Clinical trial · Interventional
Monoclonal Antibody Therapy Plus BCG in Treating Patients With Limited-Stage Small Cell Lung Cancer
The SILVA Study: Survival in an International Phase III Prospective Randomized LD Small Cell Lung Cancer Vaccination Study With Adjuvant BEC2 and BCG
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. BCG may activate the immune system to kill tumor cells. Combining monoclonal antibody therapy with BCG may kill more tumor cells. It is not yet known if monoclonal antibody therapy plus BCG is an effective treatment for limited-stage small cell lung cancer. PURPOSE: Randomized phase III trial to determine the effectiveness of monoclonal antibody therapy plus BCG in treating patients who have limited-stage small cell lung cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BCG vaccine | Biological | — | UNRESOLVED |
| monoclonal antibody BEC2 | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed limited stage small cell lung cancer (SCLC)
* Completed first line combination treatment consisting of at least a 2 drug chemotherapy regimen (4 to 6 courses) and a chest radiotherapy regimen
* Must have achieved clinical response (complete or partial) with no evidence of progression or relapse
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Karnofsky 60-100%
Life expectancy:
* Not specified
Hematopoietic:
* WBC greater than 3,000/mm\^3
* Platelet count greater than 100,000/mm\^3
Hepatic:
* AST less than 1.5 times upper limit of normal
* No hepatitis B
Renal:
* Not specified
Other:
* No history of tuberculosis
* Purified Protein Derivative negative to at least 5 IU
* HIV negative
* No severe active infection
* No active infections requiring systemic antibiotics, antiviral, or antifungal treatments
* No serious unstable chronic illness
* No other prior malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or nonmelanomatous skin cancer
* No psychological, familial, sociological, or geographical condition that would preclude study
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 4 weeks since prior immunotherapy
* No prior therapy with mouse proteins
* No other concurrent immunotherapy before first disease progression
Chemotherapy:
* See Disease Characteristics
* No concurrent chemotherapy before first disease progression
Endocrine therapy:
* No concurrent systemic or chronic corticosteroids
Radiotherapy:
* See Disease Characteristics
* No prior radiation to spleen
* No concurrent radiotherapy before first disease progression
Surgery:
* No prior surgery for SCLC
* No prior splenectomy
Other:
* At least 4 weeks since prior combination therapy
* No prior second line therapy for SCLC
* At least 4 weeks since other prior investigational agent
* No concurrent systemic antihistamines or nonsteroidal antiinflammatory drugs
* No concurrent immunosuppressant therapy before first disease progressionReferences
Publications (1)
- RESULTGiaccone G, Debruyne C, Felip E, Chapman PB, Grant SC, Millward M, Thiberville L, D'addario G, Coens C, Rome LS, Zatloukal P, Masso O, Legrand C. Phase III study of adjuvant vaccination with Bec2/bacille Calmette-Guerin in responding patients with limited-disease small-cell lung cancer (European Organisation for Research and Treatment of Cancer 08971-08971B; Silva Study). J Clin Oncol. 2005 Oct 1;23(28):6854-64. doi: 10.1200/JCO.2005.17.186. PMID 16192577