arm, Prospective Clinical Study to Investigate the Efficacy and Safety of Tislelizumab Combined With Anlotinib as Maintenance Therapy Following Tislelizumab and Chemotherapy for Treatment Naïve Extensive Stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05896059
- Acronym / sponsor ID
- [2022]-12-23
- Conditions
- Extensive Stage Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 9 Jun 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.
This is an open-label, single-arm, prospective phase 2 study, evaluating the efficacy and safety of tislelizumab combined with Anlotinib as maintenance therapy following tislelizumab and chemotherapy for treatment naïve extensive stage small cell lung cancer.
Detailed description
The study included screening period, treatment period (including induction and maintenance), safety follow-up and survival follow-up periods.
Induction treatment will be administered on a Q3W cycle for 4 cycles. Following induction treatment, patients who have received 4 cycles of tislelizumab and platinum-based chemotherapy and meet the following criteria will enter a maintenance treatment phase with tislelizumab and Anlotinib.
Patients have an ongoing response per RECIST v1.1 criteria of SD or better assessed by the investigator according to RECIST v1.1（Patients will be eligible to enter maintenance phase if chemotherapy interruption due to toxicity, but at least 3 cycles of tislelizumab combined with chemotherapy are completed and assessed as CR, PR or SD according to RECISTv1.1 criteria）.
Excluded patients with central cavitary ES-SCLC, or tumor invading or adjacent to large vessels as shown by imaging, and likely to invade large vessels and cause fatal bleeding assessed by the investigator.
During the maintenance treatment period prophylactic cranial irradiation (PCI) is permitted as per local standard of care.
Treatment may continue until 1) disease progression as assessed by the investigator per RECIST v1.1, 2) loss of clinical benefit as assessed by the investigator, 3) unacceptable toxicity, or 4) withdrawal of informed consent, whichever occurs first, 5) study treatment duration reached 2 years (including induction and maintenance period).
Per investigator's discretion, patients who may continue to benefit from study treatment after progressive disease must meet the following criteria in order to be treated and documented in the study records:
Absence of symptoms and signs indicating clinically significant progression of disease and absence of worsening of laboratory values indicating disease progression.
Stable ECOG performance status ≤ 1 Absence of rapid progression of disease or of progressive tumor at critical anatomical sites (eg,cord compression) that requires urgent alternative medical intervention Investigators must obtain written informed consent for treatment beyond radiologic disease.
Study treatment will be administered for up to 2 years (including induction and mantenance period).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tislelizumab combined with Anlotinib | Experimental | Drug: Tislelizumab, Drug: Anlotinib |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Histologically or cytologically confirmed ES-SCLC, defined by the American Joint Committee on Cancer (AJCC) 8th edition or the Veterans Administration Lung Study Group (VALG) staging system.
- No prior treatment for ES-SCLC. (Patients who have received prior chemoradiotherapy for limited-stage SCLC must have been treated with curative intent and experienced a treatment-free interval of ≥ 6 months between the completion of chemotherapy, radiotherapy, or chemoradiotherapy and diagnosis of ES-SCLC).
- ECOG performance status ≤ 1.
- Life expectancy ≥ 3 months.
- Adequate organ function as indicated by the following laboratory values (obtained ≤ 7 days before first dose):
Key exclusion criteria (40 listed)
- Active leptomeningeal disease or uncontrolled, untreated brain metastasis:
- Patients with a history of treated and, at the time of screening, asymptomatic central nervous system (CNS) metastases are eligible if they meet all the following:
- Received prior therapies targeting PD-1, PD-L1, CTLA-4 or other immune checkpoints.
- Received prior anti-VEGF or VEGFR TKI agents including but not limited to Anlotinib.
- Treatment with any approved systemic anti-cancer therapy or systemic immune-stimulatory agents (including but not limited to interferons, interleukin IL-2, and tumor necrosis factor) within 28 days prior to initiation of study treatment.
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 |
|---|---|---|
| TislelizumabTislelizumab，200mg，D1, intravenous，Q3W； | Drug | Tislelizumab combined with Anlotinib |
| AnlotinibAnlotinib，12mg，oral administration，QD. | Drug | Tislelizumab combined with Anlotinib |
Primary outcome
1-year PFS rate assessed by investigator in maintenance phase-patient analysis set per RECIST v1.1.
Time frame: Start of maintenance therapy until 1-year follow-up
PFS is defined as the time from the first dose of study drug(s) in maintenance phase to the first occurrence of disease progression as determined by investigator using RECIST v1.1 or death from any cause, whichever occurs first.
6 secondary outcomes
PFS
Time frame: up to 2 year
OS
Time frame: up to 2 year
ORR
Time frame: up to 2 year
DCR
Time frame: up to 2 year
DOR
Time frame: up to 2 year
TEAE
Time frame: up to 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
- Individual participant dataSharing planned: Undecided
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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.
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 Tislelizumab and Anlotinib in people with Extensive Stage Small Cell Lung Cancer, run by Zhejiang Cancer Hospital 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 15 inclusion and 40 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 9 Jun 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 Yun Fan (+86-13858182310, fanyun@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year PFS rate assessed by investigator in maintenance phase-patient analysis set per RECIST v1.1. (time frame: Start of maintenance therapy until 1-year follow-up). 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 9 Jun 2023.