Chemo-Immunotherapy Followed by Durvalumab and Ceralasertib in Treatment Naïve Patients With Extensive Stage Small Cell Lung Cancer

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Muhammad Furqan
Study ID
NCT04699838
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Extensive Stage Small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cisplatin — DRUG
    Cisplatin
  • Carboplatin — DRUG
    Carboplatin
  • Etoposide — DRUG
    Etoposide
  • Durvalumab — DRUG
    Durvalumab
  • Ceralasertib — DRUG
    Ceralasertib

Study Details

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.

Key Dates

Start date
Apr 20, 2021
Status verified
Jun 2026
Primary completion
Jul 31, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cisplatin or Carboplatin + Etoposide + Durvalumab + Ceralasertib
    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

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: From enrollment until the time of disease progression, assessed for a maximum of 24 months ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
University of Illinois Medical CenterChicagoIllinois60612
Lauren Talasnik
[email protected]
312-996-6275
Lawrence Feldman, MD (PRINCIPAL_INVESTIGATOR)
Indiana University Melvin and Bren Simon Comprehensive Cancer CenterIndianapolisIndiana46202
Mary Van Demark
[email protected]
317-278-5838
Misty Shields, MD (PRINCIPAL_INVESTIGATOR)
University of Iowa Hospitals and ClinicsIowa CityIowa52242
Bridget Adams
[email protected]
Umar Farooq, MD (PRINCIPAL_INVESTIGATOR)
University of MarylandBaltimoreMaryland21201
Robert Villanueva
[email protected]
Katherine Scilla, MD (PRINCIPAL_INVESTIGATOR)
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Sherry Zhang
[email protected]
614-685-4352
Asrar Alahamadi, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chicago, IL

By research site
University of Illinois Medical Center· Chicago, ILIndiana University Melvin and Bren Simon Comprehensive Cancer Center· Indianapolis, INUniversity of Iowa Hospitals and Clinics· Iowa City, IAUniversity of Maryland· Baltimore, MDOhio State University Comprehensive Cancer Center· Columbus, OH

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