Spots Global Cancer Trial Database for Anlotinib Plus Sintilimab for NSCLC Patients With First-generation EGFR-TKIs Drug Resistance Along With T790M Negative

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Trial Identification

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

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

Study ID: NCT03765775

Conditions

Carcinoma

Non-small Cell Lung Cancer

Lung Neoplasm

Interventions

Sintilimab

Anlotinib Hydrochloride

Study Description

Brief 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).