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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 vaccine is an investigational vaccine being studied for the treatment of non-small-cell lung cancer. It is given after tumour removal by surgery. The vaccine is in Phase 2 clinical development and is not yet approved for use.
GSK 249553 vaccine is being developed by GSK plc, a biopharmaceutical company traded on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the vaccine's efficacy in patients with non-small-cell lung cancer.
GSK 249553 vaccine is in Phase 2 clinical development. It is an investigational vaccine, meaning it has not been approved by regulatory authorities. A Phase 2 trial has been completed to test its efficacy in treating non-small-cell lung cancer after surgery.
GSK 249553 vaccine has been studied in one clinical trial, NCT00290355, a Phase 2 study testing its efficacy in treating non-small-cell lung cancer after tumour removal by surgery. The trial enrolled 182 participants and has been completed.
GSK 249553 vaccine is classified as a monoclonal antibody modality, though it is referred to as a vaccine. It is being investigated for use in non-small-cell lung cancer. The Phase 2 trial was randomized, double-blind, and placebo-controlled.