At a glance
ClinicalIndex Comparison Record- ✓Unresectable stage IIIA or IIIB NSCLC
- ✓No evidence of metastatic disease
- ✓No prior treatment
- ✓Adequate organ function
- ✕Metastatic disease
- ✕Prior treatment
- ✕Malignant pleural or pericardial effusion
- ✕Peripheral neuropathy grade ≥2
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A National Web-Based Randomized Phase III Study of Erlotinib or Placebo Following Concurrent Docetaxel, Carboplatin, and Thoracic Radiotherapy in Patients With Inoperable Stage III Non-Small Cell Lung Cancer (D0410).
In Brief
A Phase 3 clinical trial evaluating Erlotinib (tarceva) and Placebo for Carcinoma, Non-Small-Cell Lung and 2 related conditions. Completed, enrolled 245 participants across 65 sites.
Detailed Summary
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).
Study Details
Timeline
Interventions
Erlotinib 150mg orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events, death or completion of 3 years of therapy.
Matched placebo orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events death or completion of 3 years of therapy.