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PARP Inhibitor

Rucaparib for Non-Small Cell Lung Cancer

Phase 2
Waitlist Available
Led By Jonathan W Riess
Research Sponsored by SWOG Cancer Research Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must not have any Grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, and myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia.
Patients must not have a >= Grade 3 hypercholesterolaemia (defined by National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v]5) within 28 days prior to sub-study registration.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of registration to a maximum of 3 years or death
Awards & highlights
No Placebo-Only Group

Summary

This trial tests how well rucaparib works to treat patients with stage IV non-small cell lung cancer that has come back or has a BRCA1/2 mutation.

Who is the study for?
This trial is for adults with stage IV or recurrent non-small cell lung cancer that have high genomic loss of heterozygosity (LOH) or harmful BRCA1/2 mutations. Participants must be able to take oral medications, not have certain liver conditions, infections, or recent major surgeries. They should not have had prior treatment with PARP inhibitors and must agree to use effective contraception if of reproductive potential.
What is being tested?
The trial is testing the effectiveness of Rucaparib, a drug designed to block enzymes needed for tumor growth in patients with specific genetic profiles related to lung cancer. It's a phase II study which means it focuses on the drug's efficacy and side effects.
What are the potential side effects?
While specific side effects for Rucaparib are not listed here, common ones from drugs like this include nausea, fatigue, low blood counts leading to increased infection risk or bleeding problems, liver function changes, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I do not have severe heart disease or recent serious heart issues.
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I do not have severe high cholesterol as defined by recent medical standards.
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I can take pills by mouth.
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My bilirubin levels are within the normal range, even with liver metastases.
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I don't have specific genetic mutations in my cancer or I've tried all standard treatments for them.
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I've had a brain scan within the last 42 days and don't have untreated brain issues.
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I do not have acute hepatitis or any active infections.
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I haven't had chemotherapy, immunotherapy, or experimental drugs in the last 21 days and have recovered from their side effects. I also haven't had radiation therapy in the last 14 days.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer can be seen on scans and has been checked within the last month.
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I have never been treated with PARP inhibitors for my condition.
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I am assigned to S1900A with specific genetic markers.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of registration to a maximum of 3 years or death
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of registration to a maximum of 3 years or death for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall Response Rate
Secondary study objectives
Duration of Response (DoR)
Investigator-Assessed Progression-Free Survival (IA-PFS)
Pharmaceutical Preparations
+1 more

Side effects data

From 2022 Phase 3 trial • 564 Patients • NCT01968213
76%
Nausea
70%
Combined Asthenia/Fatigue
52%
Fatigue
39%
Combined Anaemia and/or decreased hemoglobin
38%
Constipation
38%
Vomiting
37%
Anaemia
35%
Diarrhoea
35%
Alanine aminotransferase increased
34%
Combined ALT/AST increased
33%
Abdominal pain
31%
Dysgeusia
29%
Combined Thrombocytopenia and/or decreased platelets
27%
Aspartate aminotransferase increased
25%
Decreased appetite
23%
Asthenia
22%
Arthralgia
20%
Headache
19%
Combined Neutropenia and/or decreased ANC
19%
Photosensitivity reaction
18%
Cough
17%
Thrombocytopenia
17%
Blood creatinine increased
16%
Dyspepsia
16%
Insomnia
16%
Dizziness
15%
Pruritus
15%
Rash
15%
Dyspnoea
15%
Abdominal pain upper
15%
Back pain
15%
Pyrexia
14%
Platelet count decreased
14%
Neutropenia
13%
Abdominal distension
13%
Upper respiratory tract infection
12%
Hypertension
12%
Oedema peripheral
12%
Hypomagnesaemia
10%
Nasopharyngitis
10%
Alopecia
10%
Taste disorder
10%
Dry skin
10%
Urinary tract infection
9%
Mucosal inflammation
9%
Influenza
9%
Depression
9%
Stomatitis
9%
Erythema
8%
Neutrophil count decreased
8%
Hypercholesterolaemia
8%
Anxiety
8%
Dry mouth
8%
Weight decreased
7%
Myalgia
7%
Oropharyngeal pain
7%
White blood cell count decreased
6%
Gastrooesophageal reflux disease
6%
Influenza like illness
6%
Hot flush
6%
Neck pain
6%
Pain in extremity
6%
Blood alkaline phosphatase increased
5%
Muscle spasms
5%
Sinusitis
5%
Combined Anemia and/or low hemoglobin
1%
General physical health deterioration
1%
Incarcerated hernia
1%
Intestinal obstruction
1%
Sepsis
1%
Muscular weakness
1%
Combined Thrombocytopenia and/or low platelets
1%
Osteoarthritis
1%
Gastrointestinal pain
1%
Pulmonary embolism
1%
Febrile neutropenia
1%
Pancytopenia
1%
Small intestinal obstruction
1%
Dehydration
1%
Combined Netropenia and/or low ANC
1%
Malignant melanoma
1%
Malignant neoplasm progression
1%
Myelodysplastic syndrome
1%
Seizure
1%
Acute kidney injury
1%
Renal failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Rucaparib 600 mg Tablets
Placebo Tablets

Awards & Highlights

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 (rucaparib)Experimental Treatment1 Intervention
Patients receive rucaparib PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rucaparib
2016
Completed Phase 3
~2020

Find a Location

Who is running the clinical trial?

SWOG Cancer Research NetworkLead Sponsor
398 Previous Clinical Trials
266,538 Total Patients Enrolled
Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
261,123 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,924 Previous Clinical Trials
41,017,887 Total Patients Enrolled
1 Trials studying BRCA2 Mutation
18 Patients Enrolled for BRCA2 Mutation

Media Library

Rucaparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03845296 — Phase 2
BRCA2 Mutation Research Study Groups: Treatment (rucaparib)
BRCA2 Mutation Clinical Trial 2023: Rucaparib Highlights & Side Effects. Trial Name: NCT03845296 — Phase 2
Rucaparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03845296 — Phase 2
~10 spots leftby Nov 2025
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