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

• Status: Not yet recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhejiang Cancer Hospital

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 .