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History of Changes for Study: NCT01470716
Neoadjuvant Erlotinib for Operable Stage II and IIIA Non-small-cell Lung Cancer With Epidermal Growth Factor Receptor(EGFR) Mutations
Latest version (submitted April 4, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 November 10, 2011 None (earliest Version on record)
2 November 11, 2011 Sponsor/Collaborators, Study Status and Study Identification
3 April 27, 2012 Recruitment Status, Study Status and Contacts/Locations
4 August 24, 2017 Study Status and Conditions
5 March 20, 2019 Study Status
6 September 8, 2020 Study Status
7 April 4, 2022 Recruitment Status, Study Status and Contacts/Locations
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Study NCT01470716
Submitted Date:  November 10, 2011 (v1)

Open or close this module Study Identification
Unique Protocol ID: NCCCTS-11-561
Brief Title: Neoadjuvant Erlotinib for Operable Stage II and IIIA Non-small-cell Lung Cancer With Epidermal Growth Factor Receptor(EGFR) Mutations
Official Title: A Phase II Study of Neo-adjuvant Erlotinib for Operable Stage IIB or IIIA Non-small Cell Lunc Cancer With Epidermal Growth Factor Receptor Activation Mutations
Secondary IDs:
Open or close this module Study Status
Record Verification: November 2011
Overall Status: Not yet recruiting
Study Start: January 2012
Primary Completion: June 2014 [Anticipated]
Study Completion: September 2015 [Anticipated]
First Submitted: November 4, 2011
First Submitted that
Met QC Criteria:
November 10, 2011
First Posted: November 11, 2011 [Estimate]
Last Update Submitted that
Met QC Criteria:
November 10, 2011
Last Update Posted: November 11, 2011 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: National Cancer Center, Korea
Responsible Party: Principal Investigator
Investigator: Ji-youn Han
Official Title: Principal Investigator
Affiliation: National Cancer Center, Korea
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: This study examines preoperative Erlotinib in patients with operable stage II and IIIA Non-small-cell lung cancer (NSCLC) harboring EGFR mutations.
Detailed Description: Lung cancer remains the most common cause of cancer-related death in the world. Non-small-cell lung cancer (NSCLC) is the most common type, and it accounts for 85% of cases. Unfortunately, the majority of patients with NSCLC have metastatic disease at diagnosis. However, even patients with resectable disease have poor survival. The need to improve survival rates in these patients prompted research exploring the role of systemic therapy in operable NSCLC. In the 1990s, several clinical trials of preoperative chemotherapy (also known as induction chemotherapy) followed by surgery or radiation in patients with locally advanced NSCLC showed improvements in survival. Erlotinib is an orally administered tyrosine kinase inhibitor of the epidermal growth factor receptor (EGFR). The presence of somatic mutations in the kinase domain of EGFR strongly correlates with increased responsiveness to EGFR tyrosine kinase inhibitors. Recently three randomized phase III trials showed that first-line use of EGFR-TKIs in patients with EGFR mutant NSCLC significantly improved response rate and progression-free survival (PFS) compared to platinum-based chemotherapy. These findings prompted this phase II trial of preoperative Erlotinib in patients with operable stage II and IIIA NSCLC harboring EGFR mutations.
Open or close this module Conditions
Conditions: Non-small Cell Lung Cancer Stage II
Non-small Cell Lung Cancer Stage IIIA
Epithelial Growth Factor Receptor Positive Non-small Cell Lung Cancer
Keywords: EGFR mutation
NSCLC
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 26 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Study arm
Neo-adjuvant Erlotinib treatment arm.
Drug: Erlotinib
Neo-adjuvant Erlotinib treatment during maximum 8 weeks.
Other Names:
  • treatment arm
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Progression-Free survival
[ Time Frame: every 8 week ]

Progression free survival will be calculated from the date of study treatment start to the first objective documentation of progressive disease or to the date of death, whichever occurs first.
Secondary Outcome Measures:
1. Response rate
[ Time Frame: every 4 weeks ]

The response rate will be determined by the number of patients with complete and partial responses according to RECIST criteria 1.1
2. Overall Survival Rate
[ Time Frame: every 3months, until death ]

Survival time will be calculated from the date of study treatment start to the date of death.( or date last seen )
3. Toxicity profile
[ Time Frame: Every 4 weeks ]

Safety will be evaluated by the frequency, severity, and relationship of adverse event graded by NCI Common Toxicity Criteria version 4.0 that occur during the treatment and follow up periods.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Pathologically confirmed stage II & IIIA non-small cell lung cancer
    • EGFR exon 19 or 21 mutations
    • Age ≥ 18 years and ECOG performance 0~1
    • Has measurable lesion by RECIST 1.1
    • No previous chemotherapy or radiation therapy
    • Adequate organ function by following; ANC ≥1,500/uL, hemoglobin ≥9.0g/dL, platelet ≥100,000/uL, PaO2 ≥ 60 mmHg, Serum Cr < 1 x UNL or creatinine clearance > 60 ml/min, Serum bilirubin < 1 x UNL, AST (SGOT) and ALT (SGPT) < 2.5 x UNL, alkaline phosphatase < 5 x UNL
    • Written informed consent form

Exclusion Criteria:

  • Previous chemotherapy or radiation therapy
  • Previous history of malignancy within 5 years from study entry except treated non-melanomatous skin cancer or uterine cervical cancer in situ
  • Known allergic history of erlotinib
  • Interstitial lung disease or fibrosis on chest radiogram
  • Active infection, uncontrolled systemic disease (cardiopulmonary insufficiency, fatal arrhythmias, hepatitis)
  • Pregnant or nursing women
Open or close this module Contacts/Locations
Central Contact Person: JI-YOUN HAN, M.D. PhD.
Telephone: +82-31-920-1154
Email: jymama@ncc.re.kr
Central Contact Backup: SUNG JIN YOON, R.N.
Telephone: +82-31-920-0405
Email: jinijiniya@ncc.re.kr
Study Officials: Ji-Youn Han, M.D. PhD.
Principal Investigator
National Cancer Center
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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