GMCI + Immunotherapy for Lung Cancer

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Candel Therapeutics, Inc.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?The purpose of this clinical trial is to evaluate the effects of adding CAN-2409 + prodrug for stage III/IV NSCLC patients who are on standard of care first line immune checkpoint inhibitor (ICI) treatment with evidence that the clinical response is inadequate. CAN-2409 is a viral immunotherapy approach that induces tumor-infiltrating T-cells and a consequent PD-L1 up-regulation. A combination of CAN-2409 added to standard of care (SOC) checkpoint inhibitors may lead to improved long-term outcomes for patients with NSCLC who have suboptimal response to ICI therapy.

Eligibility Criteria

This trial is for adults with Stage III/IV NSCLC who are not responding well to first-line immune checkpoint inhibitors. Participants must have stable organ function, no severe illnesses that could interfere with the study, and cannot be pregnant or planning pregnancy. They should not have had significant treatment interruptions or received certain other cancer treatments recently.

Inclusion Criteria

I have a tumor that can be measured and is suitable for injection.

I am stable enough to continue my current cancer treatment for at least 12 weeks.

I haven't changed or stopped my current immune therapy for more than 4 weeks in the last 6 months.

I am 18 years old or older.

My kidney function is within the required range.

I am fully active or can carry out light work.

Exclusion Criteria

I have no other cancer needing treatment except for skin cancer.

My brain cancer has not responded to treatment, as determined by my doctor.

I do not have any uncontrolled illnesses that could interfere with the study.

I haven't had or can't have imaging tests using contrast dye.

I am not pregnant, breastfeeding, nor plan to become pregnant during the study.

I need more than 2 liters of oxygen per minute to breathe at rest.

I do not have severe heart disease.

More than half of my liver is affected by cancer spread.

My lung cancer has specific genetic changes or I am on targeted therapy.

Treatment Details

The trial tests CAN-2409 plus a prodrug alongside standard immune checkpoint inhibitors in patients whose cancers haven't responded adequately to initial treatments. The goal is to see if this combination can improve outcomes by boosting the body's immune response against cancer cells.

1Treatment groups

Experimental Treatment

Group I: CohortsExperimental Treatment1 Intervention

Cohort 1A and 1B - persistent but stable disease at least 18 weeks after starting ICI treatment Cohort 2A and 2B - radiographic progressive disease at least 18 weeks after starting ICI treatment Cohort 3 - refractory disease defined as progressed by imaging at least 9 weeks after starting ICI treatment (CLOSED TO ENROLLMENT)