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A1:E4Updated 5/1/2024
The Americas, Europe, China,
Other Asia/Africa, Australia
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DateTrial Summary PhaseInclusion CriteriaLocationsSponsorsIdentifier- LINKComments
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Studies Recruiting for Surgically Resectable Disease - ALK NSCLC Stage 1A to IIIA
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2/1/2023Neoadjuvant Aliya™ PEF Soft Tissue Ablation With Systemic Therapy in Early-Stage Resectable NSCLC (VIGOR)4IIB to IIIA adenocarcinoma of the lung (includes ALK)
Lesion size less than or equal to 5 cm
Participant is candidate for definitive surgical resection
No cancer therapy 2 for years prior
Can not require pneumonectory
USA: Rochester MN, Philadelphia PA
Galvanize therapeuticsNCT05583188

Aliya is a Pulsed Electric Fields device. This PEF device can ablate lung tissue though a small incision into the skin or broncoscopy. Biopsies can also be obtained. Surgery and chemotherapy per establisehd protocols will follow the PEF ablation. The hope is that PEF ablation will make surgery and subsequent therapies more successful
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5/20/2021Alectinib before surgery (Neo-adjuvant) in stage III
ALK Positive NSCLC (ALNEO)

2Locally advanced stage 3 ALK+ adenocarcinoma of the lung
Mixed histology okay if adenocarcinoma is prominent
Candidate for surgical resection
No prior systemic treatment for lung cancer
Italy: Aviano, Bari, Bologna, Catania, Firenze, Genova,Lido De Camaiore. Meldola, Modela, Monza, Napoli, Obassano, Padova, Parma, Perugia, Roma, Rozzano. Verona.
Gruppo Oncologico Italiano di Ricerca ClinicaNCT05015010 


Alectinib will be adminstered 8 weeks
before surgery.
After surgery, alectinib will continue up to
96 weeks.
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7/31/2020Alectinib, (Entrectinib, or Vemurafenib Plus Cobimetinib) in Resectable Stages IB-III NSCLC with ALK,(ROS-1, NTRK or BRAFv600E) Molecular Alterations (NAUTIKA-1)
(Stages IA2 - IIIAB)
2Resectable stage 1A2, 1B, 2, 3A or selected 3B ALK+ NSCLC
Will receive up to 8 weeks Alectinib before surgical resection
and/or radiotherapy as recommended by treating physician
USA: LA, Orange, Sacramento, San Francisco, CA; Denver CO, New Haven CT,Tampa FL, Chicago IL, Boston MA, Ann Arbor, MI: Columbia, St Louis, MO; Lebanon NH, NY, NY; Columbus OH, Pittsburgh PA, Memphis TN, Houston, Kingwood, TX, Washington DC, Fairfax, VA.Genentech
NCT04302025


Innovative in that tumors will be
reduced with Alectinib before
resection. May also be possible to
continue Alectinib after surgery/radiation.
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8/18/2014
Crizotininb in patients with IB-IIIA ALK NSCLC that has
been removed by surgery
(An ALCHEMIST Treatment Trial)

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Stage IB, II, or non-squamous IIIA , ALK NSCLC - NED
Complete resection 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: 1498 sites



ECOG-ACRIN Reserach
National Cancer Institute


NCT02201992

Randomized to Crizotinib
up to 2 years vs
observation without Criz

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Studies Recruiting for Stage II-III Unresectable Disease - ALK NSCLC
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5/1/2023

Brigatinib Post Definitive Chemo-radiotherapy in Patients With ALK-fusion Non-small Cell Lung Cancer (BOUNCE)
(Brigatinib vs. durvalumab or observation)



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Newly diagnosed, Stage III unresectable ALK+ NSCLC,
Completed chemo-radiotherapy withour progression
No prior treatment







France: Angers, Caen, Italy: Novara
Spain: Alicante, Bilbao
More sites in France, Italy, Poland, UK planned
ETOP IBCSG Partners
Takeda
NCT05718297

 


Particiapants will be randomized to brigatinib 180 mg per day, or observation/durvalumab after completing chemoradiation without progression. Durvalumab is optional per investigators choice. Drugs like durvalumab have not been effective for ALK in other studies, and durvalumab may cause harm. A participant should only choose durvalumab if they have done their own research on risks and benefits, in addition to the information given by their oncologists.
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7/15/2022
Alectinib vs durvalumab: A Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Participants With Locally Advanced, Unresectable, Stage III Non-Small Cell Lung Cancer (NSCLC)



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Newly diagnosed, Stage III unresectable ALK+ NSCLC,
Prior receipt of at least 2 cycles of platinum-based chemotherapy
Prior radiation okay
(ROS1 or RET mutations included with their assocated TKIs)







USA, Australia, Belgium, Brazil, Canada, Chile, China, Columbia, Costa Rica, France, Germany, Hong Kong, Israel, Italy, Japan, Korea, Norway, Poland, Serbia, Spain, Sweden Singapore, Taiwan, Thailand, Turkey, UK, New Zealand
Hoffmann-La RocheNCT05170204




Particiapants will be randomized to receive either alectinib or durvalumab after chemotherapy.Durvalumab is an checkpoint inhibitor immunotherapy, and this class of drug is usually not effective in later stages of ALK lung cancer. Based on current research, alectinib is likely to be far more effective than durvalumab. Anyone entering this trial should have an excellent understanding of risks and benefits, preferably beyond what they are told by their oncologist.
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9/13/20219
Ipilimumab and Nivolumab in Combination With Radiation Therapy in Treating Patients With Stage 2-3 Non-small Lung Cancer
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Stage II or III unresectable ALK+ NSCLC, including ALK
Deemed to be best treated by radiotherapy
No prior lung cancer treatment for stage II or III






USA: Houston, Texas (MD Anderson)
MD Anderson
National Cancer Institute
NCT04013542



It is specifically mentioned that ALK is eligble for this trial.
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Recruiting for 1st Line ALK Inhibitor Stage IIIB to IV (No Prior ALK TKI Treatment)
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9/2023
Delayed or Upfront Brain RAdiotherapy in Treatment naïve Lung Cancer Patients With Asymptomatic or Minimally Symptomatic Brain Metastases and ALK rEarrangements (DURABLE) (Alectinib + SRS)1/2

Stage 4 ALK NSCLC
Must have 1-15 intrcranial metastases less than 3 cm with only one lesion more than 2 cm
Minimally symptomatic or asymptomatic brain mets with no plan for surgery within 28 days
Okay if symptoms are controlled with steroids or anti-sseizure meds
No prior ALK TKIs or other cancer treatment since diagnosed with stage 4
USA: Columbus, Ohio
Joshua Palmer
Genetech
NCT05987644



Participants will receive radiation therapy to brain mets prior to starting alectinib
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10/5/2023Alectinib Followed by Concomitant Consolidation Radiation Therapy in Advanced NSCLC With ALK-rearrangement (A-SAB)NA
Stage IIIB, IV or recurrent ALK NSCLC
Stable disease or partial response after 2-3 month on alectinib
Maximum 5 tumor lesions + throacic lymph nodes
No LMD
No progression after 2-3 months alectinib

Sweden: Stockholm


Karolinska University HospitalNCT05724004

Participants will receive radiation to tumors after the tumors have been shrunk with alectinib
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10/15/2022

Immunotherapy or Targeted Therapy With or Without Stereotactic Radiosurgery for Patients With Brain Metastases From Melanoma or Non-small Cell Lung Cancer (USZ-STRIKE)
III

Newly diagnosed ALK NSCLC with brain metastases
Mild symptoms from brain met(s), requiring no more than 4 mg dexamethasone.
Prior surgery for brain mets allowed
No previous treatment for lung cancer except brain surgery for mets
No previous radiation for brain mets

Italy: Siena, Perugia, (Sites planned in Napoli, Roma)
Netherlands: Amsterdam
Switzerland: Bern, Zurich,Winterthur
UK: (Sites planned in Sutton, Manchester)

ETOP IBCSG Partners Foundation
USZ Foundation
NCT05522660 

Participants will be randomized to receive ALK inhibitor alone vs. SRS brain radiation before ALK inhibitor.
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5/18/2022

Study of Safety and Efficacy of Brigatinib Plus Chemotherapy or Brigatinib Only in Advanced ALK-Positive Lung Cancer (MASTERPROTOCOL ALK)


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Advanced ALK+ NSCLC, not eligible for local treatment
TKI naïve
Brain mets must be stable
At least 12 months since chomtherapy for earlier stage lung cancer





France: 32 sites
Intergroupe Francophone de Cancerologie ThoraciqueNCT05200481


Participants with no previous TKI use will be randomized to receive either brigatinib plus 4 cycles of carbo/pemetrexed chemotherapy or brigatinib alone.
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5/1/2022
Alectinib Pharmacokinetic in Patients With NSCLC

1/2







Advanced or recurrent or metastatic ALK+ NSCLC
TKI naïve
Brain mets okay if stable: no LMD






Mexico: Mexico City Insittuto Nacional de Cancerologia de MexicoNCT05713006 Participants will be given alectinib at escalating doses and blood levels will be obtained. Alectinib dosing will be based on these blood levels
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3/23/2022



Comparison of Standard Dose Alectinib to Alectinib in Adjusted Dose Based on Alectinib Bloodlevels (ADAPT ALEC)




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Advanced or recurrent or metastatic ALK+ NSCLC
TKI naïve
One previous line of chemotherapy okay
Brain mets or LMD okay if stable






Netherlands: Amsterdam, Leiden, Rotterdam, Groningnen, Maastrich. More sites in Netherlands and France planned. Various University and Cancer Center sponsors in NetherlandsNCT05525338

Randomized to standard dose alectnib vs dose adjustments based on blood levels of the drug.
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10/1/2019
OMEGA, A Randomized Trial of Local Ablative Therapy Vs. Conventional Treatment in Oligometastatic NSCLC


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Advanced or metastatic ALK+ NSCLC
No previous systemic treatment (may consider if started systemic treatment 3 months before without progression)
Primary tumor amenable to surgery or radiation
Between 1-3 metastatic lesions




Italy: Verona
Azienda Ospedaliera Universitaria IntegrataNCT03827577

Randomized to ALK TKI vs Local Ablative Therapy (radation or surgery) to all metastatic sites, with ALK TKI
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Recruiting for 1st or 2nd+ Line Treatment (ALK TKI Treatment Naïve or Prior ALK TKIs)
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5/3/2023

Patient-centered, Optimal Integration of Survivorship and Palliative Care (POISE) (Palliative Care Intervention at Diagnosis)
NA

Age 18 or older
MGH Cancer Center patient
Within 6 months of diagnosis of metastatic ALK NSCLC
Receiving targeted therapy
Ability to respond in English or Spanish
USA: Boston, Mass General
Mass General
Americal Lung Association
NCT04900935  


Patents will receive four 60 minute visits with a palliative care physician who is trained to address the psychosoical issues and health promoting behaviors of people with long, uncertain cancer trajectories.
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8/17/2023Lorlatinib in Combination With Ramucirumab in People With Lung Cancer1/2
Metastatic or recurrent ALK lung cancer
ALK treatment naïve OR progression or intolelrance of at least one second gen ALK TKI (alectninb, ceritinb, brigatinib)
Prior chemo okay
No prior lorlatinib or ramuciramab
No active brain mets

USA: Middletown NJ, Montvale NJ, Comack, Harrison, NYNY,
Rockville Centre NY



Sloan Kettering Cancer Center
Eli Lilly and Co
NCT06007937

Participants will receive the combination or lorlatinib and ramuciramab. Ramuciramab is an angiogenesis inhibitor targeting VEGR. It limits blood supply to the cancer to limit growth. Ramuciramab is in the same drug category as Avastin (bevacizumab), but it may cause fewer side effects.
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7/21/2022Multi-modality local consolidative treatment (LCT) versus conventional care of advanced lung cancer after first line systemic anti-cancer treatment (RAMON)3
Stage 4 ALK lung cancer (or other types)
Currently prescribed TKI for a minimum of 3 months
Able to have local treatment to all areas of residual disease

UK: London (Royal Brompton). Other sites in the UK planned.


NIHR
https://fundingawards.nihr.ac.uk/award/NIHR131306Participants will be randomzed to have either LCT after starting a TKI, vs. TKI and standard treatment only.
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4/1/2022Exercise in Extended Oncogene Addicted Lung Cancer
In Active Treatment (EXcellenT)
N/A


ALK NSCLC on first or second line systemic treatment (TKI)
Not suitable for local treatment
Prior radiotherapy and chemotherapy allowed

Italy: Ravenna
AUSL Romagna Rimini
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
NCT05306652


Patients will be randomized to receive supervised physical activity vs. unsupervised physical acitivity. Qualiy of life and overall survival will be measured between the two groups.
***
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12/10/2021Personalized Dendritic Cell Vaccines in NSCLC
(ALK included)

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Advanced ALK NSCLC stage IV or unresectable stage III
On standard of care treatment with crizotinib, alectinib,or lorlatinib
No progression on current treatment

Switzerland: Lausanne


Centre Hospitalier Universitaire Vaudois
NCT05195619 

Six doses of personalized dendritic cell vaccine will be added to standard of care ALK inhibitor treatment
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11/10/2020
Observation or Upfront Cranial Radiation in Oncogene Driver Mutated NSCLC With Asymptomatic Brain Metastases (including ALK)
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ALK or EGFR lung cancer
Asymptomatic brain metastases
No previous brain radiation
No brain stem metastases


India: Mumbai, Tata Memorial Hospital



Tata Memorial Hospital
NCT05236946  

Patients with brain metastases will be randomized to receive brain radiation (SRS or WBR) before ALK-TKI, or ALK-TKI alone
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11/11/2019


TKI Alone Versus TKI and Local Consolidative Radiation Therapy in ALK (or other oncogene) NSCLC
(TARGET-01)

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Oncogene driver NSCLC
At least 2-4 months of TKI treatment without progression
1-5 sites of metastatic disease not including primary tumor and regional nodes
No prior radiation to thorax
India: Mumbai, Tata Memoral Hospital

Tata Memorial Hospital
NCT05277844 

Participants will be randomized to receive
radiation local consolidative therpy with TKI
vs. TKI alone
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9/14/2017


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

1B/2


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



Mass General
Genentech
NCT03202940  


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12/2016
Stereotactic Ablative Radiotherapy in Synchronous and Metachronous Oligo-Metastatic Non Small Cell Lung Cancer (STARTNEWERA-OM)N/A

Oligometastatic NSCLC (ALK included), either at diagnosis or progression
Ability to safely treat target lesions with raidation
Brain mets must be stable




Italy:Terni
Radiotherapy Onconogy Centre S. Maria HospitalNCT06207292Targeted radiation will be applied to residual or progressive
tumors while ALK TKI therapy is maintained
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10/7/2016

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


Mass General
NCT02927340

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Recruiting for ALK NSCLC 2nd-3rd-4th Line Treatment After One or More ALK TKIs
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8/24/2024
Prophylactic Neopeptide Vaccine in Advanced ALK+ NSCLC1/2


Advanced ALK lung cancer
Must be suitable for biopsy
Must be able to stop other cancer therapies
USA: Baltimore MD (Johns Hopkins)
Sidney Kimmel Cancer Center at Johns HopkinsNCT05950139


Participants will receive radiation therapy to all known tumor lesions after 2-3 months treatment with alectinib
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5/2024

Gilteritinib for the Treatment of ALK NSCLC1


Stage IV ALK NSCLC
Adeoncarcinoma, squamous, adenosquamous included
Progression on at least one TKI
Prior chemo, immunotherapy, and other cancer agents okay
Brain mets must be stable



USA: Ann Arbor MIUM Rogel Cancer CenterNCT06225427Giltertinib is an ALK inhibitor which also inhibits other cancer metabolic pathways. It is already approved for treatment in leukemia.
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3/15/2024

Combination of Platinum-pemetrexed Based Chemotherapy Plus Lorlatinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) With Exclusively Extracranial Disease Progression on Lorlatinib (ALK-PPL)2


Confirmed diagnosis of stage IV ALK positive NSCLC
Progression outside of brain on Lorlatinib
Lorlatinib may be in first- or further-line
No limit on prior therapies
No brain progression



Italy: Aviano.
Sites planed in Firenze, Lido Di Camaiore, Meldola, Monza, Padova, Parma, Perugia, Udine
Centro di Riferimento Oncologico - AvianoNCT06378892
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11/12/2023

MK-2870 Versus Chemotherapy in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations or Other Genomic Alterations (MK-2870-004)3


Lung Adenocarcinoma ALK-Rearranged Stage IIIA-IV
Progression after last treatment
1-2 prior lines of EGFR-TKI and prior platinum chemotherapy
(Maybe prior ALK-TKI will be accepted)



USA: Orange City FL, Marietta GA, Hattiesburg MS, Pennington NJ
Australia: Westmead,NewSouth Wales. Clayton, Melbourne. Canada: Brampton
Chile: Talca, Santiago, Valparaiso
Hong Kong: Central, Hksar, Kowloon, Lai Chi Kok
Korea: Seoul, Hwason, Goyand-si, Busan, Israel: Haifa, Jerusalem, Petah Tikva. Malaysia: Kuala Lampur
Taiwan: Hsinchu, Kaohsiung, Tainan, Taipei, Changhua, Kaohsiung, Tainan.
Merck Sharp & Dohme LLCNCT06074588

MK-2870 is an anti-TROP antibody-drug conjugate. Participants will be randomly assigned to MK-2870 or chemotherapy . The study design seems entirely based on EGFR lung cancer. Although ALK is mentioned in the study design, it's not clear ALK will be accepted.
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8/8/2023

Amivantamab With Tyrosine Kinase Inhibitor (TKI)1/2



Stage III unresectable or stage IV ALK
Known ALK, ROS1 or RET fusion
Progression on at least one TKI, on the same dose for at least 3 months prior to the study
No prior EGFR inhibitors




USA: Denver CO, Ann Arbor MI.

University of Colorado
Janssen
NCT05845671 


Amivantamab is a monoclonal antibody that is approved for the treatment of EGFR exon 20 insertion mutation after progession on platinum chemotherapy. It targets ERBB and cMET, resistance pathways in ALK and other cancers. Amivantamab will be added to the current TKI.
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12/23/2022

CD40L-Augmented TIL for Patients With EGFR, ALK, ROS1 or HER2-Driven NSCLC1/2

Stage VI or recurrent ALK NSCLC
Progression after targeted therapies
No more than 6 prior lines of systemic therapies
No prior PD-1 or PD-L1 inhibitor immunotherapies
Brain mets okay if stable
USA: Tampa, FL - Moffitt Cancer CenterMoffitt Cancer CenterNCT05681780This is a therapy where cancer-attacking while blood cells are developed in a lab using each patients' resected tumor. A short course of chemotherapy depletes the white blood cells, then there is one infusion of the enhanced white blood cells. Nivolumab will be given before and after infusion.
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7/2022

A Study of LP-300 With Carboplatin and Pemetrexed in Never Smokers With Advanced Lung Adenocarcinoma (HARMONIC)2


Inoperable advanced (stage III or IV) ALK adenocarcinoma
Other targetable mutations included
Never smoker
Has exhausted TKIs
Brain mets must be stable
Prior radiation okay
USA: Goodyear AZ. Beverly Hills, Fountain Valley, Los Alamitos, Los angeles CA. Newman GA. Rolling Meadows, Zion IL. Morristown NJ. Patchogue NY,. Dallas TX, Fairfax VA.Lantern PharmaNCT05456256

Never smokers with lung cancer will be given LP-300 with chemotherapy after exhauting TKIs.A subset of never smokers in another trial had improved survival with this combination.
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5/1/2022A Study of NVL-655 (new ALK TKI targeting ALK and resistance mutations) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)1/2



Advanced or metastatic ALK lung cancer or solid tumor
For NSCLC: progression after 1-3 lines of TKI treatment, including crizotinib, ceritinib, alectinib, brigatinib, or lorlatinib.
For ALK soild tumors: at least one prior systemic anticancer therapy, or no satifactory standard therapy exists
Measurable disease according to RECIST 1.1


USA: Orange, Sacramento, Stanford CA, Denver CO, Miami FL, Boston MA, Detroit MI, Durham NC, NYNY, Columbus OH, Nashville TN, Houston TX, Seattle WA. Washington DC
Canada: Edmonton,Toronto
Australia: Saint Leonards, Melbourne, Woolloongabba
Spain
:A Coruna, Barcelona, Madrid UK: Manchester, Sutton
Singapore

Nuvalent
NCT05384626 


NVL-655 is a new ALK inhibitor that targets resistance mutations, including compound mutations that can occur after lorlatinib treatment.
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7/8/2021SNK01 (Super Natural Killer Cells) in combination with gemcitabine chemotherapy and/or EGFR antibody in NSCLC who were failed by TKI treatment (SNK_ASTER)

1/2
Advanced NSCLC with at least one gene mutation (incl. ALK)
Progression after at least one TKI
Previous platinum chemotherapy okay
Stable brain mets okay
Must stop TKI 2 weeks before enrollment
Korea: SeoulNKMAX Co, ltd
NCT04872634

EGFR inhibitor is the monoclonal antibody cetuximab. It will be added to nautral killer cells and gemcitabine chemo in some patients.
EGFR mutation does not determine who gets the EGFR antibody.
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12/1/2020
Talazoparib and Palbociclib, Axitinib, or Crizotinib for the Treatment of Advanced or Metastatic Solid Tumors, (TALACOM Trial)1


Advanced/metastatic ALK NSCLC or selected other targetable mutations.
Progression or intolerance of standard therapies
Fresh or recent tumor sample
No unstable brain mets or brain mets requiring steroids
USA: Houston (MD Anderson)
MD Anderson
NCI
NCT04693468


Talazparib and crizotinib will be given to all ALK patients. Talaoparib is a PARP inhibitor which stops cancer cells from repairing themselves.
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5/1/2020Lorlatinib Combinations in ALK Lung Cancer
(Lorlatinib + Crizotinib / Lorlatinib + Binimetinib / Lorlatinib + TNO155 )

1/2
Advanced ALK+ NSCLC
Prior Chemo okay
Progression on at least one ALK TKI
Brain mets must be stable. LMD is included in trial.
USA: Boston: Massachsetts General,
Mass General
Array Biopharma
Pfizer
NCT04292119

Assigned to either Lor/Criz or
Lor/Binimetinib or Lor/TNO155

Unless biopsy shows MET, then receive Lor/Criz
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9/4/2019Phase II Randomized Trial of Carboplatin+Pemetrexed+Bevacizumab+/​- Atezolizumab in Stage IV NSCLC2
Advanced or metastatic ALK+ NSCLC
Progression on at least one ALK inhibitor
No more than 2 prior cycles of chemotherapy
No untreated active brain mets
France: Angers, Annecy, Brest, Caen, Creteil, Grenoble, La Reunion, Limoges, Lyon, Marseilles, Orleans, Paris, Pessac, Pierre-Benite, Rennes, Rouen, Strasbourg, Toloun, Toulouse, Villenave-d"Ornon. More sites planned in France


Centre Francois Baclesse


NCT0402558

Non-random addition of Bevacizumab to Carbo/Alimta/Tecentriq.
Tecentriq is a checkpoint inhibitor immunotherapy. This class of drug is seldom effective in ALK.

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Recruiting for Leptomeningeal Metastases
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6/12/2021
Intraventricular Administration of Rhenium-186 NanoLiposome for Leptomeningeal Metastases (ReSPECT-LM)1
Documented LMD; Type 1 and 2 of any primary tumor type.
2D LMD excluded
No serious extrameningeal progression, or other serious illness
No prior spinal cord radiation or whole brain radiation
No current CNS-penetrant chemotherapy
USA: Chicago IL, Dallas, San Antonio TX. Site planned in Houston

Plus Therapeutics
NCT05034497Participants will be given a single dose of 186RNL (radionuclide clinical study drug) into the spinal fluid
through a intraventricular catheter (Ommaya resevoir).
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