SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT03766490

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

A Prospective, Single-arm, Multicenter Study of Anlotinib Hydrochloride Combined With First-generation EGFR TKIs as Second-line Treatment in Acquired (Non-T790M Mutation) Resistance Advanced Non-small Cell Lung Cancer

After the second-line treatment of patients with non-T790M mutations, chemotherapy with platinum-containing drugs was used, and chemotherapy-related toxicity was high. Studies have shown that bevacizumab combined with EGFR TKI have a good trend of benefit. This study is aimed to evaluate the efficacy and safety of Anlotinib Hydrochloride combined with first-generation EGFR TKIs as second-line treatment in advanced non-small cell lung cancer . The patients with IV non-small lung cancer have acquired resistance to prior first-generation EGFR TKIs and have non-T790M mutation.

NCT03766490 Non-Small-Cell Lung
MeSH: Carcinoma, Non-Small-Cell Lung
HPO: Non-small cell lung carcinoma

3 Interventions

Name: Anlotinib Hydrochloride

Description: Capsule, P.O. 12mg qd ,days 1-14, 21 days a cycle

Type: Drug

Anlotinib Hydrochloride plus gefitinib or icotinib

Name: Gefitinib

Description: Tablet, P.O. 250mg qd

Type: Drug

Anlotinib Hydrochloride plus gefitinib or icotinib

Name: Icotinib

Description: Tablet, P.O. 125mg tid

Type: Drug

Anlotinib Hydrochloride plus gefitinib or icotinib


Primary Outcomes

Description: PFS defined as the time from first dose of study treatment until the first date of either objective disease progression or death due to any cause.

Measure: PFS(Progress free survival)

Time: each 42 days up to PD or death(up to 24 months)

Secondary Outcomes

Description: OS is defined as the time until death due to any cause.

Measure: Overall Survival (OS)

Time: From randomization until death (up to 24 months)

Description: ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1.prior to progression or any further therapy.

Measure: Objective Response Rate (ORR)

Time: each 42 days up to intolerance the toxicity or PD (up to 24 months)

Description: use EORTC QLQ-C30(version 3) questionnaire to evaluate the quality of life.

Measure: Quality of Life(QoL)

Time: each 42 days up to intolerance the toxicity or PD (up to 24 months)

Description: Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1.

Measure: Disease Control Rate (DCR)

Time: each 42 days up to intolerance the toxicity or PD (up to 24 months)

Purpose: Treatment

Single Group Assignment


There are 2 SNPs

SNPs


1 L858R

- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1. - Previously, EGFR gene test showed EGFR exon 19 deletion or exon 21 (L858R) mutation, and the gene test showed no T790M mutation before enrollment. --- L858R ---


2 T790M

A Prospective, Single-arm, Multicenter Study of Anlotinib Hydrochloride Combined With First-generation EGFR TKIs as Second-line Treatment in Acquired (Non-T790M Mutation) Resistance Advanced Non-small Cell Lung Cancer. --- T790M ---

Anlotinib Hydrochloride Combined With EGFR TKIs in Advanced Non-small Cell Lung Cancer After the second-line treatment of patients with non-T790M mutations, chemotherapy with platinum-containing drugs was used, and chemotherapy-related toxicity was high. --- T790M ---

The patients with IV non-small lung cancer have acquired resistance to prior first-generation EGFR TKIs and have non-T790M mutation. --- T790M ---

- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1. - Previously, EGFR gene test showed EGFR exon 19 deletion or exon 21 (L858R) mutation, and the gene test showed no T790M mutation before enrollment. --- L858R --- --- T790M ---

- Patients that cannot detect EGFR gene, or patients with known T790M mutation. --- T790M ---



HPO Nodes


HPO:
Non-small cell lung carcinoma
Genes 2
TP53 BAP1