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Non-squamous, Non-Small Cell Lung CancerPhase 3LuTK03NCT07660094

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

A Phase 3 study testing Aglatimagene Besadenovec, Valacyclovir and Pembrolizumab in people with Non-squamous, Non-Small Cell Lung Cancer, run by Candel Therapeutics, Inc. at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-squamous, Non-Small Cell Lung Cancer
What is being tested?
Aglatimagene Besadenovec, Valacyclovir and Pembrolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
1 siteUnited States
Study dates
15 Jun 2026to 22 Oct 2031
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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.
  • Prothrombin time (PT) and either partial thromboplastin (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN.
  • Completion of prior therapy with required washout and recovery:
  • Cytotoxic chemotherapy: > 14 days from the last dose.
  • Monoclonal antibodies (e.g., bevacizumab, ramucirumab): ≥ 5 half-lives or ≥ 42 days, whichever is longer.
  • Recovered to ≤ Grade 1 from prior therapy-related clinical toxicities (except alopecia and stable endocrine replacement).
  • Projected life expectancy ≥ 12 weeks (or 3 months) in the opinion of the Investigator.
  • Pregnancy test (for females of childbearing potential) negative at screening.
  • Male and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.

Who cannot join

  • Participants meeting any exclusion criteria for this trial will be disqualified from entering the study.
  • 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.
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  • 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.
  • Has a known active or known prior history of Hepatitis B (HBV) infection (e.g., hepatitis B virus surface antigen [HBsAg] reactive or detectable quantitative levels of HBV DNA) or known active Hepatitis C (HCV) (e.g., hepatitis C virus RNA [quantitative] is detected).
  • Has an uncontrolled or significant heart disease, defined as:
  • Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) prolongation > 470 msec (based on the average of Screening triplicate 12-lead electrocardiogram [ECG] determinations).
  • Myocardial infarction or uncontrolled/unstable angina within 6 months before randomization.
  • Congestive heart failure (CHF) (New York Heart Association [NYHA] Class II to IV) at Screening (see Appendix 12.3).
  • Uncontrolled or significant cardiac arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring anti-arrhythmic medications (except for atrial fibrillation that is well controlled with antiarrhythmic medication).
  • NYHA Class III or IV Functional Classification.
  • LVEF < 40% by ECHO or MUGA scan within 28 days before randomization.
  • Uncontrolled hypertension (resting systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg) within 28 days before randomization.
  • Has a concurrent malignancy requiring active systemic or local anti-cancer treatment except for the following:
  • Adequately treated non-melanoma skin cancer (squamous or basal cell cancers).
  • In situ cervical cancer that has been adequately treated.
  • Early-stage malignancies under active surveillance or observation only, including but not limited to:
  • Low-risk prostate cancer managed with active surveillance- Ductal carcinoma in situ of the breast managed with observation
  • Participants of childbearing potential, who are pregnant, lactating, or intend to become pregnant or father children during the study.
  • Any other significant physical and medical co-morbid conditions, including psychiatric conditions that, in the opinion of the Investigator, would impair study participation or cooperation.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting

  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

    New York, New York, 10016

    Daniel Sterman, MD, 212-263-8865, Daniel.Sterman@nyulangone.org

    NYU Langone Health ClinicalTrials.gov Administrators, Ct.gov@nyulangone.org

    Recruiting

Other trials in United States

About this study

Official title: A Phase 3, Multicenter, Randomized, Controlled, Open-Label Clinical Trial of Aglatimagene Besadenovec (CAN-2409) Plus Prodrug and Pembrolizumab Versus Docetaxel for Stage IV Non-Squamous Non-Small Cell Lung Cancer Progressing on Pembrolizumab-based Treatment

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To compare overall survival (OS) in participants previously treated with platinum-based chemotherapy and pembrolizumab-based immunotherapy for stage IV non-squamous, non-small cell lung cancer (NSCLC) randomized to pembrolizumab and aglatimagene plus prodrug (valacyclovir) versus standard of care docetaxel chemotherapy.

SECONDARY OBJECTIVES:

  1. To compare patient-reported outcomes (PRO) between participants treated with aglatimagene besadenovec + prodrug in combination with pembrolizumab versus SoC docetaxel chemotherapy.

II. To evaluate the safety of aglatimagene besadenovec + prodrug in combination with pembrolizumab versus SoC docetaxel chemotherapy.

OUTLINE: Patients are randomized to 1 of 2 arms. ARM 1: Patients receive two aglatimagene intratumoral injections followed by oral prodrug and pembrolizumab IV on study.

ARM 2: Patients receive docetaxel chemotherapy per standard of care on study.

Being tested
Aglatimagene Besadenovec, Valacyclovir, Pembrolizumab, Docetaxel
Keywords
NSCLC, Non-Squamous, CAN-2409, Aglatimagene besadenovec, Pembrolizumab, Docetaxel, Non-Small Cell Lung Cancer
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aglatimagene BesadenovecBiological

    via intratumoral injections into lung or lymph nodes at two timepoints

  • ValacyclovirDrug

    Oral, for14 days following each aglatimagene besadenovec injection

  • PembrolizumabBiological

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

  • DocetaxelDrug

    every 21 days with standard premedication

Study groups in NCT07660094
Study groupRoleWhat they receive
Arm 1:Continued pembrolizumab with two courses of Aglatimagene besadenovec plus prodrugExperimentalPatients continue to receive pembrolizumab with two courses of Aglatimagene besadenovec plus valacyclovir
Receives: Biological: Aglatimagene Besadenovec; Drug: Valacyclovir; Biological: Pembrolizumab
Arm 2: DocetaxelActive comparatorPatients receive standard of care docetaxel
Receives: Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (5)

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

    Defined as the time from randomization until a definitive clinically meaningful worsening in symptoms or in NSCLC-SAQ total score. The lowest score possible is 0, and the highest score possible is 20. Higher score indicates more severe symptoms.

    Measured: Baseline to Week 12

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

    NSCLC-SAQ Total Score after Week 12 compared to baseline. The lowest score possible is 0, and the highest score possible is 20. Higher score indicates more severe symptoms.

    Measured: Baseline to Week 12

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

    EORTC-QLQ-30 Global Health Status/QoL Score after Week 12 compared to baseline. The lowest score possible is 0, and the highest score possible is 100. Higher score indicates less severe symptoms.

    Measured: Baseline to Week 12

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

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

    Measured: Baseline to 120 days after last administered dose of study drug

  5. Change from baseline in clinical laboratory parameters

    Observed values and changes from baseline for continuous clinical laboratory parameters will be summarized at each scheduled timepoint using descriptive statistics.

    Measured: Baseline to 120 days after last administered dose of study drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2026
  2. Study start15 Jun 2026 (estimated)
  3. Primary completion22 Oct 2031 (estimated)
  4. Study completion22 Oct 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07660094
Sponsor's protocol ID
CAN-2409-LuTK03
Acronym
LuTK03
Status last verified
Jun 2026
First submitted
5 Jun 2026
Last updated
22 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: There is not a plan to make IPD available.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aglatimagene Besadenovec, Valacyclovir and Pembrolizumab in people with Non-squamous, Non-Small Cell Lung Cancer, run by Candel Therapeutics, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: From date of randomization until date of death from any cause, assessed for a minimum of 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07660094.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.

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