Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00290355 | Study to Test the Efficacy of the Vaccine GSK 249553 in Treating Non-small-cell Lung Cancer After Tumour Removal by Surgery | PHASE2 | COMPLETED | 182 | — | — | May 28, 2002 | Jul 19, 2011 | Jan 2, 2020 | 62 | Belgium, Estonia +13 |
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...