Description:
This study examines preoperative Erlotinib in patients with operable stage II and IIIA
Non-small-cell lung cancer (NSCLC) harboring EGFR mutations.
Title
- Brief Title: Neoadjuvant Erlotinib for Operable Stage II or IIIA NSCLC With 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
Clinical Trial IDs
- ORG STUDY ID:
NCCCTS-11-561
- NCT ID:
NCT01470716
Conditions
- NSCLC Stage II
- NSCLC, Stage IIIA
Interventions
Drug | Synonyms | Arms |
---|
Erlotinib | treatment arm | Study arm |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Study arm | Experimental | Neo-adjuvant Erlotinib treatment arm. | |
Eligibility 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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Progression-Free survival |
Time Frame: | every 8 week |
Safety Issue: | |
Description: | 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
Measure: | Response rate |
Time Frame: | every 4 weeks |
Safety Issue: | |
Description: | The response rate will be determined by the number of patients with complete and partial responses according to RECIST criteria 1.1 |
Measure: | Overall Survival Rate |
Time Frame: | every 3months, until death |
Safety Issue: | |
Description: | Survival time will be calculated from the date of study treatment start to the date of death.( or date last seen ) |
Measure: | Toxicity profile |
Time Frame: | Every 4 weeks |
Safety Issue: | |
Description: | 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. |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | National Cancer Center, Korea |
Trial Keywords
Last Updated
September 10, 2020