Chemo-Immunotherapy + Durvalumab + Ceralasertib for Small Cell Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications, but it does mention a required washout period (time without taking certain medications) for potent inhibitors or inducers of CYP3A4 before starting ceralasertib. It's best to discuss your current medications with the study team to ensure there are no interactions.
Is the combination of chemo-immunotherapy with durvalumab and ceralasertib safe for humans?
What makes the drug combination of chemo-immunotherapy, durvalumab, and ceralasertib unique for treating small cell lung cancer?
What data supports the effectiveness of the drug combination of chemo-immunotherapy, durvalumab, and ceralasertib for small cell lung cancer?
Who Is on the Research Team?
Muhammad Furqan
Principal Investigator
University of Iowa
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Initial Treatment
Participants receive chemo-immunotherapy with Cisplatin or Carboplatin, Etoposide, and Durvalumab for 4 cycles
Maintenance Therapy
Participants receive maintenance therapy with Durvalumab and oral Ceralasertib starting from Cycle 5
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Carboplatin
- Ceralasertib
- Durvalumab
- Etoposide
Carboplatin is already approved in United States, European Union, Canada for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Muhammad Furqan
Lead Sponsor
AstraZeneca
Industry Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from รcole nationale vรฉtรฉrinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from รcole nationale vรฉtรฉrinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology