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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 below
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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:
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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 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

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 • 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

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
3,067 Previous Clinical Trials
1,802,583 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,928 Previous Clinical Trials
41,017,975 Total Patients Enrolled
Marcelo V NegraoPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials

Media Library

Carboplatin (Alkylating Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04728230 — Phase 1 & 2
Small Cell Lung Cancer Research Study Groups: Treatment (chemo-immunotherapy, radiation therapy)
Small Cell Lung Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT04728230 — Phase 1 & 2
Carboplatin (Alkylating Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04728230 — Phase 1 & 2
~14 spots leftby Dec 2025
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