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Neoadjuvant Erlotinib for Operable Stage II or IIIA NSCLC With EGFR Mutations

Sponsor
National Cancer Center, Korea (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01470716
Collaborator
Hoffmann-La Roche (Industry)
26
Enrollment
1
Location
1
Arm
125.9
Anticipated Duration (Months)
0.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
26 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jan 1, 2012
Actual Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Study arm

Neo-adjuvant Erlotinib treatment arm.

Drug: Erlotinib
Neo-adjuvant Erlotinib treatment during maximum 8 weeks.
Other Names:
  • treatment arm

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Progression-Free survival [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 [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 [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Cancer Center Goyang-si Gyeonggi-do Korea, Republic of 410-769

    Sponsors and Collaborators

    • National Cancer Center, Korea
    • Hoffmann-La Roche

    Investigators

    • Principal Investigator: Ji-Youn Han, M.D. PhD., National Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ji-youn Han, Principal Investigator, National Cancer Center, Korea
    ClinicalTrials.gov Identifier:
    NCT01470716
    Other Study ID Numbers:
    • NCCCTS-11-561
    First Posted:
    Nov 11, 2011
    Last Update Posted:
    Apr 6, 2022
    Last Verified:
    Apr 1, 2022
    Keywords provided by Ji-youn Han, Principal Investigator, National Cancer Center, Korea
    EGFR mutation
    NSCLC
    Additional relevant MeSH terms:
    Carcinoma, Non-Small-Cell Lung
    Erlotinib Hydrochloride

    Study Results

    No Results Posted as of Apr 6, 2022