A Phase II Study of Sintilimab Combined With Anlotinib in Treatment of ED-SCLC

Study Overview
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Brief Summary
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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
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Subjects will receive sintilimab 200mg, IV, Q3W and anlotinib 12mg, PO, QD，d1-14, Q3W treatment until disease progression, unacceptable toxicity, or death.

Official Title
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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

Conditions
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Small Cell Lung Cancer Extensive Stage

Intervention / Treatment
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* Drug: Sintilimab
* Drug: Anlotinib hydrochloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 . Exclusion Criteria: 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 . 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 .

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sintilimab + Anlotinib<br>sintilimab 200mg, IV, d1, Q3W and anlotinib 12mg, PO, QD，d1-14, Q3W; treatment until disease progression, unacceptable toxicity, or death | Drug: Sintilimab<br>* A humanized anti-PD-1 monoclonal antibody<br>Drug: Anlotinib hydrochloride<br>* A tyrosine kinase inhibitor selectively targeting VEGFR-2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | Objective response rate according to RECIST v1.1 | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DCR | Disease control rate according to RECIST v1.1 | 12 months | 
| DoR | Duration of response according to RECIST v1.1 | 12 months | 
| PFS | Progression-free survival according to RECIST v1.1 | 12 months | 
| OS | Overall survival | on average of 2 years | 
| Adverse Event | Evaluation of adverse event rate according to CTCAE v4.03 | 12 months |