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Non-Small Cell Lung CancerNCT05236114

GEMINI-NSCLC: NSCLC Biomarker Study

An observational study of Non-Small Cell Lung Cancer, run by Tempus AI at 58 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

GEMINI NSCLC Study is a non-interventional study that will be collecting clinical and molecular health information from patients with NSCLC who will receive longitudinal blood collection in addition to their standard of care therapy and disease surveillance with the goals of identifying the molecular evolution of lung… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
Observation
Type of treatment
Injection or infusion
How many people
1,200 participants
Where
58 sitesUnited States
Study dates
22 Jun 2022to Jun 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: This protocol targets patients with Non-Small Cell Lung Cancer (NSCLC)

Who may be able to join

None listed.

Who cannot join

  • Patients without a known or suspected NSCLC diagnosis, or other disease processes such as sarcoidosis, lymphoma, or metastatic cancer from other sites.
  • Not willing to have additional blood samples collected
  • Patients with a secondary malignancy must have been both diagnosed > 2 years from the lung cancer of interest and have completed all therapy for that malignancy (including extended adjuvant therapy) > 2 years prior to diagnosis of the lung cancer of interest with the exception of the following:
  • Patients with superficial basal cell carcinoma of low-risk histology per NCCN Guidelines (Low-risk histologic subtypes include nodular, superficial, and other non-aggressive growth patterns such as keratotic, infundibulocystic, and fibroepithelioma of Pinkus) and low-risk for recurrence per NCCN Guidelines (location on trunk or extremities, size < 2 cm, primary (not recurrent), with well-defined borders) can be included even if they are diagnosed < 2 years from the lung cancer of interest.
  • Patients with superficial squamous cell carcinoma of low-risk pathology per NCCN Guidelines (verrucous, keratoacanthomatous) and low-risk for recurrence per NCCN Guidelines (located on trunk or extremities; 2 cm in size; primary lesion (vs. recurrent); well to moderately differentiated; < 2 mm thick and no invasion beyond subcutaneous fat; negative for perineural invasion; and negative for lymphatic or vascular involvement) can be included even if they are diagnosed < 2 years from the lung cancer of interest.

Trial locations and contacts

58 sites in 1 country. Contact the study team or a site near you to ask about taking part.

GEMINI NSCLC contact

(833) 514-4187

gemini-nsclc@tempus.com

58 sites in 1 country

United States58 sites, 56 recruiting

  • New York Oncology Hematology

    Albany, New York, 12206

    Josephine Faruol, 518-489-0044, Josephine.faruol@usoncology.com

    Makenzi Evangelist, MD

    Recruiting

  • ThedaCare Regional Cancer Center

    Appleton, Wisconsin, 54911

    Rachel Luedtke, 920-364-3616, Rachel.Luedtke@thedacare.org

    Matthias Weiss, MD

    Recruiting

  • Morehouse School of Medicine (MSM)

    Atlanta, Georgia, 30310

    Carla Holloway, 404-752-8452, cmholloway@msm.edu

    Roland Matthews

    Recruiting

  • Piedmont Healthcare

    Atlanta, Georgia, 30318

    Jean Dionne, dionne.jean@piedmont.org

    Robert Klafter, MD

    Recruiting

  • University of Maryland

    Baltimore, Maryland, 21201

    Kaylee Martin, Kaylee.Martin@umm.edu

    Samuel Rosner, MD

    Recruiting

  • Johns Hopkins University

    Baltimore, Maryland, 21287

    Cheryl Pai, 410-614-1926, cpai3@jhmi.edu

    Lonny Yarmus, DO

    Recruiting

  • New Jersey Cancer Center

    Belleville, New Jersey, 07109

    Michael Johnstone, mjohnstone@njcancercare.com

    James Orsini Jr.

    Recruiting

  • PeaceHealth St. Joseph Medical Center-Bellingham

    Bellingham, Washington, 98225

    Rebecca Crompton, rcrompton@peacehealth.org

    Mervat Saleh, MD

    Recruiting

  • The Center for Cancer and Blood Disorder

    Bethesda, Maryland, 20817

    Kosunique Jenkins, kosunique.jenkins@tempus.com

    Mark Goldstein, MD

    Recruiting

  • Alabama Oncology

    Birmingham, Alabama, 35223

    Amanda Joseph, Amanda.Joseph@AlabamaOncology.com

    Mathew Tucker

    Recruiting

  • Aultman Hospital

    Canton, Ohio, 44710

    Carla Larch, (330)363-1250, carla.larch@aultman.com

    Raza Khan, MD

    Recruiting

  • Southern Illinois Hospital Services

    Carterville, Illinois, 62918

    Sarmad Nomani, sarmad.nomani@sih.net

    Muhammad Popalzai

    Recruiting

  • UNC

    Chapel Hill, North Carolina, 27599

    Ashley Delgado, ashley_delgado@med.unc.edu

    Jason Akulian

    Recruiting

  • The Medical University of South Carolina

    Charleston, South Carolina, 29425

    Tyson Kelsey, tysonke@musc.edu

    Christopher Gilbert, MD

    Recruiting

  • University of Virginia

    Charlottesville, Virginia, 22908

    Ryan Gentzler Principal Investigator, rg2uc@virginia.edu

    Recruiting

  • TriHealth Cancer Institute

    Cincinnati, Ohio, 45220

    Wayne Thompson, 513-865-5020, Wayne_Thompson@trihealth.com

    Leanne Budde, MD

    Recruiting

  • Clermont Oncology Center

    Clermont, Florida, 34711

    Gopal Kunta, 352-242-1366, drgkunta@aorcorp.com

    Recruiting

  • Ohio State University

    Columbus, Ohio, 43210

    Hazel Antao, Hazel.Antao@osumc.edu

    Asrar Alahmadi

    Recruiting

  • OhioHealth Reseach Institute

    Columbus, Ohio, 43214

    Kevin Miller, Kevin.Miller@ohiohealth.com

    Arvinder Bhinder, MD

    Recruiting

  • Cancer Care Specialists of Illinois

    Decatur, Illinois, 62526

    Jade Wiemelt, jwiemelt@ccsci.net

    James Wade

    Recruiting

  • Duke University

    Durham, North Carolina, 27710

    Lauren Gray, lauren.gray@duke.edu

    Kamran Mahmood, MD

    Recruiting

  • Hematology Oncology Associates of Central New York

    East Syracuse, New York, 13057

    Nicole Coleman, ncoleman@hoacny.com

    Ajeet Gajra

    Recruiting

  • Northwestern University

    Evanston, Illinois, 60208

    Mira Pasawala, mira.pasawala@northwestern.edu

    Divya Gupta

    Recruiting

  • Mercy Clinic Oncology - Fort Smith

    Fort Smith, Arkansas, 72903

    Billy Cater, Billy.Cater@mercy.net

    Aswanth Reddy, MD

    Recruiting

  • MemorialCare

    Fountain Valley, California, 92708

    Tuyet Collucci, 562.706.1195, TCollucci@memorialcare.org

    Amol Rao, MD

    Recruiting

  • Frederick Health Regional System

    Frederick, Maryland, 21702

    Charity Drummond, cdrummond@frederick.health

    Patrick Mansky

    Recruiting

  • Southeastern Medical Oncology Center (SMOC)

    Goldsboro, North Carolina, 27534

    Jennifer Fields, 919-587-9084, jfields@cancersmoc.com

    Samer Kasbari, MD

    Recruiting

  • Hope and Healing Cancer Services

    Hinsdale, Illinois, 60521

    Ellen Gustafson, sgustafson@hopenheal.care

    Srilata Gundala

    Recruiting

  • Hawaii Cancer Care

    Honolulu, Hawaii, 96813

    Angelei Pananganan, 808-524-6115, apanangan@hawaiicancercare.com

    David Tamura, MD

    Recruiting

  • Community Health Network

    Indianapolis, Indiana, 46250

    Cindy Stoner, cstoner@ecommunity.com

    Natraj Ammakkanavar, MD

    Recruiting

  • University of Iowa

    Iowa City, Iowa, 52242

    Laura Baptista, 319-467-6412, laura-batista@uiowa.edu

    Muhammad Furqan

    Recruiting

  • Cayuga Medical Center

    Ithaca, New York, 14850

    Betty Haverlock, 607-252-3939, bhaverlock@cayugamed.org

    Anthony Mato

    Recruiting

  • Mercy Clinic Oncology and Hematology - Joplin

    Joplin, Missouri, 64804

    Cynthia Meyer, Cynthia.Meyer@mercy.net

    Samir Dalia, MD

    Recruiting

  • Gundersen Health System

    La Crosse, Wisconsin, 54601

    Jennifer Cole, 608-775-6694, jmcole@gundersenhealth.org

    Benjamin Parsons, MD

    Recruiting

  • OptumCare Cancer Care

    Las Vegas, Nevada, 89102

    Danielle Handy, Danielle.handy1@optum.com

    Russell Gollard

    Recruiting

  • Hope Cancer Care of Nevada

    Las Vegas, Nevada, 89103

    Mark Gatdula, CRC, 702-508-9128, Mark.Gatdula@aoncology.com

    Raja Mehdi, MD

    Recruiting

  • Cancer and Blood Specialty Clinic

    Los Alamitos, California, 90720

    Active, not recruiting

  • UCLA

    Los Angeles, California, 90095

    Deanna Romero, 310-694-1795, DLRomero@mednet.ucla.edu

    Amy Cummings

    Recruiting

  • Taylor Cancer Research Center

    Maumee, Ohio, 43537

    Jennifer Martinez, jmartinez@toledoclinic.com

    John Nemunaitis, MD

    Recruiting

  • Baptist Cancer Center

    Memphis, Tennessee, 38120

    Angela Gates, 901-317-0644, angela.gates@tempus.com

    Raymond Osarogiagbon, MD

    Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

    Stephanie Chang, stephanie.chang@mssm.edu

    Fred Hirsch

    Recruiting

  • Eastern CT and Hematology and Oncology Associates

    Norwich, Connecticut, 06360

    Susan Johnson, sjohnson@echoct.com

    Dennis Slater

    Recruiting

  • Hightower Clinical

    Oklahoma City, Oklahoma, 73102

    Caitlin Merrick, caitlin@hightowerclinical.com

    Thy Nguyen, MD

    Recruiting

  • Mercy Clinic Oncology and Hematology - Coletta

    Oklahoma City, Oklahoma, 73120

    Marian Nolen, Marian.Nolen@mercy.net

    Carla Kurkjian, MD

    Recruiting

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68130

    Kimberly Wendt, 531-444-1230, kwendt@nebraskacancer.com

    Timothy Huyck, MD

    Recruiting

  • Lake Regional Health System

    Osage Beach, Missouri, 65065

    Kathy Hirst, khirst@lakeregional.com

    Carla Ostronic

    Recruiting

  • Woodlands Medical Specialists

    Pensacola, Florida, 32503

    Withdrawn

  • Cancer Care Specialists Reno

    Reno, Nevada, 89511

    Layla Quinonez, 775-329-0222 ext. 230, ltapia@ccsreno.com

    Juan Adolfo Cattoni III

    Recruiting

  • OSF Saint Anthony Medical Center

    Rockford, Illinois, 61108

    Shylendra Sreenivasappa, 815-227-2859, shylendra.b.sreenivasappa2@osfhealthcare.org

    Recruiting

  • Oregon Oncology Specialists

    Salem, Oregon, 97301

    Cheryl LaBronte, clabronte@orcancer.com

    Janelle Meyer, MD

    Recruiting

  • Cancer Care Northwest

    Spokane Valley, Washington, 99216

    Ronaye Wagner, ronaye.wagner@ccnw.net

    Dr. Jessica Hellyer, MD

    Recruiting

  • Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center

    Springfield, Missouri, 65804

    Jennifer Hylton, Jennifer.Hylton@mercy.net

    Mohan Tummala, MD

    Recruiting

  • Oncology Hematology Associates

    Springfield, Missouri, 65807

    Adrianna Moore, 417-882-4880, adrianna.moore@aoncology.com

    Robert Ellis, MD

    Recruiting

  • Mercy Clinic Oncology and Hematology - Sindelar Cancer Center

    St Louis, Missouri, 63128

    Laura O'Brien, Laura.OBrien2@mercy.net

    Yifan Tu, MD

    Recruiting

  • Mercy Clinic Oncology and Hematology - David C. Pratt Cancer Center

    St Louis, Missouri, 63141

    Jessica Black, Jessica.Black@mercy.net

    Bethany Sleckman, MD

    Recruiting

  • Oklahoma Cancer Specialists and Research Institute

    Tulsa, Oklahoma, 74146

    Stephanie Sandoval, 918-505-3200, stephanie.sandoval@ocsri.org

    Paul Zito, MD

    Recruiting

  • White Plains Hospital

    White Plains, New York, 10601

    Madison Gilmore, magilmore@wphospital.org

    Dan Costin

    Recruiting

  • Cancer Care Associates of York

    York, Pennsylvania, 17403

    Jennifer Stough, 717-741-9229 ext. 149, jstough@cancercareyork.com

    Chanh Hyunh, MD

    Recruiting

Other trials in United States

About this study

Official title: TEMPUS GEMINI NSCLC STUDY: A Longitudinal Multi-Omic Biomarker Profiling Study of Patients With Non-Small Cell Lung Cancer (NSCLC)

GEMINI NSCLC Study is a non-interventional study that will be collecting clinical and molecular health information from patients with NSCLC who will receive longitudinal blood collection in addition to their standard of care therapy and disease surveillance with the goals of identifying the molecular evolution of lung cancer with standard of care therapy, and determining the utility of ctDNA dynamics to predict risk of recurrence and therapeutic outcomes.

Being tested
Observation
Keywords
Cancer, Oncology, Observational, Genomic Profiling, Precision medicine, Non-Small Cell Lung Cancer, NSCLC, NGS, Biomarkers
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ObservationOther

    No intervention

Study groups in NCT05236114
Study groupRoleWhat they receive
Cohort 1Cohort 1 will include patients with early-stage (Stages I-IIIB) who are candidates for treatment with curative intent, surgery with or without perioperative (neoadjuvant or adjuvant) therapy.
Receives: Other: Observation
Cohort 2Cohort 2 will include patients with stage IV disease receiving first line immunotherapy (as monotherapy or in combination with chemotherapy).
Receives: Other: Observation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Real-World Disease Free Survival (rwDFS)

    Measured: 5 years

  2. Real-World Overall Survival (rwOS)

    Measured: 3 years

Secondary outcomes (10)

  1. Sensitivity, Specificity, PPV and NPV of MRD assay to predict recurrence at benchmark vs physician assessment of recurrence via conventional imaging every 6 months

    Measured: 5 years

  2. Sensitivity, Specificity, PPV and NPV of MRD assay to predict recurrence across longitudinal collections vs physician assessment of recurrence via conventional imaging every 6 months

    Measured: 5 years

  3. Real-World Disease Free Survival (rwDFS) stratified by ctDNA status at benchmark

    Measured: 5 years

  4. pCR rate stratified by ctDNA status

    Measured: 5 years

  5. Real-World Overall Survival (rwOS) stratified by ctDNA status at benchmark

    Measured: 5 years

  6. Positive percent agreement and negative percent agreement between plasma ctDNA vs tumor tissue at benchmark & longitudinal time points

    Measured: 5 years

  7. Real-World Overall Survival

    Measured: 18 months

  8. Real-World Progression-Free

    Measured: 18 months

  9. Treatment patterns

    Measured: 18 months

  10. Positive percent agreement and negative percent agreement between plasma ctDNA vs. tumor tissue at benchmark & longitudinal time points

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2022
  2. Study start22 Jun 2022
  3. Primary completionJun 2029 (estimated)
  4. Study completionJun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05236114
Sponsor's protocol ID
TP-CA-002
Status last verified
Feb 2026
First submitted
12 Jan 2022
Last updated
5 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8.

    PubMed 31912902

  • Duma N, Santana-Davila R, Molina JR. Non-Small Cell Lung Cancer: Epidemiology, Screening, Diagnosis, and Treatment. Mayo Clin Proc. 2019 Aug;94(8):1623-1640. doi: 10.1016/j.mayocp.2019.01.013.

    PubMed 31378236

  • Chansky K, Sculier JP, Crowley JJ, Giroux D, Van Meerbeeck J, Goldstraw P; International Staging Committee and Participating Institutions. The International Association for the Study of Lung Cancer Staging Project: prognostic factors and pathologic TNM stage in surgically managed non-small cell lung cancer. J Thorac Oncol. 2009 Jul;4(7):792-801. doi: 10.1097/JTO.0b013e3181a7716e.

    PubMed 19458556

  • Pignon JP, Tribodet H, Scagliotti GV, Douillard JY, Shepherd FA, Stephens RJ, Dunant A, Torri V, Rosell R, Seymour L, Spiro SG, Rolland E, Fossati R, Aubert D, Ding K, Waller D, Le Chevalier T; LACE Collaborative Group. Lung adjuvant cisplatin evaluation: a pooled analysis by the LACE Collaborative Group. J Clin Oncol. 2008 Jul 20;26(21):3552-9. doi: 10.1200/JCO.2007.13.9030. Epub 2008 May 27.

    PubMed 18506026

  • Curran WJ Jr, Paulus R, Langer CJ, Komaki R, Lee JS, Hauser S, Movsas B, Wasserman T, Rosenthal SA, Gore E, Machtay M, Sause W, Cox JD. Sequential vs. concurrent chemoradiation for stage III non-small cell lung cancer: randomized phase III trial RTOG 9410. J Natl Cancer Inst. 2011 Oct 5;103(19):1452-60. doi: 10.1093/jnci/djr325. Epub 2011 Sep 8.

    PubMed 21903745

  • Antonia SJ, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Kurata T, Chiappori A, Lee KH, de Wit M, Cho BC, Bourhaba M, Quantin X, Tokito T, Mekhail T, Planchard D, Kim YC, Karapetis CS, Hiret S, Ostoros G, Kubota K, Gray JE, Paz-Ares L, de Castro Carpeno J, Faivre-Finn C, Reck M, Vansteenkiste J, Spigel DR, Wadsworth C, Melillo G, Taboada M, Dennis PA, Ozguroglu M; PACIFIC Investigators. Overall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC. N Engl J Med. 2018 Dec 13;379(24):2342-2350. doi: 10.1056/NEJMoa1809697. Epub 2018 Sep 25.

    PubMed 30280658

  • Schiller JH, Harrington D, Belani CP, Langer C, Sandler A, Krook J, Zhu J, Johnson DH; Eastern Cooperative Oncology Group. Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med. 2002 Jan 10;346(2):92-8. doi: 10.1056/NEJMoa011954.

    PubMed 11784875

  • Jordan EJ, Kim HR, Arcila ME, Barron D, Chakravarty D, Gao J, Chang MT, Ni A, Kundra R, Jonsson P, Jayakumaran G, Gao SP, Johnsen HC, Hanrahan AJ, Zehir A, Rekhtman N, Ginsberg MS, Li BT, Yu HA, Paik PK, Drilon A, Hellmann MD, Reales DN, Benayed R, Rusch VW, Kris MG, Chaft JE, Baselga J, Taylor BS, Schultz N, Rudin CM, Hyman DM, Berger MF, Solit DB, Ladanyi M, Riely GJ. Prospective Comprehensive Molecular Characterization of Lung Adenocarcinomas for Efficient Patient Matching to Approved and Emerging Therapies. Cancer Discov. 2017 Jun;7(6):596-609. doi: 10.1158/2159-8290.CD-16-1337. Epub 2017 Mar 23.

    PubMed 28336552

  • Gobbini E, Swalduz A, Levra MG, Ortiz-Cuaran S, Toffart AC, Perol M, Moro-Sibilot D, Saintigny P. Implementing ctDNA Analysis in the Clinic: Challenges and Opportunities in Non-Small Cell Lung Cancer. Cancers (Basel). 2020 Oct 24;12(11):3112. doi: 10.3390/cancers12113112.

    PubMed 33114393

  • Aggarwal C, Thompson JC, Black TA, Katz SI, Fan R, Yee SS, Chien AL, Evans TL, Bauml JM, Alley EW, Ciunci CA, Berman AT, Cohen RB, Lieberman DB, Majmundar KS, Savitch SL, Morrissette JJD, Hwang WT, Elenitoba-Johnson KSJ, Langer CJ, Carpenter EL. Clinical Implications of Plasma-Based Genotyping With the Delivery of Personalized Therapy in Metastatic Non-Small Cell Lung Cancer. JAMA Oncol. 2019 Feb 1;5(2):173-180. doi: 10.1001/jamaoncol.2018.4305.

    PubMed 30325992

  • Shepherd FA, Rodrigues Pereira J, Ciuleanu T, Tan EH, Hirsh V, Thongprasert S, Campos D, Maoleekoonpiroj S, Smylie M, Martins R, van Kooten M, Dediu M, Findlay B, Tu D, Johnston D, Bezjak A, Clark G, Santabarbara P, Seymour L; National Cancer Institute of Canada Clinical Trials Group. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med. 2005 Jul 14;353(2):123-32. doi: 10.1056/NEJMoa050753.

    PubMed 16014882

  • Lynch TJ, Bell DW, Sordella R, Gurubhagavatula S, Okimoto RA, Brannigan BW, Harris PL, Haserlat SM, Supko JG, Haluska FG, Louis DN, Christiani DC, Settleman J, Haber DA. Activating mutations in the epidermal growth factor receptor underlying responsiveness of non-small-cell lung cancer to gefitinib. N Engl J Med. 2004 May 20;350(21):2129-39. doi: 10.1056/NEJMoa040938. Epub 2004 Apr 29.

    PubMed 15118073

  • Maemondo M, Inoue A, Kobayashi K, Sugawara S, Oizumi S, Isobe H, Gemma A, Harada M, Yoshizawa H, Kinoshita I, Fujita Y, Okinaga S, Hirano H, Yoshimori K, Harada T, Ogura T, Ando M, Miyazawa H, Tanaka T, Saijo Y, Hagiwara K, Morita S, Nukiwa T; North-East Japan Study Group. Gefitinib or chemotherapy for non-small-cell lung cancer with mutated EGFR. N Engl J Med. 2010 Jun 24;362(25):2380-8. doi: 10.1056/NEJMoa0909530.

    PubMed 20573926

  • Ramalingam SS, Vansteenkiste J, Planchard D, Cho BC, Gray JE, Ohe Y, Zhou C, Reungwetwattana T, Cheng Y, Chewaskulyong B, Shah R, Cobo M, Lee KH, Cheema P, Tiseo M, John T, Lin MC, Imamura F, Kurata T, Todd A, Hodge R, Saggese M, Rukazenkov Y, Soria JC; FLAURA Investigators. Overall Survival with Osimertinib in Untreated, EGFR-Mutated Advanced NSCLC. N Engl J Med. 2020 Jan 2;382(1):41-50. doi: 10.1056/NEJMoa1913662. Epub 2019 Nov 21.

    PubMed 31751012

  • Soda M, Choi YL, Enomoto M, Takada S, Yamashita Y, Ishikawa S, Fujiwara S, Watanabe H, Kurashina K, Hatanaka H, Bando M, Ohno S, Ishikawa Y, Aburatani H, Niki T, Sohara Y, Sugiyama Y, Mano H. Identification of the transforming EML4-ALK fusion gene in non-small-cell lung cancer. Nature. 2007 Aug 2;448(7153):561-6. doi: 10.1038/nature05945. Epub 2007 Jul 11.

    PubMed 17625570

Questions about this trial

What is this clinical trial studying?

An observational study of Non-Small Cell Lung Cancer, run by Tempus AI at 58 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact GEMINI NSCLC ((833) 514-4187, gemini-nsclc@tempus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Real-World Disease Free Survival (rwDFS) (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05236114, which also lists 61 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.

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