ATRA + Atezolizumab for Lung Cancer

Overseen By The Ohio State University Comprehensive Cancer Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Dwight Owen

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Autoimmune disease, Cirrhosis, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 21

Duration: Up to 2 years

18 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests ATRA and atezolizumab in patients with advanced non-small cell lung cancer. ATRA helps cells grow normally, and atezolizumab boosts the immune system to fight cancer.

Research Team

Dwight H Owen, MD, MS, FACP

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

This trial is for adults with recurrent or metastatic non-small cell lung cancer who have tried standard treatments. They must be able to take oral medication, not have curable cancer options left, and agree to use birth control. People with certain health conditions, active autoimmune diseases, or untreated brain metastases can't join.

Inclusion Criteria

I am using two birth control methods or am not having sex to avoid pregnancy during and 5 months after the study.

I agree to use contraception and not donate sperm for 7 months after my last treatment dose.

I agree to use birth control during and for 4 months after the study.

Exclusion Criteria

I have severe liver disease with complications like confusion or fluid in my abdomen.

I have treated brain metastases and have been stable without steroids for at least 2 weeks.

I have an autoimmune disease treated with strong medication in the last 2 years.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tretinoin orally on days 1-3 and atezolizumab intravenously on day 1 of each 21-day cycle, repeated in the absence of disease progression or unacceptable toxicity

Up to 2 years

Every 21 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

Every 12 weeks

Treatment Details

Interventions

• Atezolizumab
• Tretinoin

Trial Overview The trial tests the combination of ATRA (a vitamin A derivative) and atezolizumab (an immunotherapy drug) to find the best dose and monitor side effects in patients whose lung cancer has returned or spread.

Participant Groups

Group I: Treatment (tretinoin, atezolizumab) Experimental Treatment 2 Interventions

Patients receive tretinoin PO on days 1-3 of cycles 1-3. Patients also receive atezolizumab IV on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Atezolizumab is already approved in United States, European Union for the following indications:

Approved in United States as Tecentriq for:

• Melanoma
• Hepatocellular carcinoma
• Small cell lung cancer
• Non-small cell lung cancer
• Urothelial carcinoma

Approved in European Union as Tecentriq for:

• Melanoma
• Hepatocellular carcinoma
• Small cell lung cancer
• Non-small cell lung cancer
• Urothelial carcinoma

Who Is Running the Clinical Trial?

Dwight Owen

Lead Sponsor

Trials

6

Recruited

210+