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

Conditions

• Advanced Non-squamous Non-small-cell Lung Cancer
• Advanced Squamous Non-Small Cell Lung Carcinoma
• Metastatic Non-squamous Non Small Cell Lung Cancer
• Metastatic Squamous Non-Small Cell Lung Carcinoma
• Non-small Cell Lung Cancer
• Non-small Cell Lung Cancer Recurrent
• Non-small Cell Lung Cancer Stage III
• Non-small Cell Lung Cancer Stage IV

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Olvimulogene nanivacirepvec — BIOLOGICAL
  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.

Study Details

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.

Key Dates

Start date

Sep 26, 2024

Status verified

Jun 2026

Primary completion

Feb 28, 2027

Completion

Jul 31, 2029

Study Design

Enrollment

142 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Experimental: Single-arm run-in Olvi-Vec dose escalation Cohorts
  Cohort 1: Olvi-Vec administered over 3 consecutive days at 0.5,0.5,0.5 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 1,1,1 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 1,2,3 x 10e9 pfu followed 2 to 3 weeks later with platinum-doublet chemotherapy + Physician's Choice of ICI.
• Experimental: Experimental Arm
  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.
• Active Comparator: Active Comparator Arm
  Docetaxel starts in Week 0 and continues until disease progression is assessed by the BICR.
• Other: Active Comparator Arm Cross-over
  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.

Primary Outcome Measure

Progression-free Survival per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Blinded Independent Central Review (BICR) [ Time Frame: From date of randomization up to 12 months. ]

Locations (15)

Find similar trials in Bullhead City, AZ

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