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Multicenter, phase II trial of sunitinib in previously treated, advanced non-small-cell lung cancer
Mark A Socinski1, Silvia Novello, Julie R Brahmer
1Multidisciplinary Thoracic Oncology Program, Lineberger Comprehensive Cancer Center, University of North Carolina, CB# 7305, Chapel Hill, NC 27599, USA. socinski@med.unc.edu
Purpose:
Aberrant vascular endothelial growth factor (VEGF) and platelet-derived growth factor (PDGF) signaling have been shown to play a role in non-small-cell lung cancer (NSCLC) pathogenesis and are associated with decreased survival. We evaluated the clinical activity and tolerability of sunitinib malate (SU11248), an oral, multitargeted tyrosine kinase inhibitor that blocks the activity of receptors for VEGF and PDGF, as well as related tyrosine kinases in patients with previously treated, advanced NSCLC.
Patients And Methods:
Patients with stage IIIB or IV NSCLC for whom platinum-based chemotherapy had failed received 50 mg/d of sunitinib for 4 weeks followed by 2 weeks of no treatment in 6-week treatment cycles. The primary end point was objective response rate (ORR); secondary end points included progression-free survival, overall survival, and safety.
Results:
Of the 63 patients treated with sunitinib, seven patients had confirmed partial responses, yielding an ORR of 11.1% (95% CI, 4.6% to 21.6%). An additional 18 patients (28.6%) experienced stable disease of at least 8 weeks in duration. Median progression-free survival was 12.0 weeks (95% CI, 10.0 to 16.1 weeks), and median overall survival was 23.4 weeks (95% CI, 17.0 to 28.3 weeks). Therapy was generally well tolerated.
Conclusion:
Sunitinib has promising single-agent activity in patients with recurrent NSCLC, with an ORR similar to that of currently approved agents and an acceptable safety profile. Further evaluation in combination with other targeted agents and chemotherapy in patients with NSCLC is warranted.
Insights
Sunitinib demonstrated promising activity in patients with advanced non-small-cell lung cancer (NSCLC) after chemotherapy. This oral targeted therapy showed an acceptable safety profile and potential for further investigation in NSCLC treatment.
Area of Science:
- Oncology
- Pharmacology
Background:
- Aberrant signaling of vascular endothelial growth factor (VEGF) and platelet-derived growth factor (PDGF) is implicated in non-small-cell lung cancer (NSCLC) progression.
- These signaling pathways are associated with poorer patient survival outcomes in NSCLC.
Purpose of the Study:
- To evaluate the clinical activity and tolerability of sunitinib malate, an oral multitargeted tyrosine kinase inhibitor.
- Sunitinib targets receptors for VEGF and PDGF, as well as related tyrosine kinases.
Main Methods:
- A phase II clinical trial was conducted involving patients with stage IIIB or IV NSCLC who had previously failed platinum-based chemotherapy.
- Sunitinib was administered at 50 mg/d for 4 weeks followed by a 2-week break, in 6-week cycles.
- The primary endpoint was objective response rate (ORR), with progression-free survival, overall survival, and safety as secondary endpoints.
Main Results:
- The objective response rate (ORR) for sunitinib was 11.1% (7/63 patients), with an additional 28.6% experiencing stable disease for at least 8 weeks.
- Median progression-free survival was 12.0 weeks, and median overall survival was 23.4 weeks.
- Sunitinib treatment was generally well tolerated by the patient cohort.
Conclusions:
- Sunitinib exhibits promising single-agent activity in patients with recurrent NSCLC.
- The observed ORR is comparable to currently approved agents, with an acceptable safety profile.
- Further research is warranted to explore sunitinib in combination with other targeted agents and chemotherapy for NSCLC treatment.
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