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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
Participant must have unresected or locally advanced small cell lung cancer (Cohort 1) or high-grade neuroendocrine carcinoma (Cohort 2) confirmed by staff pathologist. High-grade neuroendocrine carcinoma of prostate (e.g. aggressive variant prostate cancer, small cell of prostate, etc.) are excluded
Patients must have had at least one prior line of systemic therapy directed at their malignancy
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

Study 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.Check my eligibility
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.See study design
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 have either advanced small cell lung cancer or high-grade neuroendocrine carcinoma.
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I have received at least one treatment for my cancer.
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I am fully active or have some restrictions but can still care for myself.
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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've been on a stable dose of corticosteroids equivalent to 10 mg of prednisone or less for at least 4 weeks.
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I agree not to donate blood during the study or for 90 days after the last treatment.
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I am not pregnant and agree to use birth control during and after the study, or I cannot become pregnant.
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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 had a hysterectomy, both ovaries removed, or my tubes tied, with documentation.
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I have received radiation therapy to my pelvic area.
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I agree to use birth control from the first to 180 days after the last treatment dose.
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I am HIV positive, on treatment, and my viral load is undetectable.

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
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
6-month Progression free survival (PFS)
Objective response rate (ORR)
Secondary outcome measures
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%
Alkaline phosphatase increased
30%
Anemia
26%
Weight loss
22%
Dyspnea
22%
Abdominal pain
22%
Dizziness
22%
Insomnia
17%
Headache
17%
Creatinine increased
17%
Platelet count decreased
17%
Mucositis oral
13%
Sinus tachycardia
13%
Vomiting
13%
Aspartate aminotransferase increased
13%
Rash maculo-papular
9%
Back pain
9%
Urinary tract infection
9%
Dehydration
9%
Blood bilirubin increased
9%
Anxiety
9%
Alanine aminotransferase increased
9%
Dry mouth
9%
Cough
9%
Hypertension
9%
Non-cardiac chest pain
4%
Neutrophil count decreased
4%
Edema limbs
4%
Esophageal ulcer
4%
Depression
4%
Hyperkalemia
4%
Hypokalemia
4%
Lung infection
4%
Sore throat
4%
Skin tear
4%
Unknown infection
4%
Ascites
4%
Bruising
4%
Leukocytosis
4%
White blood cell decreased
4%
Syncope
4%
Itchy eyes
4%
Hyponatremia
4%
Flu like symptoms
4%
Postnasal drip
4%
Hypotension
4%
Hoarseness
4%
Sinus pain
4%
Bloating
4%
Diarrhea
4%
Head injury
4%
Oral petechia
4%
Peripheral sensory neuropathy
4%
Hot flashes
4%
Hyperglycemia
4%
Hematuria
4%
Upper respiratory infection
4%
Tremor
100%
80%
60%
40%
20%
0%
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

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,939 Previous Clinical Trials
1,774,045 Total Patients Enrolled
Carl M Gay, MD,PHDPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Dostarlimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04701307 — Phase 2
Lung Cancer Research Study Groups: Treatment (niraparib, dostarlimab)
Lung Cancer Clinical Trial 2023: Dostarlimab Highlights & Side Effects. Trial Name: NCT04701307 — Phase 2
Dostarlimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04701307 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which pathologies could potentially benefit from Niraparib therapy?

"Niraparib is the primary agent used to treat peritoneal cancer, but it can also provide relief for people suffering from advanced dmmr endometrial cancer,cancer that has worsened following platinum-based chemotherapy, and fallopian tube cancer."

Answered by AI

What dangers are associated with using Niraparib as a treatment?

"Niraparib has been evaluated and assigned a safety rating of 2 on the 1-3 scale, as this is only in Phase 2. Thus far clinical data supports its safety but not yet efficacy."

Answered by AI

What is the main aim of this medical experiment?

"The primary assessment for this trial is Progression Free Survival (PFS) at 3 months, which will be measured using the RECIST v.1.1 criteria and Kaplan-Meier method to generate confidence intervals of 25th percentile, median, 75th percentile. Secondary outcomes include PFS and Overall Survival estimated over 6 month and 12 month periods along with a Disease Control Rate assessed after 12 weeks of treatment initiation."

Answered by AI

Are there still spots available for this research endeavor?

"Affirmative, the information on clinicaltrials.gov states that this investigation is actively seeking participants. This research was initially advertised on February 1st 2021 and has been revised as recently as September 30th 2021. Right now, 48 individuals need to be enrolled from one medical institution."

Answered by AI

To what magnitude is enrollment for this trial expanding?

"Affirmative. According to the clinicaltrials.gov data, this medical research is currently recruiting participants; it was launched on February 1st 2021 and most recently updated on September 30th 2021. They are searching for 48 individuals at a single medical facility."

Answered by AI

What prior investigations were conducted in relation to Niraparib?

"Currently, there are 115 trials ongoing researching the effects of Niraparib. 14 of those studies have advanced to Phase 3 and were launched from Washington D.C., but there exist 3321 locations conducting this investigation worldwide."

Answered by AI
~14 spots leftby May 2025