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Efficacy & Safety of Olvimulogene Nanivacirepvec & Platinum-doublet + Physician's Choice of Immune Checkpoint Inhibitor Compared to Docetaxel in NSCL Cancer

ConditionsAdvanced Non-squamous Non-small-cell Lung CancerAdvanced Squamous Non-Small Cell Lung CarcinomaMetastatic Non-squamous Non Small Cell Lung CancerMetastatic Squamous Non-Small Cell Lung CarcinomaNon-small Cell Lung CancerNon-small Cell Lung Cancer Stage IIINon-small Cell Lung Cancer Stage IVNon-small Cell Lung Cancer Recurrent
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGenelux Corporation

About this trial

This Phase 2, open-label, randomized study in non-small-cell lung cancer (NSCLC) is designed to evaluate the efficacy and safety of an intravenously delivered oncolytic vaccinia virus, Olvi-Vec, followed by platinum-doublet chemotherapy + Physician's Choice of Immune Checkpoint Inhibitor (ICI) vs. docetaxel for patients with advanced or metastatic NSCLC who have shown first disease progression (i.e., progressive disease not yet confirmed by further scan after initial scan showing progression) while on front-line treatment or maintenance ICI therapy after front-line treatment with platinum-doublet chemotherapy + ICI as standard of care.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female 18 years or older.

ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1.

Have histologically or cytologically confirmed advanced or metastatic NSCLC.

Histologically confirmed Stage III or IV squamous or nonsquamous [American Joint Committee on Cancer (AJCC) 8th edition].

Disqualifiers

Active and untreated urinary tract infection, pneumonia, or other systemic infections.

Current symptomatic central nervous system (CNS) metastasis.

Any uncontrolled systemic disease, condition or comorbidity that, in the opinion of the Investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results.

Persistent toxicities [Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 3] caused by previous anticancer therapy; alopecia and vitiligo are excluded toxicities.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Olvimulogene nanivacirepvec

    Biological/Vaccine

    Olvi-Vec is an engineered oncolytic vaccinia virus

  • Platinum chemotherapy: carboplatin or cisplatin

    Drug

    Administered according to local practice.

  • Non-platinum chemotherapy: paclitaxel or nab-paclitaxel for squamous cell NSCLC or pemetrexed for nonsquamous cell NSCLC

    Drug

    Administered according to local practice.

  • Physician's Choice of Immune Checkpoint Inhibitor: pembrolizumab, nivolumab, cemiplimab, atezolizumab, durvalumab

    Drug

    Administered according to local practice.

  • Docetaxel

    Drug

    Administered according to local practice.

Treatment groups

142 Participants
are divided into 4 treatment groups
Group A: Single-arm run-in Olvi-Vec dose escalation CohortsExperimental treatment 4 interventions
Group B: Experimental ArmExperimental treatment 4 interventions
Group C: Active Comparator ArmActive comparator 1 intervention
Group D: Active Comparator Arm Cross-overOther 5 interventions

Trial outcomes

Primary outcomes

1

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

To assess progression-free survival from time of randomization until first documented disease progression based on radiological assessment or death from any cause.

Time frame
From date of randomization up to 12 months.

Secondary outcomes

1

Objective Response Rate (ORR) by RECIST 1.1

Ratio of the sum of complete responses (CR) \& partial responses (PR) divided by the number of participants from start of treatment to confirmation of response.

Time frame
From date of randomization up to 12 months.
2

Median Overall Survival

Time from randomization until death or study completion; assessed up to 36 months.

Time frame
From date of randomization up to 36 months.
3

Six-month Progression-free Survival Rate

Proportion of patients who remained alive and progression-free at 6 months.

Time frame
From date of randomization up to 6 months.
4

Incidence of Treatment-emergent Adverse Events

From date of first study treatment until death or study completion.

Time frame
Assessed up to 36 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Genelux Corporation

Lead sponsor

Newsoara Biopharma Co., Ltd.

Collaborator

Source ClinicalTrials.gov
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