Non Small Cell Lung Cancer
Conditions
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.
Interventions
BIOLOGICALZalutumumab
8 mg/kg
DRUGInduction chemotherapy
Combination of cisplatin and docetaxel administered as two cycles given every three weeks
RADIATIONRadiotherapy
64 Gy in 32 fractions over 6.5 weeks
Sponsors
Genmab
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival Verified by Imaging Techniques. | Until disease progression | Disease progression was planned to be confirmed using RECIST criteria J Natl Cancer Inst 2000;92:205-16 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | Up to 3 months | Number of participants reporting at least one adverse event |
Countries
Belgium, France, Netherlands, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Zalutumumab 8 mg/kg | 13 |
| Total | 13 |
Baseline characteristics
| Characteristic | Zalutumumab 8 mg/kg |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 6 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Age Continuous | 66 years |
| Region of Enrollment Belgium | 6 participants |
| Region of Enrollment France | 2 participants |
| Region of Enrollment Netherlands | 1 participants |
| Region of Enrollment United Kingdom | 2 participants |
| Region of Enrollment United States | 2 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 13 / 13 |
| serious Total, serious adverse events | 7 / 13 |
Outcome results
Primary
Progression Free Survival Verified by Imaging Techniques.
Disease progression was planned to be confirmed using RECIST criteria J Natl Cancer Inst 2000;92:205-16
Time frame: Until disease progression
Population: Data was not collected. Imaging scans were not taken during part 1A. The trial was prematurely closed when 13 patients were enrolled in part 1A. Scans were planned for part 1B and 2. No patients continued to part 1B and part 2.
Secondary
Adverse Events
Number of participants reporting at least one adverse event
Time frame: Up to 3 months
Population: Number of patients reporting at least one adverse event
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zalatumumab 8 mg/kg | Adverse Events | 13 participants |