Temozolomide + Atezolizumab for Small Cell Lung Cancer

Recruiting at 4 trial locations

Overseen By Amber Ryba

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Dwight Owen

Must not be taking: Temozolomide

Disqualifiers: CNS metastases, Active infection, Autoimmune disease, others

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

Prior Safety Data This treatment has passed at least one previous human trial

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 2 years

56 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of combining the chemotherapy drug temozolomide with the immunotherapy drug atezolizumab for treating small cell lung cancer that has spread or recurred after initial treatment. The goal is to determine if these drugs can slow the cancer's growth or spread and potentially improve patient survival. Individuals whose small cell lung cancer has returned or spread after previous chemotherapy may be suitable candidates for this trial. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on certain treatments like chemotherapy, immunotherapy, or have had recent surgery, you may need to wait for a recovery period before starting the trial. It's best to discuss your specific medications with the trial team.

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

Research is examining the effectiveness of combining temozolomide and atezolizumab as a second or third treatment option for small cell lung cancer. Temozolomide, a chemotherapy drug, kills cancer cells or stops their growth. Atezolizumab, an immunotherapy, aids the immune system in fighting cancer cells.

Earlier studies have shown that temozolomide can have positive effects in some patients with recurrent small cell lung cancer, though not universally. Atezolizumab is already a standard treatment for certain lung cancers and is generally considered safe.

This trial is in phase 2, focusing on safety monitoring. This phase assesses whether the treatment is well-tolerated and identifies any side effects. Since atezolizumab is approved for other uses, there is some confidence in its safety. However, the combination with temozolomide is still under study to ensure it does not cause unexpected issues. Participants are closely monitored for any side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of temozolomide and atezolizumab for small cell lung cancer because it brings a fresh approach to treatment. Traditionally, treatments like chemotherapy have been the go-to options, but this new combo adds an immune system boost to the mix. Atezolizumab is an immunotherapy drug that helps the body's own immune system recognize and fight cancer cells, while temozolomide, an oral chemotherapy, aims to stop cancer cells from growing. Together, they might offer a more powerful attack on cancer than using chemotherapy alone. This combination could potentially improve outcomes for patients by harnessing the body's natural defenses alongside traditional methods.

What evidence suggests that temozolomide and atezolizumab might be effective treatments for small cell lung cancer?

Research has shown that using temozolomide and atezolizumab together might help patients with small cell lung cancer live longer. In this trial, participants will join one of two cohorts, both receiving a combination of temozolomide and atezolizumab. Temozolomide, a type of chemotherapy, stops cancer cells from growing and spreading. Atezolizumab, an immunotherapy, helps the immune system fight cancer and is already approved for other types of lung cancer. Studies have found that atezolizumab, when combined with other drugs, helped patients live longer without their cancer worsening. The goal is for these two treatments together to provide similar benefits for people whose small cell lung cancer has spread or returned. ^{3 6 7 8 9}

Who Is on the Research Team?

Dwight Owen, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with small cell lung cancer that has spread or returned after initial treatment. Participants must be able to take oral meds, have measurable disease, and a good performance status. They should not have had certain treatments recently and must agree to use contraception.

Inclusion Criteria

I have been mostly active and able to carry out all pre-disease activities up to 28 days before signing up.

I am a woman who can have children and I have a negative pregnancy test from the last two weeks.

My cancer can be measured by scans as per RECIST v1.1.

Exclusion Criteria

I do not have another cancer that could affect the trial's safety or results.

I am currently on medication for a serious infection.

I haven't had cancer treatments like chemotherapy or radiation in the last 2 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive atezolizumab intravenously and temozolomide orally in two different dosing schedules. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment completion, with follow-up at 30 days and every 3 months thereafter.

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Atezolizumab
• Temozolomide

Trial Overview The study tests temozolomide (a chemotherapy drug) combined with atezolizumab (an immunotherapy antibody) as second or third line treatments in patients whose cancer has metastasized or recurred. The goal is to see if this combo can extend survival times.

How Is the Trial Designed?

Group I: Cohort II (atezolizumab, temozolomide) Experimental Treatment 2 Interventions

Patients receive atezolizumab IV over 30-60 minutes on day 1. Patients also receive temozolomide PO QD on days 1-14 of cycle 1 and days 1-21 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group II: Cohort I (atezolizumab, temozolomide) Experimental Treatment 2 Interventions

Patients receive atezolizumab IV over 30-60 minutes on day 1 and temozolomide PO QD on days 1-5. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Who Is Running the Clinical Trial?

Dwight Owen

Lead Sponsor

Trials

6

Recruited

210+

Bayer

Industry Sponsor

Trials

2,291

Recruited

25,560,000+

Founded

1863

Headquarters

Leverkusen, Germany

Known For

Pharmaceutical Innovations

Top Products

Aspirin, Aleve, Yaz, Nexavar

Bill Anderson

Bayer

Chief Executive Officer since 2023

BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT

Michael Devoy

Bayer

Chief Medical Officer since 2014

MD, PhD

Genentech, Inc.

Industry Sponsor

Trials

1,578

Recruited

569,000+

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

Published Research Related to This Trial

Atezolizumab significantly improves overall survival in patients with metastatic non-small cell lung cancer (mNSCLC), with median survival times of 13.8 months in the atezolizumab group compared to 9.6 months in the docetaxel group in the OAK trial.

The treatment has an acceptable safety profile, with common side effects including fatigue and decreased appetite, and serious immune-related adverse events occurring in a small percentage of patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

U.S. Food and Drug Administration Approval Summary: Atezolizumab for Metastatic Non-Small Cell Lung Cancer. Weinstock, C., Khozin, S., Suzman, D., et al.[2022]

Atezolizumab is a monoclonal antibody that targets PD-L1, which is being developed for treating various blood cancers and solid tumors, showing promise in cancer immunotherapy.

It has already been approved in the US as a second-line treatment for urothelial carcinoma and is pending approval for non-small cell lung cancer, highlighting its potential efficacy in these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab: First Global Approval. Markham, A.[2019]

Atezolizumab significantly improved overall survival in patients with previously treated non-small-cell lung cancer compared to docetaxel, with median survival times of 13.8 months versus 9.6 months, respectively.

The safety profile of atezolizumab was favorable, with only 15% of patients experiencing grade 3 or 4 adverse events, compared to 43% in the docetaxel group, indicating it may be a safer treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial. Rittmeyer, A., Barlesi, F., Waterkamp, D., et al.[2022]

Atezolizumab, the first anti-PD-L1 monoclonal antibody approved by the FDA, has shown promising efficacy in treating metastatic triple-negative breast cancer, supported by data from the Phase III IMpassion130 trial.

The review highlights the pharmacodynamic and pharmacokinetic properties of atezolizumab, emphasizing its safety and effectiveness in various cancers, including small-cell lung cancer and renal cell cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab for use in PD-L1-positive unresectable, locally advanced or metastatic triple-negative breast cancer. Mavratzas, A., Seitz, J., Smetanay, K., et al.[2020]

Atezolizumab, combined with carboplatin and etoposide, significantly improves overall survival and progression-free survival in patients with extensive-stage small cell lung cancer, based on data from the IMpower133 trial involving previously untreated patients.

The treatment regimen is generally well tolerated, with no new safety concerns identified, and it does not negatively impact patients' quality of life, making it a valuable first-line therapy option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab: A Review in Extensive-Stage SCLC. Frampton, JE.[2021]

In a phase 1 study involving 17 patients with relapsed or refractory small-cell lung cancer (SCLC), atezolizumab was generally well tolerated, with 64.7% experiencing any-grade treatment-related adverse events, the most common being fatigue.

Atezolizumab showed some antitumor activity, with a partial response in 5.9% of patients and a median overall survival of 5.9 months, suggesting potential benefits for patients with high T-effector gene signature and PD-L1 expression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Activity and Safety of Atezolizumab in a Phase 1 Study of Patients With Relapsed/Refractory Small-Cell Lung Cancer. Chiang, AC., Sequist, LVD., Gilbert, J., et al.[2021]

In a study of 47 patients with transformed small-cell lung cancer (T-SCLC), combining the PD-L1 inhibitor atezolizumab with chemotherapy resulted in a high objective response rate of 73% and significantly improved overall survival (20.2 months) compared to those who did not receive immunotherapy (7.9 months).

The combination therapy was well tolerated, showing a safety profile consistent with previous studies, suggesting it could be a promising treatment option for T-SCLC patients, particularly those with positive PD-L1 status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A potential treatment option for transformed small-cell lung cancer on PD-L1 inhibitor-based combination therapy improved survival. Zhang, CY., Sun, H., Su, JW., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04919382

Temozolomide and Atezolizumab as Second or Third Line ... Giving temozolomide and atezolizumab as second or third line treatment may help prolong survival in patients with small cell lung cancer. Detailed Description.

2. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK601751/

Clinical Review - Atezolizumab (Tecentriq) - NCBI Health Canada has approved atezolizumab in combination with carboplatin and etoposide for the first-line treatment of adult patients with ES-SCLC. The sponsor's ...

3. cancernetwork.com cancernetwork.com/view/atezolizumab-combo-real-world-data-match-clinical-trial-efficacy-in-sclc

Atezolizumab Combo Real-World Data Match Clinical Trial ... Real-world atezolizumab plus chemotherapy data demonstrated similar efficacy compared with what the phase 3 IMpower133 trial showed.

4. tecentriq-hcp.com tecentriq-hcp.com/sclc/efficacy/clinical-trial-results.html

IMpower133 efficacy results in 1L ES-SCLC Adding TECENTRIQ® (atezolizumab) to carbo/etop significantly improved median PFS1. 5.2-month median PFS vs 4.3 months with placebo + carbo/etop (HR=0.77*; ...

5. research-studies.allinforhealth.info research-studies.allinforhealth.info/us/en/listing/11739/temozolomide-and-atezolizumab-as/

Temozolomide and Atezolizumab as Second or Third Line Givingzolomide and atezolizumab as second or third line treatment may help prolong survival inwith small cell lung cancer. PRIMARY OBJECTIVE: I.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04919382

Temozolomide and Atezolizumab as Second or Third Line ... Giving temozolomide and atezolizumab as second or third line treatment may help prolong survival in patients with small cell lung cancer. Detailed Description.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0169500225004313

Outcome of temozolomide in relapsed small cell lung cancer Temozolomide demonstrated modest clinical activity in this real-world effectiveness analysis of patients with relapsed SCLC.

8. tlcr.amegroups.org tlcr.amegroups.org/article/view/94525/html

Long-term survival after combination therapy with ... This case report describes the remarkable long-term survival of 70 months in a patient with limited stage small-cell lung cancer (LS-SCLC) following combination ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10786446/

Treating patients with platinum-sensitive extensive-stage ... The first-line standard-of-care for ES-SCLC is platinum plus etoposide, along with 1 of the immune checkpoint inhibitors atezolizumab or durvalumab.