Erlotinib or Placebo Following Chemoradiotherapy (Chemo/RT) in Stage III Non-Small Cell Lung Cancer (NSCLC)
This is a national, randomized, web-based, double-blind study to determine whether erlotinib (Tarceva) compared to placebo improves progression-free survival (PFS) for patients with inoperable, stage III NSCLC following concurrent docetaxel, carboplatin and thoracic radiotherapy. We hypothesize that the introduction of this orally active, well-tolerated agent following concurrent chemoradiation and prior to the emergence of drug resistance will prolong the progression-free survival by 40% (10 months → 14 months).
Checked against the public recordLast updated Sep 6, 2019 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Interventions being studied
- Drug: Erlotinib (tarceva); Drug: Placebo
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: * Unresectable, stage IIIA or IIIB NSCLC (measurable disease is not required) * No evidence of metastatic disease * No prior treatment * Adequate organ function * Adequate pulmonary function (FEV \>= 1.0L or predicted FEV \>0.8L) Exclusion Criteria: * Metastasis * Prior treatment * Malignant pleural or pericardial effusion * Peripheral neuropathy \>= grade 2
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Birmingham Hematology and Oncology Associates, LLCBirmingham, Alabama
- Oncology Specialties, P.C.Huntsville, Alabama
- Cooper ClinicFort Smith, Arkansas
- Genesis Cancer CenterHot Springs, Arkansas
- Alta Bates Comprehensive Cancer CenterBerkeley, California
- Northstate Cancer SpecialityRedding, California
- Mercy General HospitalSacramento, California
- St. Francis Hospital Cancer CenterHartford, Connecticut
- Connecticut Oncology GroupMiddletown, Connecticut
- George Bray Cancer Center/New Britain General HospitalNew Britain, Connecticut
- Oncology and Hematology Associates, PCNew London, Connecticut
- Whittingham Cancer Center at Norwalk HospitalNorwalk, Connecticut
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 6, 2019. Always confirm current availability with the study team.