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* Intercalation phase (Duration: 3wks x 4 cycles = 12 wks) Pemetrexed 500mg/m2 D1, Cisplatin 75mg/m2 D1, Erlotinib 150mg D8-21 q3wks
* Maintenance phase (Duration: 1 year) Erlotinib 150mg D1-28

Duration: 3wks x 4 cycles = 12 wks Vinorelbine 25mg/m2 D1,8, Cisplatin 75mg/m2 D1 q3wks

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.

intercalation therapy using pemetrexed, cisplatin and erlotinib

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.

Vinorelbine, cisplatin

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.

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

Time from randomization to disease recurrence or death of any cause

Yonsei University

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Adjuvant Erlotinib Intercalating Chemotherapy or Adjuvant Chemotherapy Alone in NSCLC With Common EGFR Mutation	NCT02795884	NSCLC	intercalation t... Vinorelbine, ci...	19 Years -	Yonsei University
Adjuvant Erlotinib Intercalating Chemotherapy or Adjuvant Chemotherapy Alone in NSCLC With Common EGFR Mutation	NCT02795884	NSCLC	intercalation t... Vinorelbine, ci...	19 Years -	Yonsei University

Spots Global Cancer Trial Database for intercalation therapy using pemetrexed, cisplatin and erlotinib