OncoMatch/Clinical Trials/NCT07660094
Aglatimagene Besadenovec + Prodrug and Pembrolizumab vs Docetaxel for Stage IV Non-Squamous NSCLC Progressing on Pembrolizumab (AURORA)
Is NCT07660094 recruiting? Yes, currently enrolling (Jul 2026). This Phase 3 trial studies multiple treatments including Aglatimagene Besadenovec and Pembrolizumab for non-squamous, non-small cell lung cancer.
Treatment: Aglatimagene Besadenovec · Valacyclovir · Pembrolizumab · Docetaxel — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Chemotherapy
Other
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Excluded: EGFR actionable genomic alteration
Has a known actionable genomic alteration, including EGFR, ALK, or ROS1 rearrangements, for which approved targeted therapy exists
Excluded: ALK actionable genomic alteration
Has a known actionable genomic alteration, including EGFR, ALK, or ROS1 rearrangements, for which approved targeted therapy exists
Excluded: ROS1 actionable genomic alteration
Has a known actionable genomic alteration, including EGFR, ALK, or ROS1 rearrangements, for which approved targeted therapy exists
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
ECOG performance status of 0 or 1 at screening
Prior therapy
Must have received: platinum-based chemotherapy
Must have received platinum-based chemotherapy in any line of therapy
Must have received: anti-PD-1 therapy (pembrolizumab)
The participant must be currently progressing on pembrolizumab or a pembrolizumab-based regimen
Cannot have received: EGFR tyrosine kinase inhibitor
Participants who are receiving or have previously received tyrosine kinase inhibitor (TKI) therapy targeting EGFR, ALK, or ROS1 are excluded
Cannot have received: ALK inhibitor
Participants who are receiving or have previously received tyrosine kinase inhibitor (TKI) therapy targeting EGFR, ALK, or ROS1 are excluded
Cannot have received: ROS1 inhibitor
Participants who are receiving or have previously received tyrosine kinase inhibitor (TKI) therapy targeting EGFR, ALK, or ROS1 are excluded
Cannot have received: docetaxel (docetaxel)
Prior therapy with docetaxel either as monotherapy or in combination with other agents
Cannot have received: anti-CTLA-4 therapy (ipilimumab)
Prior treatment with CTLA-4 inhibitor (e.g., ipilimumab)
Lab requirements
Blood counts
Platelet count ≥ 75,000/mm3; Hemoglobin ≥ 9.0 g/dL; ANC ≥ 1500/mm3
Kidney function
Creatinine clearance ≥ 30 mL/min (Cockcroft-Gault equation)
Liver function
AST and ALT ≤ 2.5 × ULN (≤ 5.0 × ULN if due to liver metastases); total bilirubin ≤ 1.5 × ULN (< 3.0 × ULN in Gilbert's syndrome or liver metastases)
Cardiac function
Mean QTcF ≤ 470 msec; LVEF ≥ 40% by ECHO or MUGA; no NYHA Class II-IV CHF; no recent MI/unstable angina; no uncontrolled arrhythmia; no uncontrolled hypertension (SBP > 180 mmHg or DBP > 110 mmHg)
Has adequate bone marrow function, defined as: Platelet count ≥ 75,000/mm3. Hemoglobin ≥ 9.0 g/dL. ANC ≥ 1500/mm3. Has adequate organ function, defined as: AST and ALT ≤ 2.5 × ULN (≤ 5.0 × ULN if due to liver metastases); total bilirubin ≤ 1.5 × ULN (< 3.0 × ULN in Gilbert's syndrome or liver metastases); Creatinine clearance ≥ 30 mL/min (Cockcroft-Gault equation); INR < 1.5 without anticoagulants, INR < 3 if on prophylactic anticoagulation therapy; PT and PTT/aPTT ≤ 1.5 × ULN. Cardiac: Mean QTcF ≤ 470 msec; LVEF ≥ 40% by ECHO or MUGA; no NYHA Class II-IV CHF; no recent MI/unstable angina; no uncontrolled arrhythmia; no uncontrolled hypertension (SBP > 180 mmHg or DBP > 110 mmHg)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Laura & Isaac Perlmutter Cancer Center at NYU Langone Health · New York, New York
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07660094 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior EGFR tyrosine kinase inhibitor, ALK inhibitor, ROS1 inhibitor disqualifies patients from enrollment.
Are patients with EGFR alterations eligible?
No. EGFR actionable genomic alteration is an exclusion criterion.
Are patients with ALK alterations eligible?
No. ALK actionable genomic alteration is an exclusion criterion.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages