Small Cell Lung Cancer Extensive Stage
Conditions
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.
Interventions
DRUGSintilimab
A humanized anti-PD-1 monoclonal antibody
DRUGAnlotinib hydrochloride
A tyrosine kinase inhibitor selectively targeting VEGFR-2
Sponsors
Zhejiang Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR | 12 month | Objective response rate according to RECIST v1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Event | 12 months | Evaluation of adverse event rate according to CTCAE v4.03 |
| PFS | 12 months | Progression-free survival according to RECIST v1.1 |
| DCR | 12 months | Disease control rate according to RECIST v1.1 |
| OS | on average of 2 years | Overall survival |
| DoR | 12 months | Duration of response according to RECIST v1.1 |
Contacts
Primary ContactLan Shao
Outcome results
None listed