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

NCT ID: NCT04967625

Last Updated: 2021-07-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-26
• Study Completion Date: 2023-12-31

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.

Conditions

Small Cell Lung Cancer Extensive Stage

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sintilimab + Anlotinib

sintilimab 200mg, IV, d1, Q3W and anlotinib 12mg, PO, QD，d1-14, Q3W; treatment until disease progression, unacceptable toxicity, or death

Group Type: EXPERIMENTAL

Sintilimab

Intervention Type: DRUG

A humanized anti-PD-1 monoclonal antibody

Anlotinib hydrochloride

Intervention Type: DRUG

A tyrosine kinase inhibitor selectively targeting VEGFR-2

Interventions

Sintilimab

A humanized anti-PD-1 monoclonal antibody

Intervention Type: DRUG

Anlotinib hydrochloride

A tyrosine kinase inhibitor selectively targeting VEGFR-2

Intervention Type: DRUG

Eligibility Criteria

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 .

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guangyuan Lou

Role: PRINCIPAL_INVESTIGATOR

Zhejiang Cancer Hospital

Central Contacts

Lan Shao

Role: CONTACT

shaolan28@163.com

+86 13456964958

Other Identifiers

ZJCH-SCLC-01

Identifier Type: -

Identifier Source: org_study_id