Niraparib for Stage III Lung Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Stage III Lung Cancer+5 MoreNiraparib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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

Eligible Conditions
  • Stage III Lung Cancer
  • Stage IIIA Lung Cancer
  • Small Cell Lung Cancer
  • Stage IIIB Lung Cancer
  • Neuroendocrine Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: From the start of study treatment to the date of death by any cause, assessed up to 5 years

At 12 weeks
12-week disease control rate
At 3 months
Objective response rate (ORR)
Year 5
Overall survival (OS)
Month 6
6-month Progression free survival (PFS)
Month 12
Progression free survival
Day 90
Incidence of adverse events (AEs)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Stage 1 (Cohort 2): Niraparib + Pembrolizumab
57%Nausea
52%Decreased appetite
48%Anaemia
48%Constipation
43%Fatigue
38%Dyspnoea
24%Oedema peripheral
24%Vomiting
24%Stomatitis
24%Platelet count decreased
19%Insomnia
19%Blood alkaline phosphatase increased
19%Arthralgia
19%Pruritus
14%Pneumonia
14%Diarrhoea
14%Cough
14%Pain
14%Chills
14%Upper respiratory tract infection
14%Weight decreased
14%Neutrophil count decreased
14%Dysgeusia
14%Back pain
14%Muscular weakness
10%Depression
10%Erythema
10%Vision blurred
10%Pleural effusion
10%Atrial fibrillation
10%Neuropathy peripheral
10%Haemorrhoids
10%Haemorrhoidal haemorrhage
10%Anxiety
10%Proctalgia
10%Oropharyngeal pain
10%Wheezing
10%Non-cardiac chest pain
10%Productive cough
10%Gait disturbance
10%Chest pain
10%Urinary tract infection
10%Hypophosphataemia
10%Aspartate aminotransferase increased
10%Dehydration
10%Blood creatinine increased
10%Hypokalaemia
10%Lymphocyte count decreased
10%Alanine aminotransferase increased
10%Rash maculo-papular
10%Pain of skin
10%Overdose
10%Hypothyroidism
5%Angina pectoris
5%Dizziness
5%Sepsis
5%Dysphonia
5%Sinus tachycardia
5%Neuroendocrine carcinoma of the skin
5%Gastrooesophageal reflux disease
5%Candida infection
5%Fall
5%Pulmonary embolism
5%Pneumonitis
5%Respiratory failure
5%Cardiac arrest
5%Pericardial effusion
5%Intestinal obstruction
5%Lactic acidosis
5%Diverticulitis
5%Lethargy
5%Headache
5%Cancer pain
5%Toxicity to various agents
5%Abdominal pain
5%Haematochezia
5%Nasal congestion
5%Asthenia
5%Pyrexia
5%Malaise
5%Hypomagnesaemia
5%Hyponatraemia
5%Amylase increased
5%Hepatic enzyme increased
5%Peripheral sensory neuropathy
5%Pain in extremity
5%Hyperhidrosis
5%Tachycardia
5%Contusion
5%Hypotension
5%Lipase increased
5%Syncope
5%Hyperglycaemia
This histogram enumerates side effects from a completed 2021 Phase 2 trial (NCT03308942) in the Stage 1 (Cohort 2): Niraparib + Pembrolizumab ARM group. Side effects include: Nausea with 57%, Decreased appetite with 52%, Anaemia with 48%, Constipation with 48%, Fatigue with 43%.

Trial Design

1 Treatment Group

Treatment (niraparib, dostarlimab)
1 of 1

Experimental Treatment

48 Total Participants · 1 Treatment Group

Primary Treatment: Niraparib · No Placebo Group · Phase 2

Treatment (niraparib, dostarlimab)Experimental Group · 2 Interventions: Dostarlimab, Niraparib · Intervention Types: Biological, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Niraparib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from the start of study treatment to the date of death by any cause, assessed up to 5 years

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,805 Previous Clinical Trials
1,790,331 Total Patients Enrolled
Carl M Gay, MD,PHDPrincipal InvestigatorM.D. Anderson Cancer Center

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have unresected or locally advanced small cell lung cancer (Cohort 1) or high-grade neuroendocrine carcinoma (Cohort 2) confirmed by staff pathologist.
Patients must have had at least one prior line of systemic therapy directed at their malignancy.
Participants must have an ECOG performance status of =< 1.
You are eligible if you are between the ages of 18 and 65.