Open-label, randomised, multi-center study investigating Cetuximab, in combination with concurrent chemo- / radiotherapy in locally advanced non-small cell lung carcinoma

Phase 2

• Conditions: Lung cancer; 10038666

• Registration Number: NL-OMON32353
• Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 112

Inclusion Criteria

1. Histologically or cytologically confirmed diagnosis of NSCLC
2. Stage II/III non-operable disease , without malignant pleural effusion
3. Presence of at least one measurable target lesion
4. Life expectancy of at least 6 months
5. WHO performance 0-1
6. Signed written informed consent

Exclusion Criteria

1. Concurrent active malignancy other than localized, non-melanoma skin cancer or carcinoma-in-situ of the cervix (unless definitive treatment was completed 5 years or more before study entry and the patient has remained disease free);
2. Prior:
a. Ipsilateral radiotherapy to the chest;
b. Chemotherapy within the last 5 years;
c. Immunotherapy or treatment with murine monoclonal antibodies, Cetuximab, or other EGFR inhibitors.
3. WHO performance score > 1

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Phase I: Adverse events (dose-limiting toxicities are defined in Paragraph 9.4)<br /><br>Phase 2: Objective tumour response (According to RECIST) </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Overall survival (OS)<br /><br>Progression free survival (PFS)<br /><br>Duration of overall response<br /><br>Safety<br /><br>Assessment of predictors of response:<br /><br>o EGFR-IHC, EGFR-mutation analysis, KRAS-mutation analysis<br /><br>o ERCC-1 immunohistochemistry<br /><br>o FDG-PET<br /><br>o Molecular/biological parameters (serum tumour markers)</p><br>