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Rucaparib + Pembrolizumab for Lung Cancer
Phase 1 & 2
Waitlist Available
Led By Nithya Ramnath, MBBS
Research Sponsored by University of Michigan Rogel Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have a histologically confirmed diagnosis of stage IV non-squamous NSCLC without specific mutations or rearrangements and with at least one measurable lesion based on RECIST v1.1
Have a performance status of 0 or 1 on the ECOG Performance Scale
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing a new combination therapy for stage IV non-squamous non-small cell lung cancer. The trial will assess the safety and efficacy of the new therapy and will compare it to the standard of care.
Who is the study for?
This trial is for adults with stage IV non-squamous NSCLC who've had no disease progression after initial treatment. They must be able to use contraception, have good organ function and performance status, and a life expectancy over 3 months. Excluded are those with prior PD-1/PD-L1 therapy, active autoimmune diseases or infections, certain psychiatric disorders, pregnancy/breastfeeding intentions within the study period.Check my eligibility
What is being tested?
The trial tests oral rucaparib combined with intravenous pembrolizumab as maintenance therapy post-induction with carboplatin/pemetrexed/pembrolizumab in patients without progressive disease. It's a single-arm Phase I/II study evaluating safety and effectiveness of this combination.See study design
What are the potential side effects?
Potential side effects include immune-related reactions due to pembrolizumab (like inflammation in organs), fatigue, nausea from rucaparib; blood count changes from carboplatin; and skin reactions or kidney issues from pemetrexed.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung cancer is advanced, without certain genetic changes, and can be measured.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
Median duration of time from start of treatment to time of progression
Secondary outcome measures
Median duration of time from the start of treatment until death
Response rate
Side effects data
From 2022 Phase 3 trial • 564 Patients • NCT0196821376%
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%
Anxiety
8%
Neutrophil count decreased
8%
Hypercholesterolaemia
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%
Incarcerated hernia
1%
General physical health deterioration
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
Trial Design
1Treatment groups
Experimental Treatment
Group I: Rucaparib and Pembrolizumab MaintenanceExperimental Treatment4 Interventions
All patients will receive induction therapy with Pembrolizumab (200mg IV on day 1 of every 21 days), Pemetrexed (500mg/m^2 IV on day 1 of every 21 days), and Carboplatin (AUC5 IV on day 1 of every 21 days).
This will be followed by maintenance therapy with Pembrolizumab (200mg IV on day 1 of every 21 days) and Rucaparib (600mg PO BID days 1-21 of each 21 day cycle).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Pemetrexed
FDA approved
Carboplatin
FDA approved
Rucaparib
FDA approved
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,528 Total Patients Enrolled
Clovis Oncology, Inc.Industry Sponsor
64 Previous Clinical Trials
11,646 Total Patients Enrolled
University of Michigan Rogel Cancer CenterLead Sponsor
293 Previous Clinical Trials
24,072 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not received a live vaccine in the last 30 days.I had cancer before, but it's been treated and hasn't come back in over 5 years.I take more than 10mg of prednisone or equivalent daily for another condition.I have been treated for an autoimmune disease in the last 2 years.I have an immunodeficiency or have been on steroids or immunosuppressants within the last week.My organs are functioning well.I will use effective birth control during and for 6 months after the study.I received comfort-focused radiation therapy within the last week.I have been treated with drugs targeting the immune system for cancer.I have cancer that has spread to my brain or spinal cord.I am currently being treated for an infection.My lung cancer is advanced, without certain genetic changes, and can be measured.I have enough tissue available for further study.I do not take more than 10mg of prednisone or its equivalent daily.I have lung issues that needed steroids for treatment.I am fully active or restricted in physically strenuous activity but can do light work.I have an active Hepatitis B or C infection.I have had lung radiation of more than 30Gy within the last 6 months.I am a man who can father a child and will use birth control during and for 6 months after the study.I have an active tuberculosis infection.I have had treatment for stage IV non-small cell lung cancer.I have been treated with a PARP inhibitor before.
Research Study Groups:
This trial has the following groups:- Group 1: Rucaparib and Pembrolizumab Maintenance
Awards:
This trial has 3 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- 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.
Are there any reports on the efficacy of Rucaparib in prior studies?
"Presently, there is an abundance of medical studies involving Rucaparib with 1624 still active trials; 331 of which are at Phase 3. Notable locations for these investigations include Columbus, Ohio and the remaining 76904 sites around the world."
Answered by AI
Is the enrollment process currently open to participants?
"Affirmative. Clinicaltrials.gov data confirms that this experiment is actively open for enrollment and was initially posted on December 24th 2018 with the most recent update issued October 6th 2022. 55 volunteers are required to be sourced from 3 distinct clinical sites."
Answered by AI
What therapeutic conditions is Rucaparib typically employed to address?
"Rucaparib is a commonly used pharmaceutical intervention for treating malignant neoplasms. However, it has also been demonstrated to have efficacy in reducing the severity of unresectable melanoma, microsatellite instability high, and locally advanced nonsquamous non-small cell lung cancer."
Answered by AI
What is the overall participation rate of this clinical trial?
"This clinical trial necessitates the enrollment of 55 volunteers that meet its inclusion criteria. Potential participants can be sourced from Ohio State University Comprehensive Cancer Center (Columbus, OH) and The University of Michigan Rogel Cancer Center (Ann Arbor, MI)."
Answered by AI
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