Phase 2
N=106
Chemoradiotherapy in Stage III Non-small Cell Lung Cancer (NSCLC)
Stage III Non-small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01102231 ↗Enrolled (actual)
106
Serious AEs
25.5%
Results posted
Feb 2021
Primary outcome: Primary: Disease-Control Rate — 89 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Chemotherapy (Drug); ERBITUX (Drug); Radiotherapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Intergroupe Francophone de Cancerologie Thoracique
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disease-Control Rate |
89 | — |
| SECONDARY 18-month Overall Survival Rate |
42.4 | — |
| SECONDARY Progression Free Survival |
14.4 | — |
Summary
Radiochemotherapy is a standard for the treatment of unresectable stage III non-small cell lung cancer. The investigators goal is to study the efficacy and the toxicity for a promising association of new agents (cetuximab and pemetrexed) with concurrent radiotherapy.
Eligibility Criteria
Inclusion Criteria
- non-squamous stage III non-small cell lung cancer
- measurable disease (RECIST 1.1)
- ECOG performance status 0-1
- normal organ and marrow function
Exclusion Criteria
- prior chest radiation therapy
- history of any cancer other than NSCLC (except non-melanoma skin cancer or carcinoma in situ of the cervix) within the last five years.
- Prior therapy with known specific inhibitors of the EGFR.
- history of severe allergic reaction to prior therapy with monoclonal antibodies
Data sourced from ClinicalTrials.gov (NCT01102231). 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.