Conditions: Non Small Cell Lung Cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 13
Healthy volunteers: no

Brief summary:
The purpose of the study is to investigate if treatment with zalutumumab in combination with chemotherapy and radiotherapy (chemo-radiation) will lead to a prolonged life in patients with lung cancer compared to patients treated with chemo-radiation alone.

Detailed description:
Originally the study was planned as Part 1A, Part 1B and Part 2. Part 1A was one arm with zalatumumab fixed dose 8 mg/kg. Part 1B was planned as zalutumumab dose-titration and Part 2 adding a comparator. The trial was prematurely closed for enrolment when patients had only been enrolled in Part 1A due to published results showing increased toxicity from induction chemotherapy without any survival benefit.

Arms:
arm 1: None

Interventions: intervention 1: Zalutumumab intervention 2: Induction chemotherapy intervention 3: Radiotherapy
Intervention descriptions: intervention 1: 8 mg/kg intervention 2: Combination of cisplatin and docetaxel administered as two cycles given every three weeks intervention 3: 64 Gy in 32 fractions over 6.5 weeks

Protocol document: