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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Small Cell Lung Cancer Extensive Stage
• Intervention / Treatment: Drug: Sintilimab; Drug: Anlotinib hydrochloride

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 Type: Interventional
• Enrollment (Anticipated): 23
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Lan Shao; Phone Number: +86 13456964958; Email: shaolan28@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Zhejiang Cancer Hospital
• Investigators: Principal Investigator: Guangyuan Lou, Zhejiang Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): July 26, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: July 15, 2021
• First Submitted That Met QC Criteria: July 15, 2021
• First Posted (Actual): July 19, 2021

Study Record Updates

• Last Update Posted (Actual): July 28, 2021
• Last Update Submitted That Met QC Criteria: July 26, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma
• Other Study ID Numbers: ZJCH-SCLC-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No