500 Participants NeededMy employer runs this trial

Aglatimagene Besadenovec + Pembrolizumab vs Docetaxel for Non-Small Cell Lung Cancer

(LuTK03 Trial)

Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Candel Therapeutics, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for adults with stage IV non-squamous non-small cell lung cancer whose disease has gotten worse after treatment with pembrolizumab. Participants should be in generally good health aside from their cancer.

Inclusion Criteria

I have finished previous cancer treatments and recovered from most side effects.
Projected life expectancy ≥ 12 weeks in investigator's opinion
My liver, kidney, and blood clotting tests are within the required safe ranges.
See 10 more

Exclusion Criteria

Pregnant, lactating, or intending to become pregnant or father children during the study
I have been diagnosed with HIV or an AIDS-related illness.
I do not have severe ongoing side effects from previous treatments, except hair loss.
See 17 more

What Are the Treatments Tested in This Trial?

Interventions

  • Aglatimagene Besadenovec
  • Docetaxel
  • Pembrolizumab

Trial Overview

The study compares a new combination of aglatimagene besadenovec (a gene therapy) plus valacyclovir and pembrolizumab (an immunotherapy) against standard chemotherapy with docetaxel. Patients are randomly assigned to one of the two groups.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Arm 1:Continued pembrolizumab with two courses of Aglatimagene besadenovec plus prodrugExperimental Treatment3 Interventions
Group II: Arm 2: DocetaxelActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Candel Therapeutics, Inc.

Lead Sponsor

Trials
12
Recruited
1,300+