SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT03765775

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

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

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.

NCT03765775 Carcinoma Non-small Cell Lung Cancer Lung Neoplasm
MeSH: Carcinoma, Non-Small-Cell Lung Lung Neoplasms
HPO: Neoplasm of the lung Non-small cell lung carcinoma

2 Interventions

Name: Sintilimab

Description: Participants receive Sintilimab(IBI 308) 200 mg, administered as intravenous (IV) infusion on Day 1 of each 21-day cycle

Type: Biological

Anlotinib Hydrochloride+Sintilimab

Name: Anlotinib Hydrochloride

Description: Participants receive Anlotinib 10 mg, administered as PO on Day 1-14 of each 21-day cycle

Type: Drug

Anlotinib Hydrochloride+Sintilimab


Primary Outcomes

Description: PFS was defined as the time from randomization to documented disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) or death due to any cause, whichever occurred first and was based on blinded independent central radiologists' (BICR) review. Progressive Disease (PD) was defined as ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. (Note: the appearance of one or more new lesions was also considered progression). Participants were evaluated every 9 weeks with radiographic imaging to assess their response to treatment.

Measure: Progression-Free Survival (PFS)

Time: 6 months

Secondary Outcomes

Description: OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. In those instances where participants were confirmed to be alive on the visit cut-off date of 09 May 2016, survival was censored as of 09 May 2016.

Measure: Over Survival(OS)

Time: 2years

Description: ORR was defined as the percentage of participants in the analysis population who experienced a Complete Response (CR; disappearance of all target lesions) or a Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions) and was assessed using RECIST 1.1 based on BICR evaluation.

Measure: Objective Response Rate (ORR)

Time: 2yeas

Purpose: Treatment

Single Group Assignment


There is one SNP

SNPs


1 T790M

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

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

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

Has confirmation that epidermal growth factor receptor (EGFR) mutation,with first-generation EGFR-TKIs drug resistance T790M negative . --- T790M ---



HPO Nodes


HPO:
Neoplasm of the lung
Genes 43
WT1 KRAS SLC22A18 STK11 IRF1 AKT1 C11ORF95 PRKN PPP2R1B ERBB2 TRPV3 TSC1 POU6F2 TSC2 EWSR1 RELA KEAP1 REST DIS3L2 SFTPA2 GPC3 MBTPS2 LMNA PTEN BRAF BRCA2 EGFR RB1 TRIP13 PDGFRB TERT SFTPC PIK3CA TRIM28 DICER1 MAP3K8 HPGD SLCO2A1 H19 TP53 NOTCH3 BAP1 WRN
Non-small cell lung carcinoma
Genes 2
TP53 BAP1