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

Heidelberg University

Status and phase: Completed; Phase 2

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Drug: cetuximab

Study type: Interventional

Funder types: Other

Identifiers

NCT00115518

NEAR L-284/2004

Details and patient eligibility

About

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)

Full description

Study entry examinations:

• blood cell count
• liver enzymes
• ventilatory function test
• pregnancy test (premenopausal women)
• CT of the thorax
• CT of the brain
• Ultrasound of the liver
• Bone scan
• FDG PET scan (after inclusion)

Follow-up examinations (2 months, than every 3 months):

• patients history and examination
• CT scan of the thorax
• ventilatory functions test
• FDG PET scan (at least at 6 months)
• bone scan (yearly)
• ultrasound of the liver (every 6 months)

Cetuximab administration:

• 450 mg / m^2 body surface on week 1
• 250 mg /m^2 body surface weekly, week 2 -21

Radiation therapy:

• intensity modulated radiation therapy of primary tumor and mediastinum (2 Gy single dose, total dose 50 Gy; 5 fractions per week) with boost to the PET positive sites (2 Gy single doses up to 66 Gy). Radiation therapy during weeks 2-8.

Amendment 1/07: 3D conformal RT possible, but not if FeV1 < 1.5L of < 50%

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)