Clinical trial · Interventional
Combination Vaccine Immunotherapy (DRibbles) for Patients With Definitively-Treated Stage III Non-small Cell Lung Cancer
Randomized Phase II Trial of Cyclophosphamide With Allogeneic Non-Small Cell Lung Cancer (NSCLC) DRibble Vaccine Alone or With Granulocyte-Macrophage Colony-Stimulating Factor or Imiquimod for Adjuvant Treatment of Definitively-Treated Stage IIIA or IIIB NSCLC
- 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)
This study will test an investigational vaccine, called DRibbles, for the treatment of non-small cell lung cancer (NSCLC). We hypothesize that vaccination with the DRibble vaccine will cause an immune responses against proteins contained in the DRibble vaccine and the protein antigens targeted by this strong immune response will include common antigens shared by both the vaccine and the patient's tumor.
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 |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| DRibble vaccine | Biological | — | UNRESOLVED |
| GM-CSF | Drug | — | UNRESOLVED |
| HPV vaccine | Biological | — | UNRESOLVED |
| Imiquimod | Drug | Imiquimod | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- DRibble Vaccine Alone
- description
- Cyclophosphamide (300 mg/m2) will be administered as a single dose three days prior to beginning vaccine therapy. DRibble vaccine will be administered at Weeks 1, 4, 7, 10, 13, 16, 19, 25, 31, 37, and 43. Immunization with HPV vaccine intramuscular injection at the time of the first and third vaccinations.
- interventionNames
- Drug: Cyclophosphamide
- Biological: DRibble vaccine
- Biological: HPV vaccine
- type
- EXPERIMENTAL
- label
- DRibble vaccine with imiquimod
- description
- Cyclophosphamide (300 mg/m2) will be administered as a single dose three days prior to beginning vaccine therapy. DRibble vaccine will be administered at Weeks 1, 4, 7, 10, 13, 16, 19, 25, 31, 37, and 43. Imiquimod cream (5%, 250 mg containing 12.5 mg imiquimod - one packet/day) will be self applied once per day starting with the second vaccine (week 4) and for four days following each vaccine cycle. Immunization with HPV vaccine intramuscular injection at the time of the first and third vaccinations.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Stage IIIA or IIIB histologically proven non-small cell lung cancer * Completion of definitive therapy * Enrollment from 28 days to 12 weeks from completion of definitive therapy * Toxicities from definitive therapy resolved to less than grade 1 * ECOG performance status 0-1 * Negative pregnancy test in women of childbearing potential * Agree to avoid pregnancy or fathering a child while on study treatment * Ability to give informed consent and comply with protocol * Anticipated survival minimum of 6 months * Prior therapy with investigational agents must be completed at least 3 weeks prior to study enrollment * Normal organ and marrow function as defined by specific lab tests * Archived tumor tissue available Exclusion Criteria: * Active autoimmune disease except for vitilogo or hypothyroidism * Active other malignancy * Known HIV+ and/or Hepatitis B or C positive * Medical or psychiatric conditions that would preclude safe participation * Ongoing chemotherapy
References
Publications (0)
Data not yet available