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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
Must not have
Concurrent anticancer therapy
Patients with myelodysplastic syndrome (MDS) / acute myeloid leukemia (AML) or with features suggestive of MDS/AML
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Approved for 10 Other Conditions
No Placebo-Only Group
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not currently receiving any cancer treatments.
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I have been diagnosed with MDS, AML, or have symptoms suggesting these conditions.
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I cannot swallow pills or have stomach issues affecting medication absorption.
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I have had a bone marrow or double cord blood transplant.
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I have heart conditions that are not under control but can be treated.
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I have not had major surgery in the last 28 days.
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I have brain metastases that have not been treated.
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I am allergic to durvalumab, olaparib, or their ingredients.
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I have or had inflammatory bowel disease or lung inflammation.
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I am not taking strong or moderate drugs that affect enzyme activity.
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I had another cancer but was treated successfully over 3 years ago with no signs of it returning.
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My cancer is not small cell lung cancer.
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I have had an autoimmune disease in the last 2 years.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of dose limiting toxicity
Secondary study objectives
Overall response rate (ORR)
Overall survival (OS)
Progression-free survival (PFS)
Side effects data
From 2022 Phase 2 trial • 80 Patients • NCT0301512965%
Fatigue
63%
Abdominal pain
55%
Diarrhea
43%
Pain
40%
Weight loss
35%
Hypertension
30%
Anorexia
30%
Constipation
28%
Nausea
28%
Pruritus
25%
Vomiting
20%
Dyspnea
20%
Urinary tract infection
18%
Rash maculo-papular
15%
Cough
15%
Abdominal Pain
15%
Back pain
15%
Increased Urinary Frequency
15%
Weight gain
13%
Arthralgia
10%
Dizziness
10%
Anxiety
10%
Bladder infection
10%
Nasal congestion
10%
Vaginal discharge
8%
Colitis
8%
Dry mouth
8%
Dry skin
8%
Fever
8%
Anal pain
8%
Edema limbs
8%
Flatulence
8%
Headache
8%
Hot flashes
8%
Myalgia
8%
Small intestinal obstruction
8%
Thromboembolic event
8%
Urinary frequency
8%
Urinary tract pain
5%
Confusion
5%
Renal and urinary disorders - Other, specify
5%
Adrenal insufficiency
5%
Anemia
5%
Ascites
5%
Gastroesophageal reflux disease
5%
Hypomagnesemia
5%
Lymphedema
5%
Memory impairment
5%
Mucositis oral
5%
Pneumonitis
5%
Rash acneiform
5%
Sinus bradycardia
5%
Upper respiratory infection
5%
Urinary urgency
5%
Vaginal hemorrhage
3%
Alanine aminotransferase increased
3%
Aspartate aminotransferase increased
3%
Alkaline phosphatase increased
3%
Colonic perforation
3%
Dysarthria
3%
Blood bilirubin increased
3%
CPK increased
3%
Creatinine increased
3%
Myositis
3%
Rectal hemorrhage
3%
Hypothyroidism
3%
Left ventricular systolic dysfunction
3%
Lethargy
3%
Muscle weakness left-sided
3%
Myocarditis
3%
Rectal pain
3%
Weight Loss
3%
Fall
3%
Generalized muscle weakness
3%
Hyperglycemia
3%
Hyperkalemia
3%
Pain in extremity
3%
Peripheral sensory neuropathy
3%
Pleural effusion
3%
Skin infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalubmab
Durvalubmab + Tremelimumab
Awards & Highlights
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.
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
Durvalumab
FDA approved
Beta-D-Glucose
Not yet FDA approved
Carboplatin
FDA approved
Olaparib
FDA approved
Radiation Therapy
2017
Completed Phase 3
~7250
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,072 Previous Clinical Trials
1,803,163 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,956 Previous Clinical Trials
41,112,326 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.