Phase 2
Completed N=15
Tarceva And Radiotherapy in Locally Advanced Lung Cancer Non-small Cell Lung Cancer
Source: ClinicalTrials.gov NCT00888511 ↗Enrolled (actual)
15
Serious AEs
20.0%
Results posted
Nov 2020
Primary outcomePrimary: Progression Free Survival — 9.4 months
Summary
The trial is a phase II study of daily Tarceva combined with definitive radiotherapy in inoperable locally advanced non small cell lung cancer (stage IIB-IIIB). The objective of the phase II trial is to examine Tarceva concomitant with curatively intended irradiation 66 Gy (2 Gy x 33 F, 5 F per week).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival |
9.4 | — |
| SECONDARY Toxicity |
— | — |
| SECONDARY Local Tumor Control by CT-scan |
— | — |
| SECONDARY Overall Response Rate (CR + PR) |
— | — |
| SECONDARY Local Tumor Control at 9 Months Evaluated by PET-CT |
— | — |
| SECONDARY Overall Survival |
— | — |
| SECONDARY Disease Free Survival |
— | — |
| SECONDARY Late Toxicity |
— | — |
Eligibility Criteria
Inclusion Criteria
- Age ≥18 years
- Patients with histologically or cytologically documented diagnosis locally advanced NSCLC stage IIB to IIIB without pleural effusion
- Performance status ≤2 on the ECOG scale
- Serum bilirubin must be ≤1.5 upper limit of normal (ULN)
- ALAT ≤2 x ULN
- Able to comply with study and follow-up procedures
- Patients with reproductive potential must use effective contraception
- Written (signed) informed consent to participate in the study
Exclusion Criteria
- Any unstable systemic disease (including active infection, unstable angina, congestive heart failure, severe hepatic, renal, or metabolic disease)
- Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer)
- Inability to take oral medication, or requirement of intravenous alimentation
- Nursing mothers
Data sourced from ClinicalTrials.gov (NCT00888511). 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. Informational only — not medical advice.