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Updated 2/11/2026
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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7/31/2020A Study of Multiple Therapies in Biomarker-Selected Patients With Resectable Stages IB-III Non-Small Cell Lung Cancer (Alectinib) NAUTIKA12Newly diagnosed resectable stage 1A2, 1B, 2, 3A or selected 3B ALK+ NSCLC
USA: LA, Orange, Sacramento CA; New Haven CT,Tampa FL, Chicago, DeKalb, Geneva, Warrenville IL, Boston MA, Ann Arbor, MI: Rochester MN, Columbia, St Louis, MO; Lebanon NH, NY, NY; Columbus OH, Memphis TN, Houston TX, Washington DC, Fairfax, VA.Genentech
NCT04302025


Resectable 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.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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Studies Recruiting for Stage II-III Unresectable Disease - ALK NSCLC
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Recruiting for 1st Line ALK Inhibitor Stage IIIB to IV (No Prior ALK TKI Treatment)
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6/19/2025
Local Ablative Treatment (LAT) in Patients With Advanced Non-Small Cells Lung Cancer (NSCLC) with Anaplastic Lymphoma Kinase (ALK) Rearrangement Treated by Brigatinib (OPTALK)2Stage 3 non eligible for chemoradiotherapy or stage 4
NSCLC
Documented Anaplastic Lymphoma Kinase (ALK) rearrangement
Tyrosine Kinase Inhibitor (TKI) treatment naïve Oligometastatic disease (five metastatic lesions or less
Stable disease or response after initiation brigatinib treatment (at least 3 to 9 months)
At least one site of residual site for LAT
Brain mets okay if clinically stable		France: Nancy .
26 more sites in France Planned
Groupe Francais De Pneumo-CancerologieNCT06620835This clinical trial is to learn if LAT (local ablative therapy) added to systemic Brigatinib (ALUNBRIG®) improves outcomes in patients with residual disease after brigatinib monotherapy.
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1/2025
NVL-655 for TKI-naive Patients With Advanced ALK-Positive NSCLC (ALKAZAR)3
Confirmed locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC)
Documented Anaplastic Lymphoma Kinase (ALK) rearrangement via testing of tissue or blood
No prior systemic anticancer treatment for NSCLC (adjuvant/neoadjuvant chemotherapy allowed if 12 months prior to randomization)
Pretreatment tumor tissue (archived or a fresh biopsy)
Brain mets okay if clinically stable		98 Locations in :
USA:AZ; CA; CO; FL; GA; MA; MI; MO; NY; NC;, OH; TN; VA.
Argentina. Australia: Belgium. Brazil. Czchia. Denmark. France. Germany. Greece.
Hong Kong. Hungary. Italy. Japan. Malaysia:
Netherlands. Poland. Portugal. Singapore:
South Korea: Spain.
Taiwan. Thailand.
UK.
Locations may still be added. See link for all locations.
Nuvalent Clinical TrialsNCT06765109NVL-655 is a 4th gen ALK TKI, designed to be effective with ALK resistance mutations. This study randmoizes particiaptns to receive first-line NVL-655 or alectinib. A concern is that lorlatinib, rather than alectinib, is the first-line standard of care for many recently diagnosed ALK lung cancer.
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11/29/2024
Analysis of the Effectiveness and Safety of Lorlatinib in Untreated ALK-Positive NSCLC Patients in a French Real-World Context (LOREA)N/A




Locally advanced or metastatic ALK+ NSCLC
No systemic therapy for stage 4







France: Reims Cedex
PfizerNCT06487078Participants will be treated with first-line lorlatinib. This is a post-marketing study to find out more about treatment response and side effects
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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 intracranial 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-seizure meds
No prior ALK TKIs or other cancer treatment since diagnosed with stage 4
USA: Stanford CA; Denver CO; Columbus, OH
Joshua Palmer
Genentech		NCT05987644



Participants will receive radiation therapy to brain mets prior to starting alectinib. This is problematic since lorlatinib is the first line ALK TKI. Lorlatnib is extremely effecitve in the brain, so those with brain mets may be wiser to start lorlatinib rather than joining this trial.
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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 + thoracic 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, Roma, Napoli.
Netherlands: Amsterdam
Spain: Barcelona, Majadahonda, Valencia
Switzerland: Bern, Zurich,Winterthur
UK: London, 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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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 (radiation 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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11/27/2024
Shortened High-dose Palliative Radiotherapy for Lung Cancer (SHiP-Rt)N/A
Stage IIIB or IV ALK NSCLC (or other types)
Treatment naive (or limited progression after 1st line systemic therapy)
Suitable for high dose palliative RT (36Gy in 12# or 39Gy in 13#)
If on systemic therapy, 3 week washout
If treatment naïve, should be able to proceed to definitive systemic therapy within 3-4 weeks.
UK: Coventry Warwickshire.
Sites planned and Stoke-on-Trant, Birmingham, Shrewsbury
University Hospitals Coventry and Warwickshire NHS TrustNCT06483308The SHiP-Rt Study aims to investigate the safety and efficacy of reducing the number of RT fractions and RT duration, compared to the current standard of care by using shortened hypofractionated accelerated palliative radiotherapy (30Gy in 6 alternate-day fractions).
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12/21/2023
Trial Comparing Systemic Therapy Alone and With Local Ablative Treatment for Stage IV NSCL Cancer Patients (salVage)N/A
Tissue confirmed, pre-treatment stage IV NSCLC
ALK mutation or other types of NSCLC
Within 3 months of beginning starndard of care 1st line therapy, with up to 5 residual metastsases
Up to 5 cranial metastases
All persistent metastases must be amenable to radical local therapy, including surgery andor radiation		Switzerland: Aarau, Bellinzona, Chur, Fribourg, Geneva, Luzern, Zurich
Swiss Group for Clinical Cancer ResearchNCT06114108This study combines TKIs and early ablation therapies to decrease tumor burden upon initial treastment.
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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 intolerance of at least one second gen ALK TKI (alectinib, ceritinb, brigatinib)
Prior chemo okay
No prior lorlatinib or ramuciramab
No active brain mets
USA: Middletown NJ, Montvale NJ, Commack, 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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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
America Lung Association		NCT04900935  


Patents will receive four 60 minute visits with a palliative care physician who is trained to address the psychosocial issues and health promoting behaviors of people with long, uncertain cancer trajectories.
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1/8/2023

Dynamic liquid molecular profiling in anaplastic lymphoma kinase (ALK) Non-Small Cell Lung Cancer | DYNAMALKNA

Advanced ALK patients, either just starting treatment or who have had progression and will be changing TKIs.
Australia: Melbourne (may be other sites in Australia)
Peter MacCallum Cancer CentreDYNAMALK AustraliaParticipants will be asked to provide blood samples at three occasions over a 2 year period, or at any time with progression. This study is hoped to identify how DNA markers in the blood can predict TKI response or guide new therapies. Those who are TKI naive will receive lorlatinib.
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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 randomized to have either LCT after starting a TKI, vs. TKI and standard treatment only.
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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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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 activity. Quality of life and overall survival will be measured between the two groups.
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11/10/2020
Observation or Upfront Cranial Radiation in Oncogene Driver Mutated NSCLC With Asymptomatic Brain Metastases (including ALK)
3


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)

2

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 Memorial Hospital

Tata Memorial Hospital
NCT05277844 

Participants will be randomized to receive
radiation local consolidative therapy with TKI
vs. TKI alone
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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 radiation
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 in Advanced ALK and ROS1 Rearranged Lung Cancer With CNS Metastasis in the Absence of Measurable Extracranial Lesions2

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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9/30/2025
Gilteritinib in Adults With Advanced ALK-positive Non-small Cell Lung Cancer (NSCLC)1
Advanced or metastatic ALK non-small cell lung cancer (NSCLC)
Willing to submit a fresh tumor tissue sample that was collected after completion of the most recent anti-cancer treatment
Progression on at least one line of TKI, with alectinib as only treatment or prior lorlatinib.
Brain mets must be stable		USA: St Louis MO; Hackensack NJ; Fairfax VA.
Astellas Pharma Global Development, Inc.NCT07140016Gilteritinib (ALK+ inhibitor) will be given as monotherapy upon progresion with other TKIs. Gilteritinib is active against ALK I1171N + F1174I and I1171N + L1198H along with other mutations in lab studies.
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2/19/2025
Expanded Access Program of Neladalkib (NVL-655) for Patients with Advanced ALK+ NSCLC (NVL-655-EAP)NA
Confirmed locally advanced or metastatic NSCLC with a documented ALK rearrangement
Previously received lorlatinib or at least one second-generation ALK TKI and is either not eligible for or does not have access to lorlatinib
Ineligible to enroll in a current NVL-655 trial
USA: Denver CO; Boston MA: Detroit MI; St. Louis MO; NYNY; Durham NC; Columbus OH.
Australia: St. Leonards NSW; Melbourne.
Canada: Edmonton, Vancourver, Toronto.
France: Lyon, Toulouse, Nantes, Villjuif
Netherlands: Amsterdam. Singapore: Singapore.
South Korea: Seoul. Spain: Barcelona, Madrid.
Switzerland: Lucerne, Viganello.
Taiwan: Tainan City, Taipei. UK: Manchester,Surrey, London.
Locations are expanding - Contact treating MD to enroll
Phone 877-768-4303
Nuvalent Inc.NCT06834074This is not a clinical trial, but instead a program to offer NVL-655 to those who are not eligible for a clinical trial. This expanded access program is intended to be a way for patients to get NVL-655 before it is approved for general use.
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8/24/2024
Peptide Vaccine To Prevent Acquired Resistance In Patients With Advanced ALK+ NSCLC (ARCHER)1/2



Confirmed diagnosis of stage IV NSCLC (or recurrent NSCLC) not a candidate for definitive multimodality therapy
Ongoing treatment with crizotinib, ceritinb, alectinib, brigatinib, or lorlatinib with at least stable disease ≥ 4 months


USA: Baltimore MD (Johns Hopkins)
Sidney Kimmel Cancer Center at Johns HopkinsNCT05950139


Participants will receive a immunostimulating vaccine in added to their current ALK TKI.
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5/2024

Gilteritinib for the Treatment of ALK NSCLC1


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



USA: Los Angeles CA; Wahsington DC; Ann Arbor MIUM Rogel Cancer CenterNCT06225427Gilteritinib 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)



192 Locations in:
USA; Australia; Brazil; Canada;
Chile; China; Czechia, France, Germany,Greece, Hong Kong; Israel; Italy; Japan; Korea, Malaysia; Mexico; Philippines; Poland, Spain; Taiwan; Thailand; Turkey, UK, Vietnam		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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4/20/2023
A Study of TY-2136b in Patients With Advanced Solid Tumors Harboring ALK, ROS1 or NTRK1-3 Alterations1

Advanced Solid tumors with ALK, ROS1, or NTRK mutations
Progression after targeted therapies
Prior chemo or immunotherappy okay
Brain mets okay if stable
USA: Providence RI, Houston TX.TYK Medicines, IncNCT05769075TY-2136B is a next generation ROS!, TRK, and ALK inhibitor. Participants wil be givne this drug as monotherapy.
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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: Beverly Hills, Fountain Valley, Los Alamitos CA; Philadelphia PA, Dallas TX, Fairfax VA.
Japan: Sapporo, Yokohama, Sendai, Okayama, Chuo-ku
Taiwan: Tainan, Taipei, Taoyuan District.		Lantern PharmaNCT05456256

Never smokers with lung cancer will be given LP-300 with chemotherapy after exhausting 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 solid tumors: at least one prior systemic anticancer therapy, or no satisfactory standard therapy exists
Measurable disease according to RECIST 1.1


USA: Orange, Sacramento, Stanford CA, Denver CO, Miami FL, Atlanta GA, Chicago IL, Baltimore MD, Boston MA, Detroit MI, St. Louis MO, Durham NC, NYNY, Columbus OH, Philadelphia PA, Nashville TN, Seattle WA. Washington DC
Canada: Edmonton, Ottowa, Toronto, Vancouver
Australia: Saint Leonards, Melbourne, Woolloongabba
Belgium: Antwerp, Leuven. France: Lyon, Nantes, Touluse Cedex, Villejuif
Germany: Cologne, Frankfurt, Grosshansdorf, Heidelberg. Italy: Ancona, Bari, Milano, Padua, Ravenna, Rome.
Netherlands: Amsterdam, Groningen Spain:A Coruna, Barcelona, Madrid UK: Edinburgh, Manchester, Surrey. Switzerland: Bellizona, Spitalsrasse.
Japan: Kanagawa, Okayama. Wakayoma, Osaka, Shizuoka, Tokyo; Korea: Seoul, Goyang Si
Singapore; Taiwan: Taichung, Tainan, Taipei
UK: Edinburgh, London, Manchester, Sutton
Our members report many sites are closed , but these sites are still listed as recruiting.
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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10/5/2021Pembrolizumab, Lenvatinib and Chemotherapy After TKIs in NSCLC2
Unresectable or metastatic NSCLC, with EGFR, ALK, or ROS1 mutations who have received standard of care targeted therapy and have progressed on treatment.
No active brainsmets or LMD		Hong Kong: Hong KongUniversity of Hong KongNCT04989322This study looks at the combination of a angiogenesis inhibitor (stops growth of tiny blood vessels) , immunotherapy, and chemotherapy after progression on TKIs.
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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

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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


Talazoparib and crizotinib will be given to all ALK patients. Talazoparib 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: Massachusetts 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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Recruiting for Leptomeningeal Metastases
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