SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT03058094

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

A Phase III, Open-Label, Randomized Multicenter Study to Compare AC0010 and Pemetrexed/Cisplatin in Patients With Advanced NSCLC Who Have Progressed Following Prior EGFR TKI

A Phase III, Open-Label, Randomized Multicenter Study to Compare AC0010 and Pemetrexed/Cisplatin in Patients With Advanced NSCLC Who Have Progressed Following Prior EGFR TKI.

NCT03058094 NSCLC

3 Interventions

Name: Pemetrexed

Description: Pemetrexed will be administered as an intravenous infusion over 10 minutes on Day 1 of each 21-day cycle. Folic acid will be administered 1-2 weeks prior to the 1st dose, then daily during the treatment period until 21days post the last dose. Vitamin B12 will be administered on the same day of pemetrexed infusion during the treatment period. Corticosteroid will be adminstered on the day prior to, on the day, and on the day after infusion.

Type: Drug

Chemotherapy

Name: Cisplatin 75mg/m2

Description: Cisplatin will be administered as an intravenous infusion.

Type: Drug

Chemotherapy

Name: AC0010

Description: 300mg, orally, BID

Type: Drug

AC0010


Primary Outcomes

Description: To assess the Progression-Free Survival (PFS) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).

Measure: Progression-Free Survival (PFS)

Time: From the date of randomization until the date of first documented progression or the date of death from any cause, whichever came first, assessed up to 24 months.

Secondary Outcomes

Description: To assess the overall objective response rate (ORR) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).

Measure: Objective Response Rate (ORR)

Time: Baseline up to 28 days after completion of study drug, assessed up to 24 months.

Description: To assess the overall objective response rate (ORR) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).

Measure: Duration of Response (DoR)

Time: From occurring of CR or PR until progression or the date of death from any cause, whichever came first, assessed up to 24 months.

Description: To assess the Disease Control Rate (DCR) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).

Measure: Disease Control Rate (DCR)

Time: From the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.

Description: To assess the Overall Survival (OS) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).

Measure: Overall Survival (OS)

Time: From the date of randomization to death or end of study, which is assessed up to 36 months.

Description: To assess the safety of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).

Measure: Patient Reported Outcomes by EORTC QLQ-C30 Questionnaire

Time: Baseline up to 28 days after completion of study drug, assessed up to 24 months.

Other Outcomes

Description: Clinical chemistry, hematology, urinalysis, vital signs, physical examination, weight, ECG and ECOG Performance status and adverse event will be used to assess safety endpoints.

Measure: Incidence of toxicity, grading with CTCAE 4.03

Time: From the date of randomization until end of treatment,which is assessed up to 24 months

Purpose: Treatment

Allocation: Randomized

Crossover Assignment


There are 3 SNPs

SNPs


1 L858R

6. Confirmation of tumor EGFR sensitive mutation positive in previous tumor samples, including G719X, exon 19 deletion, L858R, L861Q. --- L858R ---


2 L861Q

6. Confirmation of tumor EGFR sensitive mutation positive in previous tumor samples, including G719X, exon 19 deletion, L858R, L861Q. --- L858R --- --- L861Q ---


3 T790M

To assess the Progression-Free Survival (PFS) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).. Objective Response Rate (ORR). --- T790M ---

To assess the overall objective response rate (ORR) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).. Duration of Response (DoR). --- T790M ---

To assess the overall objective response rate (ORR) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).. Disease Control Rate (DCR). --- T790M ---

To assess the Disease Control Rate (DCR) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).. Overall Survival (OS). --- T790M ---

To assess the Overall Survival (OS) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).. Patient Reported Outcomes by EORTC QLQ-C30 Questionnaire. --- T790M ---

To assess the safety of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).. Incidence of toxicity, grading with CTCAE 4.03. --- T790M ---

7. Confirmation of tumor harboring of T790M mutation by central lab with a biopsy sample taken after failure of first generation EGFR TKIs. --- T790M ---

Patients must provide a biopsy for central confirmation of T790M mutation positive. --- T790M ---



HPO Nodes