Trial Outcomes & Findings for Seneca Valley Virus-001 After Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer (NCT NCT01017601)

One-hundred twenty-one (121) participants were pre-registered and 59 participants were registered between January 2010 and January 2013. Study was terminated prematurely on 1/10/2013 due to an interim analysis that declared futility. No additional clinical and survival follow-up data are required as of 11/15/2014.

Sixty-two participants were deemed screen failures: 26 progression, 21 did not meet eligibility criteria, 6 patient decision and 9 other reason. Out of the 59 randomized participants, there were 8 cancellations and one participant was found to be ineligible upon audit. All seventy-one participants mentioned above were excluded from all analyses.

Seneca Valley Virus-001 After Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer

The progression-free survival (PFS) was defined as the time from date of randomization to the documentation of disease progression or death as a result of any cause, whichever comes first.

Overall survival was defined as the time from study enrollment (randomization) to the time of death from any cause or last follow-up.

A confirmed tumor response was defined as a complete response (CR) or partial response (PR) noted as the objective status on 2 consecutive evaluations at least 6 weeks apart. Response and progression will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all non-nodal target lesions and each target lymph node must have reduction in short axis to \<1.0 cm.; Partial Response (PR), at least a 30% decrease in the sum of the longest diameters of the non-nodal target lesions and the short axes of the target lymph nodes taking as reference the Baseline Sum of Diameters; Overall Response (OR) = CR + PR.

Duration of response was defined as the time from the date at which the patient's earliest best objective status was first noted to be either a CR or PR to the earliest date progression was documented.

Adverse events were assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death. The maximum grade for each type of adverse events were recorded for each patient.

Quality of Life (QOL) was measured using the single-item Linear Analogue Self Assessment (LASA) on a 0-10 scale, with 0=as bad as it can be and 10=as good as it can be. The QOL scores was converted to a 100-point scale, with 0=Low QOL and 100=Best QOL. Change from baseline to day 20-29 was calculated by subtracting the baseline scores from the scores at day 20-29. Negative change indicates the QOL decrease and positive change indicates the QOL improvement.

Quality of Life (QOL) was measured using the single-item Linear Analogue Self Assessment (LASA) on a 0-10 scale, with 0=as bad as it can be and 10=as good as it can be. The QOL scores was converted to a 100-point scale, with 0=Low QOL and 100=Best QOL. Change from baseline to day 30-59 was calculated by subtracting the baseline scores from the scores at day 30-59. Negative change indicates the QOL decrease and positive change indicates the QOL improvement.

Quality of Life (QOL) was measured using the single-item Linear Analogue Self Assessment (LASA) on a 0-10 scale, with 0=as bad as it can be and 10=as good as it can be. The QOL scores was converted to a 100-point scale, with 0=Low QOL and 100=Best QOL. Change from baseline to day 20-29 was calculated by subtracting the baseline scores from the scores at day 20-29. Clinical Significance change over time was determined by the percentage of patients that report an improvement of more than 10 points on the 0-100 point scale.

Quality of Life (QOL) was measured using the single-item Linear Analogue Self Assessment (LASA) on a 0-10 scale, with 0=as bad as it can be and 10=as good as it can be. The QOL scores was converted to a 100-point scale, with 0=Low QOL and 100=Best QOL. Change from baseline to day 30-59 was calculated by subtracting the baseline scores from the scores at day 30-59. Clinical Significance change over time was determined by the percentage of patients that report an improvement of more than 10 points on the 0-100 point scale.