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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
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
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 belowSelect...
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.
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
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 moreSide effects data
From 2022 Phase 2 trial • 37 Patients • NCT0320734774%
Fatigue
52%
Nausea
39%
Constipation
39%
Anorexia
30%
Anemia
30%
Alkaline phosphatase increased
26%
Weight loss
22%
Dyspnea
22%
Abdominal pain
22%
Dizziness
22%
Insomnia
17%
Headache
17%
Platelet count decreased
17%
Mucositis oral
17%
Creatinine increased
13%
Sinus tachycardia
13%
Vomiting
13%
Rash maculo-papular
13%
Aspartate aminotransferase increased
9%
Anxiety
9%
Alanine aminotransferase increased
9%
Dehydration
9%
Blood bilirubin increased
9%
Urinary tract infection
9%
Dry mouth
9%
Back pain
9%
Cough
9%
Hypertension
9%
Non-cardiac chest pain
4%
Esophageal ulcer
4%
Skin tear
4%
Diarrhea
4%
Edema limbs
4%
Leukocytosis
4%
Syncope
4%
Head injury
4%
Oral petechia
4%
Sinus pain
4%
Unknown infection
4%
Ascites
4%
Bruising
4%
Itchy eyes
4%
Flu like symptoms
4%
Hoarseness
4%
Peripheral sensory neuropathy
4%
Sore throat
4%
Upper respiratory infection
4%
Neutrophil count decreased
4%
Lung infection
4%
White blood cell decreased
4%
Hypotension
4%
Hyponatremia
4%
Hypokalemia
4%
Depression
4%
Postnasal drip
4%
Hyperkalemia
4%
Bloating
4%
Hot flashes
4%
Hyperglycemia
4%
Hematuria
4%
Tremor
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort A
Cohort B
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
2,966 Previous Clinical Trials
1,804,733 Total Patients Enrolled
Carl M Gay, MD,PHDPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am over 45 and have not had a period for more than a year.I don't have active brain cancer symptoms and any previous brain cancer has been treated and is stable.I am not pregnant and agree to use birth control during and after the study, or I cannot become pregnant.I have never been diagnosed with MDS or AML.I have never been treated with both PARP inhibitors and immunotherapy at the same time.Your blood clotting tests need to be within a certain range, unless you are already taking medication to prevent blood clots.I agree not to donate blood during the study or for 90 days after the last treatment.I haven't taken part in any experimental drug studies in the last 4 weeks.I haven't had any cancer other than skin or treated cervical cancer in the last 2 years.Your total bilirubin level should be less than or equal to 1.5 times the upper limit of normal, or less than or equal to 2.0 times the upper limit of normal if you have Gilbert's syndrome. Your direct bilirubin level should be less than or equal to 1 time the upper limit of normal.I have had a hysterectomy, both ovaries removed, or my tubes tied, with documentation.I have never had interstitial lung disease.I haven't had significant radiation therapy affecting my bone marrow recently.I have had severe blood-related side effects from my last chemotherapy that lasted more than 4 weeks.I have an autoimmune disease but haven't needed strong medication for it in the last 2 years.I have received at least one treatment for my cancer.I do not have any serious health issues that are not under control.I have active hepatitis B or C.I haven't had major surgery in the last 3 weeks and have recovered from any surgery effects.I am not allergic to niraparib or dostarlimab.You have enough white blood cells called neutrophils in your body.I am 18 years old or older.I have not received a live vaccine in the last 14 days.Your platelet count is at least 100,000 per microliter.My kidney function, measured by creatinine levels, is within the normal range.Your liver enzymes (AST and ALT) should not be more than 2.5 times the upper limit of normal, unless you have cancer that has spread to your liver, in which case they should not be more than 5 times the upper limit of normal.Your hemoglobin level is 9 grams per deciliter or higher.Women who have not had their period for less than 2 years and have not had surgery to remove their uterus and ovaries must have a specific hormone level to be eligible for the study.I have received radiation therapy to my pelvic area.I am HIV positive, on treatment, and my viral load is undetectable.I have either advanced small cell lung cancer or high-grade neuroendocrine carcinoma.I haven't taken any colony-stimulating factors in the last 4 weeks.I've been on a stable dose of corticosteroids equivalent to 10 mg of prednisone or less for at least 4 weeks.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I had a severe reaction to previous immunotherapy.I haven't had a blood transfusion in the last 4 weeks.I am fully active or have some restrictions but can still care for myself.I agree to use birth control from the first to 180 days after the last treatment dose.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (niraparib, dostarlimab)
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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