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 Genders
- 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, Alaska 98508
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Fairbanks, Alaska 99701
Goodyear, Arizona 85338
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Kingman, Arizona 86401
Phoenix, Arizona 85004
Tucson, Arizona 85719
Tucson, Arizona 85719
Jonesboro, Arkansas 72401
Little Rock, Arkansas 72205
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501-686-8274
Anaheim, California 92806
Antioch, California 94531
Arroyo Grande, California 93420
Auburn, California 95602
Auburn, California 95603
Baldwin Park, California 91706
Bellflower, California 90706
Berkeley, California 94704
Beverly Hills, California 90211
Burbank, California 91505
Burlingame, California 94010
Cameron Park, California 95682
Cameron Park, California 95682
Carmichael, California 95608
Carmichael, California 95608
Castro Valley, California 94546
Chico, California 95926
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530-332-4700
Davis, California 95616
Dublin, California 94568
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877-642-4691
Elk Grove, California 95758
Fontana, California 92335
Fremont, California 94538
Fremont, California 94538
Fresno, California 93720
Fresno, California 93720
Harbor City, California 90710
Irvine, California 92618
La Jolla, California 92093
Loma Linda, California 92354
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909-558-4050
Long Beach, California 90822
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562-826-8000
Los Angeles, California 90027
Los Angeles, California 90034
Los Angeles, California 90048
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310-423-8965
Martinez, California 94553-3156
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925-957-5400
Marysville, California 95901
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530-749-4400
Modesto, California 95355
Modesto, California 95356
Mountain View, California 94040
Mountain View, California 94040
Napa, California 94558
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707-521-3830
Novato, California 94945
Oakland, California 94611
Oakland, California 94611
Ontario, California 91761
Palo Alto, California 94301
Palo Alto, California 94304
Palo Alto, California 94304
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Panorama City, California 91402
Rancho Cordova, California 95670
Rancho Mirage, California 92270
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Redwood City, California 94063
Richmond, California 94801
Riverside, California 92505
Rocklin, California 95765
Rohnert Park, California 94928
Roseville, California 95661
Roseville, California 95661
Roseville, California 95661
Roseville, California 95678
Sacramento, California 95814
Sacramento, California 95816
Sacramento, California 95816
Sacramento, California 95817
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Sacramento, California 95823
Sacramento, California 95823
Sacramento, California 95825
Saint Helena, California 94574
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San Diego, California 92108
San Diego, California 92120
San Francisco, California 94115
San Francisco, California 94115
San Francisco, California 94121
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San Jose, California 95119
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San Rafael, California 94903
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Santa Barbara, California 93105
Santa Clara, California 95051
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Santa Cruz, California 95065
Santa Rosa, California 95403
Santa Rosa, California 95403
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707-521-3830
Santa Rosa, California 95403
Santa Rosa, California 95405
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South San Francisco, California 94080
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Sunnyvale, California 94086
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Torrance, California 90509
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Truckee, California 96161
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Aurora, Colorado 80012
Aurora, Colorado 80045
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Aurora, Colorado 80045
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Derby, Connecticut 06418
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Hartford, Connecticut 06102
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Hartford, Connecticut 06105
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Dover, Delaware 19901
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Washington, District of Columbia 20002
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Canton, Illinois 61520
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Chicago, Illinois 60611
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312-864-5204
Chicago, Illinois 60625
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773-878-8200
Chicago, Illinois 60637
Chicago, Illinois 60657
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Danville, Illinois 61832
Decatur, Illinois 62526
Decatur, Illinois 62526
DeKalb, Illinois 60115
Dixon, Illinois 61021
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815-285-7800
Downers Grove, Illinois 60515
Effingham, Illinois 62401
Effingham, Illinois 62401
Elgin, Illinois 60123
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847-429-2907
Eureka, Illinois 61530
Evanston, Illinois 60201
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847-570-2109
Galesburg, Illinois 61401
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Homer Glen, Illinois 60491
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708-216-9000
Kewanee, Illinois 61443
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Libertyville, Illinois 60048
Libertyville, Illinois 60048
Macomb, Illinois 61455
Mattoon, Illinois 61938
Maywood, Illinois 60153
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708-226-4357
Melrose Park, Illinois 60160
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708-450-4554
New Lenox, Illinois 60451
O'Fallon, Illinois 62269
O'Fallon, Illinois 62269
Oak Lawn, Illinois 60453-2699
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800-323-8622
Orland Park, Illinois 60462
Orland Park, Illinois 60462
Ottawa, Illinois 61350
Park Ridge, Illinois 60068
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Pekin, Illinois 61554
Peoria, Illinois 61615
Peoria, Illinois 61636
Peru, Illinois 61354
Peru, Illinois 61354
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815-664-4141
Princeton, Illinois 61356
Rockford, Illinois 61103
Rockford, Illinois 61108
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815-227-2633
Shiloh, Illinois 62269
Springfield, Illinois 62702
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217-545-7929
Springfield, Illinois 62702
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Springfield, Illinois 62781
Urbana, Illinois 61801
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Washington, Illinois 61571
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Fort Wayne, Indiana 46845
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Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
Michigan City, Indiana 46360
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812-238-7394
Ames, Iowa 50010
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515-956-4132
Ames, Iowa 50010
Ankeny, Iowa 50023
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515-241-3305
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Cedar Rapids, Iowa 52403
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319-365-4673
Cedar Rapids, Iowa 52403
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319-363-2690
Clive, Iowa 50325
Clive, Iowa 50325
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515-241-3305
Council Bluffs, Iowa 51503
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712-322-4136
Council Bluffs, Iowa 51503
Council Bluffs, Iowa 51503
Creston, Iowa 50801
Des Moines, Iowa 50309
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515-241-6727
Des Moines, Iowa 50309
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Des Moines, Iowa 50314
Des Moines, Iowa 50314
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Fort Dodge, Iowa 50501
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Iowa City, Iowa 52242
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Jefferson, Iowa 50129
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515-956-4132
Marshalltown, Iowa 50158
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Sioux City, Iowa 51101
Waukee, Iowa 50263
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515-241-3305
West Des Moines, Iowa 50266
Fairway, Kansas 66205
Great Bend, Kansas 67530
Hays, Kansas 67601
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785-623-5774
Kansas City, Kansas 66112
Kansas City, Kansas 66160
Lawrence, Kansas 66044
Olathe, Kansas 66061
Overland Park, Kansas 66210
Overland Park, Kansas 66211
Pittsburg, Kansas 66762
Salina, Kansas 67401
Topeka, Kansas 66606
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Topeka, Kansas 66606
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Ashland, Kentucky 41101
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606-327-6499
Corbin, Kentucky 40701
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Elizabethtown, Kentucky 42701
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Lexington, Kentucky 40509
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Lexington, Kentucky 40536
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Paducah, Kentucky 42003
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Paducah, Kentucky 42003
Richmond, Kentucky 40475
Baton Rouge, Louisiana 70805
Baton Rouge, Louisiana 70808
Baton Rouge, Louisiana 70808
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225-765-7659
Baton Rouge, Louisiana 70809
Baton Rouge, Louisiana 70809
Covington, Louisiana 70433
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Augusta, Maine 04330
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Rockport, Maine 04856
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Annapolis, Maryland 21401
Baltimore, Maryland 21215
Baltimore, Maryland 21244
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Elkton, Maryland 21921
Gaithersburg, Maryland 20879
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Salisbury, Maryland 21801
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Beverly, Massachusetts 01915
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Burlington, Massachusetts 01805
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978-283-4000
Jamaica Plain, Massachusetts 02130
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Springfield, Massachusetts 01199
Worcester, Massachusetts 01655
Ann Arbor, Michigan 48106
Ann Arbor, Michigan 48109
Battle Creek, Michigan 49017
Brighton, Michigan 48114
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Brighton, Michigan 48116
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Brownstown, Michigan 48183
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Chelsea, Michigan 48118
Chelsea, Michigan 48118
Clarkston, Michigan 48346
Clarkston, Michigan 48346
Clinton Township, Michigan 48038
Clinton Township, Michigan 48038
Dearborn, Michigan 48126
Detroit, Michigan 48202
Detroit, Michigan 48236
East China Township, Michigan 48054
Escanaba, Michigan 49829
Flint, Michigan 48503
Flint, Michigan 48503
Flint, Michigan 48503
Flint, Michigan 48503
Grand Rapids, Michigan 49503
Grosse Pointe Woods, Michigan 48236
Grosse Pointe Woods, Michigan 48236
Grosse Pointe Woods, Michigan 48236
Jackson, Michigan 49201
Kalamazoo, Michigan 49007
Kalamazoo, Michigan 49007
Kalamazoo, Michigan 49009
Kalamazoo, Michigan 49048
Lansing, Michigan 48912
Livonia, Michigan 48154
Macomb, Michigan 48044
Macomb, Michigan 48044
Novi, Michigan 48377
Pontiac, Michigan 48341
Pontiac, Michigan 48341
Pontiac, Michigan 48341
Pontiac, Michigan 48341
Saginaw, Michigan 48601
Tawas City, Michigan 48764
Traverse City, Michigan 49684
Warren, Michigan 48093
Warren, Michigan 48093
Warren, Michigan 48093
West Bloomfield, Michigan 48322
Ypsilanti, Michigan 48106
Ypsilanti, Michigan 48197
Aitkin, Minnesota 56431
Baxter, Minnesota 56425
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218-828-2880
Bemidji, Minnesota 56601
Brainerd, Minnesota 56401
Burnsville, Minnesota 55337
Cambridge, Minnesota 55008
Coon Rapids, Minnesota 55433
Deer River, Minnesota 56636
Detroit Lakes, Minnesota 56501
Duluth, Minnesota 55805
Duluth, Minnesota 55805
Duluth, Minnesota 55805
Edina, Minnesota 55435
Ely, Minnesota 55731
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218-365-7900
Fosston, Minnesota 56542
Hibbing, Minnesota 55746
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218-786-3308
International Falls, Minnesota 56649
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218-283-9431
Maple Grove, Minnesota 55369
Maplewood, Minnesota 55109
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Minneapolis, Minnesota 55407
Minneapolis, Minnesota 55415
Minneapolis, Minnesota 55417
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612-467-2800
Minneapolis, Minnesota 55454
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Moose Lake, Minnesota 55767
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218-485-4481
New Ulm, Minnesota 56073
Park Rapids, Minnesota 56470
Princeton, Minnesota 55371
Robbinsdale, Minnesota 55422
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Saint Paul, Minnesota 55102
Sandstone, Minnesota 55072
Shakopee, Minnesota 55379
Stillwater, Minnesota 55082
Thief River Falls, Minnesota 56701
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605-312-3320
Virginia, Minnesota 55792
Waconia, Minnesota 55387
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Wyoming, Minnesota 55092
Columbus, Mississippi 39705
Grenada, Mississippi 38901
Gulfport, Mississippi 39502
Jackson, Mississippi 39216
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New Albany, Mississippi 38652
Oxford, Mississippi 38655
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Ballwin, Missouri 63011
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314-251-7058
Chesterfield, Missouri 63017
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314-205-6936
Creve Coeur, Missouri 63141
Farmington, Missouri 63640
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Kansas City, Missouri 64108
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Kansas City, Missouri 64128
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Kansas City, Missouri 64154
Lee's Summit, Missouri 64064
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Saint Peters, Missouri 63376
Sainte Genevieve, Missouri 63670
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314-996-5569
Springfield, Missouri 65807
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417-269-4520
Sullivan, Missouri 63080
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314-996-5569
Sunset Hills, Missouri 63127
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314-996-5569
Anaconda, Montana 59711
Billings, Montana 59101
Bozeman, Montana 59715
Great Falls, Montana 59405
Great Falls, Montana 59405
Kalispell, Montana 59901
Missoula, Montana 59802
Missoula, Montana 59804
Omaha, Nebraska 68114
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402-334-4773
Omaha, Nebraska 68114
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402-354-5144
Omaha, Nebraska 68114
Carson City, Nevada 89703
Henderson, Nevada 89052
Henderson, Nevada 89052
Henderson, Nevada 89052
Henderson, Nevada 89052
Henderson, Nevada 89074
Henderson, Nevada 89074
Henderson, Nevada 89074
Henderson, Nevada 89074
Las Vegas, Nevada 89102
Las Vegas, Nevada 89102
Las Vegas, Nevada 89103
Las Vegas, Nevada 89106
Las Vegas, Nevada 89106
Las Vegas, Nevada 89109
Las Vegas, Nevada 89109
Las Vegas, Nevada 89113
Las Vegas, Nevada 89113
Las Vegas, Nevada 89119
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
Las Vegas, Nevada 89135
Las Vegas, Nevada 89144
Las Vegas, Nevada 89144
Las Vegas, Nevada 89144
Las Vegas, Nevada 89148
Las Vegas, Nevada 89148
Las Vegas, Nevada 89148
Las Vegas, Nevada 89169
Las Vegas, Nevada 89169
Pahrump, Nevada 89048
Reno, Nevada 89502
Reno, Nevada 89503
Reno, Nevada 89509
Concord, New Hampshire 03301
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603-224-2556
Lebanon, New Hampshire 03756
Manchester, New Hampshire 03102
Manchester, New Hampshire 03103
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800-339-6484
Nashua, New Hampshire 03063
Basking Ridge, New Jersey 07920
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212-639-7592
Holmdel, New Jersey 07733
Lakewood, New Jersey 08701
Long Branch, New Jersey 07740
Middletown, New Jersey 07748
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212-639-7592
Montvale, New Jersey 07645
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212-639-7592
Moorestown, New Jersey 08057
Neptune, New Jersey 07753
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732-776-4240
Red Bank, New Jersey 07701
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732-530-2382
Voorhees, New Jersey 08043
Albuquerque, New Mexico 87106
Albuquerque, New Mexico 87110
Rio Rancho, New Mexico 87124
Bronx, New York 10461
Bronx, New York 10461
Bronx, New York 10467
Bronx, New York 10468
Buffalo, New York 14263
Commack, New York 11725
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212-639-7592
East Hills, New York 11548
Glens Falls, New York 12801
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518-926-6700
Harrison, New York 10604
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212-639-7592
New York, New York 10011
New York, New York 10029
New York, New York 10065
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212-639-7592
Rochester, New York 14642
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585-275-5830
Uniondale, New York 11553
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212-639-7592
West Islip, New York 11795
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516-326-7514
Asheboro, North Carolina 27203
Asheville, North Carolina 28803
Burlington, North Carolina 27215
Cary, North Carolina 27518
Clyde, North Carolina 28721
Durham, North Carolina 27705
Garner, North Carolina 27529
Greensboro, North Carolina 27403
Greensboro, North Carolina 27410
Hendersonville, North Carolina 28792
Pinehurst, North Carolina 28374
Raleigh, North Carolina 27607
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919-784-7209
Raleigh, North Carolina 27607
Raleigh, North Carolina 27614
Reidsville, North Carolina 27320
Weaverville, North Carolina 28787
Winston-Salem, North Carolina 27103
Bismarck, North Dakota 58501
Fargo, North Dakota 58103
Fargo, North Dakota 58103
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701-234-6161
Fargo, North Dakota 58103
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605-312-3320
Fargo, North Dakota 58104
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800-437-4010
Fargo, North Dakota 58122
Fargo, North Dakota 58122
Jamestown, North Dakota 58401
Minot, North Dakota 58701
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800-862-0005
Alliance, Ohio 44601
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330-363-1250
Beavercreek, Ohio 45431
Belpre, Ohio 45714
Boardman, Ohio 44512
Canton, Ohio 44708
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888-293-4673
Canton, Ohio 44710
Centerville, Ohio 45459
Centerville, Ohio 45459
Chillicothe, Ohio 45601
Cincinnati, Ohio 45220
Cincinnati, Ohio 45236
Cincinnati, Ohio 45242
Cincinnati, Ohio 45247
Cincinnati, Ohio 45255
Cleveland, Ohio 44106
Cleveland, Ohio 44109
Cleveland, Ohio 44111
Cleveland, Ohio 44195
Columbus, Ohio 43213
Columbus, Ohio 43219
Columbus, Ohio 43222
Dayton, Ohio 45409
Dayton, Ohio 45409
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937-276-8320
Dayton, Ohio 45415
Dayton, Ohio 45415
Findlay, Ohio 45840
Findlay, Ohio 45840
Findlay, Ohio 45840
Franklin, Ohio 45005-1066
Franklin, Ohio 45005
Gahanna, Ohio 43230
Greenville, Ohio 45331
Greenville, Ohio 45331
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937-569-7515
Greenville, Ohio 45331
Grove City, Ohio 43123
Grove City, Ohio 43123
Kettering, Ohio 45409
Kettering, Ohio 45429
Lancaster, Ohio 43130
Lima, Ohio 45801
Marietta, Ohio 45750
Marysville, Ohio 43040
Mayfield Heights, Ohio 44124
Mount Vernon, Ohio 43050
New Albany, Ohio 43054
Newark, Ohio 43055
Newark, Ohio 43055
Perrysburg, Ohio 43551
Portsmouth, Ohio 45662
Sandusky, Ohio 44870
Springfield, Ohio 45504
Springfield, Ohio 45504
Sylvania, Ohio 43560
Toledo, Ohio 43606
Toledo, Ohio 43608
Toledo, Ohio 43623
Toledo, Ohio 43623
Troy, Ohio 45373
Troy, Ohio 45373
Warrensville Heights, Ohio 44122
Warren, Ohio 44484
Westerville, Ohio 43081
Wilmington, Ohio 45177
Youngstown, Ohio 44501
Zanesville, Ohio 43701
Lawton, Oklahoma 73505
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877-231-4440
Oklahoma City, Oklahoma 73104
Oklahoma City, Oklahoma 73120
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405-752-3402
Baker City, Oregon 97814
Bend, Oregon 97701
Clackamas, Oregon 97015
Coos Bay, Oregon 97420
Newberg, Oregon 97132
Ontario, Oregon 97914
Oregon City, Oregon 97045
Portland, Oregon 97213
Portland, Oregon 97225
Portland, Oregon 97239
Redmond, Oregon 97756
Site Public Contact
541-706-2909
Salem, Oregon 97301
Site Public Contact
503-561-2618
Allentown, Pennsylvania 18103
Bethlehem, Pennsylvania 18017
Bryn Mawr, Pennsylvania 19010
Carlisle, Pennsylvania 17015
Chadds Ford, Pennsylvania 19317
Chambersburg, Pennsylvania 17201
Chambersburg, Pennsylvania 17201
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717-217-6020
Danville, Pennsylvania 17822
East Norriton, Pennsylvania 19401
East Stroudsburg, Pennsylvania 18301
Ephrata, Pennsylvania 17522
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717-721-4840
Ephrata, Pennsylvania 17522
Gettysburg, Pennsylvania 17325
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877-441-7957
Hanover, Pennsylvania 17331
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717-632-1559
Harrisburg, Pennsylvania 17101
Harrisburg, Pennsylvania 17109
Hazleton, Pennsylvania 18201
Lebanon, Pennsylvania 17042
Lewisburg, Pennsylvania 17837
Mechanicsburg, Pennsylvania 17050
Media, Pennsylvania 19063
Paoli, Pennsylvania 19301
Philadelphia, Pennsylvania 19111
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215-728-4790
Philadelphia, Pennsylvania 19140
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215-728-2983
Pittsburgh, Pennsylvania 15232
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412-647-8073
Sayre, Pennsylvania 18840
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800-836-0388
Scranton, Pennsylvania 18510
Wilkes-Barre, Pennsylvania 18711
Wynnewood, Pennsylvania 19096
York, Pennsylvania 17403
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717-741-9229
York, Pennsylvania 17403
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877-441-7957
York, Pennsylvania 17403
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877-441-7957
York, Pennsylvania 17408
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717-724-6760
Westerly, Rhode Island 02891
Anderson, South Carolina 29621
Bluffton, South Carolina 29910
Boiling Springs, South Carolina 29316
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864-241-6251
Charleston, South Carolina 29401
Clinton, South Carolina 29325
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864-241-6251
Easley, South Carolina 29640
Greenville, South Carolina 29605
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864-241-6251
Greenville, South Carolina 29605
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864-241-6251
Greenville, South Carolina 29605
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864-241-6251
Greenville, South Carolina 29605
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864-241-6251
Greenville, South Carolina 29615
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864-241-6251
Greer, South Carolina 29650
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864-241-6251
Seneca, South Carolina 29672
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864-241-6251
Rapid City, South Dakota 57701
Sioux Falls, South Dakota 57104
Sioux Falls, South Dakota 57117-5134
Collierville, Tennessee 38017
Memphis, Tennessee 38120
Abilene, Texas 79601
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325-670-6340
Amarillo, Texas 79106
Dallas, Texas 75235
Dallas, Texas 75390
Fort Worth, Texas 76104
Houston, Texas 77030
Lubbock, Texas 79410
Richardson, Texas 75080
Salt Lake City, Utah 84112
Berlin, Vermont 05602
Site Public Contact
802-225-5400
Burlington, Vermont 05401
Burlington, Vermont 05405
White River Junction, Vermont 05009
Site Public Contact
866-687-8387
Burke, Virginia 22015
Lynchburg, Virginia 24501
McLean, Virginia 22102
Mechanicsville, Virginia 23116
Midlothian, Virginia 23113
Midlothian, Virginia 23114
Richmond, Virginia 23223
Richmond, Virginia 23226
Richmond, Virginia 23229
Richmond, Virginia 23230
Richmond, Virginia 23235
Richmond, Virginia 23249
Richmond, Virginia 23298
South Hill, Virginia 23970
Winchester, Virginia 22601
Woodbridge, Virginia 22192
Aberdeen, Washington 98520
Bellingham, Washington 98225
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360-788-8223
Centralia, Washington 98531
Edmonds, Washington 98026
Everett, Washington 98201
Issaquah, Washington 98029
Kennewick, Washington 99336
Lacey, Washington 98503
Longview, Washington 98632
Mount Vernon, Washington 98274
Port Townsend, Washington 98368
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360-344-3091
Renton, Washington 98055
Seattle, Washington 98107
Seattle, Washington 98122-5711
Seattle, Washington 98122
Sedro-Woolley, Washington 98284
Vancouver, Washington 98664
Walla Walla, Washington 99362
Yakima, Washington 98902
Charleston, West Virginia 25304
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304-388-9944
Huntington, West Virginia 25701
Huntington, West Virginia 25702
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304-526-1349
Morgantown, West Virginia 26506
Wheeling, West Virginia 26003
Site Public Contact
304-243-6442
Antigo, Wisconsin 54409
Appleton, Wisconsin 54915
Ashland, Wisconsin 54806
Ashland, Wisconsin 54806
Brookfield, Wisconsin 53045
Burlington, Wisconsin 53105
Chilton, Wisconsin 53014
Chippewa Falls, Wisconsin 54729
Cudahy, Wisconsin 53110
Eau Claire, Wisconsin 54701
Fond Du Lac, Wisconsin 54935
Site Public Contact
800-494-2927
Fond Du Lac, Wisconsin 54937
Franklin, Wisconsin 53132
Franklin, Wisconsin 53132
Germantown, Wisconsin 53022
Grafton, Wisconsin 53024
Green Bay, Wisconsin 54301
Green Bay, Wisconsin 54303
Green Bay, Wisconsin 54311
Hayward, Wisconsin 54843
Janesville, Wisconsin 53548
Kenosha, Wisconsin 53142
La Crosse, Wisconsin 54601
Ladysmith, Wisconsin 54848
Madison, Wisconsin 53718
Madison, Wisconsin 53792
Marinette, Wisconsin 54143
Marshfield, Wisconsin 54449
Medford, Wisconsin 54451
Menomonee Falls, Wisconsin 53051
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262-257-5100
Mequon, Wisconsin 53097
Milwaukee, Wisconsin 53209
Milwaukee, Wisconsin 53210
Milwaukee, Wisconsin 53211
Milwaukee, Wisconsin 53215
Milwaukee, Wisconsin 53215
Milwaukee, Wisconsin 53226
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414-805-3666
Milwaukee, Wisconsin 53233
Milwaukee, Wisconsin 53295
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888-469-6614
Minocqua, Wisconsin 54548
Mukwonago, Wisconsin 53149
New Richmond, Wisconsin 54017
Oconomowoc, Wisconsin 53066
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262-928-7878
Oconto Falls, Wisconsin 54154
Oshkosh, Wisconsin 54904
Oshkosh, Wisconsin 54904
Racine, Wisconsin 53405
Racine, Wisconsin 53406
Rhinelander, Wisconsin 54501
Rice Lake, Wisconsin 54868
Sheboygan, Wisconsin 53081
Sheboygan, Wisconsin 53081
Sheboygan, Wisconsin 53081
Spooner, Wisconsin 54801
Stevens Point, Wisconsin 54481
Stevens Point, Wisconsin 54482
Sturgeon Bay, Wisconsin 54235-1495
Summit, Wisconsin 53066
Superior, Wisconsin 54880
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701-364-6272
Two Rivers, Wisconsin 54241
Waukesha, Wisconsin 53188
Site Public Contact
262-928-7632
Waukesha, Wisconsin 53188
Wausau, Wisconsin 54401
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877-405-6866
Wausau, Wisconsin 54401
Wauwatosa, Wisconsin 53226
Wauwatosa, Wisconsin 53226
West Allis, Wisconsin 53227
West Bend, Wisconsin 53095
Site Public Contact
414-805-0505
Weston, Wisconsin 54476
Wisconsin Rapids, Wisconsin 54494
Site Public Contact
715-422-7718
Wisconsin Rapids, Wisconsin 54494
Cody, Wyoming 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.