Small Cell Lung Cancer Extensive StagePhase 2NCT04967625
A Phase II Study of Sintilimab Combined With Anlotinib in Treatment of ED-SCLC
A Phase 2 study testing Sintilimab and Anlotinib hydrochloride in people with Small Cell Lung Cancer Extensive Stage, run by Zhejiang Cancer Hospital.
Trial summary
This is a the researchers launched, single-center, prospective, open-label, single arm ,Phase II clinical study of Sintilimab combined with anlotinib in patients with extensive-stage disease small-cell lung cancer to evaluate the efficacy and safety. 23 patients are expected to be enrolled in this study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer Extensive Stage
- What is being tested?
- Sintilimab and Anlotinib hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- 26 Jul 2021to 31 Dec 2023
- 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
- Aged ≥ 18, regardless of gender .
- Histologically or cytologically confirmed small cell lung cancer .
- The time after the end of first-line treatment was less than 6 months .
- Subjects must have measurable diseases as defined in RECIST v1.1 .
- Eastern Cooperative Oncology Group (ECOG) performance status scores are 0-2 .
- Adequate hematologic and end organ function .
- Capable of understanding the trial nature and voluntarily signing the written informed consent form .
Who cannot join
- Radiographic findings showed that the tumor involved large blood vessels or was poorly demarcated from them .
- Radiographic findings showed significant pulmonary cavitation or necrotizing tumor .
- Active brain metastasis or meningeal metastasis .
- With other malignant tumors in the past 5 years, except cancers that have been cured significantly or can be focally cured, e.g. basosquamous carcinoma of skin, or carcinoma cervix in situ .
- With Interstitial lung disease, including drug- induced Interstitial lung disease or radiation pneumonitis .
- With clinically significant cardiovascular disorder .
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- Prior exposure to any immune checkpoint inhibitors, including but not limited to other anti-CTLA-4, anti-PD-1 or anti-PD-L1 antibodies .
- Prior exposure to anti-VEGFR therapy .
- Known hypersensitivity to study drug or any of its excipients .
- Treatment with any other investigational agent or participation in another clinical trial within 4 weeks prior to first administration .
- Other conditions that the investigator thinks unsuitable in this study .
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Anti-PD-1 Antibody Sintilimab Combined With Anti-angeogensis Inhibitor Anlotinib in Treatment of Extensive-stage Disease Small Cell Lung Cancer After Failure of First Line Standard Therapy : a Single-arm Prospective Phase II Clinical Study
This is a the researchers launched, single-center, prospective, open-label, single arm ,Phase II clinical study of Sintilimab combined with anlotinib in patients with extensive-stage disease small-cell lung cancer to evaluate the efficacy and safety.
23 patients are expected to be enrolled in this study.
Read the detailed description
Subjects will receive sintilimab 200mg, IV, Q3W and anlotinib 12mg, PO, QD，d1-14, Q3W treatment until disease progression, unacceptable toxicity, or death.
- Conditions
- Small Cell Lung Cancer Extensive Stage
- Being tested
- Sintilimab, Anlotinib hydrochloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SintilimabDrug
A humanized anti-PD-1 monoclonal antibody
Anlotinib hydrochlorideDrug
A tyrosine kinase inhibitor selectively targeting VEGFR-2
| Study group | Role | What they receive |
|---|---|---|
| Sintilimab + Anlotinib | Experimental | sintilimab 200mg, IV, d1, Q3W and anlotinib 12mg, PO, QD，d1-14, Q3W; treatment until disease progression, unacceptable toxicity, or death Receives: Drug: Sintilimab; Drug: Anlotinib hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective response rate according to RECIST v1.1
Measured: 12 month
Secondary outcomes (5)
DCR
Disease control rate according to RECIST v1.1
Measured: 12 months
DoR
Duration of response according to RECIST v1.1
Measured: 12 months
PFS
Progression-free survival according to RECIST v1.1
Measured: 12 months
OS
Overall survival
Measured: on average of 2 years
Adverse Event
Evaluation of adverse event rate according to CTCAE v4.03
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start26 Jul 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (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 Cancer Extensive StageStudies 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
- Model description
- Anti-PD-1 antibody sintilimab combined With anti-angeogensis inhibitor anlotinib for extensive stage disease small cell lung cancer after failure of first line standard therapy
- Masking
- None (open label)
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guangyuan Lou, Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04967625
- Sponsor's protocol ID
- ZJCH-SCLC-01
- Status last verified
- Mar 2021
- First submitted
- 15 Jul 2021
- Last updated
- 28 Jul 2021
- 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 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-PD-1 Antibody Sintilimab Combined With Anti-angeogensis Inhibitor Anlotinib in Treatment of Extensive-stage Disease Small Cell Lung Cancer After Failure of First Line Standard Therapy : a Single-arm Prospective Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT04967625
- Acronym / sponsor ID
- ZJCH-SCLC-01
- Conditions
- Small Cell Lung Cancer Extensive Stage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 26 Jul 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 19 Jul 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.
This is a the researchers launched, single-center, prospective, open-label, single arm ,Phase II clinical study of Sintilimab combined with anlotinib in patients with extensive-stage disease small-cell lung cancer to evaluate the efficacy and safety.
23 patients are expected to be enrolled in this study.
Detailed description
Subjects will receive sintilimab 200mg, IV, Q3W and anlotinib 12mg, PO, QD，d1-14, Q3W treatment until disease progression, unacceptable toxicity, or death.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Anti-PD-1 antibody sintilimab combined With anti-angeogensis inhibitor anlotinib for extensive stage disease small cell lung cancer after failure of first line standard therapy
| Arm | Type | Receives |
|---|---|---|
| Sintilimab + Anlotinib | Experimental | Drug: Sintilimab, Drug: Anlotinib hydrochloridesintilimab 200mg, IV, d1, Q3W and anlotinib 12mg, PO, QD，d1-14, Q3W; treatment until disease progression, unacceptable toxicity, or death |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged ≥ 18, regardless of gender .
- Histologically or cytologically confirmed small cell lung cancer .
- The time after the end of first-line treatment was less than 6 months .
- Subjects must have measurable diseases as defined in RECIST v1.1 .
- Eastern Cooperative Oncology Group (ECOG) performance status scores are 0-2 .
Key exclusion criteria (11 listed)
- Radiographic findings showed that the tumor involved large blood vessels or was poorly demarcated from them .
- Radiographic findings showed significant pulmonary cavitation or necrotizing tumor .
- Active brain metastasis or meningeal metastasis .
- With other malignant tumors in the past 5 years, except cancers that have been cured significantly or can be focally cured, e.g. basosquamous carcinoma of skin, or carcinoma cervix in situ .
- With Interstitial lung disease, including drug- induced Interstitial lung disease or radiation pneumonitis .
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 |
|---|---|---|
| SintilimabA humanized anti-PD-1 monoclonal antibody | Drug | Sintilimab + Anlotinib |
| Anlotinib hydrochlorideA tyrosine kinase inhibitor selectively targeting VEGFR-2 | Drug | Sintilimab + Anlotinib |
Primary outcome
ORR
Time frame: 12 month
Objective response rate according to RECIST v1.1
5 secondary outcomes
DCR
Time frame: 12 months
DoR
Time frame: 12 months
PFS
Time frame: 12 months
OS
Time frame: on average of 2 years
Adverse Event
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 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.
Guangyuan Lou principal investigator
Zhejiang Cancer Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sintilimab and Anlotinib hydrochloride in people with Small Cell Lung Cancer Extensive Stage, run by Zhejiang Cancer Hospital.
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 7 inclusion and 11 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 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Lan Shao (+86 13456964958, shaolan28@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 12 month). 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 28 Jul 2021.