Using Biomarker Tests to Select and Test New, Personalized Treatments for Extensive Stage Small Cell Lung Cancer, PRISM Study

NCT06769126 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: S2409NCI-2024-10080U10CA180888
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 148

Brief Summary

This phase II trial tests how well biomarker tests on patients tumor tissue works in selecting personalized treatments for patients with extensive stage small cell lung cancer (ES-SCLC). Biomarker tests look for certain features in cancer cells that may give doctors more information about what is driving cancer and how to treat it. Based on the biomarker test results, study doctors can determine the subtype of ES-SCLC that study treatments can target. This study also tests different types of maintenance treatment for ES-SCLC with drugs durvalumab, saruparib, ceralasertib or monalizumab. Maintenance treatment is given after initial treatment and is given to help keep the cancer under control and prevent it from getting worse. Immunotherapy with monoclonal antibodies, such as durvalumab and monalizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Saruparib is a PARP inhibitor. PARP is a protein that helps repair damaged deoxyribonucleic acid (DNA). Blocking PARP may prevent cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Ceralasertib may stop the growth of tumor cells and may kill them by blocking some of the enzymes needed for tumor cell growth. Giving biomarker selected personalized maintenance treatment with durvalumab, saruparib, ceralasertib or monalizumab may work better in treating patients with ES-SCLC.

Conditions

Extensive Stage Lung Small Cell Carcinoma; Lung Small Cell Carcinoma, A Subtype; Lung Small Cell Carcinoma, I Subtype; Lung Small Cell Carcinoma, N Subtype; Lung Small Cell Carcinoma, P Subtype

Outcome Measures

Primary Outcomes (4)

• Screen success rate (Screening)

  Will test participants' tissue specimens to determine their eligibility to 1 of the 3 treatment cohorts created based on their small cell lung cancer (SCLC) subtype and SLFN11 status. Will evaluate rate of participants who successfully get a cohort assignment based on SCLC subtype and SLNFN11 status, as appropriate.

  Up to 3 years

• Progression-free survival (PFS) (Cohort A)

  Will compare PFS in participants with extensive stage SCLC (ES-SCLC) (subtypes A or N \& SLFN11 positive) or ES-SCLC (subtype P) randomized to durvalumab (MEDI4736) with or without saruparib (AZD5305) as maintenance therapy following induction chemoimmunotherapy with platinum, etoposide, and durvalumab (MEDI4736). Will be estimated using the Kaplan-Meier method. Associated confidence intervals about the median will be performed using the Brookmeyer-Crowley method. Binary proportions and associated confidence intervals will be calculated.

  From date of randomization to treatment within a cohort to date of first documentation of progression, symptomatic deterioration, or death due to any cause, assessed up to 3 years

• PFS (Cohort B)

  Will compare PFS in participants with ES-SCLC subtypes A or N and SLFN11 negative randomized to durvalumab with or without ceralasertib (AZD6738) as maintenance therapy following induction chemoimmunotherapy with cisplatin or carboplatin, etoposide, and durvalumab (MEDI4736). Will be estimated using the Kaplan-Meier method. Associated confidence intervals about the median will be performed using the Brookmeyer-Crowley method.

  From date of randomization to treatment within a cohort to date of first documentation of progression, symptomatic deterioration, or death due to any cause, assessed up to 3 years

• PFS (Cohort C)

  Will compare PFS participants with ES-SCLC subtype I randomized to durvalumab (MEDI4736) with or without monalizumab (IPH2201) as maintenance therapy following induction chemoimmunotherapy with cisplatin or carboplatin, etoposide, and durvalumab (MEDI4736). Will be estimated using the Kaplan-Meier method. Associated confidence intervals about the median will be performed using the Brookmeyer-Crowley method.

  From date of randomization to treatment within a cohort to date of first documentation of progression, symptomatic deterioration, or death due to any cause, assessed up to 3 years

Secondary Outcomes (11)

• SCLC subtype status (Screening)

  Up to 3 years

• SLFN11 status (Screening)

  Up to 3 years

• Assigned to a cohort and register to be randomized (Screening)

  Up to 3 years

• Incidence of dose limiting toxicity (DLT) (Cohort A, safety run-in)

  During the first cycle of treatment (each cycle is 28 days)

• PFS (Cohort A)

  From date of randomization to treatment within a cohort to date of first documentation of progression, symptomatic deterioration, or death due to any cause, assessed up to 3 years

Other Outcomes (1)

• Bank specimens

  Up to 3 years

Study Arms (6)

Cohort A, Arm 1 (durvalumab)

EXPERIMENTAL

Patients with ES-SCLC determined to be subtype A or N, and to be SLFN11 positive or patients with subtype P ES-SCLC. INDUCTION: Patients may receive a platinum compound plus etoposide per standard care as well as durvalumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 28 days for 4-6 cycles in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients may undergo thoracic radiation as clinically indicated. MAINTENANCE: Patients receive durvalumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT scan or PET/CT scan and CT scan or MRI throughout the study. Patients also undergo tissue sample collection during screening and may undergo blood sample collection throughout the study.

Procedure: Biospecimen Collection; Procedure: Computed Tomography; Biological: Durvalumab; Drug: Etoposide; Procedure: Magnetic Resonance Imaging; Drug: Platinum Compound; Procedure: Positron Emission Tomography; Radiation: Thoracic Radiation Therapy

Cohort A, Arm 2 (durvalumab, saruparib)

EXPERIMENTAL

Patients with ES-SCLC determined to be subtype A or N, and to be SLFN11 positive or patients with subtype P ES-SCLC. INDUCTION: Patients may receive a platinum compound plus etoposide per standard care as well as durvalumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 28 days for 4-6 cycles in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients may undergo thoracic radiation as clinically indicated. MAINTENANCE: Patients receive durvalumab IV over 60 minutes on day 1 of each cycle and saruparib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT scan or PET/CT scan and CT scan or MRI throughout the study. Patients also undergo tissue sample collection during screening and may undergo blood sample collection throughout the study.

Procedure: Biospecimen Collection; Procedure: Computed Tomography; Biological: Durvalumab; Drug: Etoposide; Procedure: Magnetic Resonance Imaging; Drug: Platinum Compound; Procedure: Positron Emission Tomography; Drug: Saruparib; Radiation: Thoracic Radiation Therapy

Cohort B, Arm 1 (durvalumab)

EXPERIMENTAL

Patients with ES-SCLC determined to be subtype A or N, and to be SLFN11 negative. INDUCTION: Patients may receive a platinum compound plus etoposide per standard care as well as durvalumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 28 days for 4-6 cycles in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients may undergo thoracic radiation as clinically indicated. MAINTENANCE: Patients receive durvalumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT scan or PET/CT scan and CT scan or MRI throughout the study. Patients also undergo tissue sample collection during screening and may undergo blood sample collection throughout the study.

Procedure: Biospecimen Collection; Procedure: Computed Tomography; Biological: Durvalumab; Drug: Etoposide; Procedure: Magnetic Resonance Imaging; Drug: Platinum Compound; Procedure: Positron Emission Tomography; Radiation: Thoracic Radiation Therapy

Cohort B, Arm 2 (durvalumab, ceralasertib)

EXPERIMENTAL

Patients with ES-SCLC determined to be subtype A or N, and to be SLFN11 negative. INDUCTION: Patients may receive a platinum compound plus etoposide per standard care as well as durvalumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 28 days for 4-6 cycles in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients may undergo thoracic radiation as clinically indicated. MAINTENANCE: Patients receive durvalumab IV over 60 minutes on day 8 and ceralasertib PO BID on days 1-7 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT scan or PET/CT scan and CT scan or MRI throughout the study. Patients also undergo tissue sample collection during screening and may undergo blood sample collection throughout the study.

Procedure: Biospecimen Collection; Drug: Ceralasertib; Procedure: Computed Tomography; Biological: Durvalumab; Drug: Etoposide; Procedure: Magnetic Resonance Imaging; Drug: Platinum Compound; Procedure: Positron Emission Tomography; Radiation: Thoracic Radiation Therapy

Cohort C, Arm 1 (durvalumab)

EXPERIMENTAL

Patients with ES-SCLC determined to be subtype I. INDUCTION: Patients may receive a platinum compound plus etoposide per standard care as well as durvalumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 28 days for 4-6 cycles in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients may undergo thoracic radiation as clinically indicated. MAINTENANCE: Patients receive durvalumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT scan or PET/CT scan and CT scan or MRI throughout the study. Patients also undergo tissue sample collection during screening and may undergo blood sample collection throughout the study.

Procedure: Biospecimen Collection; Procedure: Computed Tomography; Biological: Durvalumab; Drug: Etoposide; Procedure: Magnetic Resonance Imaging; Drug: Platinum Compound; Procedure: Positron Emission Tomography; Radiation: Thoracic Radiation Therapy

Cohort C, Arm 2 (durvalumab, monalizumab)

EXPERIMENTAL

Patients with ES-SCLC determined to be subtype I. INDUCTION: Patients may receive a platinum compound plus etoposide per standard care as well as durvalumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 28 days for 4-6 cycles in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients may undergo thoracic radiation as clinically indicated. MAINTENANCE: Patients receive durvalumab IV over 60 minutes on day 1 and monalizumab IV over 60 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT scan or PET/CT scan and CT scan or MRI throughout the study. Patients also undergo tissue sample collection during screening and may undergo blood sample collection throughout the study.

Procedure: Biospecimen Collection; Procedure: Computed Tomography; Biological: Durvalumab; Drug: Etoposide; Procedure: Magnetic Resonance Imaging; Biological: Monalizumab; Drug: Platinum Compound; Procedure: Positron Emission Tomography; Radiation: Thoracic Radiation Therapy

Interventions

Biospecimen Collection PROCEDURE

Undergo tissue and blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Cohort A, Arm 1 (durvalumab); Cohort A, Arm 2 (durvalumab, saruparib); Cohort B, Arm 1 (durvalumab); Cohort B, Arm 2 (durvalumab, ceralasertib); Cohort C, Arm 1 (durvalumab); Cohort C, Arm 2 (durvalumab, monalizumab)

Ceralasertib DRUG

Given PO

Also known as: AZD6738

Cohort B, Arm 2 (durvalumab, ceralasertib)

Computed Tomography PROCEDURE

Undergo CT scan

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography

Cohort A, Arm 1 (durvalumab); Cohort A, Arm 2 (durvalumab, saruparib); Cohort B, Arm 1 (durvalumab); Cohort B, Arm 2 (durvalumab, ceralasertib); Cohort C, Arm 1 (durvalumab); Cohort C, Arm 2 (durvalumab, monalizumab)

Durvalumab BIOLOGICAL

Given IV

Also known as: Imfinzi, Immunoglobulin G1, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain), Disulfide with Human Monoclonal MEDI4736 Kappa-chain, Dimer, MEDI 4736, MEDI-4736, MEDI4736

Cohort A, Arm 1 (durvalumab); Cohort A, Arm 2 (durvalumab, saruparib); Cohort B, Arm 1 (durvalumab); Cohort B, Arm 2 (durvalumab, ceralasertib); Cohort C, Arm 1 (durvalumab); Cohort C, Arm 2 (durvalumab, monalizumab)

Etoposide DRUG

Given etoposide

Also known as: Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, Lastet, Toposar, Vepesid, VP 16, VP 16-213, VP 16213, VP-16, VP-16-213, VP-16213, VP16, VP16213

Cohort A, Arm 1 (durvalumab); Cohort A, Arm 2 (durvalumab, saruparib); Cohort B, Arm 1 (durvalumab); Cohort B, Arm 2 (durvalumab, ceralasertib); Cohort C, Arm 1 (durvalumab); Cohort C, Arm 2 (durvalumab, monalizumab)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

Cohort A, Arm 1 (durvalumab); Cohort A, Arm 2 (durvalumab, saruparib); Cohort B, Arm 1 (durvalumab); Cohort B, Arm 2 (durvalumab, ceralasertib); Cohort C, Arm 1 (durvalumab); Cohort C, Arm 2 (durvalumab, monalizumab)

Monalizumab BIOLOGICAL

Given IV

Also known as: Immunoglobulin G4-kappa, Anti-(Homo sapiens KLRC1 (Killer Cell Lectin-like Receptor Subfamily C Member 1, NKG2-a, NKG2a, CD159A, CD94)), Humanized Monoclonal Antibody, IPH-2201, IPH2201, NN-8765, NN8765, NN8765-3658

Cohort C, Arm 2 (durvalumab, monalizumab)

Platinum Compound DRUG

Given platinum compound

Also known as: Platinum Agents, Platinum-Based Chemotherapeutic Agent

Cohort A, Arm 1 (durvalumab); Cohort A, Arm 2 (durvalumab, saruparib); Cohort B, Arm 1 (durvalumab); Cohort B, Arm 2 (durvalumab, ceralasertib); Cohort C, Arm 1 (durvalumab); Cohort C, Arm 2 (durvalumab, monalizumab)

Positron Emission Tomography PROCEDURE

Undergo PET/CT scan

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT

Cohort A, Arm 1 (durvalumab); Cohort A, Arm 2 (durvalumab, saruparib); Cohort B, Arm 1 (durvalumab); Cohort B, Arm 2 (durvalumab, ceralasertib); Cohort C, Arm 1 (durvalumab); Cohort C, Arm 2 (durvalumab, monalizumab)

Saruparib DRUG

Given PO

Also known as: AZD 5305, AZD-5305, AZD5305, PARP Inhibitor AZD5305

Cohort A, Arm 2 (durvalumab, saruparib)

Thoracic Radiation Therapy RADIATION

Undergo thoracic radiation

Also known as: Thoracic Radiotherapy

Cohort A, Arm 1 (durvalumab); Cohort A, Arm 2 (durvalumab, saruparib); Cohort B, Arm 1 (durvalumab); Cohort B, Arm 2 (durvalumab, ceralasertib); Cohort C, Arm 1 (durvalumab); Cohort C, Arm 2 (durvalumab, monalizumab)

Eligibility Criteria

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

You may qualify if:

• STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen
• STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must not have a history of limited stage small cell lung cancer
• STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must meet 1 of the following criteria prior to step 1:
• Treatment naïve and planning to receive frontline induction treatment with platinum plus etoposide in combination with durvalumab, OR,
• Have initiated frontline induction therapy and completed at least 1 (≥ 1) cycle and at most 3 (≤ 3) cycles of platinum and etoposide. At most 2 (≤ 2) of these cycles could have been given without durvalumab
• NOTE: Participants must not have received immunotherapy other than durvalumab (e.g., atezolizumab) prior to enrollment
• STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must not have received any anti PD-1 or anti PD-L1 (including durvalumab \[MEDI4736\]) treatment for SCLC prior to starting frontline induction treatment for ES-SCLC
• STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must not have received anti PD-1 or anti PD-L1 other than durvalumab (MEDI4736) as part of frontline induction treatment for ES-SCLC. Participants must have not received atezolizumab, pembrolizumab, or nivolumab as part of frontline induction treatment
• STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must not have received any investigational agent for the treatment of ES-SCLC
• STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must not be planning to receive any concurrent non-protocol directed chemotherapy, immunotherapy, biologic or hormonal therapy for SCLC treatment while receiving treatment on this study
• NOTE: If participant has bone metastases, bisphosphonates are allowed
• STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must not have any unresolved toxicity National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) grade ≥ 2 from previous anticancer therapy with the exception of alopecia, and vitiligo
• STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must be ≥ 18 years old at the time of step 1 registration
• STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must be able to safely receive the frontline induction treatment with platinum plus etoposide in combination with durvalumab, per the current Food and Drug Administration (FDA)-approved package insert(s), institutional guidelines, and the treating investigator's discretion
• STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must have Zubrod performance status of 0-2 within 28 days prior to step 1 registration

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator

Study Sites (148)

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

RECRUITING

Eisenhower Medical Center

Rancho Mirage, California, 92270, United States

RECRUITING

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

RECRUITING

UCHealth University of Colorado Hospital

Aurora, Colorado, 80045, United States

RECRUITING

UCHealth Memorial Hospital Central

Colorado Springs, Colorado, 80909, United States

RECRUITING

Memorial Hospital North

Colorado Springs, Colorado, 80920, United States

RECRUITING

Poudre Valley Hospital

Fort Collins, Colorado, 80524, United States

RECRUITING

Cancer Care and Hematology-Fort Collins

Fort Collins, Colorado, 80528, United States

RECRUITING

Lutheran Hospital - Cancer Centers of Colorado

Golden, Colorado, 80401, United States

RECRUITING

UCHealth Greeley Hospital

Greeley, Colorado, 80631, United States

RECRUITING

Medical Center of the Rockies

Loveland, Colorado, 80538, United States

RECRUITING

Smilow Cancer Hospital-Derby Care Center

Derby, Connecticut, 06418, United States

RECRUITING

Smilow Cancer Hospital Care Center-Fairfield

Fairfield, Connecticut, 06824, United States

RECRUITING

Smilow Cancer Hospital Care Center - Guilford

Guilford, Connecticut, 06437, United States

RECRUITING

Yale University

New Haven, Connecticut, 06520, United States

RECRUITING

Yale-New Haven Hospital North Haven Medical Center

North Haven, Connecticut, 06473, United States

RECRUITING

Smilow Cancer Hospital-Torrington Care Center

Torrington, Connecticut, 06790, United States

RECRUITING

Smilow Cancer Hospital Care Center-Trumbull

Trumbull, Connecticut, 06611, United States

RECRUITING

Smilow Cancer Hospital-Waterbury Care Center

Waterbury, Connecticut, 06708, United States

RECRUITING

Smilow Cancer Hospital Care Center - Waterford

Waterford, Connecticut, 06385, United States

RECRUITING

Helen F Graham Cancer Center

Newark, Delaware, 19713, United States

RECRUITING

Medical Oncology Hematology Consultants PA

Newark, Delaware, 19713, United States

RECRUITING

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

Savannah, Georgia, 31405, United States

RECRUITING

Kootenai Health - Coeur d'Alene

Coeur d'Alene, Idaho, 83814, United States

RECRUITING

Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho, 83687, United States

RECRUITING

Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, 83854, United States

RECRUITING

Kootenai Clinic Cancer Services - Sandpoint

Sandpoint, Idaho, 83864, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Northwestern Medicine Cancer Center Kishwaukee

DeKalb, Illinois, 60115, United States

RECRUITING

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, 60134, United States

RECRUITING

Northwestern Medicine Glenview Outpatient Center

Glenview, Illinois, 60026, United States

RECRUITING

Northwestern Medicine Grayslake Outpatient Center

Grayslake, Illinois, 60030, United States

RECRUITING

Northwestern Medicine Lake Forest Hospital

Lake Forest, Illinois, 60045, United States

RECRUITING

Loyola University Medical Center

Maywood, Illinois, 60153, United States

RECRUITING

Northwestern Medicine Oak Brook

Oak Brook, Illinois, 60523, United States

RECRUITING

Northwestern Medicine Orland Park

Orland Park, Illinois, 60462, United States

RECRUITING

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, 60555, United States

RECRUITING

Mary Greeley Medical Center

Ames, Iowa, 50010, United States

RECRUITING

McFarland Clinic - Ames

Ames, Iowa, 50010, United States

RECRUITING

UI Health Care Mission Cancer and Blood - Ankeny Clinic

Ankeny, Iowa, 50023, United States

RECRUITING

McFarland Clinic - Boone

Boone, Iowa, 50036, United States

SUSPENDED

Mercy Hospital

Cedar Rapids, Iowa, 52403, United States

RECRUITING

Oncology Associates at Mercy Medical Center

Cedar Rapids, Iowa, 52403, United States

RECRUITING

UI Health Care Mission Cancer and Blood - West Des Moines Clinic

Clive, Iowa, 50325, United States

RECRUITING

Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States

RECRUITING

UI Health Care Mission Cancer and Blood - Des Moines Clinic

Des Moines, Iowa, 50309, United States

RECRUITING

Mercy Medical Center - Des Moines

Des Moines, Iowa, 50314, United States

RECRUITING

UI Health Care Mission Cancer and Blood - Laurel Clinic

Des Moines, Iowa, 50314, United States

RECRUITING

McFarland Clinic - Trinity Cancer Center

Fort Dodge, Iowa, 50501, United States

RECRUITING

McFarland Clinic - Jefferson

Jefferson, Iowa, 50129, United States

SUSPENDED

McFarland Clinic - Marshalltown

Marshalltown, Iowa, 50158, United States

RECRUITING

UI Health Care Mission Cancer and Blood - Waukee Clinic

Waukee, Iowa, 50263, United States

RECRUITING

The Iowa Clinic PC

West Des Moines, Iowa, 50266, United States

RECRUITING

University of Kansas Clinical Research Center

Fairway, Kansas, 66205, United States

RECRUITING

University of Kansas Cancer Center

Kansas City, Kansas, 66160, United States

RECRUITING

The University of Kansas Cancer Center - Olathe

Olathe, Kansas, 66061, United States

RECRUITING

University of Kansas Cancer Center-Overland Park

Overland Park, Kansas, 66210, United States

RECRUITING

Salina Regional Health Center

Salina, Kansas, 67401, United States

RECRUITING

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, 66205, United States

RECRUITING

Baptist Health Corbin

Corbin, Kentucky, 40701, United States

RECRUITING

Baptist Health Lexington

Lexington, Kentucky, 40503, United States

RECRUITING

Baptist Health Hamburg

Lexington, Kentucky, 40509, United States

RECRUITING

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, 21201, United States

RECRUITING

Tufts Medical Center

Boston, Massachusetts, 02111, United States

RECRUITING

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805, United States

RECRUITING

Lahey Medical Center-Peabody

Peabody, Massachusetts, 01960, United States

RECRUITING

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Brighton, Michigan, 48114, United States

RECRUITING

Trinity Health IHA Medical Group Hematology Oncology - Canton

Canton, Michigan, 48188, United States

RECRUITING

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Chelsea, Michigan, 48118, United States

RECRUITING

Henry Ford Health Saint John Hospital

Detroit, Michigan, 48236, United States

RECRUITING

Henry Ford River District Hospital

East China Township, Michigan, 48054, United States

RECRUITING

Henry Ford Saint John Hospital - Academic

Grosse Pointe Woods, Michigan, 48236, United States

RECRUITING

Henry Ford Saint John Hospital - Breast

Grosse Pointe Woods, Michigan, 48236, United States

RECRUITING

Henry Ford Saint John Hospital - Van Elslander

Grosse Pointe Woods, Michigan, 48236, United States

RECRUITING

University of Michigan Health - Sparrow Lansing

Lansing, Michigan, 48912, United States

RECRUITING

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, 48154, United States

RECRUITING

Henry Ford Saint John Hospital - Macomb Medical

Macomb, Michigan, 48044, United States

RECRUITING

Henry Ford Warren Hospital - Breast Macomb

Macomb, Michigan, 48044, United States

RECRUITING

Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan, 48341, United States

RECRUITING

Henry Ford Health Warren Hospital

Warren, Michigan, 48093, United States

RECRUITING

Henry Ford Madison Heights Hospital - Breast

Warren, Michigan, 48093, United States

RECRUITING

Henry Ford Warren Hospital - GLCMS

Warren, Michigan, 48093, United States

RECRUITING

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Ypsilanti, Michigan, 48197, United States

RECRUITING

Sanford Joe Lueken Cancer Center

Bemidji, Minnesota, 56601, United States

RECRUITING

Essentia Health Saint Joseph's Medical Center

Brainerd, Minnesota, 56401, United States

RECRUITING

Mercy Hospital

Coon Rapids, Minnesota, 55433, United States

RECRUITING

Essentia Health - Deer River Clinic

Deer River, Minnesota, 56636, United States

RECRUITING

Essentia Health Cancer Center

Duluth, Minnesota, 55805, United States

RECRUITING

Fairview Southdale Hospital

Edina, Minnesota, 55435, United States

RECRUITING

Essentia Health Hibbing Clinic

Hibbing, Minnesota, 55746, United States

RECRUITING

Saint John's Hospital - Healtheast

Maplewood, Minnesota, 55109, United States

RECRUITING

Abbott-Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

RECRUITING

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

RECRUITING

New Ulm Medical Center

New Ulm, Minnesota, 56073, United States

RECRUITING

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, 55416, United States

RECRUITING

Regions Hospital

Saint Paul, Minnesota, 55101, United States

RECRUITING

United Hospital

Saint Paul, Minnesota, 55102, United States

RECRUITING

Essentia Health Sandstone

Sandstone, Minnesota, 55072, United States

RECRUITING

Essentia Health Virginia Clinic

Virginia, Minnesota, 55792, United States

RECRUITING

University of Kansas Cancer Center - Briarcliff

Kansas City, Missouri, 64116, United States

RECRUITING

University of Kansas Cancer Center - North

Kansas City, Missouri, 64154, United States

RECRUITING

University of Kansas Cancer Center - Lee's Summit

Lee's Summit, Missouri, 64064, United States

RECRUITING

Mercy Hospital South

St Louis, Missouri, 63128, United States

RECRUITING

Mercy Hospital Saint Louis

St Louis, Missouri, 63141, United States

RECRUITING

Community Hospital of Anaconda

Anaconda, Montana, 59711, United States

RECRUITING

Billings Clinic Cancer Center

Billings, Montana, 59101, United States

RECRUITING

Bozeman Health Deaconess Hospital

Bozeman, Montana, 59715, United States

RECRUITING

Benefis Sletten Cancer Institute

Great Falls, Montana, 59405, United States

RECRUITING

Community Medical Center

Missoula, Montana, 59804, United States

RECRUITING

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

RECRUITING

University of Rochester

Rochester, New York, 14642, United States

RECRUITING

Wilmot Cancer Institute at Webster

Webster, New York, 14580, United States

RECRUITING

FirstHealth of the Carolinas-Moore Regional Hospital

Pinehurst, North Carolina, 28374, United States

RECRUITING

Sanford Bismarck Medical Center

Bismarck, North Dakota, 58501, United States

RECRUITING

Essentia Health Cancer Center-South University Clinic

Fargo, North Dakota, 58103, United States

RECRUITING

Sanford Broadway Medical Center

Fargo, North Dakota, 58122, United States

RECRUITING

Sanford Roger Maris Cancer Center

Fargo, North Dakota, 58122, United States

RECRUITING

Aultman Health Foundation

Canton, Ohio, 44710, United States

RECRUITING

Miami Valley Hospital South

Centerville, Ohio, 45459, United States

RECRUITING

Miami Valley Hospital

Dayton, Ohio, 45409, United States

RECRUITING

Premier Blood and Cancer Center

Dayton, Ohio, 45409, United States

RECRUITING

Miami Valley Hospital North

Dayton, Ohio, 45415, United States

RECRUITING

Atrium Medical Center-Middletown Regional Hospital

Franklin, Ohio, 45005-1066, United States

RECRUITING

Miami Valley Cancer Care and Infusion

Greenville, Ohio, 45331, United States

RECRUITING

Upper Valley Medical Center

Troy, Ohio, 45373, United States

RECRUITING

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

Providence Newberg Medical Center

Newberg, Oregon, 97132, United States

RECRUITING

Providence Willamette Falls Medical Center

Oregon City, Oregon, 97045, United States

RECRUITING

Providence Portland Medical Center

Portland, Oregon, 97213, United States

RECRUITING

Providence Saint Vincent Medical Center

Portland, Oregon, 97225, United States

RECRUITING

Saint Joseph's/Candler - Bluffton Campus

Bluffton, South Carolina, 29910, United States

RECRUITING

Prisma Health Cancer Institute - Spartanburg

Boiling Springs, South Carolina, 29316, United States

RECRUITING

Prisma Health Cancer Institute - Easley

Easley, South Carolina, 29640, United States

RECRUITING

Tidelands Georgetown Memorial Hospital

Georgetown, South Carolina, 29440, United States

RECRUITING

Prisma Health Cancer Institute - Butternut

Greenville, South Carolina, 29605, United States

RECRUITING

Prisma Health Cancer Institute - Faris

Greenville, South Carolina, 29605, United States

RECRUITING

Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, 29615, United States

RECRUITING

Prisma Health Cancer Institute - Greer

Greer, South Carolina, 29650, United States

RECRUITING

Prisma Health Cancer Institute - Seneca

Seneca, South Carolina, 29672, United States

RECRUITING

Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, 57104, United States

RECRUITING

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, 57117-5134, United States

RECRUITING

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

VCU Massey Cancer Center at Stony Point

Richmond, Virginia, 23235, United States

RECRUITING

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, 23298, United States

RECRUITING

VCU Community Memorial Health Center

South Hill, Virginia, 23970, United States

RECRUITING

VCU Health Tappahannock Hospital

Tappahannock, Virginia, 22560, United States

RECRUITING

Duluth Clinic Ashland

Ashland, Wisconsin, 54806, United States

RECRUITING

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, 54601, United States

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Specimen Handling; ceralasertib; durvalumab; Immunoglobulin G; Disulfides; Etoposide; Magnetic Resonance Spectroscopy; monalizumab; NK Cell Lectin-Like Receptor Subfamily C; Antibodies, Monoclonal, Humanized; Platinum Compounds; AZD5305

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Sulfides; Anions; Ions; Electrolytes; Inorganic Chemicals; Hydrogen Sulfide; Sulfur Compounds; Organic Chemicals; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Spectrum Analysis; Chemistry Techniques, Analytical; Receptors, NK Cell Lectin-Like; Receptors, Natural Killer Cell; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins; Antibodies, Monoclonal

Study Officials

• Anne C Chiang

  SWOG Cancer Research Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: January 10, 2025
• Study Start: November 6, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: March 30, 2026

Record last verified: 2026-01

Locations

US (148)