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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a combination of two treatments, ATRA and atezolizumab, to determine the best dose and side effects in people with non-small cell lung cancer that has returned or spread. ATRA, also known as all-trans-retinoic acid or tretinoin, is derived from vitamin A and aids cell growth. Atezolizumab, also known as Tecentriq, is an immunotherapy that helps the immune system attack cancer. This trial may suit those with non-small cell lung cancer who have tried standard treatments without success and are facing cancer that has returned or spread. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this new combination therapy.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are on systemic steroid therapy or other immunosuppressive treatments, you must stop them at least 7 days before starting the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that atezolizumab has been used in patients with advanced or spreading non-small cell lung cancer. It helps people live longer and is generally safe, meaning most people can handle it without serious problems.

Tretinoin, also known as all-trans retinoic acid or ATRA, is derived from vitamin A and aids in cell growth. In other studies, patients have taken tretinoin with other treatments, and researchers are interested in its effects when combined with atezolizumab.

In these trials, researchers monitor side effects to ensure the treatments are safe. For the combination of tretinoin and atezolizumab, they focus on finding the right dose and observing any serious side effects that might occur at certain doses. They aim to ensure any side effects are manageable and do not outweigh the treatment's benefits.

Since this trial is in its early stages, it primarily focuses on safety and dosage. As the trial progresses, more detailed information will become available about how well people tolerate this combination. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for lung cancer?

Researchers are excited about the combination of Atezolizumab and Tretinoin for lung cancer because it offers a fresh approach to treatment. Atezolizumab is already known for its role as an immune checkpoint inhibitor, which helps the immune system recognize and attack cancer cells more effectively. What makes this treatment unique is the addition of Tretinoin, a form of vitamin A that can induce cancer cell differentiation, potentially enhancing the effectiveness of Atezolizumab. This combination could provide a more powerful attack on lung cancer by not only boosting the immune response but also directly affecting cancer cell growth.

What evidence suggests that ATRA and atezolizumab might be effective for lung cancer?

Research shows that atezolizumab, a treatment that aids the immune system, can extend the lives of people with advanced non-small cell lung cancer (NSCLC). Studies have found that patients taking atezolizumab live longer and experience manageable side effects. All-trans retinoic acid (ATRA), derived from vitamin A, supports cell growth and development. In this trial, participants will receive a combination of ATRA and atezolizumab. This combination might enhance the immune system's ability to fight cancer by helping it attack tumor cells. Although specific data on using these two treatments together is limited, each has shown promise in treating NSCLC individually. ^{1 2 3 5 6}

Who Is on the Research Team?

Dwight H Owen, MD, MS, FACP

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04919369

Study Details | NCT04919369 | All-Trans Retinoic Acid ... Giving all-trans retinoic acid (ATRA) and atezolizumab may help treat patients with non-small cell lung cancer. Detailed Description. PRIMARY OBJECTIVE: I ...

2. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2021-03310

All-Trans Retinoic Acid (ATRA) and Atezolizumab for the ... Giving all-trans retinoic acid (ATRA) and atezolizumab may help treat patients with non-small cell lung cancer. Eligibility Criteria ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9716834/

updated long-term efficacy of atezolizumab in a diverse ... In patients with previously treated advanced or metastatic non-small cell lung cancer (NSCLC), atezolizumab therapy improves survival with manageable safety.

4. tecentriq.com tecentriq.com/metastatic-nsclc/results/how-tecentriq-may-help.html

Effectiveness & Safety of TECENTRIQ® (atezolizumab) for ... TECENTRIQ helped people with a type of metastatic non-small cell lung cancer (NSCLC) live longer. TECENTRIQ was studied in 4 clinical trials with over 2000 ...

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.4_suppl.TPS324

Phase II single-arm, single-center clinical trial of all-trans ... This is a single-arm, open-label, phase 2 clinical trial combining ATRA, bevacizumab, and atezolizumab in refractory MSS mCRC patients.

6. clin.larvol.com clin.larvol.com/trial-detail/NCT04919369

All-Trans Retinoic Acid (ATRA) and Atezolizumab for the ... Safety will be measured by the occurrence of dose-limited toxicities (DLTs) as well as any other adverse events as defined in Common Terminology Criteria for ...