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

NCT02795884 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2016-12-30

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

intercalation therapy using pemetrexed, cisplatin and erlotinib

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.

DRUG

Vinorelbine, cisplatin

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.

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2020-11-30
Completion
2020-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02795884 on ClinicalTrials.gov