Phase 3
N=245
Erlotinib or Placebo Following Chemoradiotherapy (Chemo/RT) in Stage III Non-Small Cell Lung Cancer (NSCLC)
Carcinoma, Non-Small-Cell Lung · Non-small Cell Lung Cancer · NSCLC
Bottom Line
View on ClinicalTrials.gov: NCT00153803 ↗Enrolled (actual)
245
Serious AEs
35.1%
Results posted
Sep 2019
Primary outcome: Primary: Progression Free Survival — 7.4; 8.1 Months — p=0.165
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Erlotinib (tarceva) (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival |
7.4; 8.1 | 0.165 |
| SECONDARY Overall Survival |
16.5; 20.3 | 0.32 |
| SECONDARY Percent of Participants Surviving 3 Years |
37; 41 | — |
| SECONDARY Serious Adverse Event Profile Relating to Death, Disability, Life-threatening, Hospitalization, and Impairment/Damage for Concurrent Chemoradiation |
7; 6; 0; 0; 2; 4 | — |
| SECONDARY Serious Adverse Event Profile Relating to Death, Disability, Life-threatening, Hospitalization, and Impairment/Damage for Erlotinib and Placebo |
10; 6; 0; 0; 1; 1 | — |
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00153803). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.