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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up death
Awards & highlights

Study 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.Check my eligibility
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.See study design
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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I am using or willing to use effective birth control during and after the study.
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I don't have active brain metastases or have been stable for 2 weeks without steroids.
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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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Best overall response
Secondary outcome measures
Overall survival (OS)
Progression-free survival (PFS)
Safety and tolerability of a combination

Side effects data

From 2022 Phase 2 trial • 80 Patients • NCT03015129
50%
Fatigue
38%
Nausea
30%
Abdominal pain
28%
Arthralgia
28%
Pruritus
25%
Dyspnea
25%
Diarrhea
23%
Myalgia
23%
Dizziness
20%
Gum infection
20%
Pain
20%
Constipation
18%
Back pain
18%
Bladder infection
18%
Urinary tract pain
15%
Fever
15%
Rash maculo-papular
15%
Vomiting
13%
Anorexia
13%
Weight gain
10%
Hypothyroidism
10%
Nasal congestion
10%
Ascites
10%
Thromboembolic event
10%
Pain in extremity
10%
Mucositis oral
10%
Urinary hesitancy
10%
Urinary tract infection
8%
Gastroesophageal reflux disease
8%
Dry skin
8%
Pleural effusion
8%
Cough
8%
Peripheral sensory neuropathy
8%
Hypertension
8%
Anxiety
8%
Fall
8%
Vaginal hemorrhage
8%
Leukocytosis
5%
Creatinine Increased
5%
Hematoma
5%
Upper respiratory infection
5%
Generalized muscle weakness
5%
Allergic rhinitis
5%
Aspartate aminotransferase increased
5%
Vaginal yeast
5%
Skin infection
5%
Hyperglycemia
5%
Sinusitis
5%
Bone pain
5%
Non-cardiac chest pain
5%
Epistaxis
5%
Abdominal distension
5%
Sore throat
5%
Edema limbs
5%
Dry mouth
5%
Hyperkalemia
5%
Flank pain
5%
Urinary frequency
3%
Hypercalcemia
3%
Confusion
3%
Spinal fracture
3%
Atrial fibrillation
3%
Stroke
3%
Seizure
3%
Urinary urgency
3%
Edema cerebral
3%
Alanine aminotransferase increased
3%
Hypoalbuminemia
3%
Acute kidney injury
3%
Vaginal discharge
3%
Alkaline phosphatase increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalubmab + Tremelimumab
Durvalubmab

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
Olaparib
2007
Completed Phase 4
~2140
Durvalumab
2017
Completed Phase 2
~3870

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,627 Previous Clinical Trials
40,927,381 Total Patients Enrolled
Anish Thomas, M.D.Principal InvestigatorNational Cancer Institute (NCI)
9 Previous Clinical Trials
798 Total Patients Enrolled

Media Library

Durvalumab (PD-L1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04538378 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: 1/Arm 1
Non-Small Cell Lung Cancer 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can people still join this scientific experiment?

"According to the details listed on clinicaltrials.gov, this health trial has been recruiting since its initial posting on July 7th 2021 and is up-to-date as of October 4th 2022."

Answered by AI

Can you give me a synopsis of the research conducted involving Durvalumab?

"Presently, there are 484 studies related to Durvalumab with 75 of them in the final stage. Primarily situated in Houston, Texas, these trials have 19978 sites around the world."

Answered by AI

To what conditions is Durvalumab commonly prescribed?

"Durvalumab is an effective pharmacotherapy for this condition and other illnesses such as primary peritoneal cancer, advance directives, and additional diseases."

Answered by AI

How many participants are being recruited for this trial?

"Affirmative, the information on clinicaltrials.gov shows that this experiment is actively recruiting participants. Initially posted on July 7th 2021 and recently updated October 4th 2022, it seeks a total of 14 individuals at one location."

Answered by AI

Has Durvalumab been accredited by the FDA?

"Durvalumab's safety rating is 2 as this Phase 2 trial has evidence of its security, yet not enough to prove effectiveness."

Answered by AI

Has this type of research been conducted previously?

"Durvalumab has been studied since 2005, when its first trial was sponsored by AstraZeneca. This initial study involving 98 patients would eventually lead to the drug's Phase 1 approval. Presently, 484 active trials are running in 65 countries and 1846 cities for Durvalumab."

Answered by AI
~6 spots leftby Dec 2025