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Chemotherapy
Chemo-Immunotherapy + Durvalumab + Ceralasertib for Small Cell Lung Cancer
Phase 2
Recruiting
Led By Muhammad Furqan, MD
Research Sponsored by Muhammad Furqan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ability to swallow and retain oral medication
Patient must be considered suitable to receive a platinum-based chemotherapy as 1st line treatment for ES-SCLC. Chemotherapy must contain either Carboplatin or Cisplatin in combination with Etoposide.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study Summary
This trial is testing a new treatment for small cell lung cancer that has not yet been approved. The goal is to see if it can help patients live longer without their cancer progressing.
Who is the study for?
Adults (18+) with untreated extensive stage small cell lung cancer suitable for platinum-based chemo (Carboplatin or Cisplatin with Etoposide). Must have measurable disease, proper organ function, and an ECOG Performance Status of 0-1. Women must use contraception and have a negative pregnancy test; men also need to agree to contraception. Excludes those with autoimmune diseases, prior SCLC therapy, certain infections like Hepatitis B/C or HIV, on strong CYP3A4 affecting drugs, severe nausea/vomiting issues, recent major surgery or live vaccines.Check my eligibility
What is being tested?
This study tests the effectiveness of initial chemo-immunotherapy followed by maintenance therapy using Durvalumab and oral Ceralasertib in patients who haven't been treated before for extensive stage small cell lung cancer. The goal is to see how long patients can live without their cancer getting worse.See study design
What are the potential side effects?
Possible side effects include immune-related reactions that may affect organs, infusion-related symptoms such as fever or chills during drug administration, fatigue, digestive problems like nausea or diarrhea, blood disorders which could lead to increased risk of infection or bleeding.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can swallow and keep down pills.
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I am deemed fit for a specific chemotherapy for small cell lung cancer.
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My cancer has spread extensively.
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I am 18 years old or older.
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I agree to use effective birth control during and 90 days after the study.
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My lung cancer is confirmed to be small cell type.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression Free Survival (PFS)
Secondary outcome measures
Disease Control Rate
Duration of Response
Objective response rate (ORR)
+6 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Cisplatin or Carboplatin + Etoposide + Durvalumab + CeralasertibExperimental Treatment5 Interventions
Initial Phase: Cycles 1-4 Cisplatin or Carboplatin: Day 1 Etoposide: Days 1-3 Durvalumab, 1500 mg: Day 1 q 3 weeks
Maintenance Phase, Cycles 5+ Durvalumab, 1500 mg: Day 8 q 4 wks. Ceralasertib at 240mg po BID twice a day: Days 1-7
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ceralasertib
2017
Completed Phase 1
~30
Carboplatin
2014
Completed Phase 3
~6670
Etoposide
2010
Completed Phase 3
~2440
Durvalumab
2017
Completed Phase 2
~3870
Cisplatin
2013
Completed Phase 3
~1940
Find a Location
Who is running the clinical trial?
Muhammad FurqanLead Sponsor
4 Previous Clinical Trials
97 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,271 Previous Clinical Trials
288,613,330 Total Patients Enrolled
Muhammad Furqan, MDPrincipal Investigator - University of Iowa
Big Ten Cancer Research Consortium
2 Previous Clinical Trials
36 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am post-menopausal or not pregnant if of childbearing age.I have had a transplant of stem cells or an organ from another person.I can swallow and keep down pills.I am deemed fit for a specific chemotherapy for small cell lung cancer.My cancer has spread extensively.I am 18 years old or older.I am not on high-dose steroids or drugs that weaken my immune system.You must have a measurable solid tumor according to specific guidelines within the past 28 days before joining the study.I have severe stomach issues that could affect how I absorb medication.I have a history of Ataxia telangiectasia.I do not have any serious ongoing health issues that my doctor hasn't been able to get under control.You are allergic to durvalumab or ceralasertib.I have a history of Hepatitis B, C, or HIV but meet specific conditions for treatment eligibility.I agree to use effective birth control during and 90 days after the study.I've completed palliative radiation for bone pain and recovered, with no recent brain radiation or worsening brain symptoms.I do not have active autoimmune or inflammatory disorders.I have had treatment for extensive or recurrent small cell lung cancer.I am not taking strong drugs that affect liver enzyme CYP3A4.I have an active case of tuberculosis.I haven't had any live vaccines in the last 4 weeks.I weigh 30 Kg or less.My organ functions are within normal ranges as required.I understand and can follow the study's procedures.I have no active cancer needing treatment except for my lung cancer.I have been mostly active and able to carry on all pre-disease activities without restriction in the last 2 weeks.You are expected to live for at least 12 more weeks.My small cell lung cancer has returned after treatment.My lung cancer is confirmed to be small cell type.I have not had major surgery in the last 4 weeks.I am currently being treated for a serious infection.
Research Study Groups:
This trial has the following groups:- Group 1: Cisplatin or Carboplatin + Etoposide + Durvalumab + Ceralasertib
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Ceralasertib been cleared by the FDA?
"While Phase 2 trials don't have the same data supporting efficacy, Ceralasertib did receive a score of 2 for safety."
Answered by AI
In how many different medical clinics is this research study being conducted today?
"Additional hospitals and clinics conducting this clinical trial are University of Illinois Medical Center, Ohio State University Comprehensive Cancer Center, and University of Iowa Hospitals and Clinics."
Answered by AI
What is the most common reason that doctors prescribe Ceralasertib?
"Ceralasertib has shown to be an effective treatment for hodgkin disease, malignant pleural mesothelioma, and advanced head and neck cancer."
Answered by AI
What other medication trials has Ceralasertib been involved in?
"Ceralasertib is being studied in 1598 clinical trials, 456 of which are currently active. Many of these live Phase 3 trials are based in Shanghai; however, Ceralasertib's clinical trials can be found in 79917 locations globally."
Answered by AI
How many individuals are allowed to be in this clinical trial according to the protocol?
"Indeed, the trial is still recruiting patients according to information on clinicaltrials.gov. 30 individuals are needed for the study which is taking place at 4 medical facilities. The listing was created on April 20th, 2021 and updated on August 26th, 2022."
Answered by AI
Are patients being accepted into the trial at this time?
"The information available on clinicaltrials.gov suggests that this research is still looking for qualifying individuals. The study was created on 4/20/2021 and updated as recently as 8/26/2022. There are 30 spots open for willing participants at 4 different locations."
Answered by AI
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