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Compares treatment options for Non-squamous, Non-Small Cell Lung Cancer
Official title Aglatimagene Besadenovec + Prodrug and Pembrolizumab vs Docetaxel for Stage IV Non-Squamous NSCLC Progressing on Pembrolizumab (AURORA)
ClinicalTrials.gov ID: NCT07660094
What this study is testing
What is Aglatimagene Besadenovec?
Aglatimagene Besadenovec is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non-squamous, non-small cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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)...
- Documented radiographic progression observed in at least 3 consecutive scans or according to RECIST v1.1 criteria after a minimum of 12 weeks on...
- Prior treatment requirements:
You likely can't join if
- 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...
- 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...
See the full eligibility criteria
Who can 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...
- 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...
- 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...
- 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.
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.