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Due to considerations regarding the appropriate therapeutic regimen for these patients.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zalutumumab 8 mg/kg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zalutumumab | Biological | 8 mg/kg |
| |
| Induction chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Until disease progression |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Number of participants reporting at least one adverse event | Up to 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steen Lisby, MD, PHD | Genmab employee | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Towson | Maryland | 21204 | United States | |||
| Providence Portland Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Zalutumumab 8 mg/kg |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Zalutumumab 8 mg/kg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Adverse Events | Number of participants reporting at least one adverse event | Number of patients reporting at least one adverse event | Posted | Number | participants | Up to 3 months |
|
|
Up to 3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Zalutumumab 8 mg/kg |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | CTCAE (3.0) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) |
The trial was prematurely closed. The original protocol contained Part 1A, followed by Part 1B and Part 2. The trial was terminated when 13 patients were enrolled in Part 1A. Scans for efficacy were planned for Part 1B and Part 2.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eva Järlid Westerberg PhD | Genmab A/S | +45 7020 2728 | E.Westerberg@genmab.com |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C546618 | zalutumumab |
| D060828 | Induction Chemotherapy |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D012074 | Remission Induction |
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| Drug |
Combination of cisplatin and docetaxel administered as two cycles given every three weeks |
|
| Radiotherapy | Radiation | 64 Gy in 32 fractions over 6.5 weeks |
|
| Portland |
| Oregon |
| 97213-2967 |
| United States |
| UZ Gent | Ghent | 9000 | Belgium |
| CHR La Citadelle | Liège | 4000 | Belgium |
| CHU Sart-Tilman Domaine Universitaire du Sart-Tilman | Liège | 4000 | Belgium |
| CHRU Reims, Hospital Maison Blanche | Reims | Cedex | 51092 | France |
| VU Medisch Centrum (VUMC) | Amsterdam | 1004MB | Netherlands |
| The Institute of Cancer Research and the Royal Marsden NHS Foundation Trust | Sutton, Surrey | SM2 5PT | United Kingdom |
| Participants |
|
| Age Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 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 | 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. | Posted | Number | Participants | Until disease progression |
|
|
| 7 |
| 13 |
| 13 |
| 13 |
| Constipation | Gastrointestinal disorders | CTCAE (3.0) |
|
| Ileus | Gastrointestinal disorders | CTCAE (3.0) |
|
| Stomatitis | Gastrointestinal disorders | CTCAE (3.0) |
|
| Neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) |
|
| Chills | General disorders | CTCAE (3.0) |
|
| Malaise | General disorders | CTCAE (3.0) |
|
| Gastroenteritis | Infections and infestations | CTCAE (3.0) |
|
| Viral infection | Infections and infestations | CTCAE (3.0) |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) |
|
| Constipation | Gastrointestinal disorders | CTCAE (3.0) |
|
| Diarrhoea | Gastrointestinal disorders | CTCAE (3.0) |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) |
|
| Fatigue | General disorders | CTCAE (3.0) |
|
| Dyspepsia | Gastrointestinal disorders | CTCAE (3.0) |
|
| Dysphagia | Gastrointestinal disorders | CTCAE (3.0) |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) |
|
The site and the PI may be required to withhold the publication for up to 90 days. Subject to a reasoned request from the sponsor, the publication may be further delayed for a period up to 6 months from the date of first submission to the sponsor.
The sponsor has the right to require deletion of any trade secret, proprietary, or confidential information supplied by the sponsor to the site or the PI. The sponsor shall not otherwise have the right to censor publications.
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |