← Back to Search

Virus Therapy

Virus Therapy and Chemotherapy for Lung Cancer (VIRO-25 Trial)

Phase 2

Recruiting

Research Sponsored by Genelux Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG performance status of 0 or 1.

Have histologically or cytologically confirmed advanced or metastatic NSCLC.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed up to 36 months.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment for advanced lung cancer. It involves giving patients a virus called Olvi-Vec through an IV. After this, patients will receive chemotherapy and an immune checkpoint inhibitor.

Who is the study for?

This trial is for adults over 18 with advanced or metastatic non-small cell lung cancer (NSCLC) who've had progression after initial treatment. They should have received 2-6 cycles of platinum-based chemo with immune therapy and be in good physical condition (ECOG status 0 or 1). Pregnant women can't participate, and participants must have adequate organ function.

What is being tested?

The study compares Olvimulogene Nanivacirepvec (an oncolytic virus) followed by platinum-doublet chemotherapy plus a physician's choice of an immune checkpoint inhibitor against the standard drug Docetaxel. It aims to see which is more effective and safe for NSCLC patients after their first disease progression.

What are the potential side effects?

Possible side effects include typical reactions to immunotherapy such as fatigue, skin reactions, flu-like symptoms, potential organ inflammation, and issues related to chemotherapy like nausea, hair loss, low blood counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can carry out all my usual activities without help.

Select...

My lung cancer is confirmed to be advanced or has spread.

Select...

My cancer is confirmed as Stage III or IV.

Select...

My cancer progressed after initial immunotherapy.

Select...

I have a tumor that can be measured by scans, not in my brain.

Select...

I've had 2 to 6 rounds of initial chemo with immune therapy for my cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed up to 36 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed up to 36 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed up to 36 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free Survival per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Blinded Independent Central Review (BICR)

Secondary study objectives

Disease Control Rate (DCR)

Duration of Response by RECIST 1.1

Incidence of Treatment-emergent Adverse Events

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Single-arm run-in Olvi-Vec dose escalation CohortsExperimental Treatment4 Interventions

Cohort 1: Olvi-Vec administered over 3 consecutive days at 1,2,3 x 10e9 pfu followed 2 to 3 weeks later with platinum-doublet chemotherapy + Physician's Choice of ICI. Cohort 2: Olvi-Vec administered over 3 consecutive days at 2,3,5 x 10e9 pfu followed 2 to 3 weeks later with platinum-doublet chemotherapy + Physician's Choice of ICI. Cohort 3: Olvi-Vec administered over 4 consecutive days at 2,3,5,5 x 10e9 pfu followed 2 to 3 weeks later with platinum-doublet chemotherapy + Physician's Choice of ICI.

Group II: Experimental ArmExperimental Treatment4 Interventions

Olvi-Vec will be administered at the dose and schedule selected from the single-arm run-in Olvi-Vec dose escalation cohorts followed 2 to 3 weeks later with platinum-doublet chemotherapy + Physician's Choice of ICI.

Group III: Active Comparator Arm Cross-overExperimental Treatment5 Interventions

Patients randomized into the Active Comparator can cross-over to receive the same treatment as given in the Experimental Arm following determination of (1) disease progression by BICR after receiving docetaxel treatment and (2) confirming eligibility.

Group IV: Active Comparator ArmActive Control1 Intervention

Docetaxel starts in Week 0 and continues until disease progression is assessed by the BICR.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Docetaxel

1995

Completed Phase 4

~6550

0 / 6Eligibility criteria met