SNPMiner Trials by Shray Alag


SNPMiner SNPMiner Trials (Home Page)


Report for Clinical Trial NCT03976856

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase Ib Clinical Study With Extension Phase to Evaluate Safety and Efficacy of Genolimzumab (GB226) in Combination With Fruquintinib in the Treatment of Relapsed or Metastatic NSCLC Patients

This study is a multi-center, open-label, dose-finding phase Ib clinical study with extension phase, which is aimed at evaluating the efficacy and safety of GB226 combined with fruquintinib in treatment of relapsed or metastatic NSCLC patients with EGFR-sensitive mutations who have failed to respond to EGFR-TKI treatment,evaluating the pharmacokinetic characteristics of GB226 and fruquintinib, and the immunogenicity of GB226, and preliminarily evaluating the antitumor activity of GB226 and fruquintinib.

NCT03976856 Metastatic Non-small Cell Lung Cancer
MeSH:Carcinoma, Non-Small-Cell Lung
HPO:Non-small cell lung carcinoma

2 Interventions

Name: GB226

Description: Geptanolimab, 210mg,q2w,ivgtt.
Type: Drug
Group Labels: 1

GB226+Fruquintinib

Name: Fruquintinib

Description: Fruquintinib, 3mg or 4mg or 5mg, qd.po. 3 weeks-on,1 week-off
Type: Drug
Group Labels: 1

GB226+Fruquintinib


Primary Outcomes

Description: Assessment of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v4.03

Measure: Incidence of Adverse Event

Time: all adverse events will be recorded from the time the consent form is signed through 90 days following cessation of treatment.

Description: Assessment of serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v4.03

Measure: Incidence of Serious Adverse Event

Time: all adverse events will be recorded from the time the consent form is signed through 90 days following cessation of treatment.

Description: Incidence of Dose Limited Toxicity

Measure: Dose Limited Toxicity

Time: Day 1 to Day 28 after first dose

Description: Defined as the highest dose tested in which only 0 or 1 out of 6 evaluable patients experience a dose limiting toxicity, as graded by the National Cancer Institute (NCI) Common terminology Criteria for Adverse Events (CTCAE) version 4.03

Measure: Maximum Tolerated Dose

Time: Day 1 to Day 28 after first dose

Secondary Outcomes

Description: Cmax

Measure: Cmax

Time: up to 90 days after the last administration

Description: Tmax

Measure: Tmax

Time: up to 90 days after the last administration

Description: AUC0-t

Measure: AUC0-t

Time: up to 90 days after the last administration

Description: AUC0-∞

Measure: AUC0-∞

Time: up to 90 days after the last administration

Description: MRT

Measure: MRT

Time: up to 90 days after the last administration

Description: Vd

Measure: Vd

Time: up to 90 days after the last administration

Description: CL

Measure: CL

Time: up to 90 days after the last administration

Description: AUC 0-τ

Measure: AUC 0-τ

Time: up to 90 days after the last administration

Description: C avg

Measure: C avg

Time: up to 90 days after the last administration

Description: C min

Measure: C min

Time: up to 90 days after the last administration

Description: CL ss

Measure: CL ss

Time: up to 90 days after the last administration

Description: To evaluate the efficacy of GB226 as defined by objective response rate in patients with lung cancer.

Measure: Objective Response Rate, ORR

Time: up to 90 days after the last administration

Description: To evaluate the efficacy of GB226 as defined by disease control rate in patients with lung cancer.

Measure: Disease control rate,DCR

Time: up to 90 days after the last administration

Description: To evaluate the duration of response (DOR) of GB226 in patients with lung cancer

Measure: Duration of response, DOR

Time: up to 90 days after the last administration

Description: To evaluate the efficacy of GB226 as defined by progression-free survival in patients with lung cancer

Measure: Progression-free survival, PFS

Time: up to 90 days after the last administration

Description: To evaluate the efficacy of GB226 as defined by overall survival in patients with lung cancer.

Measure: Overall survival, OS

Time: up to 90 days after the last administration

Description: To evaluate the immunogenicity of GB226 in Chinese patients with lung cancer.

Measure: Concentration of AntiDrug Antibody, ADA

Time: up to 90 days after the last administration

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There are 4 SNPs

SNPs


1 L858R

To evaluate the immunogenicity of GB226 in Chinese patients with lung cancer.. Inclusion Criteria: 1. Aged 18-75 years, male or female; 2. Understanding the procedures and contents of the study, and voluntarily signing the written informed consent form; 3. Histologically or cytology confirmed relapsed or metastatic NSCLC; 4. EGFR gene sensitive mutation is confirmed positive, any of following is met: exon 19 deletion (19DEL), exon 21 point mutation (L858R / L861Q), 18 exon point mutation (G719X), 20 exon point mutation (S768I). --- L858R ---

Inclusion Criteria: 1. Aged 18-75 years, male or female; 2. Understanding the procedures and contents of the study, and voluntarily signing the written informed consent form; 3. Histologically or cytology confirmed relapsed or metastatic NSCLC; 4. EGFR gene sensitive mutation is confirmed positive, any of following is met: exon 19 deletion (19DEL), exon 21 point mutation (L858R / L861Q), 18 exon point mutation (G719X), 20 exon point mutation (S768I). --- L858R ---


2 L861Q

To evaluate the immunogenicity of GB226 in Chinese patients with lung cancer.. Inclusion Criteria: 1. Aged 18-75 years, male or female; 2. Understanding the procedures and contents of the study, and voluntarily signing the written informed consent form; 3. Histologically or cytology confirmed relapsed or metastatic NSCLC; 4. EGFR gene sensitive mutation is confirmed positive, any of following is met: exon 19 deletion (19DEL), exon 21 point mutation (L858R / L861Q), 18 exon point mutation (G719X), 20 exon point mutation (S768I). --- L858R --- --- L861Q ---

Inclusion Criteria: 1. Aged 18-75 years, male or female; 2. Understanding the procedures and contents of the study, and voluntarily signing the written informed consent form; 3. Histologically or cytology confirmed relapsed or metastatic NSCLC; 4. EGFR gene sensitive mutation is confirmed positive, any of following is met: exon 19 deletion (19DEL), exon 21 point mutation (L858R / L861Q), 18 exon point mutation (G719X), 20 exon point mutation (S768I). --- L858R --- --- L861Q ---


3 S768I

To evaluate the immunogenicity of GB226 in Chinese patients with lung cancer.. Inclusion Criteria: 1. Aged 18-75 years, male or female; 2. Understanding the procedures and contents of the study, and voluntarily signing the written informed consent form; 3. Histologically or cytology confirmed relapsed or metastatic NSCLC; 4. EGFR gene sensitive mutation is confirmed positive, any of following is met: exon 19 deletion (19DEL), exon 21 point mutation (L858R / L861Q), 18 exon point mutation (G719X), 20 exon point mutation (S768I). --- L858R --- --- L861Q --- --- S768I ---

Inclusion Criteria: 1. Aged 18-75 years, male or female; 2. Understanding the procedures and contents of the study, and voluntarily signing the written informed consent form; 3. Histologically or cytology confirmed relapsed or metastatic NSCLC; 4. EGFR gene sensitive mutation is confirmed positive, any of following is met: exon 19 deletion (19DEL), exon 21 point mutation (L858R / L861Q), 18 exon point mutation (G719X), 20 exon point mutation (S768I). --- L858R --- --- L861Q --- --- S768I ---


4 T790M

No T790M mutation after failure of EGFR-TKI treatment; 2. T790M mutation after EGFR-TKI treatment failure, and failed to respond to third-generation EGFR-TKI treatment; primary T790M mutation, progressed after third-generation EGFR-TKI treatment or no other available effective therapies; 3. The above patients failed to respond to chemotherapy or are unwilling to or intolerable to chemotherapy; 5. --- T790M ---

No T790M mutation after failure of EGFR-TKI treatment; 2. T790M mutation after EGFR-TKI treatment failure, and failed to respond to third-generation EGFR-TKI treatment; primary T790M mutation, progressed after third-generation EGFR-TKI treatment or no other available effective therapies; 3. The above patients failed to respond to chemotherapy or are unwilling to or intolerable to chemotherapy; 5. --- T790M --- --- T790M ---

No T790M mutation after failure of EGFR-TKI treatment; 2. T790M mutation after EGFR-TKI treatment failure, and failed to respond to third-generation EGFR-TKI treatment; primary T790M mutation, progressed after third-generation EGFR-TKI treatment or no other available effective therapies; 3. The above patients failed to respond to chemotherapy or are unwilling to or intolerable to chemotherapy; 5. --- T790M --- --- T790M --- --- T790M ---



HPO Nodes


HPO: