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
Birmingham, Alabama 35233
Mobile, Alabama 36688
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Fairbanks, Alaska 99701
Jonesboro, Arkansas 72401
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Raleigh, North Carolina 27614
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919-784-7209
Reidsville, North Carolina 27320
Statesville, North Carolina 28625
Thomasville, North Carolina 27360
Wilkesboro, North Carolina 28659
Winston-Salem, North Carolina 27103
Winston-Salem, North Carolina 27103
Bismarck, North Dakota 58501
Fargo, North Dakota 58103
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
Beachwood, Ohio 44122
Belpre, Ohio 45714
Canton, Ohio 44708
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330-453-9993
Canton, Ohio 44708
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888-293-4673
Canton, Ohio 44710
Chardon, Ohio 44024
Chillicothe, Ohio 45601
Cincinnati, Ohio 45220
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Cleveland, Ohio 44106
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Cleveland, Ohio 44111
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Columbus, Ohio 43210
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Delaware, Ohio 43015
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Findlay, Ohio 45840
Franklin, Ohio 45005
Lancaster, Ohio 43130
Mansfield, Ohio 44903
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Marietta, Ohio 45750
Marion, Ohio 43302
Mayfield Heights, Ohio 44124
Mentor, Ohio 44060
Middleburg Heights, Ohio 44130
Mount Vernon, Ohio 43050
Newark, Ohio 43055
Parma, Ohio 44129
Portsmouth, Ohio 45662
Ravenna, Ohio 44266
Sandusky, Ohio 44870
Sandusky, Ohio 44870
Strongsville, Ohio 44136
Sylvania, Ohio 43560
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419-824-1842
Troy, Ohio 45373
Troy, Ohio 45373
Wadsworth, Ohio 44281
Warrensville Heights, Ohio 44122
Westerville, Ohio 43081
Westlake, Ohio 44145
Wooster, Ohio 44691
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
Tulsa, Oklahoma 74133
Bend, Oregon 97701
Clackamas, Oregon 97015
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Ontario, Oregon 97914
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Portland, Oregon 97227
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503-561-2618
Allentown, Pennsylvania 18103
Bethlehem, Pennsylvania 18017
Bryn Mawr, Pennsylvania 19010
Chambersburg, Pennsylvania 17201
Collegeville, Pennsylvania 19426
East Norriton, Pennsylvania 19401
Ephrata, Pennsylvania 17522
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717-721-4840
Ephrata, Pennsylvania 17522
Exton, Pennsylvania 19341
Gettysburg, Pennsylvania 17325
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Hanover, Pennsylvania 17331
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Harrisburg, Pennsylvania 17101
Harrisburg, Pennsylvania 17109
Hershey, Pennsylvania 17033-0850
Lebanon, Pennsylvania 17042
Media, Pennsylvania 19063
Paoli, Pennsylvania 19301
Philadelphia, Pennsylvania 19107
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Philadelphia, Pennsylvania 19111
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Philadelphia, Pennsylvania 19140
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Pittsburgh, Pennsylvania 15232
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Pottstown, Pennsylvania 19464
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Reading, Pennsylvania 19605
Sayre, Pennsylvania 18840
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West Chester, Pennsylvania 19380
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Williamsport, Pennsylvania 17701
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Wynnewood, Pennsylvania 19096
York, Pennsylvania 17403
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York, Pennsylvania 17403
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Anderson, South Carolina 29621
Boiling Springs, South Carolina 29316
Charleston, South Carolina 29401
Charleston, South Carolina 29425
Easley, South Carolina 29640
Gaffney, South Carolina 29341
Greenville, South Carolina 29605
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Greenville, South Carolina 29615
Greer, South Carolina 29650
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Seneca, South Carolina 29672
Spartanburg, South Carolina 29303
Union, South Carolina 29379
Rapid City, South Dakota 57701
Sioux Falls, South Dakota 57104
Sioux Falls, South Dakota 57117-5134
Collierville, Tennessee 38017
Cookeville, Tennessee 38501
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Memphis, Tennessee 38120
Amarillo, Texas 79106
Dallas, Texas 75235
Dallas, Texas 75390
Fort Worth, Texas 76104
Houston, Texas 77030
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Lubbock, Texas 79410
Richardson, Texas 75080
Berlin, Vermont 05602
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Burlington, Vermont 05401
Burlington, Vermont 05405
White River Junction, Vermont 05009
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Burke, Virginia 22015
Lynchburg, Virginia 24501
McLean, Virginia 22102
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240-632-4284
Mechanicsville, Virginia 23116
Midlothian, Virginia 23114
Richmond, Virginia 23226
Richmond, Virginia 23230
Richmond, Virginia 23235
Richmond, Virginia 23298
South Hill, Virginia 23970
Winchester, Virginia 22601
Bellevue, Washington 98004
Bellingham, Washington 98225
Bremerton, Washington 98310
Edmonds, Washington 98026
Issaquah, Washington 98029
Kennewick, Washington 99336
Kirkland, Washington 98034
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425-899-6000
Longview, Washington 98632
Port Townsend, Washington 98368
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360-344-3091
Poulsbo, Washington 98370
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800-804-8824
Seattle, Washington 98109
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Seattle, Washington 98122-4307
Seattle, Washington 98133
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Seattle, Washington 98195
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Sedro-Woolley, Washington 98284
Vancouver, Washington 98664
Charleston, West Virginia 25304
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304-388-9944
Huntington, West Virginia 25701
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304-399-6617
Huntington, West Virginia 25702
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304-526-1349
Antigo, Wisconsin 54409
Appleton, Wisconsin 54915
Ashland, Wisconsin 54806
Ashland, Wisconsin 54806
Brookfield, Wisconsin 53045
Burlington, Wisconsin 53105
Chippewa Falls, Wisconsin 54729
Eau Claire, Wisconsin 54701
Fond Du Lac, Wisconsin 54935
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800-494-2927
Fond Du Lac, Wisconsin 54937
Franklin, Wisconsin 53132
Germantown, Wisconsin 53022
Grafton, Wisconsin 53024
Green Bay, Wisconsin 54301
Green Bay, Wisconsin 54303
Green Bay, Wisconsin 54311
Janesville, Wisconsin 53548
Kenosha, Wisconsin 53142
La Crosse, Wisconsin 54601
Ladysmith, Wisconsin 54848
Madison, Wisconsin 53792
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800-622-8922
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 53211
Milwaukee, Wisconsin 53215
Milwaukee, Wisconsin 53226
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414-805-3666
Milwaukee, Wisconsin 53233
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
Rice Lake, Wisconsin 54868
Sheboygan, Wisconsin 53081
Stevens Point, Wisconsin 54482
Sturgeon Bay, Wisconsin 54235-1495
Summit, Wisconsin 53066
Two Rivers, Wisconsin 54241
Waukesha, Wisconsin 53188
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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
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414-805-0505
Weston, Wisconsin 54476
Wisconsin Rapids, Wisconsin 54494
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715-422-7718
Wisconsin Rapids, Wisconsin 54494
Cody, Wyoming 82414
Sheridan, Wyoming 82801
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.