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GSK 249553 vaccine · 1 trial · 1 indication
Types of recurrence included local, regional and distant metastasis and second primary lung tumours, and comprised: Local recurrence, defined as a tumour within the same lung or at the bronchial stump; Regional recurrence, involving a clinically or radiologically manifest disease in the mediastinum or in supraclavicular nodes; and Distant recurrence, i.e., any tumour arising in the contralateral lung or outside the hemithorax. The time to recurrence was defined as the interval from the date of surgical resection to the date of recurrence. The latter was defined as the date of the first study assessment at which new lesion(s) were found and confirmed by appropriate imaging.
| Arm | Type | Description |
|---|---|---|
| GSK 249553 Group | EXPERIMENTAL | Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of GSK 249553 vaccine, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals. |
| Placebo Group | PLACEBO_COMPARATOR | Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of placebo, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals. |
| Name | Type | Description |
|---|---|---|
| GSK 249553 vaccine | BIOLOGICAL | Intramuscular injection, 13 doses |
| Placebo | BIOLOGICAL | Intramuscular administration, 13 doses |
Inclusion Criteria: * Written informed consent has been obtained prior to surgical tumour resection and prior to the performance of any other protocol-specific procedures. * At least 18 years of age at the time of resection. * Pathologically proven, surgically staged squamous or non-squamous IB, II...
GSK 249553 is an investigational therapeutic vaccine developed by GSK plc for non-small cell lung cancer. It was studied as a treatment given after tumor removal by surgery, with the goal of targeting residual disease in patients whose tumors had been resected. It is a Phase 2 oncology vaccine candidate.
GSK 249553 was studied in non-small cell lung cancer as a post-surgical treatment, given after tumor removal by surgery. The Phase 2 trial evaluated the vaccine in patients with resected non-small cell lung cancer across multiple European countries, including Belgium, France, Germany, Italy, Spain, and the United Kingdom.
GSK 249553 is developed by GSK plc, which trades under the ticker GSK. The company sponsored the Phase 2 clinical trial of the vaccine in non-small cell lung cancer.
GSK 249553 is in Phase 2 development. It is an investigational vaccine candidate and has not been approved for commercial use. The Phase 2 trial in non-small cell lung cancer has been completed, and no active trials of this vaccine are currently listed.
GSK 249553 was evaluated in one Phase 2 clinical trial, NCT00290355, titled a study to test the efficacy of the vaccine GSK 249553 in treating non-small-cell lung cancer after tumour removal by surgery. The trial enrolled 182 patients, was randomized, double-blind, and placebo-controlled, and has been completed.
The Phase 2 trial NCT00290355 was a randomized, double-blind, placebo-controlled study of GSK 249553 in non-small cell lung cancer after tumor removal by surgery. It enrolled 182 patients aged 18 years and older, included all sexes, did not enroll healthy volunteers, and was conducted across 14 European countries.