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Report for Clinical Trial NCT02795884

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Adjuvant Erlotinib Intercalating Chemotherapy or Adjuvant Chemotherapy Alone in NSCLC With Common EGFR Mutation

This study will be performed as a local multicenter, randomized, phase III clinical study. It will compare the adjuvant chemotherapy in Stage IB-IIIA NSCLC with common EGFR mutation (Exon 19 deletion or L858R) who underwent total resection and the Erlotinib-Intercalation adjuvant chemotherapy with the chemotherapy alone. The patients will be randomly assigned to the Intercalation combination chemotherapy regimen and the chemotherapy alone regimen at the ratio of 1:1. The treatment regimen of each arm is as follows.

NCT02795884 NSCLC
MeSH:Carcinoma, Non-Small-Cell Lung
HPO:Non-small cell lung carcinoma

2 Interventions

Name: intercalation therapy using pemetrexed, cisplatin and erlotinib

Description: During the intercalation phase of the initial 12-week period, erlotinib is to be orally administered at the dose of 150 mg daily from Day 8 to Day 21 at every cycle of 21 days. During the maintenance phase after 12 weeks, it is orally administered at the cycle of 28 days without a wash-out period at the dose of 150 mg daily for one year. The combination of pemetrexed and cisplatin will be administered for 4 cycles in total by each cycle of 21 days, and it is to be administered by intravenous (IV) infusion on every Day 1. Pemetrexed 500 mg/m2 will be diluted in 100 ml of 0.9% saline solution and will be administered by intravenous (IV) infusion for 10 minutes. Cisplatin 75 mg/m2 will be diluted in 150 ml of 0.9% saline solution and will be administered by intravenous (IV) infusion for 10 to 15 minutes. The combination of pemetrexed and cisplatin will be administered for 4 cycles in total by each cycle of 21 days, and it is to be administered by intravenous (IV) infusion on every Day 1.
Type: Drug
Group Labels: 1

Intercalation arm

Name: Vinorelbine, cisplatin

Description: Vinorelbine 25mg/m2 will be diluted in 50 ml of 0.9% saline solution and will be administered by intravenous (IV) infusion for 6 to 10 minutes and then wash the catheter using 100 ml of 0.9% saline solution. Cisplatin 75 mg/m2 will be diluted in 150 ml of 0.9% saline solution and will be administered by intravenous (IV) infusion for 10 to 15 minutes.
Type: Drug
Group Labels: 1

Chemotherapy alone arm


Primary Outcomes

Description: Time from randomization to disease recurrence or death of any cause

Measure: Disease-free survival (DFS)

Time: 3 years

Secondary Outcomes

Measure: Overall survival (OS)

Time: 3 years

Measure: Treatment-related adverse events assessed by CTCAE v4.0

Time: 3 years

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There are 2 SNPs

SNPs


1 L858R

It will compare the adjuvant chemotherapy in Stage IB-IIIA NSCLC with common EGFR mutation (Exon 19 deletion or L858R) who underwent total resection and the Erlotinib-Intercalation adjuvant chemotherapy with the chemotherapy alone. --- L858R ---

- Stage IB-IIIA Non-squamous NSCLC (Based on AJCC Version 7 TNM Disease Stages) - Surgically complete resection - Confirmed with Exon 19 deletion or L858R EGFR mutation - Complete recovery from the surgery. --- L858R ---


2 T790M

- Age to be ≥ 19 years old - Patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Patients who are not pregnant or breastfeeding - Appropriate functions of bone marrow, liver and kidney, when assessed with the following requirements of the laboratory tests to be conducted within 14 days before the initial dose of the study drug: - Absolute neutrophil count (ANC) ≥ 1.5 x 109/L - Platelet count ≥ 100 x 109/L - Total bilirubin ≤ 1.5 times greater than the upper limit of normal - ALT and AST ≤ 2.5 times greater than the upper limit of normal - Alkaline phosphatase ≤ 2.5 times greater than the upper limit of normal - INR and PTT ≤ 1.5 times greater than the upper limit of normal - Appropriate renal function: Serum creatinine ≤ 1.25 × upper limit of normal, or serum creatinine clearance according to Cockcroft-Gault formula(below) ≥50 mL/min Woman CrCl = (140- age [years old]) x weight (kg) x 0.85 72 x serum creatinine (mg/dL) Man CrCl = (140- age [years old]) x weight (kg) x 1.00 72 x serum creatinine (mg/dL) - Patients who are capable of complying with the clinical study protocol and who can take medication orally - Patient who can hear sufficient explanation and sign on the informed consent form Exclusion Criteria: - Any subject who shows any of the following criteria should be excluded from this clinical study: - Patient identified with T790M mutation - Treatable with topical treatments (radiotherapy or surgery) - Previous treatment to inhibit the human epidermal growth factor receptor (EGFR) (e.g. --- T790M ---



HPO Nodes


HPO: