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

University of Chinese Academy Sciences

Status and phase

Unknown

Phase 2

Conditions

Small Cell Lung Cancer Extensive Stage

Treatments

Drug: Anlotinib hydrochloride

Drug: Sintilimab

Study type

Interventional

Funder types

Other

Identifiers

NCT04967625

ZJCH-SCLC-01

Details and patient eligibility

About

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.

Full description

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

Enrollment

23 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 .