GEMINI-NSCLC: NSCLC Biomarker Study
TEMPUS GEMINI NSCLC STUDY: A Longitudinal Multi-Omic Biomarker Profiling Study of Patients With Non-Small Cell Lung Cancer (NSCLC)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study looks at how non-small cell lung cancer (NSCLC) changes during usual care. It uses health records, tumor samples, and repeated blood tests to learn whether cancer DNA in blood can help predict cancer's return and treatment results. It is for adults with NSCLC who will have surgery or who have stage IV cancer and plan to start immune-based treatment.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Both groups: Be age 18 or older and willing and able to give informed consent, meaning you agree to join after learning about the study.
- Both groups: Agree to extra blood draws during routine follow-up visits and provide a tumor sample that reflects your current cancer.
- Group 1: Have known or suspected stage I–IIIB NSCLC that can be removed with surgery aimed at a cure. Suspected cancer must be confirmed as NSCLC.
- Group 1: Have had or plan to have surgery. People with or without cancer gene changes may join.
- Group 2: Have stage IV NSCLC confirmed by a tissue test that cannot be cured with surgery or radiation. Radiation to ease pain or other problems is allowed.
- Group 2: Plan to start immunotherapy, which helps the immune system fight cancer, alone or with chemotherapy. Any earlier immunotherapy given before or after surgery must have ended at least 12 months ago.
- Group 2: Tumor testing must show no listed EGFR, ALK, ROS1, BRAF, NTRK, MET, or RET gene changes with available first-choice targeted treatments. KRAS G12C or HER2 changes may qualify if the study's immunotherapy rules are met.
- Group 1 members may move to Group 2 if cancer returns, a tissue test confirms it, and they meet all Group 2 rules.
Who can't join
- Both groups: Do not have known or suspected NSCLC, or have another disease instead, such as sarcoidosis, lymphoma, or cancer that spread to the lung from elsewhere.
- Both groups: Are unwilling to have extra blood draws.
- Both groups: Have another cancer unless it was diagnosed and all its treatment ended more than 2 years before the lung cancer diagnosis. Certain low-risk basal cell or squamous cell skin cancers are exceptions.
- Group 1: Have a tumor at the top of the lung for which chemotherapy and radiation together before surgery are recommended.
- Group 1: Have stage III cancer that cannot be removed with surgery and are a candidate for chemotherapy and radiation followed by immunotherapy.
- Group 1: Have stage IIIB or IIIC cancer with confirmed tumor or lymph node spread for which chemotherapy and radiation, rather than surgery, are recommended.
- Group 1: Receive radiation as the main treatment instead of surgery.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
For Cohort 1 Inclusion, the participant has/is: * A known or suspected NSCLC treated with curative intent -(surgery with or without perioperative (neoadjuvant or adjuvant) therapy). * Suspected NSCLC - Patients with a high index of suspicion for the diagnosis of NSCLC that is resectable may sign informed consent prior to undergoing diagnostic procedure at the discretion of the physician. NCCN Guidelines allow for clinical stage IA cancers to proceed directly to definitive surgery. Per NCCN Guidelines, if a preoperative tissue diagnosis has not been obtained, then an intraoperative diagnosis will be obtained. If a diagnosis of NSCLC is not confirmed and/or the tumor is not resectable, then the patient will be a screen failure. * Undergone or planning to undergo a surgical resection - (Patients with stages I-IIIB who are resectable - per NCCN guidelines of resectability) * Both patients who lack molecular abnormalities and those with identified molecular abnormalities may enroll. Choice of perioperative therapy is to follow SOC therapeutic guidelines for the participant's molecular and PD-L1 profile. * 18 years old or older * Willing and able to provide informed consent * Willing to have additional blood samples collected during routine surveillance visits * Must submit tumor sample representative of current disease For Cohort 1 Exclusion, the participant has/is: * Patients with superior sulcus tumors who are candidates for preoperative concurrent chemoradiation. * Stage III locally advanced and unresectable patients who are candidates for chemoradiation followed by immunotherapy. * It is expected that all patients on the cohort will be treated with a definitive surgical resection. Thus, clinical stage IIIB and IIIC patients who subsequently demonstrate pathologically confirmed N3 nodal disease or T4 N2 or 3 per any confirmatory procedure listed in NCCN guidelines for which definitive chemoradiotherapy rather than surgery is recommended per NCCN Guidelines are not eligible. * Patients who receive primary radiation (in lieu of surgery if they are not surgical candidates). For Cohort 2 Inclusion, the participant has/is: * Histologically documented Stage IV NSCLC (de novo metastatic or relapse setting) not amenable to curative surgery or radiation therapy. Palliative radiation (for instance for impending bony fracture or to control pain) is allowed at any time during the protocol at the physician's discretion. * Intended to receive first line immunotherapy (as monotherapy or in combination with chemotherapy). Patients who have had previous exposure to immunotherapy in the neoadjuvant or adjuvant setting are allowed to enroll as long as 12 months have elapsed since the prior exposure. * Patients in surveillance on Cohort 1 are eligible to roll over to Cohort 2 at the time of recurrence as long as they have had histologic confirmation of recurrence and have been off immunotherapy for 12 months or greater and meet all other inclusion/exclusion criteria. * Tumors that lack activating EGFR mutations (e.g., exon 19 deletion or exon 21 L858R, exon 21 L861Q, exon 18 G719X, or exon 20 S768I mutation) and ALK fusions. Also, per NCCN Guideline recommended testing, tumors must also lack ROS1, BRAF, NTRK 1/2/3, METex14 skipping mutations, and RET for which there is available front-line targeted therapy. Only those patients with KRAS G12C mutations and ERBB2 (HER2) mutations with no contraindications to immunotherapy (PD-L1 1) for which there are no approved front-line targeted therapies and for whom immunotherapy would be the preferred front-line therapy are eligible. * Patients may be enrolled with local molecular testing and those results will be provided. * Patients may be enrolled with local molecular testing and those results will be provided. * 18 years and older * Willing and able to provide informed consent * Willing to have additional blood samples collected during routine surveillance visits * Must submit tumor sample representative of current disease Exclusion Criteria (both Cohorts): * 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.
Study sites (58)
AL
- Alabama Oncology · Birmingham, AL 35223Amanda Joseph · Study contact · Amanda.Joseph@AlabamaOncology.comMathew Tucker · Principal investigatorMore trials in Birmingham
AR
- Mercy Clinic Oncology - Fort Smith · Fort Smith, AR 72903Billy Cater · Study contact · Billy.Cater@mercy.netAswanth Reddy, MD · Principal investigatorMore trials in Fort Smith
CA
- MemorialCare · Fountain Valley, CA 92708Tuyet Collucci · Study contact · 562.706.1195 · TCollucci@memorialcare.orgAmol Rao, MD · Principal investigatorMore trials in Fountain Valley
- Cancer and Blood Specialty Clinic · Los Alamitos, CA 90720More trials in Los Alamitos
- UCLA · Los Angeles, CA 90095Deanna Romero · Study contact · 310-694-1795 · DLRomero@mednet.ucla.eduAmy Cummings · Principal investigatorMore trials in Los Angeles
CT
- Eastern CT and Hematology and Oncology Associates · Norwich, CT 06360Susan Johnson · Study contact · sjohnson@echoct.comDennis Slater · Principal investigatorMore trials in Norwich
FL
- Clermont Oncology Center · Clermont, FL 34711Gopal Kunta · Study contact · 352-242-1366 · drgkunta@aorcorp.comMore trials in Clermont
- Woodlands Medical Specialists · Pensacola, FL 32503More trials in Pensacola
GA
- Morehouse School of Medicine (MSM) · Atlanta, GA 30310Carla Holloway · Study contact · 404-752-8452 · cmholloway@msm.eduRoland Matthews · Principal investigatorMore trials in Atlanta
- Piedmont Healthcare · Atlanta, GA 30318Jean Dionne · Study contact · dionne.jean@piedmont.orgRobert Klafter, MD · Principal investigatorMore trials in Atlanta
HI
- Hawaii Cancer Care · Honolulu, HI 96813Angelei Pananganan · Study contact · 808-524-6115 · apanangan@hawaiicancercare.comDavid Tamura, MD · Principal investigatorMore trials in Honolulu
IA
- University of Iowa · Iowa City, IA 52242Laura Baptista · Study contact · 319-467-6412 · laura-batista@uiowa.eduMuhammad Furqan · Principal investigatorMore trials in Iowa City
IL
- Southern Illinois Hospital Services · Carterville, IL 62918Sarmad Nomani · Study contact · sarmad.nomani@sih.netMuhammad Popalzai · Principal investigatorMore trials in Carterville
- Cancer Care Specialists of Illinois · Decatur, IL 62526Jade Wiemelt · Study contact · jwiemelt@ccsci.netJames Wade · Principal investigatorMore trials in Decatur
- Northwestern University · Evanston, IL 60208Mira Pasawala · Study contact · mira.pasawala@northwestern.eduDivya Gupta · Sub-investigatorMore trials in Evanston
- Hope and Healing Cancer Services · Hinsdale, IL 60521Ellen Gustafson · Study contact · sgustafson@hopenheal.careSrilata Gundala · Principal investigatorMore trials in Hinsdale
- OSF Saint Anthony Medical Center · Rockford, IL 61108Shylendra Sreenivasappa · Study contact · 815-227-2859 · shylendra.b.sreenivasappa2@osfhealthcare.orgMore trials in Rockford
IN
- Community Health Network · Indianapolis, IN 46250Cindy Stoner · Study contact · cstoner@ecommunity.comNatraj Ammakkanavar, MD · Principal investigatorMore trials in Indianapolis
MD
- University of Maryland · Baltimore, MD 21201Kaylee Martin · Study contact · Kaylee.Martin@umm.eduSamuel Rosner, MD · Principal investigatorMore trials in Baltimore
- Johns Hopkins University · Baltimore, MD 21287Cheryl Pai · Study contact · 410-614-1926 · cpai3@jhmi.eduLonny Yarmus, DO · Principal investigatorMore trials in Baltimore
- The Center for Cancer and Blood Disorder · Bethesda, MD 20817Kosunique Jenkins · Study contact · kosunique.jenkins@tempus.comMark Goldstein, MD · Principal investigatorMore trials in Bethesda
- Frederick Health Regional System · Frederick, MD 21702Charity Drummond · Study contact · cdrummond@frederick.healthPatrick Mansky · Principal investigatorMore trials in Frederick
MO
- Mercy Clinic Oncology and Hematology - Joplin · Joplin, MO 64804Cynthia Meyer · Study contact · Cynthia.Meyer@mercy.netSamir Dalia, MD · Principal investigatorMore trials in Joplin
- Lake Regional Health System · Osage Beach, MO 65065Kathy Hirst · Study contact · khirst@lakeregional.comCarla Ostronic · Principal investigatorMore trials in Osage Beach
- Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center · Springfield, MO 65804Jennifer Hylton · Study contact · Jennifer.Hylton@mercy.netMohan Tummala, MD · Principal investigatorMore trials in Springfield
- Oncology Hematology Associates · Springfield, MO 65807Adrianna Moore · Study contact · 417-882-4880 · adrianna.moore@aoncology.comRobert Ellis, MD · Principal investigatorMore trials in Springfield
- Mercy Clinic Oncology and Hematology - Sindelar Cancer Center · St Louis, MO 63128Laura O'Brien · Study contact · Laura.OBrien2@mercy.netYifan Tu, MD · Principal investigatorMore trials in St Louis
- Mercy Clinic Oncology and Hematology - David C. Pratt Cancer Center · St Louis, MO 63141Jessica Black · Study contact · Jessica.Black@mercy.netBethany Sleckman, MD · Principal investigatorMore trials in St Louis
NC
- UNC · Chapel Hill, NC 27599Ashley Delgado · Study contact · ashley_delgado@med.unc.eduJason Akulian · Principal investigatorMore trials in Chapel Hill
- Duke University · Durham, NC 27710Lauren Gray · Study contact · lauren.gray@duke.eduKamran Mahmood, MD · Principal investigatorMore trials in Durham
- Southeastern Medical Oncology Center (SMOC) · Goldsboro, NC 27534Jennifer Fields · Study contact · 919-587-9084 · jfields@cancersmoc.comSamer Kasbari, MD · Principal investigatorMore trials in Goldsboro
NE
- Nebraska Cancer Specialists · Omaha, NE 68130Kimberly Wendt · Study contact · 531-444-1230 · kwendt@nebraskacancer.comTimothy Huyck, MD · Principal investigatorMore trials in Omaha
NJ
- New Jersey Cancer Center · Belleville, NJ 07109Michael Johnstone · Study contact · mjohnstone@njcancercare.comJames Orsini Jr. · Principal investigatorMore trials in Belleville
NV
- OptumCare Cancer Care · Las Vegas, NV 89102Danielle Handy · Study contact · Danielle.handy1@optum.comRussell Gollard · Principal investigatorMore trials in Las Vegas
- Hope Cancer Care of Nevada · Las Vegas, NV 89103Mark Gatdula, CRC · Study contact · 702-508-9128 · Mark.Gatdula@aoncology.comRaja Mehdi, MD · Principal investigatorMore trials in Las Vegas
- Cancer Care Specialists Reno · Reno, NV 89511Layla Quinonez · Study contact · 775-329-0222 ext. 230 · ltapia@ccsreno.comJuan Adolfo Cattoni III · Principal investigatorMore trials in Reno
NY
- New York Oncology Hematology · Albany, NY 12206Josephine Faruol · Study contact · 518-489-0044 · Josephine.faruol@usoncology.comMakenzi Evangelist, MD · Principal investigatorMore trials in Albany
- Hematology Oncology Associates of Central New York · East Syracuse, NY 13057Nicole Coleman · Study contact · ncoleman@hoacny.comAjeet Gajra · Principal investigatorMore trials in East Syracuse
- Cayuga Medical Center · Ithaca, NY 14850Betty Haverlock · Study contact · 607-252-3939 · bhaverlock@cayugamed.orgAnthony Mato · Principal investigatorMore trials in Ithaca
- Icahn School of Medicine at Mount Sinai · New York, NY 10029Stephanie Chang · Study contact · stephanie.chang@mssm.eduFred Hirsch · Principal investigatorMore trials in New York
- White Plains Hospital · White Plains, NY 10601Madison Gilmore · Study contact · magilmore@wphospital.orgDan Costin · Principal investigatorMore trials in White Plains
OH
- Aultman Hospital · Canton, OH 44710Carla Larch · Study contact · (330)363-1250 · carla.larch@aultman.comRaza Khan, MD · Principal investigatorMore trials in Canton
- TriHealth Cancer Institute · Cincinnati, OH 45220Wayne Thompson · Study contact · 513-865-5020 · Wayne_Thompson@trihealth.comLeanne Budde, MD · Principal investigatorMore trials in Cincinnati
- Ohio State University · Columbus, OH 43210Hazel Antao · Study contact · Hazel.Antao@osumc.eduAsrar Alahmadi · Principal investigatorMore trials in Columbus
- OhioHealth Reseach Institute · Columbus, OH 43214Kevin Miller · Study contact · Kevin.Miller@ohiohealth.comArvinder Bhinder, MD · Principal investigatorMore trials in Columbus
- Taylor Cancer Research Center · Maumee, OH 43537Jennifer Martinez · Study contact · jmartinez@toledoclinic.comJohn Nemunaitis, MD · Principal investigatorMore trials in Maumee
OK
- Hightower Clinical · Oklahoma City, OK 73102Caitlin Merrick · Study contact · caitlin@hightowerclinical.comThy Nguyen, MD · Principal investigatorMore trials in Oklahoma City
- Mercy Clinic Oncology and Hematology - Coletta · Oklahoma City, OK 73120Marian Nolen · Study contact · Marian.Nolen@mercy.netCarla Kurkjian, MD · Principal investigatorMore trials in Oklahoma City
- Oklahoma Cancer Specialists and Research Institute · Tulsa, OK 74146Stephanie Sandoval · Study contact · 918-505-3200 · stephanie.sandoval@ocsri.orgPaul Zito, MD · Principal investigatorMore trials in Tulsa
OR
- Oregon Oncology Specialists · Salem, OR 97301Cheryl LaBronte · Study contact · clabronte@orcancer.comJanelle Meyer, MD · Principal investigatorMore trials in Salem
PA
- Cancer Care Associates of York · York, PA 17403Jennifer Stough · Study contact · 717-741-9229 ext. 149 · jstough@cancercareyork.comChanh Hyunh, MD · Principal investigatorMore trials in York
SC
- The Medical University of South Carolina · Charleston, SC 29425Tyson Kelsey · Study contact · tysonke@musc.eduChristopher Gilbert, MD · Principal investigatorMore trials in Charleston
TN
- Baptist Cancer Center · Memphis, TN 38120Angela Gates · Study contact · 901-317-0644 · angela.gates@tempus.comRaymond Osarogiagbon, MD · Principal investigatorMore trials in Memphis
VA
- University of Virginia · Charlottesville, VA 22908Ryan Gentzler Principal Investigator · Study contact · rg2uc@virginia.eduMore trials in Charlottesville
WA
- PeaceHealth St. Joseph Medical Center-Bellingham · Bellingham, WA 98225Rebecca Crompton · Study contact · rcrompton@peacehealth.orgMervat Saleh, MD · Principal investigatorMore trials in Bellingham
- Cancer Care Northwest · Spokane Valley, WA 99216Ronaye Wagner · Study contact · ronaye.wagner@ccnw.netDr. Jessica Hellyer, MD · Principal investigatorMore trials in Spokane Valley
WI
- ThedaCare Regional Cancer Center · Appleton, WI 54911Rachel Luedtke · Study contact · 920-364-3616 · Rachel.Luedtke@thedacare.orgMatthias Weiss, MD · Principal investigatorMore trials in Appleton
- Gundersen Health System · La Crosse, WI 54601Jennifer Cole · Study contact · 608-775-6694 · jmcole@gundersenhealth.orgBenjamin Parsons, MD · Principal investigatorMore trials in La Crosse