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Monoclonal Antibodies

Niraparib + Dostarlimab for Small Cell Lung Cancer

Phase 2

Waitlist Available

Led By Carl M Gay, MD,PHD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

>= 45 years of age and has not had menses for > 1 year

Patients must have had at least one prior line of systemic therapy directed at their malignancy

Must not have

Participant must not have any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)

Participant must not have previously received a simultaneous combination of PARP inhibitor and immune checkpoint blockade (immunotherapy)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the start of study treatment to the date of death by any cause, assessed up to 5 years

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is testing the combination of two drugs, niraparib and dostarlimab, to treat small cell lung cancer and other high-grade neuroendocrine carcinomas. Niraparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. Immunotherapy with monoclonal antibodies, such as dostarlimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and

Who is the study for?

Adults with small cell lung cancer or high-grade neuroendocrine carcinomas who've had at least one prior treatment can join. They must be generally healthy, not pregnant, and agree to contraception. Excluded are those with certain infections, recent major surgery, known allergies to trial drugs, brain metastases, autoimmune diseases requiring recent treatment, a second cancer within the last two years, or severe blood disorders from past treatments.

What is being tested?

The trial is testing niraparib (a PARP inhibitor that blocks cancer cells' DNA repair) combined with dostarlimab (an immunotherapy antibody). It's for patients whose disease didn't respond well to initial treatments. The study aims to see if this combination helps control the disease better than existing therapies.

What are the potential side effects?

Possible side effects include allergic reactions to drug components, immune system-related issues due to immunotherapy which could affect various organs and functions in the body. Blood-related side effects like anemia or clotting problems may occur due to interference with DNA repair in normal cells.

Eligibility Criteria

Inclusion Criteria

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

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I am over 45 and have not had a period for more than a year.

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I have received at least one treatment for my cancer.

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I am 18 years old or older.

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My kidney function, measured by creatinine levels, is within the normal range.

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I have received radiation therapy to my pelvic area.

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I have either advanced small cell lung cancer or high-grade neuroendocrine carcinoma.

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I am fully active or have some restrictions but can still care for myself.

Exclusion Criteria

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

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I have never been diagnosed with MDS or AML.

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I have never been treated with both PARP inhibitors and immunotherapy at the same time.

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I haven't had any cancer other than skin or treated cervical cancer in the last 2 years.

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I have never had interstitial lung disease.

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I haven't had significant radiation therapy affecting my bone marrow recently.

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I have an autoimmune disease but haven't needed strong medication for it in the last 2 years.

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I do not have any serious health issues that are not under control.

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I have active hepatitis B or C.

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I am not allergic to niraparib or dostarlimab.

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I have not received a live vaccine in the last 14 days.

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I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.

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I had a severe reaction to previous immunotherapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the start of study treatment to the date of death by any cause, assessed up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the start of study treatment to the date of death by any cause, assessed up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the start of study treatment to the date of death by any cause, assessed up to 5 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

6-month Progression free survival (PFS)

Objective response rate (ORR)

Secondary study objectives

12-week disease control rate

Incidence of adverse events (AEs)

Overall survival (OS)

+1 more

Side effects data

From 2022 Phase 2 trial • 37 Patients • NCT03207347

74%

Fatigue

52%

Nausea

39%

Constipation

39%

Anorexia

30%

Anemia

30%

Alkaline phosphatase increased

26%

Weight loss

22%

Dizziness

22%

Insomnia

22%

Dyspnea

22%

Abdominal pain

17%

Headache

17%

Mucositis oral

17%

Platelet count decreased

17%

Creatinine increased

13%

Vomiting

13%

Rash maculo-papular

13%

Aspartate aminotransferase increased

13%

Sinus tachycardia

Urinary tract infection

Cough

Dehydration

Dry mouth

Hypertension

Non-cardiac chest pain

Alanine aminotransferase increased

Anxiety

Blood bilirubin increased

Back pain

Postnasal drip

Hoarseness

Hypotension

Hot flashes

Peripheral sensory neuropathy

Hyperkalemia

Head injury

Hypokalemia

Hyponatremia

Flu like symptoms

Skin tear

Hyperglycemia

Neutrophil count decreased

Tremor

Bruising

Esophageal ulcer

Diarrhea

Depression

Itchy eyes

Oral petechia

Edema limbs

Upper respiratory infection

Leukocytosis

White blood cell decreased

Lung infection

Bloating

Unknown infection

Hematuria

Ascites

Sinus pain

Sore throat

Syncope

100%

80%

60%

40%

20%

Study treatment Arm

Cohort A

Cohort B

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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 (niraparib, dostarlimab)Experimental Treatment2 Interventions

Patients receive niraparib PO QD on days 1-21 of cycles 1-4, and on days 1-42 of subsequent cycles. Patients also receive dostarlimab IV over 30 minutes on day 1. Cycles repeat every 21 days for cycles 1-4 and every 42 days for subsequent cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dostarlimab

FDA approved

Niraparib

FDA approved

0 / 19Eligibility criteria met