Tazemetostat + Topotecan + Pembrolizumab for Small Cell Lung Cancer

Recruiting in Palo Alto (17 mi)

+14 other locations

Overseen ByAnish Thomas

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This phase I trial tests the safety, side effects, and best dose of tazemetostat in combination with topotecan and pembrolizumab in treating patients with small cell lung cancer that has come back after a period of improvement (recurrent). Tazemetostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving tazemetostat in combination with topotecan and pembrolizumab may shrink or stabilize recurrent small cell lung cancer.

Eligibility Criteria

Adults with recurrent small cell lung cancer who've had platinum-based chemotherapy can join. They must have measurable disease, stable brain metastases if present, and adequate organ function. HIV-positive patients on effective therapy are eligible. Participants need to use contraception and cannot be pregnant or breastfeeding.

Inclusion Criteria

I am mostly self-sufficient and can carry out daily activities.

My heart condition allows me to perform daily activities with slight limitations.

I am 18 years old or older.

My hepatitis B virus load is undetectable with treatment.

I had hepatitis C but am cured, or I'm being treated with an undetectable viral load.

Exclusion Criteria

My tests show genetic changes linked to MDS or MPN.

I have had T-cell lymphoblastic lymphoma or T-cell acute leukemia in the past.

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

I have had pneumonitis treated with steroids or have it now.

I have recovered from side effects of previous cancer treatments.

I have severe blood cell count issues or a history of certain blood cancers.

Participant Groups

The trial is testing the combination of Tazemetostat (an enzyme inhibitor), Topotecan (chemotherapy), and Pembrolizumab (immunotherapy) to see if it's safe and effective for treating recurrent small cell lung cancer by targeting tumor growth in various ways.

1Treatment groups

Experimental Treatment

Group I: Treatment (tazemetostat, pembrolizumab, topotecan)Experimental Treatment6 Interventions

Patients receive tazemetostat PO BID on days 1-21, pembrolizumab IV over 30 minutes on day 1, and topotecan IV over 30 minutes on days 1-5. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan throughout the study and may also undergo biopsy and collection of blood on study.

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

🇺🇸 Approved in United States as KEYTRUDA for: