NCT03765775

Anlotinib Plus Sintilimab for NSCLC Patients With First-generation EGFR-TKIs Drug Resistance Along With T790M Negative

A Randomized, Phase II Study of Anlotinib Combined With Sintilimab(IBI 308) in First-generation EGFR-TKIs Drug Resistance Along With T790M Negative NSCLC

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: First Hospital of Shijiazhuang City · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an efficacy and safety study of Anlotinib combined with Sintilimab (IBI 308) in participants with advanced or metastatic non-small cell lung cancer (NSCLC) who have received first-generation EGFR-TKIs resistance along with T790M negative.

Detailed description

Participants receive Sintilimab(IBI 308) 200 mg, administered as intravenous (IV) infusion on Day 1, Anlotinib 12mg, administered as PO on Day1-14 of each 21-day cycle until documented PD.The primary hypothesis of this study is that participants will have a longer Progression Free Survival (PFS), as assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) when treated with Anlotinib plus Sintilimab(IBI 308).

Conditions

• Carcinoma
• Non-small Cell Lung Cancer
• Lung Neoplasm

Interventions

Type	Name	Description
BIOLOGICAL	Sintilimab	Participants receive Sintilimab(IBI 308) 200 mg, administered as intravenous (IV) infusion on Day 1 of each 21-day cycle
DRUG	Anlotinib Hydrochloride	Participants receive Anlotinib 10 mg, administered as PO on Day 1-14 of each 21-day cycle

Timeline

• Start date: 2018-11-20
• Primary completion: 2019-12-31
• Completion: 2021-12-31
• First posted: 2018-12-05
• Last updated: 2018-12-06

Locations

1 site across 1 country: China