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

NCT04699838 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: BTCRC-LUN18-363
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 5

Brief Summary

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

Extensive Stage Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  Progression free survival (PFS) is defined as the time from the initiation of treatment (C1D1) to the time when the criteria for disease progression is met as defined by RECIST v1.1 OR death due to any cause. The PFS is subject to right censoring due to loss to follow-up or at the end of study duration.

  From enrollment until the time of disease progression, assessed for a maximum of 24 months

Secondary Outcomes (9)

• Time to disease progression

  From enrollment until the time of disease progression,assessed for a maximum of 24 months

• Time to CNS Progression

  From enrollment until the time of cns progression, assessed for a maximum of 24 months

• Time to Systemic Progression

  From enrollment until the time of systemic progression, assessed for a maximum of 24 months

• Progression free survival for maintenance therapy

  From Cycle 5, Day 1 of maintenance therapy until disease progression, assessed for a maximum of 19 months

• Objective response rate (ORR)

  24 months

Study Arms (1)

Cisplatin or Carboplatin + Etoposide + Durvalumab + Ceralasertib

EXPERIMENTAL

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

Drug: Cisplatin; Drug: Carboplatin; Drug: Etoposide; Drug: Durvalumab; Drug: Ceralasertib

Interventions

Cisplatin DRUG

Cisplatin

Cisplatin or Carboplatin + Etoposide + Durvalumab + Ceralasertib

Carboplatin DRUG

Carboplatin

Cisplatin or Carboplatin + Etoposide + Durvalumab + Ceralasertib

Etoposide DRUG

Etoposide

Cisplatin or Carboplatin + Etoposide + Durvalumab + Ceralasertib

Durvalumab DRUG

Durvalumab

Cisplatin or Carboplatin + Etoposide + Durvalumab + Ceralasertib

Ceralasertib DRUG

Ceralasertib

Cisplatin or Carboplatin + Etoposide + Durvalumab + Ceralasertib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
• Age \>= 18 years at the time of consent.
• ECOG Performance Status of 0-1 within 14 days prior to registration (Appendix A of Protocol).
• Histological or cytological confirmed small cell lung carcinoma
• Extensive stage disease
• 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.
• Measurable disease according to RECIST v1.1 for solid tumors within 28 days prior to registration.
• Prior treatment must be completed within the following number of days prior to registration:
• Palliative radiation: for painful bony lesion must be completed prior to registration and recovered from significant bone marrow toxicity. For patients who received WBRT, 14 days washout is required prior to study therapy. Patient's must be off steroids without worsening of symptoms related to brain metastases. Patient should be on stable doses of anti-convulsant.
• Demonstrate adequate organ function as defined in the protocol; all screening labs to be obtained within 14 days prior to registration
• Hematological
• Absolute Neutrophil Count (ANC) \>/= 1500/mm\^3
• Platelet \>/= 100,000/mm\^3
• Hemoglobin (Hgb) \>/= 9 g/dL
• Renal

You may not qualify if:

• Prior systemic therapy for extensive stage or recurrent SCLC
• Patients with recurrent SCLC, who received chemotherapy or definitive chest radiation in the past for limited-stage SCLC.
• Clinically significant active infection requiring systemic therapy
• Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
• Participants who have undergone major surgery within 28 days before first dose of study drug
• Participants who are currently receiving any other investigational agents
• Active malignancy requiring therapy other than small cell lung cancer, excluding: non-melanoma skin cancer, noninvasive colonic polyps, superficial bladder tumors, cervical cancer in-situ, ductal carcinoma in situ of the breast, monoclonal B-cell lymphocytosis, or monoclonal gammopathy of undetermined significance.
• Diagnosis of immunodeficiency or is receiving systemic steroid therapy (\> 10 mg of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to study enrolment. Patient's on physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Topical, inhaled or intra-articular steroids are not considered as systemic steroids. Steroids as premedication for hypersensitivity reaction (e.g. CT scan premedication) or prior to chemotherapy is allowed.
• Active autoimmune or inflammatory disorders (including inflammatory bowel disease \[e.g., colitis or Crohn's disease\], systemic lupus erythematosus, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\]). The following are exceptions to this criterion:
• Patients with vitiligo or alopecia
• Patients with hyperthyroidism or hypothyroidism (e.g., following Hashimoto syndrome) clinically stable on hormone replacement
• Any chronic skin condition that does not require systemic immunosuppressive therapy
• Patients with celiac disease controlled by diet alone
• Diabetes mellitus with or without insulin replacement therapy
• Has history of immune therapy related pneumonitis that required steroids

Sponsors & Collaborators

• Muhammad Furqan: lead
• AstraZeneca: collaborator

Study Sites (5)

University of Illinois Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, 46202, United States

RECRUITING

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

RECRUITING

University of Maryland

Baltimore, Maryland, 21201, United States

RECRUITING

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

MeSH Terms

Interventions

Cisplatin; Carboplatin; Etoposide; durvalumab; ceralasertib

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Muhammad Furqan, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Furqan, MD

CONTACT

319-356-1527; muhammad-furqan@uiowa.edu

Amber Ryba

CONTACT

317-634-5842; aryba@hoosiercancer.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Associate Professor.

Study Record Dates

• First Submitted: December 23, 2020
• First Posted: January 7, 2021
• Study Start: April 20, 2021
• Primary Completion: March 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)