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Phase 1b Study of Sintilimab Plus Anlotinib as First-line Therapy in Patients With Advanced NSCLC
Tianqing Chu1, Runbo Zhong1, Hua Zhong1
1Respiratory Department, Shanghai Chest Hospital, Shanghai Jiaotong University, Shanghai, People's Republic of China.
Introduction:
Although the interaction between tumor immune microenvironment and angiogenesis has been well established, evidence supporting the chemo-free combination of immune checkpoint inhibitors plus antiangiogenic tyrosine kinase inhibitors in treatment-naive patients with advanced NSCLC is insufficient. This report provides the efficacy and safety of sintilimab combined with anlotinib as first-line therapy for advanced NSCLC from a phase 1b trial (NCT03628521).
Methods:
Eligible patients who were treatment-naive and had unresectable stage IIIB/C or IV NSCLC without EGFR/ALK/ROS1 mutations received sintilimab (200 mg, day 1) and anlotinib (12 mg, day 1-14) every 3 weeks till disease progression or unacceptable toxicity. Baseline programmed death-ligand 1 expression and tumor mutation burden status was assessed in all patients. The primary end points were objective response rate and safety.
Results:
A total of 22 patients received sintilimab and anlotinib. Median follow-up was 15.8 months (range: 8.3-19.3). Sixteen patients achieved confirmed partial response with an objective response rate of 72.7% (95% confidence interval [CI]: 49.8%-89.3%) and disease control rate of 100% (95% CI: 84.6%-100%). Median progression-free survival was 15 months (95% CI: 8.3 m, not reached), and the 12-month progression-free survival rate was 71.4% (95% CI: 47.2%-86.0%). The incidence rate of grade 3 or higher treatment-related adverse events was 54.5%, and grade 3 hypertension was predominant (two of 22, 9.1%). No grade 4 treatment-related adverse events were observed, and one case of grade 5 immune-related pneumonitis occurred.
Conclusions:
To the best of our knowledge, this is the first study that assessed an anti-programmed cell death protein 1 antibody combined with a multitarget antiangiogenic tyrosine kinase inhibitor in the frontline setting for patients with NSCLC. In view of its encouraging efficacy, durability, and safety profile, sintilimab plus anlotinib represents a novel chemotherapy-free regimen in this patient population.
Insights
Sintilimab plus anlotinib showed promising efficacy and safety as a first-line, chemotherapy-free treatment for advanced non-small cell lung cancer (NSCLC). This combination achieved a high objective response rate and durable progression-free survival in treatment-naive patients.
Area of Science:
- Oncology
- Immunotherapy
- Medical Research
Background:
- The interplay between the tumor immune microenvironment and angiogenesis is recognized.
- Limited data exists on chemo-free combinations of immune checkpoint inhibitors and antiangiogenic tyrosine kinase inhibitors for treatment-naive advanced NSCLC.
Purpose of the Study:
- To evaluate the efficacy and safety of sintilimab combined with anlotinib as a first-line therapy for advanced NSCLC.
- To assess this novel regimen in treatment-naive patients.
Main Methods:
- A phase 1b trial (NCT03628521) enrolled treatment-naive patients with unresectable stage IIIB/C or IV NSCLC.
- Patients received sintilimab (anti-PD-1) plus anlotinib (antiangiogenic TKI) every 3 weeks until disease progression or toxicity.
- Primary endpoints included objective response rate and safety assessments.
Main Results:
- The study included 22 patients with a median follow-up of 15.8 months.
- An objective response rate of 72.7% and a 100% disease control rate were observed.
- Median progression-free survival was 15 months, with a 12-month PFS rate of 71.4%.
- Grade 3+ treatment-related adverse events occurred in 54.5% of patients, with grade 3 hypertension being most common.
Conclusions:
- Sintilimab plus anlotinib demonstrates encouraging efficacy, durability, and a manageable safety profile.
- This combination represents a novel, chemotherapy-free first-line treatment option for advanced NSCLC patients.
- This is the first study to evaluate this specific combination in the frontline setting.
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