Clinical trial · Interventional
A Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Patients With Squamous Cell Carcinoma of the Lung
A Phase 2 Study of Intravenous Administration of REOLYSIN® (Reovirus Type 3 Dearing) in Combination With Paclitaxel and Carboplatin in Patients With Squamous Cell Carcinoma of the Lung
NCT00998192CI-TRIAL-00021555completedPhase 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)
The purpose of this Phase 2 study is to investigate whether intravenous administration of REOLYSIN therapeutic reovirus in combination with paclitaxel and carboplatin is effective and safe in the treatment of squamous cell carinoma of the lung.
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 |
|---|---|---|---|
| Metastatic or Recurrent Squamous Cell Carcinoma of the Lung | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| REOLYSIN | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Objective response rate (complete response (CR) + partial response (PR)) of the treatment regimen in the study population
- timeFrame
- 6 months
Secondary outcomes (4)
- measure
- Evaluate the safety and tolerability of the treatment regimen in the study population as measured by adverse events associated with the study treatment, and defined by established criteria.
- timeFrame
- Within 30 days of last dose of REOLYSIN
- measure
- To assess progression-free survival (PFS) for the treatment regimen in the study population.
- timeFrame
- 9-12 months
- measure
- Determine the proportion of patients receiving the treatment who are alive and free of disease progression at 6 months.
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * have histologically or cytologically confirmed metastatic stage IIIB (pleural effusion; IVA on revised IASLC staging) or stage IV, or recurrent squamous cell carcinoma of the lung. * have measurable disease. * be chemotherapy naïve for their metastatic or recurrent SCCLC, with some exceptions. * have NO continuing acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedures. * have an ECOG Performance Score of ≤ 2. * have a life expectancy of at least 3 months. * absolute neutrophil count (ANC) ≥ 1.5 x 10\^9; Platelets ≥ 100 x10\^9 (without platelet transfusion);Hemoglobin ≥ 9.0 g/dL (with or without RBC transfusion); Serum creatinine ≤ 1.5 x upper limit of normal (ULN); Bilirubin ≤ 1.5 x ULN; AST/ALT ≤ 2.5 x ULN. * negative pregnancy test for females with childbearing potential. Exclusion Criteria: * receive concurrent therapy with any other investigational anticancer agent while on study. * have a known past or current history of brain metastasis(es). * be on immunosuppressive therapy or have known HIV infection or active hepatitis B or C. * be a pregnant or breast-feeding woman. * have clinically significant cardiac disease. * have dementia or altered mental status that would prohibit informed consent. * have any other acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the Principal Investigator, would make the patient inappropriate for this study.
References
Publications (0)
Data not yet available
No reference posted for this study.