Clinical trial · Interventional
Seneca Valley Virus-001 After Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer
A Randomized Double-Blinded Phase II Study of NTX-010, a Replication-Competent Picornavirus, After Standard Platinum-Containing Cytoreductive Induction Chemotherapy in Patients With Extensive Stage Small Cell Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Interim analysis declared futility.
Summary
Brief summary (as posted)
RATIONALE: A virus called Seneca Valley virus-001 (NTX-010) may be able to kill tumor cells without damaging normal cells. It is not yet known whether NTX-010 is more effective than a placebo in treating small cell lung cancer. PURPOSE: This randomized phase II trial is studying NTX-010 to see how well it works compared with a placebo when given after chemotherapy in treating patients with extensive-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 |
|---|---|---|---|
| placebo | Other | — | UNRESOLVED |
| Seneca Valley virus-001 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1.
- interventionNames
- Biological: Seneca Valley virus-001
- type
- PLACEBO_COMPARATOR
- label
- Arm II
- description
- Patients receive a single dose of placebo IV over 1 hour on day 1.
- interventionNames
- Other: placebo
Primary outcomes (1)
- measure
- Progression-free Survival
- timeFrame
- Time from randomization to the disease progression or death (up to 5 years)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed diagnosis of extensive-stage small cell lung cancer (SCLC)
* No mixed histology
* Presence of ≥ 1 neuroendocrine marker (synaptophysin, chromogranin, or CD56) in tumor tissue
* Achieved partial response (PR), complete response (CR), or stable disease (SD) ≤ 12 weeks of completing 4-6 courses of platinum-based chemotherapy regimen for extensive-stage SCLC
* Patients with PR or SD must have measurable disease, defined as ≥ 1 lesion whose longest diameter can be accurately measured as ≥ 2.0 cm but \< 10 cm by chest x-ray OR as ≥ 1.0 cm but \< 10 cm by CT scan, CT component of a PET/CT scan, or MRI
* If CT scan is used, it must be used for both pre- and post-treatment tumor assessments
* Measurable disease is not required for patients with CR
* Brain metastases allowed provided they have been stable for ≥ 4 weeks after completion of prior radiotherapy
PATIENT CHARACTERISTICS:
* ECOG performance status 0 or 1
* Life expectancy of ≥ 8 weeks
* ANC ≥ 1,500/μL
* Platelet count ≥ 100,000/μL
* Hemoglobin ≥ 9 g/dL
* Total bilirubin ≤ 1.5 times upper limit of normal (ULN) OR direct bilirubin normal
* AST ≤ 3 times ULN (≤ 5 times ULN if liver has tumor involvement)
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use adequate contraception
* Able to comply with study procedures to minimize virus exposure to others
* Willing to provide required biologic specimens
* Willing to return to NCCTG/CTSU enrolling institution for follow-up
* Adequate lung function (i.e., not oxygen dependent)
* The patient is eligible if not on a 24-hour oxygen schedule
* No second primary malignancy within the past 5 years, except for the following:
* Carcinoma in situ of the cervix
* Non-melanomatous skin cancer
* History of low-grade (Gleason score ≤ 6) localized prostate cancer (even if diagnosed \< 5 years prior to study entry)
* Stage I breast cancer that was treated ≥ 5 years before study entry
* Transitional cell carcinoma of the bladder (in situ)
* No active hepatitis B or hepatitis C
* No clinically significant infection
* No significant traumatic injury within the past 4 weeks
* No concurrent uncontrolled illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* More than 4 weeks since prior radiotherapy (2 weeks for palliative radiotherapy to skeletal metastases)
* Other prior radiation therapy (including WBRT, PCI, or Gamma Knife) is permitted as long as the following are true:
* Recovered from prior radiotherapy (alopecia allowed)
* No prior consolidation radiation therapy to the chest
* No prior radiotherapy to \> 25% of bone marrow
* For patients without brain metastases, WBRT or standard of care PCI completed ≥ 2 weeks before administration of NTX- 010/placebo
* More than 365 days since prior immunotherapy or biologic therapy
* More than 4 weeks since prior major surgery\* (i.e., laparotomy) or open biopsy
* More than 2 weeks since prior minor surgery\*
* No prior exposure to the Seneca Valley virus (NTX-010), as determined by negative serum antibodies
* No concurrent combination antiretroviral therapy for HIV-positive patients NOTE: \*Insertion of a vascular access device is not considered major or minor surgery.References
Publications (1)
- DERIVEDSchenk EL, Mandrekar SJ, Dy GK, Aubry MC, Tan AD, Dakhil SR, Sachs BA, Nieva JJ, Bertino E, Lee Hann C, Schild SE, Wadsworth TW, Adjei AA, Molina JR. A Randomized Double-Blind Phase II Study of the Seneca Valley Virus (NTX-010) versus Placebo for Patients with Extensive-Stage SCLC (ES SCLC) Who Were Stable or Responding after at Least Four Cycles of Platinum-Based Chemotherapy: North Central Cancer Treatment Group (Alliance) N0923 Study. J Thorac Oncol. 2020 Jan;15(1):110-119. doi: 10.1016/j.jtho.2019.09.083. Epub 2019 Oct 9. PMID 31605793