A Phase II Study of Sintilimab Combined With Anlotinib in... | NCT04967625

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

NCT04967625

Sponsor

Zhejiang Cancer Hospital

Status

Unknown status

Last Update Posted

Jul 28, 2021Actual

Enrollment

23Estimated

Phase

Phase 2

Conditions

Small Cell Lung Cancer Extensive Stage

Interventions

Sintilimab
Anlotinib hydrochloride

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 26, 2021Estimated

Primary Completion Date

Dec 31, 2022Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Jul 15, 2021

First Submission Date that Met QC Criteria

Jul 15, 2021

First Posted Date

Jul 19, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 26, 2021

Last Update Posted Date

Jul 28, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

23Estimated

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sintilimab	Drug	A humanized anti-PD-1 monoclonal antibody	Sintilimab + Anlotinib

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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 .

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided