Candel Therapeutics, Inc.
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.
PRIMARY OBJECTIVE: I. 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: I. 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 bes…
Inclusion Criteria: 1. Age ≥ 18 years, at the time of signing the informed consent. 2. Histologically confirmed metastatic Stage IV non-squamous NSCLC. 3. 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. 4. Documented radiographic progression observed in at least 3 consecutive scans or according to RECIST v1.1 criteria af…
via intratumoral injections into lung or lymph nodes at two timepoints
Oral, for14 days following each aglatimagene besadenovec injection
every 3 weeks (Q3W) or every 6 weeks (Q6W)
every 21 days with standard premedication