NCT04312204

Clinical Trial of Sintilimab Combined With Gemcitabine/Carboplatin Regimen in the Treatment of Advanced Primary Pulmonary Lymphoepithelioma-like Carcinoma

Exploratory Clinical Trial of Sintilimab Combined With Gemcitabine/Carboplatin Regimen in the Treatment of Advanced Primary Pulmonary Lymphoepithelioma-like Carcinoma（LELC）

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Zhou Chengzhi · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The trial was designed to explore the safety and efficacy of sintilimab combined with gemcitabine and carboplatin in the treatment of advanced LELC.

Conditions

• Primary Pulmonary Lymphoepithelioma-like Carcinoma
• Lung Cancer

Interventions

Type	Name	Description
DRUG	Sintilimab combined with Gemcitabine and Carboplatin	The patients will received Gemcitabine1000mg/m2(d1,d8)(iv)+carboplatin AUC 5 (d1)(iv),4 cycles, Sintilimab 200 mg (3mg/kg when the weight \<40kg ) (d1) (iv) in one cycle every 3 weeks, until PD or death. Radiological examinations (according to the RECIST 1.1 criteria) at baseline will be repeated for tumor response evaluation following every two cycles of chemotherapy. Patients will be followed up to 30 days after the last dose of study chemotherapy, and then every 3 months.

Timeline

• Start date: 2020-03-01
• Primary completion: 2021-08-01
• Completion: 2022-08-01
• First posted: 2020-03-18
• Last updated: 2020-03-18

Locations

1 site across 1 country: China