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PD-1 Inhibitor

Tazemetostat + Topotecan + Pembrolizumab for Small Cell Lung Cancer

Phase 1

Waitlist Available

Led By Anish Thomas

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 70%)

Patients should be class 2B or better on the New York Heart Association Functional Classification.

Must not have

Has abnormalities known to be associated with MDS (e.g. del 5q, chromosome [chr] 7 abnormality [abn]) and myeloproliferative neoplasm (MPN) (e.g. JAK2 V617F) observed in cytogenetic testing and deoxyribonucleic acid (DNA) sequencing

Has a prior history of T-cell lymphoblastic lymphoma (T-LBL) or T-cell acute leukemia (T-ALL)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of drugs to treat small cell lung cancer that has come back after a period of treatment. The drugs work in different ways to stop the growth of tumor cells. The combination of these drugs may shrink or stabilize the cancer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include reactions related to immune system activation, such as inflammation in organs, infusion-related reactions, fatigue, digestive issues like nausea or diarrhea, blood disorders that could affect clotting or immunity levels.

Eligibility Criteria

Inclusion Criteria

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

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

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

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I am 18 years old or older.

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My hepatitis B virus load is undetectable with treatment.

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

Exclusion Criteria

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

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My tests show genetic changes linked to MDS or MPN.

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

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

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

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I have recovered from side effects of previous cancer treatments.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 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

Incidence of adverse events (expansion cohort)

Secondary study objectives

Duration of response

Overall response rate

Overall survival

+1 more

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999

64%

Radiation skin injury

63%

Stomatitis

58%

Anaemia

56%

Nausea

48%

Dry mouth

45%

Constipation

45%

Weight decreased

44%

Dysphagia

42%

Neutrophil count decreased

33%

Dysgeusia

33%

Vomiting

32%

Fatigue

31%

White blood cell count decreased

28%

Hypomagnesaemia

26%

Decreased appetite

25%

Hypothyroidism

25%

Hypokalaemia

24%

Lymphocyte count decreased

24%

Platelet count decreased

23%

Oropharyngeal pain

23%

Blood creatinine increased

22%

Diarrhoea

22%

Odynophagia

20%

Hypoacusis

20%

Alanine aminotransferase increased

20%

Hyponatraemia

19%

Tinnitus

19%

Oral candidiasis

19%

Asthenia

16%

Pyrexia

16%

Cough

15%

Aspartate aminotransferase increased

15%

Rash

14%

Insomnia

13%

Acute kidney injury

13%

Pharyngeal inflammation

13%

Pruritus

12%

Dysphonia

12%

Gamma-glutamyltransferase increased

11%

Pneumonia

11%

Dehydration

10%

Hyperthyroidism

10%

Hypoalbuminaemia

10%

Hypocalcaemia

10%

Headache

10%

Productive cough

Neck pain

Peripheral sensory neuropathy

Gastrooesophageal reflux disease

Hiccups

Hyperglycaemia

Hyperuricaemia

Dizziness

Hypophosphataemia

Urinary tract infection

Ear pain

Localised oedema

Hyperkalaemia

Erythema

Oral pain

Abdominal pain upper

Arthralgia

Anxiety

Febrile neutropenia

Dyspepsia

Saliva altered

Back pain

Oedema peripheral

Hypertension

Dyspnoea

Nasopharyngitis

Alopecia

Dry skin

Sepsis

Pneumonia aspiration

Trismus

Pneumonitis

Laryngeal oedema

Malnutrition

Pharyngeal haemorrhage

Cellulitis

Septic shock

Systemic infection

Clostridium difficile colitis

Cardiac arrest

Death

Bronchitis

Hepatitis

Immune-mediated hepatitis

Oesophagitis

General physical health deterioration

Hypophagia

Tumour haemorrhage

Cerebrovascular accident

Syncope

Acute respiratory failure

Aspiration

Colitis

Mouth haemorrhage

Hypersensitivity

Acute myocardial infarction

Abscess neck

Device related infection

Stoma site infection

Vascular device infection

Wound infection

Hypercalcaemia

Pulmonary embolism

Respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Pembrolizumab + CRT Followed by Pembrolizumab

Placebo + CRT Followed by Placebo

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: 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Topotecan Hydrochloride

2013

Completed Phase 3

~6270

Biopsy

2014

Completed Phase 4

~1150