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

NCT02795884 | Withdrawn Phase 3

• 1 other identifier: 4-2015-0926
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

NSCLC

Keywords

Lung cancer; NSCLC; adjuvant treatment

Outcome Measures

Primary Outcomes (1)

• Disease-free survival (DFS)

  Time from randomization to disease recurrence or death of any cause

  3 years

Secondary Outcomes (2)

• Overall survival (OS)

  3 years

• Treatment-related adverse events assessed by CTCAE v4.0

  3 years

Study Arms (2)

Intercalation arm

EXPERIMENTAL

* 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

Drug: intercalation therapy using pemetrexed, cisplatin and erlotinib

Chemotherapy alone arm

ACTIVE COMPARATOR

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

Drug: Vinorelbine, cisplatin

Interventions

intercalation therapy using pemetrexed, cisplatin and erlotinib DRUG

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 arm

Vinorelbine, cisplatin DRUG

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.

Chemotherapy alone arm

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• Seizures in need of treatment (steroid or antiepileptic treatment)
• Medical history of interstitial lung disease
• Medical history of organ allograft within six months
• Subjects under dialysis
• A subject diagnosed with another cancer within 3 years before participating in this clinical study (treated carcinoma in situ of the cervix, treated skin basal cell carcinoma, and treated superficial bladder tumors \[Ta and Tis\] will not be applicable). For surgically completely resected thyroid cancer, it will be determined at the discretion of the investigator.
• Unstable or any status that would potentially put the subject in danger or that would interfere with compliance of the subject in the clinical study.
• Treatment with the investigational products other than the one to be used in this clinical study during participation in the clinical study or within 4 weeks prior to participation in the clinical study
• Pregnant or breastfeeding women. The women at childbearing ages should show negative response to the serum pregnancy test being conducted within 7 days before the initial administration of the study drug. Not only the women at childbearing ages, but also men who give consent to use appropriate contraceptive methods before entering the clinical study and during the period of the clinical study including 30 days after the last dose of the study drug. Post-menopausal women are defined as:

Sponsors & Collaborators

• Yonsei University: lead

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Cisplatin; Erlotinib Hydrochloride; Vinorelbine

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2016
• First Posted: June 10, 2016
• Study Start: June 1, 2016
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2020
• Last Updated: December 30, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share