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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00037713 | Survival in a Randomized Phase III Trial in Patients With Limited Disease (LD) Small Cell Lung Cancer Vaccinated With Adjuvant BEC2 and BCG | PHASE3 | COMPLETED | 515 | — | — | Sep 1, 1998 | Oct 1, 2002 | Apr 8, 2010 | - | — |
| Arm | Type | Description |
|---|---|---|
| 1 | NO_INTERVENTION | Best supportive care, but no cancer specific therapy (cytotoxic, radiation or other tumor reductive therapy) can be given until documented progression of disease. |
| 2 | EXPERIMENTAL | Treatment will consist of 5 vaccinations (each consisting of 8 single intradermal injections) over a period of 10 to 12 weeks unless one of the following occur: 1. intolerable toxicity precluding further treatment progression of disease 2. patient refusal 3. occurrence of pregnancy |
| Name | Type | Description |
|---|---|---|
| BEC2 Vaccine | BIOLOGICAL | 5 vaccinations of BEC2 (2.5 mg) + BCG given day 1 of weeks 0,2,4,6 \& 10. |
Inclusion Criteria: * Histo-cytologically proven SCLC * Limited disease at diagnosis * Age greater than or equal to 18 * Patients with a clinical response of CR or PR to first line combined modality therapy * KPS greater than or equal to 60 * Adequate bone marrow, liver and heart functions * Writte...