Clinical trial · Interventional
Trial of Tumor Vaccine Used for Adjuvant Therapy in Post Radical Operation Patients With Lung Cancer
Phase I/II Trial of Tumor Vaccine in Post Radical Operation Patients With Lung Cancer
NCT03807102CI-TRIAL-00072625TVATLC01unknownPhase 1 / Phase 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)
Tumor vaccines may make the body build an immune response to kill tumor cells. This research study is evaluating a new type of tumor vaccine termed as "Neoantigen Tumor Vaccine". The purpose of this phase I/II trial study is to assess the safety and effectiveness of neoantigentumor vaccine in post radical operation patients with stage IIIA 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tumor Vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tumor Vaccine
- description
- Injection of NeoAntigen Tumor Vaccine
- interventionNames
- Biological: Tumor Vaccine
Primary outcomes (2)
- measure
- Disease-free Survival (DFS)
- timeFrame
- Approximately 2 years
- description
- The time that participants stay free of cancer after surgery following administration of tumor vaccine
- measure
- Adverse Events (AEs)
- timeFrame
- 30 days from first study vaccine administration
- description
- Number of participants experiencing clinical and laboratory adverse events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Age: 18 to 70 years, Male or Female * Histological or cytologically diagnosis of lung adenocarcinoma * After surgical treatment (lobectomy and systematic lymph node dissection) * Pathological stage IIIA (According to the IASLC Lung Cancer Staging (eight Edition)) * Postoperative standard treatment (platinum-based double-drug adjuvant treatment with or without chemotherapy) or no adjuvant treatment * Have potential dynamic tumor biomarkers * Able and willing to give witnessed, written informed consent form prior to receiving any study related procedure, agree to participate in long-term follow-up for up to 3 years Exclusion Criteria: * Age \< 18 or\< 70 years * Lung squamous cell carcinoma, small cell lung cancer, large cell lung cancer * Without surgical treatment * Pathological stage I、II、IIIB、IIIC or IV (According to the IASLC Lung Cancer Staging (eight Edition)) * Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dose of study vaccine * Drug or alcohol abusers * Pregnant or breast-feeding patients * History of immunodeficiency disease or autoimmune disease * Patients with chronic disease which is undergoing immune reagents or hormone therapy * Concurrent other medical condition that would prevent the patient from undergoing protocol-based therapy * Lack of availability of a patient for immunological and clinical follow-up
References
Publications (0)
Data not yet available
No reference posted for this study.