Lung-MAP: A Master Screening Protocol for Previously-Treated Non-Small Cell Lung Cancer
Purpose
This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study hybrid Master Protocol (Lung-MAP). The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes non-match sub-studies which will include all screened patients not eligible for any of the biomarker-driven sub-studies.
Condition
- Previously Treated Non-Small Cell Lung Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Criteria
5.1 Registration
Step 0:
1. Patients who need the fresh biopsy must also submit whole blood for ctDNA testing
(see Section 15.3). These patients must be registered to Step 0 to obtain a patient
ID number for the submission.
Patients registered to Step 0 are not registered to the LUNGMAP protocol. To
participate in LUNGMAP, patients must be registered to Step 1 after evaluation of
patient eligibility, including tumor tissue adequacy, per protocol Section 5.1, Step
1.
Patients registered at Step 0 must use the same SWOG patient ID for registration at
Step 1.
Step 1:
2. Patients must have pathologically proven non-small cell lung cancer (all histologic
types) confirmed by tumor biopsy and/or fine-needle aspiration. Disease must be
Stage IV as defined in Section 4.0, or recurrent. The primary diagnosis of non-small
cell lung cancer should be established using the current WHO/IASLC-classification of
Thoracic Malignancies. All histologies, including mixed, are allowed.
3. Patients must either be eligible to be screened at progression on prior treatment or
to be pre-screened prior to progression on current treatment.
These criteria are:
1. Screening at progression on prior treatment:
To be eligible for screening at progression, patients must have received at
least one line of systemic therapy for any stage of disease (Stages I-IV) and
must have progressed during or following their most recent line of therapy.
- For patients whose prior systemic therapy was for Stage I-III disease only
(i.e. patient has not received any treatment for Stage IV or recurrent
disease), disease progression on platinum-based chemotherapy must have
occurred within one year from the last date that patient received that
therapy. For patients treated with consolidation anti-PD-1 or anti-PD-L1
therapy for Stage III disease, disease progression on consolidation
anti-PD-1 or anti-PD-L1 therapy must have occurred within one year from
the date or initiation of such therapy.
- For patients whose prior therapy was for Stage IV or recurrent disease,
the patient must have received at least one line of a platinum-based
chemotherapy regimen or anti-PD-1/PD-L1 therapy, alone or in combination
(e.g. Nivolumab or Pembrolizumab).
2. Pre-Screening prior to progression on current treatment:
To be eligible for pre-screening, current treatment must be for Stage IV or
recurrent disease and patient must have received at least one dose of the current
regimen. Patients must have previously received or currently be receiving a
platinum-based chemotherapy regimen or anti-PD-1/PD-L1 therapy, alone or in
combination (e.g. Nivolumab or Pembrolizumab). Patients on first-line treatment are
eligible upon receiving Cycle 1, Day 1 infusion. Note: Patients will not receive
their sub-study assignment until they progress and the LUNGMAP Notice of Progression
is submitted.
4. Patients must have adequate tumor tissue available, defined as ≥ 20% tumor cells and
≥ 0.2 mm3 tumor volume.
- The local interpreting pathologist must review the specimen.
- The pathologist must sign the LUNGMAP Local Pathology Review Form confirming
tissue adequacy prior to Step 1 registration.
Patients must agree to have this tissue submitted to Foundation Medicine for common
broad platform CLIA biomarker profiling, PD-L1, and c-MET IHC (see Section 15.2). If
archival tumor material is exhausted, then a new fresh tumor biopsy that is
formalin-fixed and paraffin-embedded (FFPE) must be obtained. Patients who need the
fresh biopsy must also submit whole peripheral blood for ctDNA testing. A tumor
block or FFPE slides 4-5 microns thick must be submitted. Bone biopsies are not
allowed. If FFPE slides are to be submitted, at least 12 unstained slides plus an
H&E stained slide, or 13 unstained slides must be submitted. However, it is strongly
recommended that 20 FFPE slides be submitted. Note: Previous next-generation DNA
sequencing (NGS) will be repeated if done outside this study for sub-study
assignment.
Patients must agree to have any tissue that remains after testing retained for the
use of sub-study Translational Medicine (TM) studies at the time of consent the
patient is enrolled in.
5. Patients with known EGFR sensitizing mutations, EGFR T790M mutation, ALK gene
fusion, ROS 1 gene rearrangement, or BRAF V600E mutation are not eligible unless
they have progressed following all standard of care targeted therapy.
EGFR/ALK/ROS/BRAF testing is not required prior to Step 1 registration, as it is
included in the Foundation One testing for screening/pre-screening.
6. Patients must have Zubrod performance status 0-1 (see Section 10.2) documented
within 28 days prior to Step 1 registration.
7. Patients must be ≥ 18 years of age.
8. Patients must also be offered participation in banking for future use of specimens
as described in Section 15.0.
9. Patients must be willing to provide prior smoking history as required on the LUNGMAP
Onstudy Form.
10. As a part of the OPEN registration process (see Section 13.4 for OPEN access
instructions) the treating institution's identity is provided in order to ensure
that the current (within 365 days) date of institutional review board approval for
this study has been entered in the system.
11. Patients must be informed of the investigational nature of this study and must sign
and give written informed consent in accordance with institutional and federal
guidelines.
12. U.S. patients who can complete the survey and the interview by telephone or email in
English must be offered participation in the S1400GEN Survey Ancillary Study if
local institution's policies allow participants to receive the Amazon gift card (see
Sections 15.7 and 18.5). Patients at institutions that cannot offer the survey must
still participate in the main study.
Study Design
- Phase
- Phase 2/Phase 3
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Sequential Assignment
- Intervention Model Description
- The Lung-MAP study is an umbrella protocol which contains a screening component and a clinical trial component. Patients are allowed to participate in the screening component either at progression on prior therapy or to be pre-screened while receiving therapy for stage IV or recurrent NSCLC. The clinical trial component consists of biomarker-driven studies evaluating drug-biomarker combination for patients determined to have a matching biomarker and non-match studies evaluating therapies in patients without any of the study biomarkers.
- Primary Purpose
- Screening
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Other Lung-MAP Screening |
This is a screening study and does not have an intervention. LUNGMAP is an overarching umbrella study to which patients are screened and then assigned to a treatment sub-study. The treatment sub-studies are standalone trials and have their own NCT numbers. The Lung-MAP Study is considered a single study under one IND, consisting of the Screening Protocol and multiple sub-studies. Each sub-study protocol operates independently and has its own version date. |
|
Recruiting Locations
Anchorage 5879400, Alaska 5879092 98508
Anchorage 5879400, Alaska 5879092 99508
Anchorage 5879400, Alaska 5879092 99508
Anchorage 5879400, Alaska 5879092 99508
Anchorage 5879400, Alaska 5879092 99508
Anchorage 5879400, Alaska 5879092 99508
Fairbanks 5861897, Alaska 5879092 99701
Goodyear 5296266, Arizona 5551752 85338
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Jonesboro 4116834, Arkansas 4099753 72401
Little Rock 4119403, Arkansas 4099753 72205
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Anaheim 5323810, California 5332921 92806
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Baldwin Park 5325866, California 5332921 91706
Bellflower 5327422, California 5332921 90706
Berkeley 5327684, California 5332921 94704
Beverly Hills 5328041, California 5332921 90211
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Alton 4232679, Illinois 4896861 62002
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Ames 4846834, Iowa 4862182 50010
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Lawrence 4274277, Kansas 4273857 66044
Olathe 4276614, Kansas 4273857 66061
Overland Park 4276873, Kansas 4273857 66210
Overland Park 4276873, Kansas 4273857 66211
Pittsburg 4277241, Kansas 4273857 66762
Salina 4278890, Kansas 4273857 67401
Topeka 4280539, Kansas 4273857 66606
Site Public Contact
785-270-4939
Topeka 4280539, Kansas 4273857 66606
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785-295-8000
Westwood 4281639, Kansas 4273857 66205
Ashland 4282757, Kentucky 6254925 41101
Site Public Contact
606-327-6499
Corbin 4288656, Kentucky 6254925 40701
Site Public Contact
859-523-1934
Elizabethtown 4290988, Kentucky 6254925 42701
Site Public Contact
270-706-5470
Lexington 4297983, Kentucky 6254925 40503
Site Public Contact
859-260-6425
Lexington 4297983, Kentucky 6254925 40509
Site Public Contact
866-213-3025
Lexington 4297983, Kentucky 6254925 40536
Site Public Contact
859-257-3379
London 4298960, Kentucky 6254925 40741
Louisville 4299276, Kentucky 6254925 40207
Owensboro 4303436, Kentucky 6254925 42303
Paducah 4048662, Kentucky 6254925 42003
Site Public Contact
270-575-2928
Paducah 4048662, Kentucky 6254925 42003
Richmond 4305974, Kentucky 6254925 40475
Baton Rouge 4315588, Louisiana 4331987 70805
Baton Rouge 4315588, Louisiana 4331987 70808
Baton Rouge 4315588, Louisiana 4331987 70808
Site Public Contact
225-765-7659
Baton Rouge 4315588, Louisiana 4331987 70809
Baton Rouge 4315588, Louisiana 4331987 70809
Covington 4321005, Louisiana 4331987 70433
Houma 4328010, Louisiana 4331987 70360
New Orleans 4335045, Louisiana 4331987 70112
Augusta 4957003, Maine 4971068 04330
Site Public Contact
207-626-4855
Bangor 4957280, Maine 4971068 04401
Site Public Contact
207-973-4274
Belfast 4957956, Maine 4971068 04915
Site Public Contact
207-338-2500
Biddeford 4958141, Maine 4971068 04005
Brewer 4959233, Maine 4971068 04412
Site Public Contact
800-987-3005
Rockport 4976817, Maine 4971068 04856
Sanford 4977762, Maine 4971068 04073
South Portland 4979244, Maine 4971068 04106
Annapolis 4347242, Maryland 4361885 21401
Baltimore 4347778, Maryland 4361885 21215
Baltimore 4347778, Maryland 4361885 21244
Cumberland 4352681, Maryland 4361885 21502
Site Public Contact
240-964-1400
Elkton 4354234, Maryland 4361885 21921
Gaithersburg 4355843, Maryland 4361885 20879
Kensington 4359760, Maryland 4361885 20895
Largo 4360345, Maryland 4361885 20774
Lutherville 4361379, Maryland 4361885 21093
Ocean Pines 4364326, Maryland 4361885 21811
Randallstown 4366476, Maryland 4361885 21133
Salisbury 4368711, Maryland 4361885 21801
Westminster 4373238, Maryland 4361885 21157
Site Public Contact
410-871-6400
Beverly 4930505, Massachusetts 6254926 01915
Site Public Contact
978-922-3000
Burlington 4931737, Massachusetts 6254926 01805
Gloucester 4937829, Massachusetts 6254926 01930
Site Public Contact
978-283-4000
Jamaica Plain 4940764, Massachusetts 6254926 02130
Lowell 4942618, Massachusetts 6254926 01854
Peabody 4946863, Massachusetts 6254926 01960
Springfield 4951788, Massachusetts 6254926 01199
Worcester 4956184, Massachusetts 6254926 01655
Ann Arbor 4984247, Michigan 5001836 48106
Ann Arbor 4984247, Michigan 5001836 48109
Battle Creek 4985153, Michigan 5001836 49017
Brighton 4986994, Michigan 5001836 48114
Brighton 4986994, Michigan 5001836 48114
Brighton 4986994, Michigan 5001836 48116
Site Public Contact
800-865-1125
Brownstown, Michigan 5001836 48183
Canton 4987990, Michigan 5001836 48188
Canton 4987990, Michigan 5001836 48188
Chelsea 4988628, Michigan 5001836 48118
Chelsea 4988628, Michigan 5001836 48118
Clarkston 4988997, Michigan 5001836 48346
Clarkston 4988997, Michigan 5001836 48346
Clinton Township 4989133, Michigan 5001836 48038
Clinton Township 4989133, Michigan 5001836 48038
Dearborn 4990510, Michigan 5001836 48126
Detroit 4990729, Michigan 5001836 48202
Detroit 4990729, Michigan 5001836 48236
East China Township, Michigan 5001836 48054
Escanaba 4992232, Michigan 5001836 49829
Flint 4992982, Michigan 5001836 48503
Flint 4992982, Michigan 5001836 48503
Flint 4992982, Michigan 5001836 48503
Flint 4992982, Michigan 5001836 48503
Grand Rapids 4994358, Michigan 5001836 49503
Grosse Pointe Woods 4994871, Michigan 5001836 48236
Grosse Pointe Woods 4994871, Michigan 5001836 48236
Grosse Pointe Woods 4994871, Michigan 5001836 48236
Jackson 4997384, Michigan 5001836 49201
Kalamazoo 4997787, Michigan 5001836 49007
Kalamazoo 4997787, Michigan 5001836 49007
Kalamazoo 4997787, Michigan 5001836 49009
Kalamazoo 4997787, Michigan 5001836 49048
Lansing 4998830, Michigan 5001836 48912
Livonia 4999837, Michigan 5001836 48154
Macomb 5000473, Michigan 5001836 48044
Macomb 5000473, Michigan 5001836 48044
Novi 5004062, Michigan 5001836 48377
Pontiac 5006166, Michigan 5001836 48341
Pontiac 5006166, Michigan 5001836 48341
Pontiac 5006166, Michigan 5001836 48341
Pontiac 5006166, Michigan 5001836 48341
Saginaw 5007989, Michigan 5001836 48601
Tawas City 5011900, Michigan 5001836 48764
Traverse City 5012495, Michigan 5001836 49684
Warren 5014051, Michigan 5001836 48093
Warren 5014051, Michigan 5001836 48093
Warren 5014051, Michigan 5001836 48093
West Bloomfield 7259621, Michigan 5001836 48322
Ypsilanti 5015688, Michigan 5001836 48106
Ypsilanti 5015688, Michigan 5001836 48197
Aitkin 5015978, Minnesota 5037779 56431
Baxter 5017396, Minnesota 5037779 56425
Site Public Contact
218-828-2880
Bemidji 5017822, Minnesota 5037779 56601
Brainerd 5019116, Minnesota 5037779 56401
Burnsville 5019767, Minnesota 5037779 55337
Cambridge 5020068, Minnesota 5037779 55008
Coon Rapids 5022025, Minnesota 5037779 55433
Deer River 5024099, Minnesota 5037779 56636
Detroit Lakes 5024237, Minnesota 5037779 56501
Duluth 5024719, Minnesota 5037779 55805
Duluth 5024719, Minnesota 5037779 55805
Duluth 5024719, Minnesota 5037779 55805
Edina 5025264, Minnesota 5037779 55435
Ely 5025627, Minnesota 5037779 55731
Site Public Contact
218-365-7900
Fosston 5027191, Minnesota 5037779 56542
Hibbing 5030005, Minnesota 5037779 55746
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218-786-3308
International Falls 5031404, Minnesota 5037779 56649
Site Public Contact
218-283-9431
Maple Grove 5036493, Minnesota 5037779 55369
Maplewood 5036588, Minnesota 5037779 55109
Maplewood 5036588, Minnesota 5037779 55109
Minneapolis 5037649, Minnesota 5037779 55407
Minneapolis 5037649, Minnesota 5037779 55415
Minneapolis 5037649, Minnesota 5037779 55417
Site Public Contact
612-467-2800
Minneapolis 5037649, Minnesota 5037779 55454
Monticello 5038045, Minnesota 5037779 55362
Moose Lake 5038132, Minnesota 5037779 55767
Site Public Contact
218-485-4481
New Ulm 5039173, Minnesota 5037779 56073
Park Rapids 5040822, Minnesota 5037779 56470
Princeton 5042360, Minnesota 5037779 55371
Robbinsdale 5043439, Minnesota 5037779 55422
Saint Louis Park 5045021, Minnesota 5037779 55416
Saint Paul 5045360, Minnesota 5037779 55101
Saint Paul 5045360, Minnesota 5037779 55102
Sandstone 5045908, Minnesota 5037779 55072
Shakopee 5046997, Minnesota 5037779 55379
Stillwater 5048814, Minnesota 5037779 55082
Thief River Falls 5049970, Minnesota 5037779 56701
Site Public Contact
605-312-3320
Virginia 5051468, Minnesota 5037779 55792
Waconia 5051640, Minnesota 5037779 55387
Willmar 5052916, Minnesota 5037779 56201
Woodbury 5053358, Minnesota 5037779 55125
Worthington 5053460, Minnesota 5037779 56187
Site Public Contact
605-312-3320
Wyoming 5053526, Minnesota 5037779 55092
Columbus 4422442, Mississippi 4436296 39705
Grenada 4428539, Mississippi 4436296 38901
Gulfport 4428667, Mississippi 4436296 39502
Jackson 4431410, Mississippi 4436296 39216
Site Public Contact
601-815-6700
New Albany 4438121, Mississippi 4436296 38652
Oxford 4440076, Mississippi 4436296 38655
Southhaven 4446702, Mississippi 4436296 38671
Ballwin 4375663, Missouri 4398678 63011
Site Public Contact
314-251-7058
Chesterfield 4381072, Missouri 4398678 63017
Site Public Contact
314-205-6936
City of Saint Peters 4407237, Missouri 4398678 63376
Creve Coeur 4382837, Missouri 4398678 63141
Farmington 4386289, Missouri 4398678 63640
Site Public Contact
314-996-5569
Kansas City 4393217, Missouri 4398678 64108
Site Public Contact
816-404-4375
Kansas City 4393217, Missouri 4398678 64111
Kansas City 4393217, Missouri 4398678 64128
Site Public Contact
800-525-1483
Kansas City 4393217, Missouri 4398678 64154
Lee's Summit 4394870, Missouri 4398678 64064
Lee's Summit 4394870, Missouri 4398678 64086
North Kansas City 4400860, Missouri 4398678 64116
Sainte Genevieve 4407294, Missouri 4398678 63670
Site Public Contact
314-996-5569
Springfield 4409896, Missouri 4398678 65807
Site Public Contact
417-269-4520
St Louis 4407066, Missouri 4398678 63109
Site Public Contact
314-353-1870
St Louis 4407066, Missouri 4398678 63110
St Louis 4407066, Missouri 4398678 63125
St Louis 4407066, Missouri 4398678 63128
St Louis 4407066, Missouri 4398678 63129
St Louis 4407066, Missouri 4398678 63131
Site Public Contact
314-996-5569
St Louis 4407066, Missouri 4398678 63141
Site Public Contact
314-251-7066
Sullivan 4410669, Missouri 4398678 63080
Site Public Contact
314-996-5569
Sunset Hills 4410836, Missouri 4398678 63127
Site Public Contact
314-996-5569
Anaconda 5637146, Montana 5667009 59711
Billings 5640350, Montana 5667009 59101
Bozeman 5641727, Montana 5667009 59715
Great Falls 5655240, Montana 5667009 59405
Great Falls 5655240, Montana 5667009 59405
Havre 5656497, Montana 5667009 59501
Kalispell 5660340, Montana 5667009 59901
Missoula 5666639, Montana 5667009 59802
Missoula 5666639, Montana 5667009 59804
Omaha 5074472, Nebraska 5073708 68114
Site Public Contact
402-334-4773
Omaha 5074472, Nebraska 5073708 68114
Site Public Contact
402-354-5144
Omaha 5074472, Nebraska 5073708 68114
Carson City 5501344, Nevada 5509151 89703
Henderson 5505411, Nevada 5509151 89052
Henderson 5505411, Nevada 5509151 89052
Henderson 5505411, Nevada 5509151 89052
Henderson 5505411, Nevada 5509151 89052
Henderson 5505411, Nevada 5509151 89074
Henderson 5505411, Nevada 5509151 89074
Henderson 5505411, Nevada 5509151 89074
Henderson 5505411, Nevada 5509151 89074
Henderson 5505411, Nevada 5509151 89074
Las Vegas 5506956, Nevada 5509151 89074
Las Vegas 5506956, Nevada 5509151 89102
Las Vegas 5506956, Nevada 5509151 89102
Las Vegas 5506956, Nevada 5509151 89103
Las Vegas 5506956, Nevada 5509151 89106
Las Vegas 5506956, Nevada 5509151 89106
Las Vegas 5506956, Nevada 5509151 89109
Las Vegas 5506956, Nevada 5509151 89109
Las Vegas 5506956, Nevada 5509151 89113
Las Vegas 5506956, Nevada 5509151 89113
Las Vegas 5506956, Nevada 5509151 89113
Las Vegas 5506956, Nevada 5509151 89119
Las Vegas 5506956, Nevada 5509151 89128
Las Vegas 5506956, Nevada 5509151 89128
Las Vegas 5506956, Nevada 5509151 89128
Las Vegas 5506956, Nevada 5509151 89128
Las Vegas 5506956, Nevada 5509151 89128
Las Vegas 5506956, Nevada 5509151 89128
Las Vegas 5506956, Nevada 5509151 89128
Las Vegas 5506956, Nevada 5509151 89135
Las Vegas 5506956, Nevada 5509151 89144
Las Vegas 5506956, Nevada 5509151 89144
Las Vegas 5506956, Nevada 5509151 89144
Las Vegas 5506956, Nevada 5509151 89148
Las Vegas 5506956, Nevada 5509151 89148
Las Vegas 5506956, Nevada 5509151 89148
Las Vegas 5506956, Nevada 5509151 89169
Las Vegas 5506956, Nevada 5509151 89169
Pahrump 5509851, Nevada 5509151 89048
Reno 5511077, Nevada 5509151 89502
Reno 5511077, Nevada 5509151 89503
Reno 5511077, Nevada 5509151 89509
Concord 5084868, New Hampshire 5090174 03301
Site Public Contact
603-224-2556
Lebanon 5088597, New Hampshire 5090174 03756
Manchester 5089178, New Hampshire 5090174 03102
Manchester 5089178, New Hampshire 5090174 03103
Site Public Contact
800-339-6484
Nashua 5090046, New Hampshire 5090174 03063
Basking Ridge 5095409, New Jersey 5101760 07920
Site Public Contact
212-639-7592
Holmdel 5099193, New Jersey 5101760 07733
Lakewood 5100280, New Jersey 5101760 08701
Long Branch 5100619, New Jersey 5101760 07740
Middletown 5101170, New Jersey 5101760 07748
Site Public Contact
212-639-7592
Montvale 5101361, New Jersey 5101760 07645
Site Public Contact
212-639-7592
Moorestown 4503106, New Jersey 5101760 08057
Neptune City 5101687, New Jersey 5101760 07753
Site Public Contact
732-776-4240
Red Bank 5103159, New Jersey 5101760 07701
Site Public Contact
732-530-2382
Voorhees Township 5105860, New Jersey 5101760 08043
Albuquerque 5454711, New Mexico 5481136 87106
Albuquerque 5454711, New Mexico 5481136 87110
Rio Rancho 5487811, New Mexico 5481136 87124
Buffalo 5110629, New York 5128638 14263
Commack 5113412, New York 5128638 11725
Site Public Contact
212-639-7592
East Hills 5115904, New York 5128638 11548
Glens Falls 5118693, New York 5128638 12801
Site Public Contact
518-926-6700
Harrison 5120095, New York 5128638 10604
Site Public Contact
212-639-7592
New York 5128581, New York 5128638 10011
New York 5128581, New York 5128638 10029
New York 5128581, New York 5128638 10065
Site Public Contact
212-639-7592
Rochester 5134086, New York 5128638 14642
Site Public Contact
585-275-5830
The Bronx 5110266, New York 5128638 10461
The Bronx 5110266, New York 5128638 10461
The Bronx 5110266, New York 5128638 10467
The Bronx 5110266, New York 5128638 10468
Uniondale 5141927, New York 5128638 11553
Site Public Contact
212-639-7592
West Islip 5143866, New York 5128638 11795
Site Public Contact
516-326-7514
Asheboro 4453035, North Carolina 4482348 27203
Asheville 4453066, North Carolina 4482348 28803
Burlington 4458228, North Carolina 4482348 27215
Cary 4459467, North Carolina 4482348 27518
Clyde 4461150, North Carolina 4482348 28721
Durham 4464368, North Carolina 4482348 27705
Garner 4467657, North Carolina 4482348 27529
Greensboro 4469146, North Carolina 4482348 27403
Greensboro 4469146, North Carolina 4482348 27410
Hendersonville 4470592, North Carolina 4482348 28792
Pinehurst 4485272, North Carolina 4482348 28374
Raleigh 4487042, North Carolina 4482348 27607
Site Public Contact
919-784-7209
Raleigh 4487042, North Carolina 4482348 27607
Raleigh 4487042, North Carolina 4482348 27614
Reidsville 4487682, North Carolina 4482348 27320
Weaverville 4497912, North Carolina 4482348 28787
Winston-Salem 4499612, North Carolina 4482348 27103
Bismarck 5688025, North Dakota 5690763 58501
Fargo 5059163, North Dakota 5690763 58103
Fargo 5059163, North Dakota 5690763 58103
Site Public Contact
701-234-6161
Fargo 5059163, North Dakota 5690763 58103
Site Public Contact
605-312-3320
Fargo 5059163, North Dakota 5690763 58104
Site Public Contact
800-437-4010
Fargo 5059163, North Dakota 5690763 58122
Fargo 5059163, North Dakota 5690763 58122
Jamestown 5059836, North Dakota 5690763 58401
Minot 5690532, North Dakota 5690763 58701
Site Public Contact
800-862-0005
Alliance 5145607, Ohio 5165418 44601
Site Public Contact
330-363-1250
Beavercreek 4506008, Ohio 5165418 45431
Belpre 4506187, Ohio 5165418 45714
Boardman 5147784, Ohio 5165418 44512
Canton 5149222, Ohio 5165418 44708
Site Public Contact
888-293-4673
Canton 5149222, Ohio 5165418 44710
Centerville 4508204, Ohio 5165418 45459
Centerville 4508204, Ohio 5165418 45459
Chillicothe 4828890, Ohio 5165418 45601
Cincinnati 4508722, Ohio 5165418 45220
Cincinnati 4508722, Ohio 5165418 45236
Cincinnati 4508722, Ohio 5165418 45242
Cincinnati 4508722, Ohio 5165418 45247
Cincinnati 4508722, Ohio 5165418 45255
Cleveland 5150529, Ohio 5165418 44106
Cleveland 5150529, Ohio 5165418 44109
Cleveland 5150529, Ohio 5165418 44111
Cleveland 5150529, Ohio 5165418 44195
Columbus 4509177, Ohio 5165418 43213
Columbus 4509177, Ohio 5165418 43219
Columbus 4509177, Ohio 5165418 43222
Dayton 4509884, Ohio 5165418 45409
Dayton 4509884, Ohio 5165418 45409
Site Public Contact
937-276-8320
Dayton 4509884, Ohio 5165418 45415
Dayton 4509884, Ohio 5165418 45415
Findlay 5153924, Ohio 5165418 45840
Findlay 5153924, Ohio 5165418 45840
Findlay 5153924, Ohio 5165418 45840
Franklin 4512203, Ohio 5165418 45005-1066
Franklin 4512203, Ohio 5165418 45005
Gahanna 5155393, Ohio 5165418 43230
Greenville 5156493, Ohio 5165418 45331
Greenville 5156493, Ohio 5165418 45331
Site Public Contact
937-569-7515
Greenville 5156493, Ohio 5165418 45331
Grove City 4513409, Ohio 5165418 43123
Grove City 4513409, Ohio 5165418 43123
Kettering 4515843, Ohio 5165418 45409
Kettering 4515843, Ohio 5165418 45429
Lancaster 4516233, Ohio 5165418 43130
Lima 5160783, Ohio 5165418 45801
Marietta 4517586, Ohio 5165418 45750
Marysville 5162077, Ohio 5165418 43040
Mayfield Heights 5162188, Ohio 5165418 44124
Mount Vernon 5163799, Ohio 5165418 43050
New Albany 5164202, Ohio 5165418 43054
Newark 5164466, Ohio 5165418 43055
Newark 5164466, Ohio 5165418 43055
Perrysburg 5166516, Ohio 5165418 43551
Portsmouth 4521816, Ohio 5165418 45662
Sandusky 5170691, Ohio 5165418 44870
Springfield 4525353, Ohio 5165418 45504
Springfield 4525353, Ohio 5165418 45504
Sylvania 5173572, Ohio 5165418 43560
Toledo 5174035, Ohio 5165418 43606
Toledo 5174035, Ohio 5165418 43608
Toledo 5174035, Ohio 5165418 43623
Toledo 5174035, Ohio 5165418 43623
Troy 5174358, Ohio 5165418 45373
Troy 5174358, Ohio 5165418 45373
Warren 5175865, Ohio 5165418 44484
Warrensville Heights 5175726, Ohio 5165418 44122
Westerville 5176472, Ohio 5165418 43081
Wilmington 4528463, Ohio 5165418 45177
Youngstown 5177568, Ohio 5165418 44501
Zanesville 4528923, Ohio 5165418 43701
Lawton 4540737, Oklahoma 4544379 73505
Site Public Contact
877-231-4440
Oklahoma City 4544349, Oklahoma 4544379 73104
Oklahoma City 4544349, Oklahoma 4544379 73120
Site Public Contact
405-752-3402
Baker City 5712169, Oregon 5744337 97814
Bend 5713587, Oregon 5744337 97701
Clackamas 5719308, Oregon 5744337 97015
Coos Bay 5720495, Oregon 5744337 97420
Newberg 5742726, Oregon 5744337 97132
Ontario 5744166, Oregon 5744337 97914
Oregon City 5744253, Oregon 5744337 97045
Portland 5746545, Oregon 5744337 97213
Portland 5746545, Oregon 5744337 97225
Portland 5746545, Oregon 5744337 97239
Redmond 5747882, Oregon 5744337 97756
Site Public Contact
541-706-2909
Salem 5750162, Oregon 5744337 97301
Site Public Contact
503-561-2618
Allentown 5178127, Pennsylvania 6254927 18103
Bethlehem 5180225, Pennsylvania 6254927 18017
Bryn Mawr 5182063, Pennsylvania 6254927 19010
Carlisle 5183234, Pennsylvania 6254927 17015
Chadds Ford 4557084, Pennsylvania 6254927 19317
Chambersburg 4557109, Pennsylvania 6254927 17201
Chambersburg 4557109, Pennsylvania 6254927 17201
Site Public Contact
717-217-6020
Danville 5186327, Pennsylvania 6254927 17822
East Norriton 7258242, Pennsylvania 6254927 19401
East Stroudsburg 5188075, Pennsylvania 6254927 18301
Ephrata 5188815, Pennsylvania 6254927 17522
Site Public Contact
717-721-4840
Ephrata 5188815, Pennsylvania 6254927 17522
Gettysburg 4558183, Pennsylvania 6254927 17325
Site Public Contact
877-441-7957
Hanover 4558475, Pennsylvania 6254927 17331
Site Public Contact
717-632-1559
Harrisburg 5192726, Pennsylvania 6254927 17101
Harrisburg 5192726, Pennsylvania 6254927 17109
Hazleton 5193011, Pennsylvania 6254927 18201
Lebanon 5197517, Pennsylvania 6254927 17042
Lewisburg 5197842, Pennsylvania 6254927 17837
Mechanicsburg 5200657, Pennsylvania 6254927 17050
Media 4559575, Pennsylvania 6254927 19063
Paoli 5205037, Pennsylvania 6254927 19301
Philadelphia 4560349, Pennsylvania 6254927 19111
Site Public Contact
215-728-4790
Philadelphia 4560349, Pennsylvania 6254927 19140
Site Public Contact
215-728-2983
Pittsburgh 5206379, Pennsylvania 6254927 15232
Site Public Contact
412-647-8073
Sayre 5211037, Pennsylvania 6254927 18840
Site Public Contact
800-836-0388
Scranton 5211303, Pennsylvania 6254927 18510
Wilkes-Barre 5219488, Pennsylvania 6254927 18711
Wynnewood 5220230, Pennsylvania 6254927 19096
York 4562407, Pennsylvania 6254927 17403
Site Public Contact
717-741-9229
York 4562407, Pennsylvania 6254927 17403
Site Public Contact
877-441-7957
York 4562407, Pennsylvania 6254927 17403
Site Public Contact
877-441-7957
York 4562407, Pennsylvania 6254927 17408
Site Public Contact
717-724-6760
Westerly 5225631, Rhode Island 5224323 02891
Anderson 4569298, South Carolina 4597040 29621
Bluffton 4571722, South Carolina 4597040 29910
Boiling Springs 4571805, South Carolina 4597040 29316
Site Public Contact
864-241-6251
Charleston 4574324, South Carolina 4597040 29401
Clinton 4575028, South Carolina 4597040 29325
Site Public Contact
864-241-6251
Easley 4577263, South Carolina 4597040 29640
Greenville 4580543, South Carolina 4597040 29605
Site Public Contact
864-241-6251
Greenville 4580543, South Carolina 4597040 29605
Site Public Contact
864-241-6251
Greenville 4580543, South Carolina 4597040 29605
Site Public Contact
864-241-6251
Greenville 4580543, South Carolina 4597040 29605
Site Public Contact
864-241-6251
Greenville 4580543, South Carolina 4597040 29615
Site Public Contact
864-241-6251
Greer 4580599, South Carolina 4597040 29650
Site Public Contact
864-241-6251
Seneca 4595346, South Carolina 4597040 29672
Site Public Contact
864-241-6251
Rapid City 5768233, South Dakota 5769223 57701
Sioux Falls 5231851, South Dakota 5769223 57104
Sioux Falls 5231851, South Dakota 5769223 57117-5134
Collierville 4614748, Tennessee 4662168 38017
Memphis 4641239, Tennessee 4662168 38120
Abilene 4669635, Texas 4736286 79601
Site Public Contact
325-670-6340
Amarillo 5516233, Texas 4736286 79106
Dallas 4684888, Texas 4736286 75235
Dallas 4684888, Texas 4736286 75390
Fort Worth 4691930, Texas 4736286 76104
Houston 4699066, Texas 4736286 77030
Lubbock 5525577, Texas 4736286 79410
Richardson 4722625, Texas 4736286 75080
Salt Lake City 5780993, Utah 5549030 84112
Berlin Corners 5233780, Vermont 5242283 05602
Site Public Contact
802-225-5400
Burlington 5234372, Vermont 5242283 05401
Burlington 5234372, Vermont 5242283 05405
White River Junction 5242889, Vermont 5242283 05009
Site Public Contact
866-687-8387
Burke 4749950, Virginia 6254928 22015
Lynchburg 4771075, Virginia 6254928 24501
McLean 4772354, Virginia 6254928 22102
Mechanicsville 4772566, Virginia 6254928 23116
Midlothian 4772943, Virginia 6254928 23113
Midlothian 4772943, Virginia 6254928 23114
Richmond 4781708, Virginia 6254928 23223
Richmond 4781708, Virginia 6254928 23226
Richmond 4781708, Virginia 6254928 23229
Richmond 4781708, Virginia 6254928 23230
Richmond 4781708, Virginia 6254928 23235
Richmond 4781708, Virginia 6254928 23249
Richmond 4781708, Virginia 6254928 23298
South Hill 4786619, Virginia 6254928 23970
Winchester 4794120, Virginia 6254928 22601
Woodbridge 4794457, Virginia 6254928 22192
Aberdeen 5785243, Washington 5815135 98520
Bellingham 5786899, Washington 5815135 98225
Site Public Contact
360-788-8223
Centralia 5789683, Washington 5815135 98531
Edmonds 5793427, Washington 5815135 98026
Everett 5793933, Washington 5815135 98201
Issaquah 5798487, Washington 5815135 98029
Kennewick 5799610, Washington 5815135 99336
Lacey 5800112, Washington 5815135 98503
Longview 5801617, Washington 5815135 98632
Mount Vernon 5804127, Washington 5815135 98274
Port Townsend 5807239, Washington 5815135 98368
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360-344-3091
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Charleston 4801859, West Virginia 4826850 25304
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Cody 5821593, Wyoming 5843591 82414
More Details
- NCT ID
- NCT03851445
- Status
- Recruiting
- Sponsor
- SWOG Cancer Research Network
Detailed Description
Primary Objective of the Master Protocol (LUNGMAP) The primary objective of this screening study is to test patient specimens to determine eligibility for participation in the biomarker-driven and non-matched sub-studies included within the Lung-MAP umbrella protocol. Secondary Objectives 1. Screening Success Rate Objective To evaluate the screen success rate defined as the percentage of screened patients that register for a therapeutic sub-study. Screen success rates will be evaluated for the total screened population and by the subset of patients screened following progression on previous therapy or pre-screened on current therapy. 2. Translational Medicine Objectives 1. To evaluate circulating tumor DNA (ctDNA) and compare to the FMI Foundation tissue molecular profiling results in patients who submit a new biopsy for screening. 2. To establish a tissue/blood repository. Ancillary Study S1400GEN Objectives The Lung-MAP Screening Study includes an ancillary study evaluating patient and physician attitudes regarding the return of somatic mutation findings suggestive of a germline mutation. Participation in this study is optional. 1. Primary Objective To evaluate patient attitudes and preferences about return of somatic mutation findings suggestive of a germline mutation in the Lung-MAP Screening Study. 2. Secondary Objectives 1. To evaluate Lung-MAP study physician attitudes and preferences about return of somatic mutation findings suggestive of a germline mutation in the Lung-MAP Screening Study. 2. To evaluate Lung-MAP patients' and study physicians' knowledge of cancer genomics. 3. To evaluate Lung-MAP patients' and study physicians' knowledge of the design of the Lung-MAP Screening Study. 4. To explore whether physician and patient knowledge of cancer genomics and attitudes and preferences about return of genomic profiling findings are correlated.