Stage IIIB Non-Small Cell Lung Cancer Clinical Trial
Official title:
EValuation of Erlotinib as a Neoadjuvant Therapy in Stage III NSCLC Patients With EGFR Mutations (EVENT Trial)
This phase II trial studies how well erlotinib hydrochloride works before surgery in treating patients with stage III non-small cell lung cancer. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving erlotinib hydrochloride before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PRIMARY OBJECTIVES:
I. To estimate the rate of mediastinal nodal clearance and complete pathological response
after neoadjuvant erlotinib (erlotinib hydrochloride) in patients with epidermal growth
factor receptor (EGFR) mutated stage III non-small cell lung cancer (NSCLC).
SECONDARY OBJECTIVES:
I. To determine the progression free survival in patient population of EGFR mutated stage III
NSCLC patients who are treated with neoadjuvant erlotinib therapy.
II. To determine the overall survival. III. To estimate the overall response rate from
neoadjuvant erlotinib. IV. To estimate the surgical resection rate. V. To evaluate the safety
of neoadjuvant erlotinib.
TERTIARY OBJECTIVES:
I. To determine several molecular and cellular biomarkers in the tumors, the skin and the
serum that are predictive of the efficacy of neoadjuvant erlotinib.
OUTLINE:
Patients receive erlotinib hydrochloride orally (PO) once daily (QD) for 2 months and then
undergo thoracotomy.
After completion of study treatment, patients are followed up at 30 days, every 3 months for
1 year, and then every 6 months for 5 years.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT02106559 -
Photodynamic Therapy During Surgery in Treating Patients With Pleural Malignancy
|
N/A | |
| Active, not recruiting |
NCT01711697 -
An Alternative Radiation Fractionation Strategy for Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
|
Phase 1 | |
| Completed |
NCT02364609 -
Pembrolizumab and Afatinib in Patients With Non-small Cell Lung Cancer With Resistance to Erlotinib
|
Phase 1 | |
| Terminated |
NCT02495896 -
Recombinant EphB4-HSA Fusion Protein With Standard Chemotherapy Regimens in Treating Patients With Advanced or Metastatic Solid Tumors
|
Phase 1 | |
| Completed |
NCT01935336 -
Study of Ponatinib in Patients With Lung Cancer Preselected Using Different Candidate Predictive Biomarkers
|
Phase 2 | |
| Withdrawn |
NCT01971489 -
Buparlisib, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT01839955 -
Erlotinib Hydrochloride and Quinacrine Dihydrochloride in Stage IIIB-IV Non-Small Cell Lung Cancer
|
Phase 1 | |
| Terminated |
NCT01193868 -
RO4929097 in Treating Patients With Advanced Non-Small Cell Lung Cancer Who Have Recently Completed Treatment With Front-Line Chemotherapy
|
Phase 2 | |
| Completed |
NCT00986674 -
Carboplatin and Paclitaxel Combined With Cetuximab and/or IMC-A12 in Patients With Advanced Non-Small Cell Lung Cancer
|
Phase 2 | |
| Completed |
NCT00087412 -
S0341: Erlotinib in Treating Patients With Advanced Primary Non-Small Cell Lung Cancer
|
Phase 2 | |
| Completed |
NCT00085280 -
Erlotinib in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
|
N/A | |
| Completed |
NCT00093756 -
Bortezomib, Paclitaxel, Carboplatin and Radiation Therapy for Non-Small Cell Lung Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT00052338 -
Bortezomib Plus Gemcitabine and Carboplatin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
|
Phase 1 | |
| Completed |
NCT00006929 -
Suramin, Paclitaxel, and Carboplatin in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
|
Phase 2 | |
| Completed |
NCT02879994 -
Pembrolizumab in Treating Patients With EGFR Mutant, Tyrosine Kinase Inhibitor Naive Advanced Non-Small Cell Lung Cancer
|
Phase 2 | |
| Completed |
NCT02728596 -
S1415CD, Trial Assessing CSF Prescribing Effectiveness and Risk (TrACER)
|
N/A | |
| Completed |
NCT02897375 -
Palbociclib With Cisplatin or Carboplatin in Advanced Solid Tumors
|
Phase 1 | |
| Terminated |
NCT02566421 -
Genomic Sequencing in Determining Treatment in Patients With Metastatic Cancer or Cancer That Cannot Be Removed by Surgery
|
N/A | |
| Withdrawn |
NCT02017925 -
Pulmonary Rehabilitation in Improving Lung Function in Patients With Locally Advanced Non-Small Cell Lung Cancer Undergoing Chemoradiation
|
N/A | |
| Terminated |
NCT01707823 -
Low-Dose Acetylsalicylic Acid in Treating Patients With Stage I-III Non-Small Cell Lung Cancer
|
Early Phase 1 |