Actively Recruiting
PRISM: Precision in Small Cell Lung Cancer Via Randomized Phase II Studies Evaluating Maintenance Durvalumab With or Without Biomarker-Directed Therapy for Extensive Stage Small Cell Lung Cancer
Led by SWOG Cancer Research Network ยท Updated on 2026-03-30
900
Participants Needed
148
Research Sites
52 weeks
Total Duration
On this page
Sponsors
S
SWOG Cancer Research Network
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating biomarker tests on tumor tissue to select personalized maintenance treatments for patients with extensive stage small cell lung cancer (ES-SCLC). This phase II trial aims to determine how well these tests identify cancer subtypes and guide targeted therapies. The study also compares different maintenance treatments, including durvalumab, saruparib, ceralasertib, and monalizumab, which may affect tumor growth and immune response. Participants receive induction treatment with a platinum compound, etoposide, and durvalumab every 28 days for 4 to 6 cycles. After possible thoracic radiation, they are assigned to one of three cohorts based on cancer subtype and SLFN11 status. Each cohort is randomized to receive durvalumab alone or combined with another drug: saruparib for cohort A, ceralasertib for cohort B, or monalizumab for cohort C. Maintenance cycles repeat every 28 days if disease does not progress or toxicity occurs. During the study, participants undergo imaging tests such as CT, PET/CT, or MRI scans, and tissue and blood samples are collected for analysis. Researchers monitor progression-free survival and overall survival, as well as treatment safety and side effects, for up to three years. After completing study treatment, patients are followed for up to three years to assess long-term outcomes and collect specimens for future research.
CONDITIONS
Brief Title
Using Biomarker Tests to Select and Test New, Personalized Treatments for Extensive Stage Small Cell Lung Cancer, PRISM Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 18 years or older at the time of registration
- Diagnosis of extensive stage small cell lung cancer (ES-SCLC) without history of limited stage SCLC
- Treatment-naive and planning to receive frontline induction treatment with platinum plus etoposide and durvalumab, or have completed 1 to 3 cycles of such treatment
- No prior immunotherapy for SCLC other than durvalumab
- No prior investigational agents for ES-SCLC
- Able to safely receive frontline induction treatment with platinum plus etoposide and durvalumab
- Zubrod performance status of 0 to 2 within 28 days prior to registration
- Fully recovered from prior surgery within 28 days prior to registration
- Adequate tumor tissue available for testing and consent to tissue and specimen use
- Completion of frontline induction therapy with 4 to 6 cycles of platinum plus etoposide and 4 cycles of durvalumab
- No disease progression during induction treatment
- Completion of consolidation thoracic radiation therapy at least 14 days prior to cohort registration, if applicable
- Body weight over 30 kg
- Adequate blood counts and organ function within 28 days prior to cohort registration
- Not pregnant or nursing and agreement to use effective contraception during and 6 months after therapy
- No live vaccines within 30 days prior to cohort registration
- Ability to provide informed consent
You will not qualify if you...
- History of limited stage small cell lung cancer
- Prior immunotherapy for SCLC other than durvalumab
- Receipt of non-protocol chemotherapy, immunotherapy, biologic, or hormonal therapy during study treatment
- Unresolved toxicity grade 2 or higher from previous anticancer therapy except alopecia and vitiligo
- History of allogenic organ transplantation
- Medical contraindications to immunotherapy, including recent autoimmune disease requiring systemic treatment or pneumonitis requiring steroids
- Presence of symptomatic brain metastases or leptomeningeal disease unless treated and stable
- Disease progression during induction treatment
- Receipt of prophylactic cranial irradiation
- Live or live attenuated vaccine within 30 days prior to cohort registration
- Pregnancy or nursing
- Known HIV, HBV, or HCV infection not controlled or treated as specified
- Grade 3 or worse immune-mediated adverse events during induction requiring discontinuation of durvalumab
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 to 6 months
Participants receive frontline induction treatment with platinum plus etoposide and durvalumab intravenously every 28 days for 4 to 6 cycles in the absence of disease progression or unacceptable toxicity.
4 to 6 visits (in-person, every 28 days)
Duration - Up to 3 weeks
Participants may undergo thoracic radiation therapy as clinically indicated after induction treatment.
Approximately 1 to 2 visits depending on clinical need
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants are assigned to one of three cohorts based on small cell lung cancer subtype and SLFN11 status and randomized to receive durvalumab alone or in combination with another drug every 28 days in the absence of disease progression or unacceptable toxicity.
Monthly visits every 28 days for treatment and monitoring
Duration - Throughout the study duration
Participants undergo regular CT, PET/CT, or MRI scans and may have blood samples collected throughout the study to monitor disease status and safety.
Scheduled imaging visits and blood sample collections aligned with treatment visits
Duration - Up to 3 years
After completion of study treatment, participants are followed for up to 3 years to monitor long-term outcomes and safety.
Periodic follow-up visits as scheduled
Trial Site Locations
Total: 148 locations
1
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Actively Recruiting
2
Eisenhower Medical Center
Rancho Mirage, California, United States, 92270
Actively Recruiting
3
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
4
UCHealth University of Colorado Hospital
Aurora, Colorado, United States, 80045
Actively Recruiting
5
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, United States, 80909
Actively Recruiting
6
Memorial Hospital North
Colorado Springs, Colorado, United States, 80920
Actively Recruiting
7
Poudre Valley Hospital
Fort Collins, Colorado, United States, 80524
Actively Recruiting
8
Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado, United States, 80528
Actively Recruiting
9
Lutheran Hospital - Cancer Centers of Colorado
Golden, Colorado, United States, 80401
Actively Recruiting
10
UCHealth Greeley Hospital
Greeley, Colorado, United States, 80631
Actively Recruiting
11
Medical Center of the Rockies
Loveland, Colorado, United States, 80538
Actively Recruiting
12
Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut, United States, 06418
Actively Recruiting
13
Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut, United States, 06824
Actively Recruiting
14
Smilow Cancer Hospital Care Center - Guilford
Guilford, Connecticut, United States, 06437
Actively Recruiting
15
Yale University
New Haven, Connecticut, United States, 06520
Actively Recruiting
16
Yale-New Haven Hospital North Haven Medical Center
North Haven, Connecticut, United States, 06473
Actively Recruiting
17
Smilow Cancer Hospital-Torrington Care Center
Torrington, Connecticut, United States, 06790
Actively Recruiting
18
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, United States, 06611
Actively Recruiting
19
Smilow Cancer Hospital-Waterbury Care Center
Waterbury, Connecticut, United States, 06708
Actively Recruiting
20
Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut, United States, 06385
Actively Recruiting
21
Helen F Graham Cancer Center
Newark, Delaware, United States, 19713
Actively Recruiting
22
Medical Oncology Hematology Consultants PA
Newark, Delaware, United States, 19713
Actively Recruiting
23
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, United States, 31405
Actively Recruiting
24
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, United States, 83814
Actively Recruiting
25
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho, United States, 83687
Actively Recruiting
26
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, United States, 83854
Actively Recruiting
27
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, United States, 83864
Actively Recruiting
28
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
29
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, United States, 60115
Actively Recruiting
30
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, United States, 60134
Actively Recruiting
31
Northwestern Medicine Glenview Outpatient Center
Glenview, Illinois, United States, 60026
Actively Recruiting
32
Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois, United States, 60030
Actively Recruiting
33
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, United States, 60045
Actively Recruiting
34
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Actively Recruiting
35
Northwestern Medicine Oak Brook
Oak Brook, Illinois, United States, 60523
Actively Recruiting
36
Northwestern Medicine Orland Park
Orland Park, Illinois, United States, 60462
Actively Recruiting
37
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, United States, 60555
Actively Recruiting
38
Mary Greeley Medical Center
Ames, Iowa, United States, 50010
Actively Recruiting
39
McFarland Clinic - Ames
Ames, Iowa, United States, 50010
Actively Recruiting
40
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, United States, 50023
Actively Recruiting
41
McFarland Clinic - Boone
Boone, Iowa, United States, 50036
Suspended
42
Mercy Hospital
Cedar Rapids, Iowa, United States, 52403
Actively Recruiting
43
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, United States, 52403
Actively Recruiting
44
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, United States, 50325
Actively Recruiting
45
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Actively Recruiting
46
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, United States, 50309
Actively Recruiting
47
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
Actively Recruiting
48
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, United States, 50314
Actively Recruiting
49
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa, United States, 50501
Actively Recruiting
50
McFarland Clinic - Jefferson
Jefferson, Iowa, United States, 50129
Suspended
51
McFarland Clinic - Marshalltown
Marshalltown, Iowa, United States, 50158
Actively Recruiting
52
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa, United States, 50263
Actively Recruiting
53
The Iowa Clinic PC
West Des Moines, Iowa, United States, 50266
Actively Recruiting
54
University of Kansas Clinical Research Center
Fairway, Kansas, United States, 66205
Actively Recruiting
55
University of Kansas Cancer Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
56
The University of Kansas Cancer Center - Olathe
Olathe, Kansas, United States, 66061
Actively Recruiting
57
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, United States, 66210
Actively Recruiting
58
Salina Regional Health Center
Salina, Kansas, United States, 67401
Actively Recruiting
59
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, United States, 66205
Actively Recruiting
60
Baptist Health Corbin
Corbin, Kentucky, United States, 40701
Actively Recruiting
61
Baptist Health Lexington
Lexington, Kentucky, United States, 40503
Actively Recruiting
62
Baptist Health Hamburg
Lexington, Kentucky, United States, 40509
Actively Recruiting
63
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
64
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Actively Recruiting
65
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States, 01805
Actively Recruiting
66
Lahey Medical Center-Peabody
Peabody, Massachusetts, United States, 01960
Actively Recruiting
67
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, United States, 48114
Actively Recruiting
68
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, United States, 48188
Actively Recruiting
69
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, United States, 48118
Actively Recruiting
70
Henry Ford Health Saint John Hospital
Detroit, Michigan, United States, 48236
Actively Recruiting
71
Henry Ford River District Hospital
East China Township, Michigan, United States, 48054
Actively Recruiting
72
Henry Ford Saint John Hospital - Academic
Grosse Pointe Woods, Michigan, United States, 48236
Actively Recruiting
73
Henry Ford Saint John Hospital - Breast
Grosse Pointe Woods, Michigan, United States, 48236
Actively Recruiting
74
Henry Ford Saint John Hospital - Van Elslander
Grosse Pointe Woods, Michigan, United States, 48236
Actively Recruiting
75
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, United States, 48912
Actively Recruiting
76
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, United States, 48154
Actively Recruiting
77
Henry Ford Saint John Hospital - Macomb Medical
Macomb, Michigan, United States, 48044
Actively Recruiting
78
Henry Ford Warren Hospital - Breast Macomb
Macomb, Michigan, United States, 48044
Actively Recruiting
79
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, United States, 48341
Actively Recruiting
80
Henry Ford Health Warren Hospital
Warren, Michigan, United States, 48093
Actively Recruiting
81
Henry Ford Madison Heights Hospital - Breast
Warren, Michigan, United States, 48093
Actively Recruiting
82
Henry Ford Warren Hospital - GLCMS
Warren, Michigan, United States, 48093
Actively Recruiting
83
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, United States, 48197
Actively Recruiting
84
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, United States, 56601
Actively Recruiting
85
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, United States, 56401
Actively Recruiting
86
Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Actively Recruiting
87
Essentia Health - Deer River Clinic
Deer River, Minnesota, United States, 56636
Actively Recruiting
88
Essentia Health Cancer Center
Duluth, Minnesota, United States, 55805
Actively Recruiting
89
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
Actively Recruiting
90
Essentia Health Hibbing Clinic
Hibbing, Minnesota, United States, 55746
Actively Recruiting
91
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States, 55109
Actively Recruiting
92
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Actively Recruiting
93
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Actively Recruiting
94
New Ulm Medical Center
New Ulm, Minnesota, United States, 56073
Actively Recruiting
95
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States, 55416
Actively Recruiting
96
Regions Hospital
Saint Paul, Minnesota, United States, 55101
Actively Recruiting
97
United Hospital
Saint Paul, Minnesota, United States, 55102
Actively Recruiting
98
Essentia Health Sandstone
Sandstone, Minnesota, United States, 55072
Actively Recruiting
99
Essentia Health Virginia Clinic
Virginia, Minnesota, United States, 55792
Actively Recruiting
100
University of Kansas Cancer Center - Briarcliff
Kansas City, Missouri, United States, 64116
Actively Recruiting
101
University of Kansas Cancer Center - North
Kansas City, Missouri, United States, 64154
Actively Recruiting
102
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, United States, 64064
Actively Recruiting
103
Mercy Hospital South
St Louis, Missouri, United States, 63128
Actively Recruiting
104
Mercy Hospital Saint Louis
St Louis, Missouri, United States, 63141
Actively Recruiting
105
Community Hospital of Anaconda
Anaconda, Montana, United States, 59711
Actively Recruiting
106
Billings Clinic Cancer Center
Billings, Montana, United States, 59101
Actively Recruiting
107
Bozeman Health Deaconess Hospital
Bozeman, Montana, United States, 59715
Actively Recruiting
108
Benefis Sletten Cancer Institute
Great Falls, Montana, United States, 59405
Actively Recruiting
109
Community Medical Center
Missoula, Montana, United States, 59804
Actively Recruiting
110
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
111
University of Rochester
Rochester, New York, United States, 14642
Actively Recruiting
112
Wilmot Cancer Institute at Webster
Webster, New York, United States, 14580
Actively Recruiting
113
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst, North Carolina, United States, 28374
Actively Recruiting
114
Sanford Bismarck Medical Center
Bismarck, North Dakota, United States, 58501
Actively Recruiting
115
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota, United States, 58103
Actively Recruiting
116
Sanford Broadway Medical Center
Fargo, North Dakota, United States, 58122
Actively Recruiting
117
Sanford Roger Maris Cancer Center
Fargo, North Dakota, United States, 58122
Actively Recruiting
118
Aultman Health Foundation
Canton, Ohio, United States, 44710
Actively Recruiting
119
Miami Valley Hospital South
Centerville, Ohio, United States, 45459
Actively Recruiting
120
Miami Valley Hospital
Dayton, Ohio, United States, 45409
Actively Recruiting
121
Premier Blood and Cancer Center
Dayton, Ohio, United States, 45409
Actively Recruiting
122
Miami Valley Hospital North
Dayton, Ohio, United States, 45415
Actively Recruiting
123
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, United States, 45005-1066
Actively Recruiting
124
Miami Valley Cancer Care and Infusion
Greenville, Ohio, United States, 45331
Actively Recruiting
125
Upper Valley Medical Center
Troy, Ohio, United States, 45373
Actively Recruiting
126
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
127
Providence Newberg Medical Center
Newberg, Oregon, United States, 97132
Actively Recruiting
128
Providence Willamette Falls Medical Center
Oregon City, Oregon, United States, 97045
Actively Recruiting
129
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Actively Recruiting
130
Providence Saint Vincent Medical Center
Portland, Oregon, United States, 97225
Actively Recruiting
131
Saint Joseph's/Candler - Bluffton Campus
Bluffton, South Carolina, United States, 29910
Actively Recruiting
132
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, United States, 29316
Actively Recruiting
133
Prisma Health Cancer Institute - Easley
Easley, South Carolina, United States, 29640
Actively Recruiting
134
Tidelands Georgetown Memorial Hospital
Georgetown, South Carolina, United States, 29440
Actively Recruiting
135
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, United States, 29605
Actively Recruiting
136
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, United States, 29605
Actively Recruiting
137
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, United States, 29615
Actively Recruiting
138
Prisma Health Cancer Institute - Greer
Greer, South Carolina, United States, 29650
Actively Recruiting
139
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, United States, 29672
Actively Recruiting
140
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, United States, 57104
Actively Recruiting
141
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States, 57117-5134
Actively Recruiting
142
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
143
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, United States, 23235
Actively Recruiting
144
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States, 23298
Actively Recruiting
145
VCU Community Memorial Health Center
South Hill, Virginia, United States, 23970
Actively Recruiting
146
VCU Health Tappahannock Hospital
Tappahannock, Virginia, United States, 22560
Actively Recruiting
147
Duluth Clinic Ashland
Ashland, Wisconsin, United States, 54806
Actively Recruiting
148
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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