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

Phase 2

• Conditions: Small Cell Lung Cancer Extensive Stage
• Interventions: Drug: Sintilimab; Drug: Anlotinib hydrochloride

• Registration Number: NCT04967625
• Lead Sponsor: Zhejiang Cancer Hospital

Brief 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.

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 Timeline

• Status Verified: 2021-03
• Study First Submitted: 2021-07-15
• Study First Submitted QC: 2021-07-15
• Study First Posted: 2021-07-19
• Study Start: 2021-07-26
• Last Update Submitted: 2021-07-26
• Last Update Posted: 2021-07-28
• Primary Completion: 2022-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 23

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 .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sintilimab + Anlotinib	Anlotinib hydrochloride	sintilimab 200mg, IV, d1, Q3W and anlotinib 12mg, PO, QD，d1-14, Q3W; treatment until disease progression, unacceptable toxicity, or death
Sintilimab + Anlotinib	Sintilimab	sintilimab 200mg, IV, d1, Q3W and anlotinib 12mg, PO, QD，d1-14, Q3W; treatment until disease progression, unacceptable toxicity, or death

Primary Outcome Measures

Name	Time	Method
ORR	12 month	Objective response rate according to RECIST v1.1

Secondary Outcome Measures

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