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

Small Cell Lung Cancer Extensive Stage Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04967625
• Other study ID #: ZJCH-SCLC-01
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 26, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2021
• Source: Zhejiang Cancer Hospital
• Contact: Lan Shao
• Phone: +86 13456964958
• Email: shaolan28[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 23
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 .

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer Extensive Stage
• Small Cell Lung Carcinoma

Intervention

Drug:
• Sintilimab
A humanized anti-PD-1 monoclonal antibody
• Anlotinib hydrochloride
A tyrosine kinase inhibitor selectively targeting VEGFR-2

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR	Objective response rate according to RECIST v1.1	12 month
Secondary	DCR	Disease control rate according to RECIST v1.1	12 months
Secondary	DoR	Duration of response according to RECIST v1.1	12 months
Secondary	PFS	Progression-free survival according to RECIST v1.1	12 months
Secondary	OS	Overall survival	on average of 2 years
Secondary	Adverse Event	Evaluation of adverse event rate according to CTCAE v4.03	12 months