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Report for Clinical Trial NCT03823807

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Multicenter, Open-label, Phase II Study to Evaluate the Safety and Efficacy of SH-1028 in Locally Advanced or Metastatic NSCLC

A Phase II, Open Label, Single-arm Study to Assess the Safety and Efficacy of SH-1028 with Locally Advanced/Metastatic Non-Small Cell Lung Cancer whose Disease has Progressed with Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and whose Tumours harbour a T790M mutation within the Epidermal Growth Factor Receptor Gene.

NCT03823807 Non-Small Cell Lung Cancer
MeSH:Carcinoma, Non-Small-Cell Lung
HPO:Non-small cell lung carcinoma

1 Interventions

Name: SH-1028

Description: Oral,100mg or 200mg ,QD, fasted
Type: Drug
Group Labels: 1

SH-1028


Primary Outcomes

Measure: Objective Response Rate (ORR)

Time: Every 2 cycles (21 days for 1 cycle) until end of treatment, an average of 1 year.

Secondary Outcomes

Measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Time: From Baseline up to 30 days after the last dose, an average of 1 year.

Measure: Maximum Plasma Concentration (Cmax)

Time: Part A: Day 1 of Cycle 1 and 2 (21 days for 1 cycle).

Measure: Area Under the Curve [AUC]

Time: Part A: Day 1 of Cycle 1 and 2 (21 days for 1 cycle).

Measure: Progression-free survival (PFS)

Time: Every 2 cycles (21 days for 1 cycle) until end of follow-up, an average of 1 year.

Measure: Duration of Response(DOR)

Time: Every 2 cycles (21 days for 1 cycle) until end of treatment, an average of 1 year.

Measure: Disease Control Rates(DCR)

Time: Every 2 cycles (21 days for 1 cycle) until end of treatment, an average of 1 year.

Measure: Overall survival(OS)

Time: Every 2 cycles (21 days for 1 cycle) until end of treatment; Every 12 weeks until end of follow-up, an average of 2 years.

Other Outcomes

Description: optional,use NGS to analyse the gene associated with NSCLC and to determine the reason of SH-1028-resistance.

Measure: Biomakers (eg. AF value of KRAS,MET mutation or other gene mutations ) of drug-resistance measured by next-generation sequencing (NGS).

Time: at end of treatment,an average of 1 years.

Measure: Minimum Plasma Concentration (Cmin)

Time: Before administration in Day 1 of cycle 2, 3 and 5 (21 days for 1 cycle).

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There are 3 SNPs

SNPs


1 L858R

- Confirmation that the tumor harbors an EGFR mutation known to be associated with EGFR-TKI sensitivity (including exon 19 deletion, L858R, L861Q, G719X or dual mutation) for treatment-naive NSCLC patients (without systemic therapy or with relapse after previous surgery; patients with locally treatment for non-target lesions are accepted ).(This criteria applies to treatment-naïve NSCLC patients in Part B). - Patients must have confirmation of T790M+ mutation status, which have experienced disease progression while on a previous continuous treatment with an EGFR-TKI or clinical benefit from EGFR-TKI according to the Jackman criteria while on continuous treatment with an EGFR-TKI (PR/CR, or SD continued ≥6 months); Patients can receive more than one line of systemic therapy. --- L858R ---


2 L861Q

- Confirmation that the tumor harbors an EGFR mutation known to be associated with EGFR-TKI sensitivity (including exon 19 deletion, L858R, L861Q, G719X or dual mutation) for treatment-naive NSCLC patients (without systemic therapy or with relapse after previous surgery; patients with locally treatment for non-target lesions are accepted ).(This criteria applies to treatment-naïve NSCLC patients in Part B). - Patients must have confirmation of T790M+ mutation status, which have experienced disease progression while on a previous continuous treatment with an EGFR-TKI or clinical benefit from EGFR-TKI according to the Jackman criteria while on continuous treatment with an EGFR-TKI (PR/CR, or SD continued ≥6 months); Patients can receive more than one line of systemic therapy. --- L858R --- --- L861Q ---


3 T790M

A Study to Evaluate the Safety and Efficacy of SH-1028 in Locally Advanced or Metastatic NSCLC A Phase II, Open Label, Single-arm Study to Assess the Safety and Efficacy of SH-1028 with Locally Advanced/Metastatic Non-Small Cell Lung Cancer whose Disease has Progressed with Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and whose Tumours harbour a T790M mutation within the Epidermal Growth Factor Receptor Gene. --- T790M ---

Non-Small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung This is a multicenter, open-label, phase II study to evaluate the safety and efficacy of SH-1028 in locally advanced or metastatic NSCLC.The trail is divided into two parts:part A is dose extension phase,and Part B is expand sample size phase to confirm the efficacy of SH-1028.Patients must agree to provide a biopsy for central confirmation of T790M mutation status following confirmed disease progression on the most recent treatment regimen. --- T790M ---



HPO Nodes


HPO: