NCT04124731

Combination Therapy of Sintilimab and Anlotinib as a First-line Treatment in Advanced NSCLC (SUNRISE)

SUNRISE: A Phase II Randomized Control Study of Sintilimab Combined With Anlotinib Versus Standard Platinum-based Chemotherapy as a First-line Treatment in Patients With Advanced NSCLC

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 98 (estimated)
• Sponsor: Shanghai Chest Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open label, multi-center, randomized control phase II trial, to compare the efficacy and safety of sintilimab combined with anlotinib versus standard platinum-based chemotherapy as a first-line treatment in advanced NSCLC patients without driven-gene mutations.

Detailed description

This is an open label, multi-center, randomized control study comparing the combination of sintilimab and anlotinib with standard platinum-based chemotherapy in treat-naïve advanced (unresectable stage IIIB, IIIC and IV patients without driven-gene mutations) NSCLC patients. Eligible subjects are 1:1 randomized into the experimental group (sintilimab combined with anlotinib) or the control group (standard platinum-based chemotherapy).

Conditions

• Carcinoma
• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	sintilimab plus anlotinib	Sintilimab 200 mg administered intravenously (IV) on Day 1 of each 21-day cycle plus anlotinib capsules 12 mg given orally in fasting conditions, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21
DRUG	Chemotherapy	1. Pemetrexed combined with platinum regimen (non-squamous cell carcinoma): pemetrexed 500mg/m2, intravenous infusion on the first day of each cycle, cisplatin 75mg/m2 or carboplatin AUC 5, intravenous infusion on the first day of each cycle, 1 cycle every 3 weeks (Q3W), 4 cycles in total. Patients who did not progress after 4 cycles received maintenance monotherapy with pemetrexide at the same dose as before. 2. Gemcitabine combined with platinum regimen (squamous cell carcinoma): gemcitabine 1250mg/m2, intravenous infusion on day 1 and day 8 of each cycle, cisplatin: 75mg/m2 or carboplatin: AUC 5, intravenous infusion on day 1 of each cycle, 1 cycle every 3 weeks (Q3W), 4-6 cycles in total.

Timeline

• Start date: 2019-10-01
• Primary completion: 2021-04-01
• Completion: 2022-04-01
• First posted: 2019-10-11
• Last updated: 2019-10-11