Radiation Plus Cetuximab in Locally Advanced Non-Small Cell Lung Cancer (NSCLC)

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial is to study combined locoregional radiotherapy with cetuximab in non-operable NSCLC Stage III (Phase II trial).

Endpoints:

safety and feasibility (primary) response, survival, time to progression (secondary)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Heidelberg University
• Treatments: Cetuximab

Criteria

Inclusion Criteria:

• Histologically verified NSCLC

• Not eligible for Radiochemotherapy or patient refuses chemotherapy

• FeV1 >1.5 L or min. 50%

• KPI >= 70%

• Life expectancy > 6 months

• Weight loss less than 10% of body weight in 12 months

• Compliance

• Adequate blood counts (LC > 3000 x 10^3/ml, Tc >100000 x 10^3/ml, Hb > 10 g/dl)

• Effective contraception

Amendment 1/07: FeV1 >1.2 L or min 40%

Exclusion Criteria:

• Active infection

• Reduced liver function

• Vena cava superior syndrome

• Malignant pleural effusion

• Pregnancy or breast feeding

• Additional serious systemic disease

• Secondary malignancy (except carcinoma in situ of the cervix, basalioma of the skin, secondary cancer in remission for > 5 years)

• Known allergies against proteins

• History of former antibody therapy

• Allergy against i.v. contrast agents