Aglatimagene Besadenovec + Prodrug and Pembrolizumab vs Docetaxel for Stage IV Non-Squamous NSCLC Progressing on Pembrolizumab (AURORA)

NCT07660094 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: CAN-2409-LuTK03
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

This phase III trial compares the effect of the combination of aglatimagene besadenovec and pembrolizumab versus standard of care docetaxel chemotherapy for the treatment of stage IV non-squamous, non-small cell lung cancer. Aglatimagene besadenovec is a replication-deficient adenoviral vector encoding the herpes simplex virus thymidine kinase (HSV-tk) gene. When combined with an oral prodrug (valacyclovir), injection of aglatimagene induces targeted tumor cell death and stimulates a systemic immune response. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial may help doctors find out if giving aglatimagene with pembrolizumab is more effective at treating patients with stage IV non-squamous, non-small cell lung cancer than standard chemotherapy.

Conditions

Non-squamous, Non-Small Cell Lung Cancer

Keywords

NSCLC; Non-Squamous; CAN-2409; Aglatimagene besadenovec; Pembrolizumab; Docetaxel; Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  To evaluate whether treatment with aglatimagene besadenovec (CAN-2409) plus valacyclovir and continued pembrolizumab improves overall survival (OS) compared to standard of care (SoC) docetaxel chemotherapy, in participants with Stage IV non-squamous non-small cell lung cancer (NSCLC) whose disease has progressed following prior pembrolizumab-based platinum chemoimmunotherapy

  From date of randomization until date of death from any cause, assessed for a minimum of 24 months

Secondary Outcomes (5)

• Time to meaningful deterioration based on the Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) Total Score

  Baseline to Week 12

• Change from baseline of Total Score of NSCLC-SAQ at Week 12

  Baseline to Week 12

• Change from baseline of Global Health Status/QoL Score of EORTC-QLQ-30 at Week 12

  Baseline to Week 12

• Frequency of Treatment Emergent Adverse Events (TEAEs) graded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)

  Baseline to 120 days after last administered dose of study drug

• Change from baseline in clinical laboratory parameters

  Baseline to 120 days after last administered dose of study drug

Study Arms (2)

Arm 1:Continued pembrolizumab with two courses of Aglatimagene besadenovec plus prodrug

EXPERIMENTAL

Patients continue to receive pembrolizumab with two courses of Aglatimagene besadenovec plus valacyclovir

Biological: Aglatimagene Besadenovec; Drug: Valacyclovir; Biological: Pembrolizumab

Arm 2: Docetaxel

ACTIVE COMPARATOR

Patients receive standard of care docetaxel

Drug: Docetaxel

Interventions

Aglatimagene Besadenovec BIOLOGICAL

via intratumoral injections into lung or lymph nodes at two timepoints

Arm 1:Continued pembrolizumab with two courses of Aglatimagene besadenovec plus prodrug

Valacyclovir DRUG

Oral, for14 days following each aglatimagene besadenovec injection

Arm 1:Continued pembrolizumab with two courses of Aglatimagene besadenovec plus prodrug

Pembrolizumab BIOLOGICAL

every 3 weeks (Q3W) or every 6 weeks (Q6W)

Arm 1:Continued pembrolizumab with two courses of Aglatimagene besadenovec plus prodrug

Docetaxel DRUG

every 21 days with standard premedication

Arm 2: Docetaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years, at the time of signing the informed consent.
• Histologically confirmed metastatic Stage IV non-squamous NSCLC.
• Measurable disease per RECIST v1.1 with at least 1 thoracic lesion amenable to intratumoral injection (e.g., pathological lymph node or lung lesion).
• Note: Able to be reached by bronchoscopy (including robotic bronchoscopy or flexible bronchoscopy with or without endobronchial ultrasound), or by percutaneous injection.
• Documented radiographic progression observed in at least 3 consecutive scans or according to RECIST v1.1 criteria after a minimum of 12 weeks on continued pembrolizumab, determined by central review.
• Note: Participants on a pembrolizumab-based regimen should have achieved a best overall response (BOR) of at least SD (e.g., participants with a BOR of PD while on pembrolizumab are not eligible).
• Prior treatment requirements:
• Must have received platinum-based chemotherapy in any line of therapy.
• May have received pembrolizumab therapy in combination with chemotherapy or sequentially. Note: The participant must be currently progressing on pembrolizumab or a pembrolizumab-based regimen.
• ECOG performance status of 0 or 1 at screening.
• Has adequate bone marrow function, defined as:
• Platelet count ≥ 75,000/mm3.
• Hemoglobin ≥ 9.0 g/dL (
• Absolute neutrophil count (ANC) ≥ 1500/mm3
• Has adequate organ function, defined as: a) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 ×upper limit of normal (ULN); (≤ 5.0 × ULN if transferase elevation is due to liver metastases) AND b) Total bilirubin ≤ 1.5 × ULN (\< 3.0 × ULN in the presence of documented Gilbert's syndrome \[unconjugated hyperbilirubinemia\] or liver metastases at baseline). c) Creatinine clearance ≥ 30 mL/min as calculated using the Cockcroft-Gault equation). d) International normalized ratio (INR) \< 1.5 without anticoagulants, INR \< 3 if on prophylactic anticoagulation therapy.

You may not qualify if:

• Has a known actionable genomic alteration, including EGFR, ALK, or ROS1 rearrangements, for which approved targeted therapy exists. Participants who are receiving or have previously received tyrosine kinase inhibitor (TKI) therapy targeting EGFR, ALK, or ROS1 are excluded.
• Prior therapy with docetaxel either as monotherapy or in combination with other agents.
• Prior treatment with CTLA-4 inhibitor (e.g., ipilimumab).
• History of severe irAEs related to ICI.
• Has a known history of active autoimmune disease requiring systemic immunosuppressive therapy within the past 2 years is excluded. Note: Participants receiving physiologic corticosteroid replacement (e.g., ≤ 10 mg/day prednisone equivalent) are eligible.
• History of hypersensitivity or allergic reactions to valacyclovir.
• Active, uncontrolled, clinically significant bacterial, fungal, or viral infection, or any ongoing infection requiring systemic therapy.
• Clinically active central nervous system (CNS) metastases or leptomeningeal disease. Evidence of new or progression of CNS confirmed by imaging during the study screening.
• Persistently symptomatic bone metastases.
• Has liver metastases involving more than half of the liver.
• Prior radiotherapy within 2 weeks of the start of the study drug.
• Has a known history of active interstitial lung diseases (ILD) (≥ grade 2) or noninfectious pneumonitis requiring active therapy, or for whom suspected ILD/pneumonitis cannot be ruled out by imaging at screening, or clinically severe pulmonary compromise due to intercurrent pulmonary illness and/or pulmonary disorder (e.g., severe chronic obstructive pulmonary disease, restrictive lung disease, etc.) requiring supplemental oxygen (\>2L/min at rest) or any autoimmune, connective tissue or inflammatory disorders with active pulmonary involvement (i.e., rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc.), or any prior pneumonectomy.
• Receiving or anticipated to receive investigational agents or has used an investigational device within 4 weeks prior to the first dose of study drug.
• Ongoing clinically significant toxicity (\> Grade 2 except alopecia), associated with prior treatment including systemic therapy, radiotherapy, or surgery.
• Has a known history of Human Immunodeficiency Virus (HIV) infection and/or acquired immunodeficiency syndrome (AIDS)-related illness.

Sponsors & Collaborators

• Candel Therapeutics, Inc.: lead

Study Sites (1)

Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Valacyclovir; pembrolizumab; Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 22, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): October 22, 2031
• Study Completion (Estimated): October 22, 2031
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)