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Virus Therapy

Gene-Mediated Immunotherapy for Lung Cancer

Phase 1
Waitlist Available
Research Sponsored by Candel Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Resectable with negative lymph nodes based on imaging with histologic confirmation at time of the staging procedure prior to AdV-tk injection
Pathologically documented non-small cell carcinoma (cytology or histology) that is accessible via standard-of-care staging procedures: (1) EBUS or (2) surgical approaches (eg mediastinoscopy, mediastinotomy or VATS)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study Summary

This trial is testing a new cancer treatment, which uses a person's own immune cells to fight their cancer. The goal is to see if it is safe and if it causes any changes in the immune system.

Who is the study for?
This trial is for adults with non-small cell lung cancer that can be removed by surgery, have no lymph node involvement, and a tumor size of at least 4cm. Participants should be relatively healthy (ECOG status 0 or 1) and not on strong immunosuppressants or have had recent chemotherapy. Pregnant women and those with severe chronic diseases or known allergies to the study medication are excluded.Check my eligibility
What is being tested?
The trial tests CAN-2409 plus valacyclovir in patients undergoing standard surgery for non-small cell lung cancer. It aims to find the safest dose while observing how this combination affects the body's immune response against cancer cells.See study design
What are the potential side effects?
Potential side effects may include reactions related to gene therapy such as flu-like symptoms, pain at injection site, fatigue, and possible allergic reactions to valacyclovir including skin rash and other signs of intolerance.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is operable and my lymph nodes are cancer-free, confirmed by tests before AdV-tk injection.
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My lung cancer diagnosis was confirmed through standard tests.
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I am fully active or can carry out light work.
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My kidneys are functioning well enough to clear waste.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of treatment emergent adverse events
Secondary outcome measures
Overall survival (OS)
Progression free survival (PFS)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Study ArmExperimental Treatment1 Intervention
CAN-2409 + valacyclovir

Find a Location

Who is running the clinical trial?

Candel Therapeutics, Inc.Lead Sponsor
11 Previous Clinical Trials
1,261 Total Patients Enrolled
University of PennsylvaniaOTHER
2,000 Previous Clinical Trials
42,880,076 Total Patients Enrolled

Media Library

AdV-tk (aglatimagene besadenovec) + valacyclovir (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03131037 — Phase 1
Lung Cancer Research Study Groups: Study Arm
Lung Cancer Clinical Trial 2023: AdV-tk (aglatimagene besadenovec) + valacyclovir Highlights & Side Effects. Trial Name: NCT03131037 — Phase 1
AdV-tk (aglatimagene besadenovec) + valacyclovir (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03131037 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~2 spots leftby Apr 2025