Actively Recruiting
Chemo-Immunotherapy Followed by Durvalumab and Ceralasertib in Treatment Naïve Patients With Extensive Stage Small Cell Lung Cancer
Led by Muhammad Furqan · Updated on 2026-01-02
30
Participants Needed
5
Research Sites
288 weeks
Total Duration
On this page
Sponsors
M
Muhammad Furqan
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
The primary objective of this single arm study is to estimate the progression free survival of previously-untreated patients with extensive stage small cell lung cancer. Patients will receive initial chemo-immunotherapy followed by maintenance therapy with durvalumab and oral ceralasertib.
CONDITIONS
Official Title
Chemo-Immunotherapy Followed by Durvalumab and Ceralasertib in Treatment Naïve Patients With Extensive Stage Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent and HIPAA authorization
- Age 18 years or older at consent
- ECOG Performance Status of 0-1 within 14 days before registration
- Confirmed histological or cytological small cell lung carcinoma
- Extensive stage disease
- Suitable for first-line platinum-based chemotherapy with Carboplatin or Cisplatin plus Etoposide
- Measurable disease per RECIST v1.1 within 28 days before registration
- Completed prior palliative radiation or whole brain radiation with required recovery periods
- Adequate organ function shown by recent lab tests
- Agree to use effective contraception during and 6 months after treatment if applicable
- Female participants must be post-menopausal or have a negative pregnancy test
- Ability to understand and comply with study procedures
- Ability to swallow and retain oral medication
- Life expectancy of at least 12 weeks
You will not qualify if you...
- Prior systemic therapy for extensive stage or recurrent small cell lung cancer
- Prior chemotherapy or definitive chest radiation for limited-stage small cell lung cancer
- Active infection requiring systemic therapy
- Pregnant or breastfeeding
- Major surgery within 28 days before first study drug dose
- Receiving other investigational agents
- Active malignancy requiring therapy other than small cell lung cancer except specified exceptions
- Diagnosis of immunodeficiency or recent systemic immunosuppressive therapy
- Active autoimmune or inflammatory disorders except specified exceptions
- History of immune therapy related pneumonitis requiring steroids
- Untreated or symptomatic central nervous system metastases or leptomeningeal carcinomatosis
- Known hepatitis B, hepatitis C (unless RNA negative), or HIV infection
- Known active tuberculosis
- History of allogeneic stem cell or solid organ transplant
- History of Ataxia telangiectasia
- Uncontrolled serious illness limiting study compliance
- Known hypersensitivity to study drugs or excipients
- Live vaccine within 4 weeks before first study drug dose
- Severe gastrointestinal conditions affecting drug absorption
- Body weight 30 kg or less
- Use of potent CYP3A4 inhibitors or inducers without required washout
AI-Screening
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Trial Site Locations
Total: 5 locations
1
University of Illinois Medical Center
Chicago, Illinois, United States, 60612
Actively Recruiting
2
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States, 46202
Actively Recruiting
3
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Actively Recruiting
4
University of Maryland
Baltimore, Maryland, United States, 21201
Actively Recruiting
5
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
M
Muhammad Furqan, MD
CONTACT
A
Amber Ryba
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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