Clinical trial NCT04967625: A Phase II Study of Sintilimab Combined With Anlotinib in Treatment of ED-SCLC
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Small Cell Lung Cancer Extensive Stage
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2021-07-19
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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
Primary purpose: TREATMENT

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.

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 .

Primary outcomes:
measure: ORR
timeFrame: 12 month
Secondary outcomes:
measure: DCR
timeFrame: 12 months
measure: DoR
timeFrame: 12 months
measure: PFS
timeFrame: 12 months
measure: OS
timeFrame: on average of 2 years
measure: Adverse Event
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Guangyuan Lou
role: PRINCIPAL_INVESTIGATOR
References: