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GMCI + Immunotherapy for Lung Cancer

Phase 2

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

RECIST evaluable disease including a lesion that is amenable to injection

Clinically stable and able to continue ICI for at least the 12-week treatment period

Must not have

Patients must have no concurrent malignancy requiring treatment (except squamous or basal cell skin cancers)

Patients with uncontrolled brain metastases as per investigator

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether adding a new cancer treatment, Gene Mediated Cytotoxic Immunotherapy (GMCI™), to the standard of care improves response rates and clinical outcomes for patients with stage III/IV non-small cell lung cancer who have stopped responding to their first line of immune checkpoint inhibitor (ICI) treatment.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include typical reactions related to immunotherapy such as flu-like symptoms, fatigue, skin reactions, and possible inflammation around the tumor site due to injection of CAN-2409. As it involves modifying the immune system, there might also be risks of autoimmune responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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

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I am 18 years old or older.

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My kidney function is within the required range.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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

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

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

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

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I do not have severe heart disease.

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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety graded by CTCAE version 5.0

Secondary study objectives

Biomarker Studies

Changes in patient-reported symptoms using the NSCLC-SAQ

Overall Survival (OS)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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)

0 / 15Eligibility criteria met