Clinical trial · Interventional
A Phase II Study of Sintilimab Combined With Anlotinib in Treatment of ED-SCLC
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Small Cell Lung Cancer Extensive Stage | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anlotinib hydrochloride | Drug | — | UNRESOLVED |
| Sintilimab | Drug | Sintilimab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sintilimab + Anlotinib
- description
- sintilimab 200mg, IV, d1, Q3W and anlotinib 12mg, PO, QD，d1-14, Q3W; treatment until disease progression, unacceptable toxicity, or death
- interventionNames
- Drug: Sintilimab
- Drug: Anlotinib hydrochloride
Primary outcomes (1)
- measure
- ORR
- timeFrame
- 12 month
- description
- Objective response rate according to RECIST v1.1
Secondary outcomes (5)
- measure
- DCR
- timeFrame
- 12 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 .
References
Publications (0)
Data not yet available