Clinical Trials ALK Recruiting July 2019
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ALK Clinical Trials - Currently Recruiting Updated 7/9/2019
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Studies Recruiting for Surgically Resectable Disease - ALK NSCLC Stage 1A to IIIA
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DateTrial Summary PhaseInclusion CriteriaLocationsSponsorsIdentifierComments
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19/13/2018Adjuvant Alectinib vs. Adjuvant Platinum Based Chemo
in surgically resected ALK Positive NSCLC
(Stages IB - IIIAB)
IIIComplete resection of lung tumor and Lymph nodes
4-12 weeks before enrollment
No prior or need for adjuvant radiation treatment for NSCLC
No prior chemo or ALK TKIs
USA, Australia, Austria, Bosnia, Denmark, France, Korea, Japan, Italy, Israel, Hungary, Greece, Latvia, Macedonia, Poland, Russia, Singapore, Spain, Ukraine, Thailand, Taiwan, Turkey, UKHoffman La-RocheNCT03456076

Randomized to Alectinib or Chemo
5
23/23/2017
Crizotinib in the neo-adjuvant setting in patients with
ALK NSCLC (stages IA - IIIA)
II
Stage IA-IIIA surgically resectable ALK NSCLC
No metastatic dz. No prior ALK inhibitor or chemo.
USA: Denver - University. of Colorado
University of Colorado
Pfizer
NCT03088930
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3
12/20/2016



Nivolumab plus chemotherapy vs chemotherapy alone after surgery for early stage NSCLC (Checkmate 816)


III





Early stage IB-IIIA operable NSCLC
No autoimmune disease
Tissue from primary lung tumor available
No prior immunotherapy


USA, Argentina, Brazil, Canada, China, France, Greece, Italy, Japan, Korea, Romania, Spain, Taiwan, Turkey


Bristol-Myers Squibb



NCT02998528 

7
47/28/2015



Crizotininb in patients with IB-IIIA ALK NSCLC that has
been removed by surgery
(An ALCHEMIST Treatment Trial)

III


Stage IB, II, or non-squamous IIIA , ALK NSCLC - NED
Complete rescetion of tumors with negative margins
No prior treatment with ALK TKI
Surgery 4 weeks to 300 days prior (depends on situation)
Adjuvant radiation or chemo okay
USA: 1289 sites



ECOG-ACRIN Reserach
National Cancer Institute


NCT02201992



Randomized to Crizotinib
up to 2 years vs
observation without Criz

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Recruiting for 1st Line ALK Inhibitor Stage IIIB to IV (No Prior ALK TKI Treatment)
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DateTrial Summary PhaseInclusion CriteriaLocationsSponsorsIdentifierComments
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112/20/2018




Brigatinib and Local consolodative therapy (LCT) in
patients with stage IV or recurrent ALK NSCLC
(BRIGHTSTAR)


I





TKI naïve or within 8 weeks of starting Brigatinib as first TKI
No symptomatic brain metastases



USA, Texas, Houston - MD Anderson


MD Anderson National Cancer Institute



NCT03707938

Surgery, radiation, or other local
therapies are given 2 months after
starting Brigatinib
11
27/7/2017




Alectininb: Multiple Targeted Therapies as treatments for
patients with NSCLC
(B-FAST)


II/III




Stage IIIB or IV NSCLC - ALK included
No prior systemic treatment (TKIs or chemo)


USA, Argentina, AUS, Belgium, Brazil,
Canada, Chile, France, Germany, Hong Kong, Israel, Italy, Japan, Korea,
Mexico, New Zealand, Poland, Russia, Serbia, Singapore, Spain,
Switzerland, Taiwan, Thailand, Turkey, Costa Rica, Peru, Panama

Hoffman La-Roche




NCT03178552



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32/14/2017



Lorlatinib vs Crizotinib in first line treatment of patients
with ALK positive NSCLC


III



ALK stage IIIB or IV
No prior chemo or TKIs
Randomized to either Lor or Criz

USA, Argentina, AUS, Belgium,
Canada, China, Czechia, France, Germany, Hong Kong, India, Italy, Japan, Korea, Mexico, Netherlands, Poland, RUS,
Singapore, Spain, Taiwan, UK,
Pfizer



NCT03052608




Problematic now since
Crizotinib not 1st line tx of choice. Gina Hollenbeck heard that this study is no longer recruiting in US.
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412/11/2014



SBRT (targeted radiation) integrated with Targeted
therapy in Stage IV Oncogene driven NSCLC
II



Stage IV ALK NSCLC
Within 6 months of starting first TKI. Responding or stable.
1-3 lung lesions, 1-4 liver mets, small brain lesions okay
If bone lesions, 1-2 lesions, only in spine
Max 5 target lesions outside brain (low burden dz)
USA: Boston - Mass General
Mass General
National Cancer Institute


NCT02314364



No prior radiation to sites
other than brain or bone.
No hilar or mediastinal
greater than 1 cm.
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51/27/2016

Crizotinib: National Lung MATRIX Trial: Multi-drug
Phase II trial in NSCLC
II

Recurrence after surgery, radiation, or chemo
Currently stage III or IV ALK NSCLC
Tissue available for genomic testing
20 locations in UK

AstraZeneca
Pfizer
Cancer Research UK
NCT02664935

This trial uses Crizotininb
first line. Cost of biopsy covered by trial
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Recruiting for 1st or 2nd+ Line Treatment (ALK TKI Treatment Naïve or Prior ALK TKIs)
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DateTrial Summary PhaseInclusion CriteriaLocationsSponsorsIdentifierComments
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14/10/2019Lorlatinib in ALK-inhibitor treated NSCLC in ChinaII
ALK NSCLC progressed on Crizotinib or another ALK inhibitor
Measurable tumor outside of brain
No more than one chemotherapy regimen in past
China: Guangzhou Guandong, Zhejiang, and Shanghai
Site planned in Sichuan
Pfizer
NCT03909971


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21/25/2018
Brigatinib in Japanese patients with ALK NSCLC
II
ALK stage IIIB, IIIC, or IV
Either TKI naïve (expansion group added 12/25/2018) or Progressive dz on no more than 2 ALK TKIs
Japan: Aichi, Chiba, Ehime, Fukuoka, Kobe, Hokaido, Hyogo, Ishikawa, Iwate, Mie, Miyagi, Niigata, Osaka, Nagoya, Saitama,Shizuoka, Tochigi, Kyoto, Okayama,Tokyo, KanagawaTakeda
NCT03410108  
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36/29/2017


Alectinib combined with Cobimetinib (MEK inhibitor)
in advanced ALK NSCLC

IB/II


ALK stage IV
Treatment naïve or previously treated with ALK TKIs or chemo
Brain mets must be treated if progresssed on Alectinib
USA: Boston - Mass General


Alice Shaw MD
Mass General
Genentech
NCT03202940  


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43/22/2017Ceritinib and Trametinib (MEK inhibitor) in ALK NSCLCI/II

ALK stage IIIB or IV
Either ALK TKI naïve or previously treated with TKIs
USA: San Francisco - Helen DillerUCSF
Novartis
NCT03087448 
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510/7/2016

Lorlatinib with brain mets and/or LMD in the absence of
measurable lesions outside the brain
II

Treatment naïve or previous ALK TKIs or chemo
LMD or at least one brain met 5 mm or larger
No measurable disease outside brain or nervous system
USA: Boston - Mass General

Alice Shaw, MD
Mass General
NCT02927340

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68/13/2015

Alectinib combined with Bevacizumab (anitangiogenesis)
In advanced ALK NSCLC
Focus on brain mets for phase II
I/II

ALK stage IIIB or IV. Prior ALK-TKIs okay
Measurable brain lesion for phase II
At least one lesion outside brain. Non-Squamous
USA: Boston - Mass General, Beth Israel

Justin Gainor MD
Mass General
Genentech
NCT02521051 

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77/31/2015

Ceritinib combined with stereotactic ablative radiation
in metastatic ALK NSCLC
II

ALK NSCLC - Metastatic
ALK-TKI naïve or one prior ALK TKI.
No prior therapy with Certitinib
USA: Dallas - UT Southwestern

UT Southwestern
Novartis
NCT02513667

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83/19/2015
Ceritinib in combo with Nivolumab (immunotherapy)
In ALK NSCLC
I
ALK stage IIIB or IV. Prior TKIs and therapies okay.
No autoimune disease
USA: Boston, Canada: Toronto, Spain: CatalunyaNovartis
NCT02393625 
So far rash and increase
liver enzymes. Protocol changed.
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96/21/2012

Ensartininb (X396), an oral ALK inhibitor
in patients with ALK NSCLC - Phase 1-2 study
I/II

ALK stage IIIB or IV
May have been treated with other TKIs
USA: Duarte, LaJolla, Los Angeles, Stanford
Tampa, Bethesda, Boston, St. Louis, NYC,
Portland OR, Nashville, Madison, and
China
Xcovery

NCT01625234
NCT02959619 China

I emailed Xcoery and they are still
recruiting for this trial 7/12/2018
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Recruiting for 2nd line Treatment After Progression on Crizotinib as Only ALK TKI
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DateTrial Summary PhaseInclusion CriteriaLocationsSponsorsIdentifierComments
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17/24/2018Comparing Brigatinib vs. Alectinib in ALK NSCLC
patients who have progressed on Crizotinib
IIIAdvanced ALK NSCLC
Progression on Crizotinib as only TKI
Previous Chemo allowed
Brain mets allowed if asymptomatic
USA: Whittier CA, Athens GA, Fairfax VA. Canada (not recuriting yet)
Halifax,Toronto
Ariad Pharmaceuticals
Takeda
NCT03596866


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27/31/2018A Phase I Study of Alkotinib in Patients With Advanced Non Small Cell Lung Cancer (NSCLC)IAdvanced ALK NSCLC
Previously treated withCrizotinib treatment or chemotherapy
Brain mets allowed if asymptomatic
China:ShanghaiSuzhou Zelgen BiopharmNCT03607188

I don't see anything out about this
drug, except it inhibits ROS-1
in addition to ALK
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37/12/2017Ensartinib after previous treatment with Crizotinib
in ALK NSCLC
IIALK stage IV
Progression during Crizotinib treatment
China: Bejing - 4 SitesBetta PharmaceuticalsNCT03215693
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410/5/2015


Entrectinib basket study for solid tumors with NTRK,
ROS1 or ALK
(ALK NSCLC with brain/CNS only progression with
prior Crizotinib)
II


Stage IV ALK NSCLC with CNS only mets
(Crizotinib as only prior ALK TKI)
ALK Solid Tumors
ALK Metastatic Colorectal Cancer
USA, Belgium, France, Australia,
Germany,Hong Kong, Italy, Japan, Korea,
Netherlands, Poland, Singapore, Spain
Taiwan, UK.
Hoffman-La Roche


NCT02568267


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Recruiting for ALK NSCLC 2nd-3rd-4th Line Treatment After One or More ALK TKIs
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DateTrial Summary PhaseInclusion CriteriaLocationsSponsorsIdentifierComments
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15/29/2019
Alternating Lorlatinib with Crizotinib in ALK NSCLC progressed on a 2nd generation ALK Inhibitor
(Lorlatinib x 8 weeks, then Crizotinib x 4 weeks
repeated indefinitely)
I/II
Stage IV ALK+ NSCLC per FISH or IHC
Confirmed progression on Ceritinib, Alectinib, or Brigatinib
Past chemotherapy or radiation okay
Brain mets okay if stable for at least 14 days
No prior Lorlatinib treatment
Australia: Melbourne, St. Leonards (Sydney)Pfizer
Fight for a Cure
Australasian Trials Group
https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377668&isReview=trueEntriely new concept of alternating different ALK inhibitors in 4-8 week
cycles
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2222211/12/2018
Biomarker/ALK Inhibitor Combos in Stage IV ALK NSCLC
progressed on 2nd generation ALK Inhibitor
(The NCI-NRG ALK Master Protocol)
II
Stage IV ALK+ NSCLC per FISH, IHC, or NGS
Willing to have fresh biopsy or have adquate recent tissue
Progression after Ceritinib, Alectinib, Ensartinib, Brigatinib, or
Lorlatinib
Brain mets okay in certain circumstances
USA: Arkansas, California, Colorado, Delaware, Hawaii, Idaho, Illinois, Indiana, Iowa, Kentucky, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, N. Carolina, N. Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, S. Dakota, Tennessee, Texas, Washington St, Wisconsin, Wyoming. National Cancer Inst
Alice Shaw MD
NCT03737994


Submutations found on biopsy will
determine treatment with ALK TKIs
or chemotherapy
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33/11/2016

Brigatinib after treatment with next generation ALK TKIs

II

ALK advanced or metastatic
Progression on Alectinib or Ceritinib
Progression on Brigatinib in some circumstances
USA: Denver, Durham NC, Nashville, Dallas

U of CO, Duke, Vanderbilt
UT Southwestern,
Criterium, Inc. Takeda
NCT02706626

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45/24/2018
Brigatinib in ALK+ NSCLC progressed on Alectinib or
Certinib (ALTA-2)
II
Stage IIIB or IV ALK + MSCLC with tumor sample available
Been on Alectinib or Ceritinib at least 12 wks before
progression
No other ALK TKI in past except Criz, Alec, or Certinib
No symptomatic brain mets
USA: So California, Orlando, Detroit, St. Louis, Charlotte NC, Nashville, Fairfax, VA, Portland OR, Australia, Austria, China, France, Korea, Italy, Spain, Canada, Hong Kong, Sweden, Netherlands, TaiwanAriad Pharmaceuticals
Takeda
NCT03535740Similar smaller study recruiting in
Denver, Durham NC, Dallas
Clin Trials.gov ID NCT02706626
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52/28/2018
Ceritinib + Everolimus (mTOR inhibitor) for advanced or
metastatic ALK NSCLC
I
Stage IIIB or IV ALK who have failed at least one therapy
Tumor suitable for needle or other biopsy
USA: Houston TX - MD Anderson
MD Anderson
Novartis
NCT02321501
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68/8/2017

Pembrolizumab (Keytruda immunotherapy) combined with
Platinum Doublet Chemo with ALK or EGFR NSCLC
Progression on TKIs
II

Progressive dz after ALK TKI
PD-L1 has been assessed or tissue available to test
NO prior chemo or immunotherapy
USA: Ann Arbor, Detroit, Bronx NY, Nashville
Chicago (Rush University)
Shirish M Gadgeel, M.D
University of Michigan
Cancer Center
NCT03242915

Rush Univeriswty at Chicago is
new recruiting site. ALK is now listed in inclusion criteria
40
712/11/2014

Alectinib: Deciphering anti tumor response and resistance
with intratumor heterogenicity
(Darwin II)
II

ALK/RET gene fusion relapsed disease
Biopsy of relapsed disease
Multi-region sequencing of the primary tumor available
UK: London - University College Hospital

University College, London
Hoffman-La Roche
NCT02314481

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Recruiting for All Advanced NSCLC After Progression with Standard Treatments (ALK included)
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DateTrial Summary PhaseInclusion CriteriaLocationsSponsorsIdentifierComments
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2
10/22/2018


Carboplatin Plus Pemetrexed Plus Atezolizumab Plus Bevacizumab in Chemotherapy and Immunotherapy-naïve Patients With Stage IV Non-squamous Non-small Cell Lung CancerII


Advanced or metastatic NSCLC
ALK Included if recurence on TKIs
PD-L1 status is known
No prior immunotherapy or antiangiogenic therapy
Prior Carbo or Pemetrexed okay if given for stage III
USA: Illinois- Chicago, Indiana - IndianapolisBig Ten Cancer Research
Genentech

NCT03713944

Similar to IM Power 150 trial except using Carbo/Pemetrexed chemo instead of Carbo/Paclitaxel
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2
8/27/2018


Combination therapy with IV VSV-IFN8-NIS (virus anit-cancer agent) and Pembrolizumab (Keytruda immunotherapy) in refractory NSCLCI


Advanced or metastatic NSCLC with no existing effective treatment options. ALK included
Willing to provide fresh tumor biopsy
No brain involvement, but imaging of brain not required if asymptomatic
USA: Mayo Clinic, Rochester MNVyriad, Inc
Mayo Clinic

NCT03647163

 
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3
8/17/2018


Dose Escalation of RMC-4630 (SHP2 Inhibitor) Monotherapy in Relapsed/Refractory Solid TumorsI


Patients with advanced solid tumors that have failed or
are intolerant to standard treatments, including drugs for
oncogenic drivers in their tumor type
No brain metastases
USA: Scottsdale AZ, Duarte CA, Orange CA (UC Irvine), Sacramento CA, San Franisco CA, Denver CO, Sarasota FL,
Tampa FL, Boston MA, Oklahoma City OK,
Nashville TN (Sarah Cannon Inst)
Revolution Medicines

NCT03634982 


 
46
41/31/2018



GRN-1202 (cancer peptide vaccine) with Pembrolizumab
(Keytruda immunotherapy) in metastatic PD-L1+ NSCLC

II


Stage IV NSCLC - ALK included if progressed on TKIs
HLA-A*02 positive. No LMD
PD-L1 TPS 50% or more
No more than one chemo regimen in the past
USA: Chicago, Denver, Pittsburgh, Hilton Head, Knoxville, Louisville, Orlando.
Site in New Hampshire,
planned in future.
BrightPath Therapeutics

NCT03417882


If ALK, may not be eligible for
ALK TKI at time of study
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512/13/2017

AST-VAC2 Vaccine in patients with NSCLC
(immune therapy targeting hTERT protein)
I


Advanced NSCLC with no other suitable treatment options
OR previously treated NSCLC who are disease free (adjuvant treatment)
No active autoimmune disease
UK: Birmingham, Southhampton

Cancer Research UK

NCT03371485

Six vaccinations over six weeks
48
68/21/2017

Nivolumab (immunotherapy) combined with Chemotherapy
or Nivolumab combined with Ipilimumab (immunotherapy)
(non-randomized) in EGFR or ALK NSCLC
II


NSCLC stage IIIB or IV - ALK included
Progression on one or more next generation ALK TKIs
One prior platinum-based chemo in Nivo/Ipi arm
Tissue sample after last line of therapy
USA: Boston - Mass General, Dana Farber
Beth Israel

Mass General
Bristol-Myers Squibb

NCT03256136


49
77/12/2017

Nivolumab and Tumor Infiltrating Lymphocytes (TIL) in Advanced Non-Small Cell Lung Cancer (Car-T type treatment combined with immunotherapy)I

Stage IV NSCLC
Tumor surgically accessible
ALK not excluded if progressed with TKIs
No previous immunohterapy
Treated brain mets okay
USA: Florida - Gainsville, TampaMoffitt Cancer Center
Bristol Myers Squibb
Prometheus, Iovance
Stand up to Cancer
NCT03215810


50
77/11/2017

Dose Finding Study of TNO155 (SHP2 Inhibitor) in Adult
Patients with Solid Tumors
I

Specifically recruiting for advanced EGFR NSCLC and other
solid tumors, but does not exclulde ALK.
Progressed following standard therapy, or no effective
standard therapy exists
USA: Boston, NYC, Nashville Canada: Toronto
Japan :Kobe-shi, Netherlands: Amsterdam, Rotterdam
Singapore, Spain: Barcelona
Novartis PharmaceuticalsNCT03114319


First in Human study
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82/10/2017

Recombinant EphB4-HAS Fusion Protein combined with
Pembrolizumab (immunotherapy)
II

Stage IIIB or IV NSCLC (including ALK)
Progression after ALK-TKI and platinum based chemo
No previous Immunotherapy
USA: Los Angeles, CA - USC Norris

USC
National Cancer Institute
NCT03049618

52
911/4/2016
CIMAvax vaccine and Anti-PD1 immunotherapy
with previously treated advanced NSCLC or squamous head and neck cancer
(Optivo or Keytruda combined with CIMAvax)
I

Stage IIIB or IV NSCLC: ALK included
Prior treatment and progression with ALK-TKI(s)
USA: Buffalo NY - Rosewell Park Cancer Inst
Roswell Park Cancer Inst
National Cancer Institute
NCT02955290
Keytruda option is new for 2019
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108/2/2016

Treosulfan (chemotherapy), metronomic low dose,
Pioglitazone, (diabetes drug) and Clarithromycin (antibx)
vs. Nivolumab; randomized (MODULUNG)
II

Stage IIIB or IV NSCLC - ALK included
Progression with ALK-TKI
No LMD and most with CNS mets excluded
Germany: Bavaria, Norderhein-Westfalen,
Sachen-Anhalt, Saarland
U Hospital Regensburg
The Anticancer Fund
NCT02852083

This implies there
could be randomization
to monotherapy Nivolumab.
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1112/30/2015Mifepristone (synthetic hormone) as Salvage Therapy for Advanced NSCOCIIAdvanced, recurrent or Metastatic NSCLC
Progression on at least 2 standard treatments
If ALK, previous treatment with TKI
Can not be on steroid medication
USA: Melrose Park, PA (Philadelphia)Corecept Therapeutics
Jerome Check MD
NCT02642939 


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1210/30/2015Mage A10 c798-T for Advanced NSCLC
(Like CAR-T Cell Therapy)
IStage IIIB or IV NSCLC
If ALK, ROS-1, or EGFR has progressed with at least 1 TKI
No limit to lines of prior anti-cancer treatments
HLA-A 02:01 or HLA 02:06 positive
Tumor with MAGE-A10 expression
USA: Duarte, CA, Palo Alto, Miami, Tampa,
Atlanta, Indianapolis, Baltimore, Boston,
Saint Louis, Durham NC, Columbus OH,
Philadelphia, Nashville, Houston

Can:
Toronto, EUR: Madrid, London, Manchstr
AdaptimmuneNCT02592577


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Recruting for Unspecified ALK-TKI Line of Treatment (China)
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DateTrial Summary PhaseInclusion CriteriaLocationsSponsorsIdentifierComments
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11/4/2018WX-0593 (ALK inhibitor) in advanced solid tumorsI/IIAdvanced ALK who can't accept chemo or can't afford ALK-TKI or failed in standard treatment
Asymptomatic brain mets okay
China: Bejing - Cancer Hospial of Chinese
Academy of Medical Sciences
Qilu PharmaceuticalsNCT03389815
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ADD NON LUNG ALK
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