Erlotinib in Post Radical Operation NSCLC Patients With EGFR Mutation

• ClinicalTrials.gov Identifier: NCT01683175
• Recruitment Status: Unknown
• First Posted: September 11, 2012
• Last Update Posted: October 20, 2016
• Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Collaborator: Roche Pharma AG
• Information provided by (Responsible Party): Tianjin Medical University Cancer Institute and Hospital

Tracking Information

• First Submitted Date: August 30, 2012
• First Posted Date: September 11, 2012
• Last Update Posted Date: October 20, 2016
• Study Start Date: August 2012
• Estimated Primary Completion Date: October 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 6, 2012)

2-year disease free survival rate (DFSR) [ Time Frame: 2 years ]

2-year disease free survival rate is defined as the estimation percentage of disease free survival patients with study treatment at 2-year.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 6, 2012)

• disease free survival [ Time Frame: 5 years ]
  Disease free survival is defined as the time from randomization to disease recurrence or death which comes first.
• overall survival (OS) [ Time Frame: 5 years ]
  Overall survival is defined as the time from randomization to death.
• Quality of Life [ Time Frame: 5 years ]
  The score of Functional Assessment of Cancer Therapy - Lung (FACT-L) subscale and Lung Cancer Symptom Scale (LCSS)
• Adverse Event (AE) [ Time Frame: 5 years ]
  frequency of Adverse Event
• Serious Adverse Event (SAE) [ Time Frame: 5 years ]
  Frequency of Serious Adverse Event (SAE)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Erlotinib in Post Radical Operation NSCLC Patients With EGFR Mutation
• Official Title: A Prospective, Open-labelled, Randomized, Multicenter Phase II Study to Evaluate Efficacy and Safety of Erlotinib vs NP Chemotherapy as Adjuvant Therapy in Post Radical Operation NSCLC Patients With EGFR19 or 21 Exon Mutation
• Brief Summary: This study is to compare 2-year Disease Free Survival Rate (DFSR) in post radical operation IIIA Non-Small Cell Lung Cancer (NSCLC) patients with Epidermal Growth Factor Receptor (EGFR) 19 or 21 exon mutation treated Erlotinib vs NP chemotherapy as adjuvant therapy.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Non-small Cell Lung Cancer Stage III

Intervention

• Drug: Erlotinib
• Drug: cis-platinum
• Drug: Vinorelbine

Study Arms

• Experimental: Arm 1
  Erlotinib 150mg daily oral up to 2 years
  Intervention: Drug: Erlotinib
• Active Comparator: Arm 2
  NP Chemotherapy for 4 cycles
  Interventions:

  • Drug: cis-platinum
  • Drug: Vinorelbine

• Publications *: Yue D, Xu S, Wang Q, Li X, Shen Y, Zhao H, Chen C, Mao W, Liu W, Liu J, Zhang L, Ma H, Li Q, Yang Y, Liu Y, Chen H, Wang C. Erlotinib versus vinorelbine plus cisplatin as adjuvant therapy in Chinese patients with stage IIIA EGFR mutation-positive non-small-cell lung cancer (EVAN): a randomised, open-label, phase 2 trial. Lancet Respir Med. 2018 Nov;6(11):863-873. doi: 10.1016/S2213-2600(18)30277-7. Epub 2018 Aug 24.

Recruitment Information

• Recruitment Status: Unknown status
• Actual Enrollment (submitted: September 6, 2012): 94
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 2020
• Estimated Primary Completion Date: October 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• IIIA NSCLC patients according to TMN-staging of Lung Staging Standard version 7 2009, confirmed by histopathology or cytology after radical operation, and having EGFR exon 19 deletion mutation or exon 21 L858R single base substitution;
• Accept study adjuvant therapy within 6 weeks post radical operation;
• ECOP PS 0-1; Life expectancy ≥12 weeks;
• Hematology: absolute neutrophil count (ANC) ≥1.5×10^9/L; platelet count ≥100×10^9/L; hemoglobin concentration ≥ 9.0 g/dL (permit to maintain hematologic criteria by blood transfusion);
• Liver Function: TBil ≤1.5xULN; ALT and AST ≤2.5xULN;
• Renal Function: Cr ≤1.25xULN, and Ccr ≥60ml/min;
• Female patients of childbearing potential must have a negative serum or urine pregnancy test within 7 days before study treatment;
• Signed inform consent form by patient or his/her legal representative;
• Comply with study protocol and procedure, and be able to take oral medication; Aged ≥18 years and ≦75 years;
• Eligible patients of reproductive potential (both sexes) must agree to use a reliable method of birth control before enrollment, during the study period and for at least 30 days after their last dose of study therapy;

Exclusion Criteria:

• Having treated by Her-Target therapy, i.e. erlotinib, gefitinib, cetuximab, trastuzumab;
• Having treated by any systemic anti-tumor therapy of NSCLC, including cytotoxic therapy, target medication treatment (i.e. monoclonal antibody), investigational therapy;
• Having local radiotherapy of NSCLC; Upper gastrointestinal physiological disorders, or malabsorption syndrome, or intolerance of oral medication, or active peptic ulcer;
• The findings in radical operation are lymph nodes with extracapsular invasion, or fusion, or all of dissection lymph nodes positive by pathology;
• Diagnosed other malignant tumor besides NSCLC within 5 years prior the study treatment (except having simple surgical resection with 5-year disease free survival,cured in situ of cervical carcinoma, cured basal cell carcinoma and bladder epithelial tumor);
• Confirmed recurrent cancer by Clinical objective evidence (pathology or radiography images) before the study adjuvant therapy;
• Known hypersensitivity to platinum, Vinorelbine, EGFR-TKI agents or relevant components in the formulation;
• Uncontrolled eye inflammation or infection, or any potential circumstances lead to eye inflammation or infection;
• Active interstitial lung disease (ILD) by any clinical evidence; patients with any co-morbidities, or motalic disorders, or any abnormal findings in physical examination or laboratory tests are suspected to have contraindication of study therapy or high risk of study treatment complications;
• Any unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, angina starting in latest 3 months, Congestive heart failure (NYHA ≥ II), myocardial infarction within 6 months prior enrollment, under medication treatment of severe arrhythmia, liver, renal or metabolic disease;
• know HIV infection Pregnant or breastfeeding women;
• ECOG PS ≥2;
• Mixed with small cell lung cancer;
• Other conditions investigators evaluate that patient is not eligible to this study.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT01683175
• Other Study ID Numbers: ML28280
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Tianjin Medical University Cancer Institute and Hospital
• Original Responsible Party: Changli Wang, Tianjin Medical University Cancer Institute and Hospital, Professor
• Current Study Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Original Study Sponsor: Changli Wang
• Collaborators: Roche Pharma AG

Investigators

• Principal Investigator: Changli Wang; Tianjin Medical University Cancer Institute and Hospital

• PRS Account: Tianjin Medical University Cancer Institute and Hospital
• Verification Date: October 2016