Study Comparing Aglatimagene Besadenovec with Pembrolizumab to Standard Chemotherapy for Advanced Non-Squamous Lung Cancer
Sponsor: Candel Therapeutics, Inc.
ClinicalTrials ID:NCT07660094
This clinical trial is testing a new treatment combination of aglatimagene besadenovec and pembrolizumab against the standard chemotherapy drug docetaxel for patients with advanced non-squamous non-small cell lung cancer (NSCLC) that has progressed after initial treatment.
Patient Parameters
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Program Overview
The study aims to determine if a new combination of treatments, aglatimagene besadenovec with pembrolizumab, is more effective than the standard chemotherapy drug docetaxel for treating stage IV non-squamous non-small cell lung cancer (NSCLC). Aglatimagene besadenovec is a type of gene therapy that, when combined with a prodrug, targets and kills cancer cells while boosting the immune system. Pembrolizumab is an immunotherapy that helps the immune system attack cancer cells. This trial will help doctors understand if this new combination can better control cancer growth compared to traditional chemotherapy.
Description
The main goal of this study is to compare the overall survival of patients with advanced non-squamous non-small cell lung cancer (NSCLC) who have already been treated with chemotherapy and pembrolizumab. Participants will be randomly assigned to one of two groups: one group will receive the new treatment combination of aglatimagene besadenovec with a prodrug and pembrolizumab, while the other group will receive the standard chemotherapy drug docetaxel.
The study will also look at how patients feel during treatment and the safety of the new treatment combination compared to standard chemotherapy. Participants in the first group will receive injections of aglatimagene directly into the tumor, followed by an oral prodrug and pembrolizumab through an IV. Participants in the second group will receive docetaxel chemotherapy as per standard care.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have stage IV non-squamous non-small cell lung cancer (NSCLC) that can be measured and has at least one tumor that can be injected directly.
- Cancer must have shown progression after at least 12 weeks on pembrolizumab treatment.
- Must have previously received platinum-based chemotherapy.
- Must be currently receiving pembrolizumab or a similar treatment.
- Must be in good general health with a performance status of 0 or 1.
- Must have adequate blood cell counts and organ function.
- Must have completed previous treatments with enough time for recovery.
- Must have a life expectancy of at least 12 weeks.
- Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
Exclusion Criteria
- Have a genetic mutation for which targeted therapy exists, such as EGFR, ALK, or ROS1.
- Have previously received docetaxel or CTLA-4 inhibitors.
- Have a history of severe immune-related side effects from immunotherapy.
- Have an active autoimmune disease requiring treatment in the past 2 years.
- Have allergies to valacyclovir.
- Have active infections or uncontrolled health conditions.
- Have cancer that has spread to the brain or spinal cord.
- Have significant liver involvement or other severe health issues.
- Have had recent radiotherapy or investigational treatments.
- Have a history of heart disease or uncontrolled high blood pressure.
- Have other active cancers requiring treatment.
- Are pregnant, breastfeeding, or planning to become pregnant during the study.
- Have any other significant health conditions that could affect participation.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Laura & Isaac Perlmutter Cancer Center at NYU Langone Health | 10016 | New York | New York |
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