Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06769126

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

Led by SWOG Cancer Research Network · Updated on 2026-03-30

900

Participants Needed

148

Research Sites

216 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

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • No prior or concurrent cancer that might interfere with treatment or safety assessment
  • No history of limited stage small cell lung cancer
  • Treatment naive or have received 1 to 3 cycles of frontline induction therapy with platinum plus etoposide and durvalumab
  • No prior immunotherapy for SCLC other than durvalumab
  • No investigational agents received for ES-SCLC
  • No concurrent non-protocol chemotherapy, immunotherapy, biologic, or hormonal therapy planned during study
  • No unresolved grade 2 or higher toxicity from previous anticancer therapy except alopecia or vitiligo
  • At least 18 years old
  • Able to safely receive platinum plus etoposide with durvalumab
  • Zubrod performance status 0-2 within 28 days before registration
  • Fully recovered from prior surgery within 28 days before registration
  • No history of allogenic organ transplantation
  • No medical contraindications to immunotherapy including recent active autoimmune disease or pneumonitis
  • Not pregnant or nursing and agree to use effective contraception during and 6 months after therapy
  • Adequate tumor tissue available and consent to submit for biomarker testing and future studies
  • Disease assessed by CT or MRI scans as required before cohort registration
  • No leptomeningeal disease, spinal cord compression, or symptomatic brain metastases unless treated and stable
  • No disease progression during induction treatment
  • Completed frontline induction therapy with required cycles of platinum plus etoposide and durvalumab
  • Completed consolidation thoracic radiation at least 14 days prior if received
  • Registration timing between 3 to 8 weeks after last frontline induction therapy dose
  • No prior treatment with atezolizumab, pembrolizumab, nivolumab, or prophylactic cranial irradiation
  • Complete medical history and physical exam within 28 days before cohort registration
  • Body weight over 30 kg
  • Hemoglobin above 9.0 g/dL, neutrophils above 1.5 x10^3/uL, platelets above 100 x10^3/uL
  • Liver and kidney function within specified limits
  • If HIV, HBV, or HCV positive, meet viral load and treatment status requirements
  • No severe immune-mediated adverse events during induction or unresolved moderate irAEs
  • No live vaccines within 30 days prior to cohort registration
  • Consent to participate and specimen banking
Not Eligible

You will not qualify if you...

  • History of limited stage small cell lung cancer
  • Prior immunotherapy for SCLC other than durvalumab
  • Prior investigational agents for ES-SCLC
  • Concurrent non-protocol treatments planned
  • Unresolved toxicities grade 2 or higher from previous therapies except alopecia or vitiligo
  • History of allogenic organ transplantation
  • Medical contraindications to immunotherapy, including recent active autoimmune disease or pneumonitis
  • Pregnant or nursing
  • Disease progression during induction therapy
  • Prior treatment with atezolizumab, pembrolizumab, nivolumab, or prophylactic cranial irradiation
  • Symptomatic brain metastases not treated or stable
  • Severe immune-mediated adverse events during induction or unresolved moderate irAEs
  • Receipt of live or live attenuated vaccines within 30 days prior to cohort registration

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

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

Loading map...

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

6

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here