Adjuvant Erlotinib Intercalating Chemotherapy or Adjuvant Chemotherapy Alone in NSCLC With Common EGFR Mutation
Overview
- Phase
- Phase 3
- Intervention
- intercalation therapy using pemetrexed, cisplatin and erlotinib
- Conditions
- NSCLC
- Sponsor
- Yonsei University
- Primary Endpoint
- Disease-free survival (DFS)
- Status
- Withdrawn
- Last Updated
- 9 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •A screening examination should be implemented within 14 after obtaining the informed consent, and the treatment should be started within 14 days after the randomization of subjects. Subjects who are applicable to all of the following criteria will be eligible for inclusion in this clinical study.
- •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. The period up to the post-operative randomization can be 3 weeks at minimum up to 8 weeks at maximum.
- •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
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. erlotinib, gefitinib, cetuximab, trastuzumab, etc.)
- •Prior systemic chemotherapy
- •Any prior known hypersensitive reaction to the study agents
- •CTCAE\> grade 2 clinically significant active infection
- •Any known infection with Human Immunodeficiency Virus (HIV) or chronic hepatitis type B or type C virus For the patients positive to chronic hepatitis type B or type C virus without elevation of AST/ALT, their inclusion/exclusion will be determined at the discretion of the investigator.
- •Seizures in need of treatment (steroid or antiepileptic treatment)
- •Medical history of interstitial lung disease
Arms & Interventions
Intercalation arm
* 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
Intervention: intercalation therapy using pemetrexed, cisplatin and erlotinib
Chemotherapy alone arm
Duration: 3wks x 4 cycles = 12 wks Vinorelbine 25mg/m2 D1,8, Cisplatin 75mg/m2 D1 q3wks
Intervention: Vinorelbine, cisplatin
Outcomes
Primary Outcomes
Disease-free survival (DFS)
Time Frame: 3 years
Time from randomization to disease recurrence or death of any cause
Secondary Outcomes
- Overall survival (OS)(3 years)
- Treatment-related adverse events assessed by CTCAE v4.0(3 years)