← Back to Search

PARP Inhibitor

Niraparib + Osimertinib for Lung Cancer

Phase 1

Recruiting

Led By Zofia Piotrowska, MD, MPH

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

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

Must have

Participants must have access to commercial osimertinib

Presence of evaluable disease, either measure or non-measurable, in accordance with RECIST 1.1 criteria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is testing a new combination therapy for a specific type of lung cancer.

Who is the study for?

This trial is for adults with stage IV lung cancer that has a specific mutation (EGFR). They must have seen their cancer progress after treatment with osimertinib, but haven't had PARP inhibitors before. Participants need to be able to take pills and not be breastfeeding or planning pregnancy; they should use birth control during the study. People can't join if they're in another clinical trial, recently had major surgery, have untreated brain metastases, serious heart issues, other active cancers or certain blood disorders.Check my eligibility

What is being tested?

The study tests combining two drugs—Niraparib and Osimertinib—as a potential treatment for advanced lung cancer with EGFR mutations. Patients who've progressed on osimertinib will add Niraparib to see if it helps control the cancer better than osimertinib alone.See study design

What are the potential side effects?

Possible side effects include nausea, fatigue, low blood cell counts leading to increased infection risk or bleeding problems, high blood pressure and shortness of breath. There may also be risks related to liver function changes and allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

Select...

I can get osimertinib through a commercial source.

Select...

My cancer can be measured or observed for changes.

Select...

I have never been treated with PARP inhibitors.

Select...

I am 18 years old or older.

Select...

My blood counts and liver/kidney functions are within normal ranges.

Select...

I am mostly able to carry out my daily activities.

Select...

I can swallow pills without any issues.

Select...

My stage IV NSCLC has an EGFR mutation, confirmed by a lab test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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

Maximum Tolerated Dose of Niraparib

Secondary outcome measures

Median Progression Free Survival time of Niraparib

Objective response rate of niraparib

Rate of toxicity of combined niraparib and osimertinib

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%

Abdominal pain

22%

Dyspnea

22%

Dizziness

22%

Insomnia

17%

Headache

17%

Platelet count decreased

17%

Mucositis oral

17%

Creatinine increased

13%

Sinus tachycardia

13%

Rash maculo-papular

13%

Aspartate aminotransferase increased

13%

Vomiting

Anxiety

Alanine aminotransferase increased

Dehydration

Blood bilirubin increased

Urinary tract infection

Dry mouth

Back pain

Cough

Hypertension

Non-cardiac chest pain

Esophageal ulcer

Skin tear

Diarrhea

Flu like symptoms

Leukocytosis

Oral petechia

Sinus pain

Syncope

Bruising

Unknown infection

Ascites

Itchy eyes

Hoarseness

Peripheral sensory neuropathy

Sore throat

Upper respiratory infection

Depression

Edema limbs

Neutrophil count decreased

Lung infection

White blood cell decreased

Hypotension

Hyponatremia

Head injury

Hypokalemia

Hyperkalemia

Postnasal drip

Bloating

Hot flashes

Hyperglycemia

Hematuria

Tremor

100%

80%

60%

40%

20%

Study treatment Arm

Cohort A

Cohort B

Trial Design

1Treatment groups

Experimental Treatment

Group I: Niraparib + OsimertinibExperimental Treatment2 Interventions

Niraparib will be administered orally once daily Osimertinib will be administered by mouth once daily

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Niraparib

FDA approved

Osimertinib

FDA approved

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Tesaro, Inc.Industry Sponsor

56 Previous Clinical Trials

10,526 Total Patients Enrolled

Massachusetts General HospitalLead Sponsor

2,933 Previous Clinical Trials

13,198,451 Total Patients Enrolled

Zofia Piotrowska, MD, MPHPrincipal Investigator - Dana-Farber Cancer Institute

Massachusetts General Hospital, North Shore Cancer Center

Yale University School Of Medicine (Medical School)

Media Library

Lung Cancer Clinical Trial 2023: Niraparib Highlights & Side Effects. Trial Name: NCT03891615 — Phase 1

Frequently Asked Questions

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

Could you elucidate the potential risks of using Niraparib?

"There is limited evidence suggesting the safety and efficacy of Niraparib, so it earned a score of 1."

Answered by AI

What medical conditions is Niraparib commonly employed to treat?

"Niraparib has proven to be a successful treatment for primary peritoneal cancer, fallopian tube carcinoma, and other forms of the disease."

Answered by AI

Could you please elaborate on earlier investigations involving Niraparib?

"Currently, Niraparib is the focus of 199 clinical investigations. 30 of these are at Phase 3 and they all originate from Washington D.C.. Nonetheless, there are 7516 different medical centres worldwide trialling this medication."

Answered by AI

Is this a pioneering trial within its field?

"Research into niraparib began in 2013, with a study sponsored by AstraZeneca. After the initial 603-person trial was completed, Phase 1&2 drug approval were granted. In 2021 there are 199 clinical trials conducted across 56 countries and 1289 cities that feature niraparib."

Answered by AI

Is recruitment still taking place for this research endeavor?

"Affirmative. Clinicaltrials.gov's records indicate that recruitment for this clinical trial has been ongoing since June 6th 2019 and the listing was last updated on December 14th 2020. Presently, 30 patients are required to join from 3 different sites."

Answered by AI

What is the quota for enrolment in this medical experiment?

"Affirmative. Clinicaltrials.gov unveils that the trial, initially posted on June 6th 2019 and modified lastly on December 14th 2020, is currently accepting participants. 30 individuals from 3 locations are expected to join this research study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Niraparib in Combination With Osimertinib in EGFR-Mutated Advanced Lung Cancer

Zofia Piotrowska 2019. "Niraparib in Combination With Osimertinib in EGFR-Mutated Advanced Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03891615.

All > Lung Cancer Boston