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

NCT04967625 | Unknown Phase 2

• 1 other identifier: ZJCH-SCLC-01
• Study Type: interventional
• Target: 23
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Small Cell Lung Cancer Extensive Stage

Outcome Measures

Primary Outcomes (1)

• ORR

  Objective response rate according to RECIST v1.1

  12 month

Secondary Outcomes (5)

• DCR

  12 months

• DoR

  12 months

• PFS

  12 months

• OS

  on average of 2 years

• Adverse Event

  12 months

Study Arms (1)

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

Sintilimab DRUG

A humanized anti-PD-1 monoclonal antibody

Sintilimab + Anlotinib

Anlotinib hydrochloride DRUG

A tyrosine kinase inhibitor selectively targeting VEGFR-2

Sintilimab + Anlotinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

MeSH Terms

Interventions

sintilimab

Study Officials

• Guangyuan Lou

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lan Shao

CONTACT

+86 13456964958; shaolan28@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Anti-PD-1 antibody sintilimab combined With anti-angeogensis inhibitor anlotinib for extensive stage disease small cell lung cancer after failure of first line standard therapy

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: July 19, 2021
• Study Start: July 26, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: July 28, 2021

Record last verified: 2021-03