A Phase 2 interventional study of Zalutumumab and Induction chemotherapy in Non Small Cell Lung Cancer, sponsored by Genmab. Terminated at 8 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-12-06.
Sponsored by Genmab · Phase 2, Interventional, and Treatment
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.
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.
6,641 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,665 are open to participants now.
This study's enrollment of 13 is below the median of 62 across 5,327 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Genmab is the lead sponsor of 68 studies on the registry; 14 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 12 (52%) have results posted.
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Exclusion Criteria:
Biological: Zalutumumab · Drug: Induction chemotherapy · Radiation: Radiotherapy
8 mg/kg
Combination of cisplatin and docetaxel administered as two cycles given every three weeks
64 Gy in 32 fractions over 6.5 weeks
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
Adverse Events
Number of participants reporting at least one adverse event
Time frame: Up to 3 months
| Milestone | Zalutumumab 8 mg/kg |
|---|---|
| Started | 13 |
| Completed | 13 |
| Not completed | 0 |
Number of participants reporting at least one adverse event
| participants | Zalatumumab 8 mg/kg |
|---|---|
| Adverse Events | 13 |
Disease progression was planned to be confirmed using RECIST criteria J Natl Cancer Inst 2000;92:205-16
No measurements were reported for this outcome.
Collected over Up to 3 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Zalutumumab 8 mg/kg | — | 7/13 (53.8%) | 13/13 (100%) |
| Event | Zalutumumab 8 mg/kg |
|---|---|
| DiarrhoeaGastrointestinal disorders | 3/13 |
| NeutropeniaBlood and lymphatic system disorders | 2/13 |
| ConstipationGastrointestinal disorders | 1/13 |
| IleusGastrointestinal disorders | 1/13 |
| StomatitisGastrointestinal disorders | 1/13 |
| ChillsGeneral disorders | 1/13 |
| MalaiseGeneral disorders | 1/13 |
| GastroenteritisInfections and infestations | 1/13 |
| Viral infectionInfections and infestations | 1/13 |
| DehydrationMetabolism and nutrition disorders | 1/13 |
| Event | Zalutumumab 8 mg/kg |
|---|---|
| RashSkin and subcutaneous tissue disorders | 13/13 |
| ConstipationGastrointestinal disorders | 10/13 |
| DiarrhoeaGastrointestinal disorders | 8/13 |
| NauseaGastrointestinal disorders | 8/13 |
| FatigueGeneral disorders | 8/13 |
| DyspepsiaGastrointestinal disorders | 5/13 |
| DysphagiaGastrointestinal disorders | 5/13 |
| AlopeciaSkin and subcutaneous tissue disorders | 5/13 |
| CoughRespiratory, thoracic and mediastinal disorders | 5/13 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 5/13 |
| Age, Categorical(Participants) | Zalutumumab 8 mg/kg |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 7 |
| >=65 years | 6 |
| Age Continuous(years) | Zalutumumab 8 mg/kg |
|---|---|
| Median | 66 (42 to 78) |
| Sex: Female, Male(Participants) | Zalutumumab 8 mg/kg |
|---|---|
| Female | 3 |
| Male | 10 |
| Region of Enrollment(participants) | Zalutumumab 8 mg/kg |
|---|---|
| France | 2 |
| United States | 2 |
| Belgium | 6 |
| Netherlands | 1 |
| United Kingdom | 2 |
This study is terminated, as verified in Dec 2011. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Zalutumumab
Carcinoma, Non-Small-Cell Lung →