Zalutumumab in Combination With Chemo-Radiation in a Certain Type of Lung Cancer

Genmab

Status and phase: Terminated; Phase 2

Conditions: Non Small Cell Lung Cancer

Treatments: Radiation: Radiotherapy; Drug: Induction chemotherapy; Biological: Zalutumumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00460551

GEN204

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• NSCLC stage IIIA-IIIB
• Performance status 0 or 1 (Zubrod or WHO Scale)

Exclusion criteria

• Evidence of metastases either in a separate lobe of the lung, or extra thoracic
• Patients with high risk of radiation pneumonitis and or compromised lung function
• Estimated life expectancy of less than 3 months
• Prior chemotherapy for lung cancer
• Prior radiotherapy to the chest
• Prior surgery with curative intent for lung cancer

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

13 participants in 1 patient group

Zalutumumab 8 mg/kg

Experimental group

Treatment:

Biological: Zalutumumab

Drug: Induction chemotherapy

Radiation: Radiotherapy