Clinical trial · Interventional
Vaccine Therapy in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
A Phase II, Open Label, Multi-center Study of EP2101 Therapeutic Vaccine in Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer (NSCLC)
NCT00104780CI-TRIAL-00012585unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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: Vaccines made from peptides may make the body build an effective immune response to kill tumor cells. PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with stage IIIB, stage IV, or recurrent non-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 |
|---|---|---|---|
| EP-2101 | Biological | — | UNRESOLVED |
| incomplete Freund's adjuvant | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Comparison of overall survival with historical controls
- measure
- Safety
Secondary outcomes (2)
- measure
- Progression-free survival
- measure
- Frequency, magnitude, and breadth of cytotoxic and helper T-cell response to vaccine epitopes
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed non-small cell lung cancer meeting 1 of the following stage criteria: * Stage IIIB disease * Stage IV disease * Recurrent disease * HLA-A2-positive disease * HLA-A2 negative patients are eligible to enroll in group II (observation) only * Measurable disease * Estimated tumor volume ≤ 125 cc * No CNS signs or symptoms of brain metastases * Brain metastases that are clinically stable for ≥ 2 months AND do not require anticonvulsants or systemic steroids are allowed PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-1 Life expectancy * At least 12 weeks Hematopoietic * Hemoglobin ≥ 10 g/dL * Platelet count \> 100,000/mm\^3 * WBC \> 3,000/mm\^3 * Absolute neutrophil count \> 1,500/mm\^3 * Absolute lymphocyte count \> 500/mm\^3 Hepatic * AST and ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN for patients with liver involvement by tumor) * Bilirubin ≤ 2.0 mg/dL (3.0 mg/dL for patients with liver involvement by tumor) * Albumin ≥ 2.5 g/dL * Alkaline phosphatase ≤ 2.5 times ULN * No history of hepatitis B or C positivity Renal * Creatinine ≤ 2 times ULN Immunologic * No history of any of the following active conditions: * Systemic lupus erythematosus * Scleroderma * Connective tissue disease * Sjögren's syndrome * Multiple sclerosis * Rheumatoid arthritis * Inflammatory bowel disease * No history of HIV positivity * No history of serious adverse reaction, including anaphylaxis, or hypersensitivity to study vaccine or to any of its components Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 weeks after completion of study treatment * No other malignancy within the past 5 years except curatively excised nonmelanoma skin cancer or surgically cured carcinoma in situ of the cervix * No other acute medical condition that would preclude study treatment * No mental or psychiatric condition that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy * More than 1 month since prior interferon therapy * More than 1 month since prior interleukin therapy * No prior cancer vaccine therapy, including participation in a vaccine study Chemotherapy * At least 4 weeks since prior chemotherapy Endocrine therapy * See Disease Characteristics * More than 1 month since prior systemic corticosteroids except stable doses of inhaled corticosteroids Radiotherapy * At least 4 weeks since prior radiotherapy Surgery * Not specified Other * No concurrent participation in another investigational study
References
Publications (0)
Data not yet available
No reference posted for this study.