Clinical trial · Interventional
A Phase 2 Study of Viagenpumatucel-L (HS-110) in Patients With Non-Small Cell Lung Cancer
A Phase 2, Multicenter, Randomized Study to Evaluate the Safety and Efficacy of Viagenpumatucel-L (HS-110) in Combination With Low Dose (Metronomic) Cyclophosphamide Versus Chemotherapy Alone in Patients With Non-Small Cell Lung Adenocarcinoma After Failure of Two or Three Previous Treatment Regimens for Advanced Disease
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor Decision; strategic - based on changing treatment landscape
Summary
Brief summary (as posted)
Determine whether viagenpumatucel-L combined with low-dose cyclophosphamide prolongs survival in patients with NSCLC who failed 2 or 3 prior lines of therapy for incurable or metastatic disease compared with chemotherapy alone.
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 |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metronomic Cyclophosphamide | Drug | — | UNRESOLVED |
| Physician's Choice Regimen (Vinorelbine, Erlotinib, Gemcitabine, Paclitaxel, Docetaxel, Pemetrexed) | Drug | — | UNRESOLVED |
| Viagenpumatucel-L | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Viagenpumatucel-L Plus Metronomic Cyclophosphamide
- description
- Viagenpumatucel-L (HS-110) given as 1\*10\^7 cells for 12 weekly injections followed by injections every 9 weeks for up to 12 months or until discontinuation from study treatment, whichever occurs first, plus metronomic cyclophosphamide therapy for the first 12 weeks.
- interventionNames
- Drug: Viagenpumatucel-L
- Drug: Metronomic Cyclophosphamide
- type
- ACTIVE_COMPARATOR
- label
- Chemotherapy Alone
- description
- Patients will be treated with a physician's choice regimen until progression.
- interventionNames
- Drug: Physician's Choice Regimen (Vinorelbine, Erlotinib, Gemcitabine, Paclitaxel, Docetaxel, Pemetrexed)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Non-small cell lung adenocarcinoma * At least 2 and no more than 3 prior lines of therapy for incurable or metastatic NSCLC * Suitable for conventional single agent chemotherapy * Disease progression at study entry * Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1; PS=2 patients may be considered * Central nervous system (CNS) metastases may be permitted but must be treated and neurologically stable * Adequate laboratory parameters * Willing and able to comply with the protocol and sign informed consent * Female patients who are of childbearing potential and fertile male patients must agree to use an effective form of contraception throughout study participation Exclusion Criteria: * Received systemic anticancer therapy or radiation therapy within the previous 14 days * Received more than 3 lines of prior conventional therapy for advanced disease * Human immunodeficiency virus (HIV), hepatitis B or C, or severe/uncontrolled infections or intercurrent illness, unrelated to the tumor, requiring active therapy * Any condition requiring concurrent systemic immunosuppressive therapy * Known immunodeficiency disorders * Known leptomeningeal disease * Other active malignancies * Prior treatment with a cancer vaccine for this indication * Pregnant or breastfeeding
References
Publications (0)
Data not yet available