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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 below
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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:
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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 weeks
Treatment ~ Varies
Follow Up ~disease progression
This trial's timeline: 3 weeks for screening, Varies for treatment, and disease progression for reporting.

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 • NCT03015129
65%
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
~3750
Olaparib
2007
Completed Phase 4
~2190

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,928 Previous Clinical Trials
41,018,035 Total Patients Enrolled
40 Trials studying Carcinoid Tumor
2,488 Patients Enrolled for Carcinoid Tumor
Anish Thomas, M.D.Principal InvestigatorNational Cancer Institute (NCI)
9 Previous Clinical Trials
891 Total Patients Enrolled

Media Library

Durvalumab (PD-L1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04538378 — Phase 2
Carcinoid Tumor Research Study Groups: 1/Arm 1
Carcinoid Tumor Clinical Trial 2023: Durvalumab Highlights & Side Effects. Trial Name: NCT04538378 — Phase 2
Durvalumab (PD-L1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04538378 — Phase 2
~6 spots leftby Dec 2025
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