Study on CAN-2409 Plus Prodrug with Standard Immune Therapy for Advanced Lung Cancer
Sponsor: Candel Therapeutics, Inc.
ClinicalTrials ID:NCT04495153
This clinical trial is testing whether adding CAN-2409 and a prodrug to the usual immune therapy can improve treatment for patients with advanced lung cancer who are not responding well to their current treatment.
Patient Parameters
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Program Overview
The aim of this study is to see if adding CAN-2409 and a prodrug to the standard immune therapy can help patients with advanced non-small cell lung cancer (NSCLC) who are not responding well to their current treatment. CAN-2409 is a type of viral therapy that helps the immune system attack cancer cells. Researchers hope this combination will lead to better long-term outcomes for these patients.
Description
This study is for patients with advanced non-small cell lung cancer (NSCLC) who are already receiving standard immune therapy but are not seeing the desired results. The trial will test if adding CAN-2409 and a prodrug can improve their response to treatment. CAN-2409 has shown promise in animal studies and has been tested in over 950 cancer patients, including those with lung, pancreas, prostate, and brain cancers. The study includes different groups of patients based on their response to current treatment:
- Group 1: Patients whose cancer is stable but not improving after at least 18 weeks of immune therapy.
- Group 2: Patients whose cancer is worsening after at least 18 weeks of immune therapy but are still in stable health.
The study allows for different standard treatments, such as immune therapy alone or combined with chemotherapy. It also includes patients with stage III cancer who have received chemoradiation and are on durvalumab. The study has expanded to include more patients in Groups 1 and 2, and is testing a new 3-dose regimen of CAN-2409 and prodrug.
Eligibility Criteria
Inclusion Criteria
- Have stage III or IV non-small cell lung cancer (NSCLC) and are receiving first-line immune therapy, with or without chemotherapy.
- Fit into one of the study groups based on response to treatment: stable disease after 18 weeks or worsening disease after 18 weeks.
- Have a tumor that can be measured and injected.
- Willing to have biopsies before and during treatment, if possible.
- Be in good overall health with a performance status of 0 or 1.
- Be 18 years or older.
- Meet specific blood count and organ function requirements.
- Be stable enough to continue immune therapy for at least 12 weeks.
- Have not changed immune therapy or had long interruptions in the past 6 months.
- Have not received radiation at more than three sites in the past year.
- Agree to provide informed consent before joining the study.
Exclusion Criteria
- Have had severe side effects from immune therapy in the past.
- Need ongoing treatment with certain immune-suppressing drugs.
- Have active autoimmune disease needing treatment in the past 2 years.
- Have uncontrolled health issues like infections, heart failure, or psychiatric conditions.
- Are pregnant, breastfeeding, or planning to become pregnant.
- Are HIV positive.
- Have allergies to certain medications used in the study.
- Have serious heart disease or need continuous oxygen.
- Have tumors affecting important nerves or blood vessels.
- Have uncontrolled brain metastases.
- Have extensive liver metastases.
- Have specific genetic mutations or are on certain targeted therapies.
- Have lung diseases needing treatment.
- Have used certain cancer drugs recently.
- Have another cancer needing treatment, except for some skin cancers.
- Cannot have contrast imaging or have contraindications to it.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Mayo Clinic Hospital | 85054 | Phoenix | Arizona |
| UConn Health | 06030 | Farmington | Connecticut |
| Yale University, Yale Cancer Center | 06510 | New Haven | Connecticut |
| University of Chicago | 60637 | Chicago | Illinois |
| University of Maryland, Baltimore | 21201 | Baltimore | Maryland |
| Mayo Clinic | 55905 | Rochester | Minnesota |
| NYU Langone Health | 10016 | New York | New York |
| The Ohio State University Wexner Medical Center | 43210 | Columbus | Ohio |
| University of Pennsylvania | 19104 | Philadelphia | Pennsylvania |
| Vanderbilt University Medical Center | 37232 | Nashville | Tennessee |
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