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PD-L1 Inhibitor
Olaparib + Durvalumab for Small Cell Lung Cancer
Phase 2
Recruiting
Led By Anish Thomas, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects should have received platinum-based chemotherapy with or without immunotherapy for small cell/neuroendocrine transformation or refused such therapy
ECOG performance status less than or equal to 2
Must not have
History of auto-immune disease requiring steroid maintenance, or history of primary immunodeficiency
History of allogenic organ transplantation, bone marrow transplant or double umbilical cord blood transplantation (dUCBT)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up death
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a combination of drugs to see if it can help people with a specific type of lung cancer that has transformed into another cancer.
Who is the study for?
Adults over 18 with EGFR-mutated non-small-cell lung cancer that has transformed into small cell or neuroendocrine tumors after treatment. They must have stable brain metastases if present, measurable disease, and adequate organ function. Women of childbearing potential and men must agree to contraception.
What is being tested?
The trial is testing a combination of two drugs: Olaparib taken orally twice daily and Durvalumab given intravenously every 28 days. The goal is to see if these drugs can shrink the tumors in patients whose lung cancer has changed form.
What are the potential side effects?
Possible side effects include immune-related reactions, fatigue, nausea, blood count changes, heart rhythm problems, and allergic responses similar to other compounds like Olaparib or Durvalumab.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had or refused platinum-based chemotherapy for my cancer.
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I can take care of myself but might not be able to do heavy physical work.
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My liver is functioning well according to recent tests.
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My lung cancer changed to a different type after treatment with a specific medication.
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My kidney function is within the required range for the study.
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I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have an autoimmune disease that needs steroids or a primary immunodeficiency.
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I have had an organ or bone marrow transplant.
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I am not pregnant or breastfeeding.
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I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.
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I do not have any severe illnesses that could worsen with the study treatment.
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I have received high-dose chest radiation within the last 2 weeks.
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I have not had cancer treatment or major surgery in the last 2 weeks.
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I have received palliative radiation within the last 24 hours.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ disease progression
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~disease progression
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Best overall response
Secondary study objectives
Overall survival (OS)
Progression-free survival (PFS)
Safety and tolerability of a combination
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
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: 1/Arm 1Experimental Treatment2 Interventions
Combination of durvalumab and olaparib
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3780
Olaparib
2007
Completed Phase 4
~2190
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,887 Previous Clinical Trials
41,020,988 Total Patients Enrolled
Anish Thomas, M.D.Principal InvestigatorNational Cancer Institute (NCI)
9 Previous Clinical Trials
878 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently participating in another clinical trial or receiving treatment.I have an autoimmune disease that needs steroids or a primary immunodeficiency.You have had allergic reactions to drugs similar to olaparib or durvalumab.I am not pregnant or breastfeeding.I have had or refused platinum-based chemotherapy for my cancer.I haven't had major surgery in the last 28 days, except for minor procedures to relieve symptoms.I am not taking strong or moderate drugs that affect liver enzyme CYP3A4, except for certain heart medications.I can take care of myself but might not be able to do heavy physical work.I have had an organ or bone marrow transplant.I haven't taken strong immune-weakening medicines in the last 14 days, except for small doses of steroids or short-term use.I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.I do not have any severe illnesses that could worsen with the study treatment.I can't take pills by mouth or have stomach issues affecting medicine absorption.My liver is functioning well according to recent tests.I am using or willing to use effective birth control during and after the study.I don't have active brain metastases or have been stable for 2 weeks without steroids.My lung cancer changed to a different type after treatment with a specific medication.My kidney function is within the required range for the study.Your heart's electrical activity shows signs of uncontrolled or reversible heart problems, or you have a congenital long QT syndrome.I do not have an active infection like TB, hepatitis B, or hepatitis C.I am HIV-positive but have been stable on antiretroviral therapy for over 5 years with an undetectable viral load and CD4 count over 150.I have lasting side effects from cancer treatment, but not hair loss.I have received high-dose chest radiation within the last 2 weeks.I have not had cancer treatment or major surgery in the last 2 weeks.I have received palliative radiation within the last 24 hours.I am 18 years old or older.Your blood counts should be at a certain level within the last 28 days before joining the study. This includes white blood cells, neutrophils, platelets, and hemoglobin.You must have a disease that can be measured according to specific guidelines.
Research Study Groups:
This trial has the following groups:- Group 1: 1/Arm 1
Awards:
This trial has 1 awards, including:- 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.
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