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Alkylating Agent
Olaparib + Durvalumab + Chemotherapy/Radiation for Small Cell Lung Cancer
Phase 1 & 2
Recruiting
Led By Marcelo V Negrao
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
ALT and AST =< 2.5 x institutional ULN, unless liver metastases are present in which case they must be =< 5 x ULN
Body weight > 30 kg
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study Summary
This trialinvestigates if olaparib & durvalumab, in combination with chemo/radiation, can treat patients with ES-SCLC. PARP inhibitors & immunotherapy may help stop tumor growth, while chemo & radiation kill tumor cells.
Who is the study for?
This trial is for adults with extensive-stage small cell lung cancer (ES-SCLC) who haven't had treatment yet. They should have at least one lesion visible on a CT scan, be in good physical condition (ECOG 0-1), weigh over 30 kg, and agree to use two effective forms of contraception if sexually active. People can't join if they've used certain medications recently, have uncontrolled heart conditions or other serious health issues, are pregnant or breastfeeding, or have allergies to the drugs being tested.Check my eligibility
What is being tested?
The PRIO trial is testing how well patients with ES-SCLC respond to a combination of olaparib and durvalumab along with carboplatin and etoposide chemotherapy and/or radiation therapy. Olaparib inhibits DNA repair in tumor cells while durvalumab helps the immune system attack cancer. The study aims to see if this combo can improve outcomes for these patients.See study design
What are the potential side effects?
Possible side effects include nausea, fatigue, blood count changes leading to increased infection risk or bleeding problems, potential liver function changes indicated by altered lab tests, allergic reactions to medication components, as well as specific risks associated with immunotherapy such as inflammation of organs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver enzymes are within the required limits for the trial.
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My body weight is over 30 kg.
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I am a male and will use a condom and not donate sperm.
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I haven't received any systemic therapy for small cell lung cancer.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My small cell lung cancer is at stage IV, with extensive lung nodules or large tumor volume.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of dose limiting toxicity
Secondary outcome measures
Intra- and extra-thoracic recurrence rates
Overall response rate (ORR)
Overall survival (OS)
+1 moreSide effects data
From 2022 Phase 2 trial • 80 Patients • NCT0301512965%
Fatigue
63%
Abdominal pain
55%
Diarrhea
43%
Pain
40%
Weight loss
35%
Hypertension
30%
Constipation
30%
Anorexia
28%
Nausea
28%
Pruritus
25%
Vomiting
20%
Dyspnea
20%
Urinary tract infection
18%
Rash maculo-papular
15%
Back pain
15%
Cough
15%
Abdominal Pain
15%
Weight gain
15%
Increased Urinary Frequency
13%
Arthralgia
10%
Anxiety
10%
Bladder infection
10%
Dizziness
10%
Nasal congestion
10%
Vaginal discharge
8%
Edema limbs
8%
Fever
8%
Anal pain
8%
Dry skin
8%
Colitis
8%
Thromboembolic event
8%
Dry mouth
8%
Flatulence
8%
Headache
8%
Hot flashes
8%
Myalgia
8%
Urinary tract pain
8%
Urinary frequency
8%
Small intestinal obstruction
5%
Anemia
5%
Ascites
5%
Confusion
5%
Pneumonitis
5%
Sinus bradycardia
5%
Renal and urinary disorders - Other, specify
5%
Adrenal insufficiency
5%
Memory impairment
5%
Vaginal hemorrhage
5%
Hypomagnesemia
5%
Upper respiratory infection
5%
Mucositis oral
5%
Rash acneiform
5%
Urinary urgency
5%
Gastroesophageal reflux disease
5%
Lymphedema
3%
Rectal hemorrhage
3%
Colonic perforation
3%
Generalized muscle weakness
3%
Hyperkalemia
3%
Lethargy
3%
Myocarditis
3%
Fall
3%
Skin infection
3%
Hypothyroidism
3%
Muscle weakness left-sided
3%
Alanine aminotransferase increased
3%
Hyperglycemia
3%
Pleural effusion
3%
Creatinine increased
3%
Rectal pain
3%
Aspartate aminotransferase increased
3%
Dysarthria
3%
Myositis
3%
CPK increased
3%
Pain in extremity
3%
Peripheral sensory neuropathy
3%
Alkaline phosphatase increased
3%
Blood bilirubin increased
3%
Left ventricular systolic dysfunction
3%
Weight Loss
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalubmab
Durvalubmab + Tremelimumab
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (chemo-immunotherapy, radiation therapy)Experimental Treatment5 Interventions
See detailed description.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
FDA approved
Beta-D-Glucose
Not yet FDA approved
Carboplatin
FDA approved
Durvalumab
FDA approved
Radiation Therapy
2017
Completed Phase 3
~7250
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,333 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,667 Previous Clinical Trials
40,926,069 Total Patients Enrolled
Marcelo V NegraoPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your neutrophil count is at least 1.5 billion per liter.I haven't taken immunosuppressive drugs in the last 14 days.I have a serious health condition that is not under control.My liver enzymes are within the required limits for the trial.My body weight is over 30 kg.You have at least one spot that can be checked with a CT scan before starting the study.I am not currently receiving any cancer treatments.I have been diagnosed with MDS, AML, or have symptoms suggesting these conditions.I have brain metastases but don't have symptoms and take 10 mg or less of prednisone daily.My spinal cord compression hasn't been definitively treated, but my condition has been stable for 28 days.I have agreed to participate in genetic and biomarker research.I am a male and will use a condom and not donate sperm.I cannot swallow pills or have stomach issues affecting medication absorption.I have lasting side effects from cancer treatment, but they are not severe.I haven't received any systemic therapy for small cell lung cancer.I have received treatments like chemotherapy for small cell lung cancer before.I am fully active or restricted in physically strenuous activity but can do light work.My small cell lung cancer is at stage IV, with extensive lung nodules or large tumor volume.I can choose not to participate in genetic research without affecting my participation in the study.I have had a bone marrow or double cord blood transplant.I have heart conditions that are not under control but can be treated.I have not had major surgery in the last 28 days.I have brain metastases that have not been treated.I am allergic to durvalumab, olaparib, or their ingredients.Your platelet count is at least 100 billion per liter.I have not received a live vaccine in the last 30 days.I am willing and able to follow the study's requirements.I have or had inflammatory bowel disease or lung inflammation.I have not had a blood transfusion in the last 4 months.My hemoglobin level is at least 10.0 g/dL and I haven't had a blood transfusion in the last 28 days.Your bilirubin levels in the blood should be within a certain range.Your kidney function is good, with a clearance rate of at least 51 mL/min.People with weakened immune systemsI am not taking strong or moderate drugs that affect enzyme activity.I had another cancer but was treated successfully over 3 years ago with no signs of it returning.I do not have severe nerve damage or other side effects that the study treatment would worsen.My cancer is not small cell lung cancer.I have had an autoimmune disease in the last 2 years.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (chemo-immunotherapy, radiation therapy)
Awards:
This trial has 2 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- 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.
What is the aggregate count of participants in this trial?
"Affirmative. Data hosted on clinicaltrials.gov verifies that this medical research, which was first listed in January 5th 2021, is still open for recruitment. 63 subjects are being sought from 1 specific study site."
Answered by AI
Are there any opportunities to participate in this research endeavor?
"Affirmative. Clinicaltrials.gov provides evidence that this clinical trial is actively enrolling candidates, with the original post being made on May 1st 2021 and the most recent update occuring on November 8th 2022."
Answered by AI
Has Durvalumab been subjected to any previous medical studies?
"Currently, 1284 clinical trials are in the works to investigate Durvalumab with 322 of them at Phase 3. While Shanghai is home to most of these studies, 67577 locations across the world have taken part in this medical research."
Answered by AI
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