NSCLC (Non-small Cell Lung Cancer)ELEPHAS-01NCT05478538
Observational Lung Trial to Collect Tissue to Train and Validate a Live Tumor Diagnostic Platform (ELEPHAS-01)
An observational study of NSCLC (Non-small Cell Lung Cancer) and Metastatic NSCLC - Non-Small Cell Lung Cancer, run by Elephas at 7 sites in United States.
Trial summary
The primary objective of this study is to determine the ex-vivo prognostic accuracy of the Cybrid live tumor diagnostic platform using in-vivo RECIST 1.1 as the reference method. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC (Non-small Cell Lung Cancer), Metastatic NSCLC - Non-Small Cell Lung Cancer
- What is being tested?
- Core Needle, Forceps, or Punch Biopsy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 200 participants
- Where
- 7 sitesUnited States
- Study dates
- 31 Jan 2023to Dec 2026
- 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: Patients suspected of or diagnosed with metastatic non-small cell lung cancer (NSCLC).
Subject Inclusion Criteria
- Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- Age ≥ 18 years at the time of consent.
- Subjects suspected of or diagnosed with Stage IV/metastatic NSCLC and meet one of the following criteria:
- Subjects who are undiagnosed, have undergone imaging and are suspected to have Stage IV lung cancer.
- Subjects with a previous Stage I, II, or III diagnosis of NSCLC, who are being re-biopsied due to suspected progression to metastatic disease.
- Subjects who have a newly confirmed diagnosis of Stage IV NSCLC, have undergone a SOC biopsy procedure and will undergo a separate procedure for the purposes of this study prior to starting first line treatment.
- Subjects who have a previous Stage IV/metastatic NSCLC diagnosis and have already received first line treatment.
- Subjects must be clinically able, at investigator discretion, to undergo additional CNB or forceps biopsy passes during their biopsy. These additional biopsies may either be collected from the primary tumor or a metastatic site amenable to additional passes (e.g., liver or lymph nodes) per the clinician.
- Subjects who are newly diagnosed or have suspected cancer must be treatment-naïve at the time of biopsy. All other subjects should have the biopsy performed before starting their next line of treatment.
Subject Exclusion Criteria
- Any patient for whom an extra biopsy might pose a clinical risk based on the discretion of the clinician.
- Any mental impairment that would render the patient unable to understand his/her participation in the study would disqualify the patient from consenting and participating.
- Subjects with an auto-immune disease that would render them ineligible for immune- oncology treatment.
- Immunocompromised subjects, and subjects known to be HIV positive and currently receiving antiretroviral therapy. NOTE: Patients known to be HIV positive, but without clinician evidence of an immunocompromised state, are eligible for this trial.
- Subjects who are enrolled or plan to be enrolled in a blinded oncology treatment trial are not eligible.
- Subjects who are pregnant are not eligible.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Gabrail Cancer Center
Canton, Ohio, 44718
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
JPS Health Network
Fort Worth, Texas, 76104
James M Stockman Cancer Institute
Frederick, Maryland, 21702
UCLA Medical Center
Los Angeles, California, 90095
New York Cancer & Blood Specialists
Shirley, New York, 11967
Baylor Scott & White Research Institute
Temple, Texas, 76508
About this study
Official title: Observational Lung Trial to Collect Tissue to Train and Validate a Live Tumor Diagnostic Platform (CYBRID-01)
The primary objective of this study is to determine the ex-vivo prognostic accuracy of the Cybrid live tumor diagnostic platform using in-vivo RECIST 1.1 as the reference method.
Read the detailed description
Cancer is a leading cause of death and despite many new drugs, a major diagnostic challenge remains knowing which drug will work best for a patient. A new class of drugs called immune checkpoint inhibitors (ICIs) have revolutionized cancer treatment. However, current diagnostic methods (e.g. PDL1, MSI and TMB) do not accurately predict which patients will respond.
Elephas is developing a diagnostic platform using small 3D Live Tumor Fragments (LTFs) from participants for accurate prediction of drug response with a focus on ICIs such as Pembrolizumab (Keytruda). These LTFs contain both tumor cells and infiltrating immune cells, which are critical in determining response to ICIs and other immunotherapies.
In this observational clinical trial, 200 Non-Small Cell Lung Cancer (NSCLC) participants will be recruited and their actual clinical response to ICIs (using RECIST 1.1) will be compared to the platform's predictive Artificial Intelligence (AI) score that is based on RNA, clinical data, and 3D microscopy images. The sensitivity and specificity of the platform's score will be determined and compared to current diagnostic methods for ICIs like PDL1, MSI, and TMB.
- Being tested
- Core Needle, Forceps, or Punch Biopsy
- Keywords
- Metastatic NSCLC, NSCLC, Non Small Cell Lung Cancer, Core needle biopsy, Live tumor fragments, Immunotherapy, Immunotherapy prediction, 3D culture, Ex vivo platform, Immune checkpoint inhibitors, Forceps biopsy, Punch biopsy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core Needle, Forceps, or Punch BiopsyProcedure or surgery
Subjects must be clinically able, at investigator discretion, to undergo additional core needle, forceps, or punch biopsy during their biopsy. These additional biopsies may either be collected from the primary tumor or a metastatic site amenable to additional passes (e.g., liver or lymph nodes) per the clinician.
| Study group | Role | What they receive |
|---|---|---|
| Stage IV or metastatic Non Small Cell Lung Cancer (NSCLC) | Subjects suspected of or diagnosed with Stage IV NSCLC and meet one of the following criteria:
1. Subjects who are undiagnosed, have undergone imaging and are suspected to have Stage IV lung cancer.
2. Subjects with a Stage I, II, or III diagnosis of NSCLC, who are being re-biopsied after imaging-confirmed progression to metastatic disease
3. Subjects who have a confirmed diagnosis of NSCLC, and have undergone a SOC biopsy procedure and will undergo a separate procedure for the purposes of this study.
4. Subjects who have a previous Stage IV/metastatic NSCLC diagnosis and have already received first line treatment. Receives: Procedure: Core Needle, Forceps, or Punch Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity of Cybrid Score for Predicting In-Vivo Clinical Response to Immune Checkpoint Inhibitors
The ex-vivo prognostic accuracy of the Cybrid live tumor diagnostic platform will be determined using in-vivo RECIST 1.1 as the reference method.
Measured: 3 years
Secondary outcomes (1)
Determine the Area Under the Receiver Operating Characteristic Curve (AUC) of Cybrid Score and Compare to the AUCs of Current FDA Approved Predictive Biomarkers PD-L1 and Tumor Mutation Burden (TMB)
The AUC of Cybrid Score will be established with a clinically meaningful confidence interval and compared to the AUCs of established FDA approved biomarkers for predicting clinical response to ICIs.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start31 Jan 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for NSCLC (Non-small Cell Lung Cancer)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elephas
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fred Hausheer, MD, FACP, Study director, Elephas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05478538
- Sponsor's protocol ID
- ELEP-2022-CYBRID-01
- Acronym
- ELEPHAS-01
- Status last verified
- Jun 2026
- First submitted
- 26 Jul 2022
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.
PubMed 19097774Seymour L, Bogaerts J, Perrone A, Ford R, Schwartz LH, Mandrekar S, Lin NU, Litiere S, Dancey J, Chen A, Hodi FS, Therasse P, Hoekstra OS, Shankar LK, Wolchok JD, Ballinger M, Caramella C, de Vries EGE; RECIST working group. iRECIST: guidelines for response criteria for use in trials testing immunotherapeutics. Lancet Oncol. 2017 Mar;18(3):e143-e152. doi: 10.1016/S1470-2045(17)30074-8. Epub 2017 Mar 2.
PubMed 28271869Chen S, Zhang Z, Zheng X, Tao H, Zhang S, Ma J, Liu Z, Wang J, Qian Y, Cui P, Huang D, Huang Z, Wu Z, Hu Y. Response Efficacy of PD-1 and PD-L1 Inhibitors in Clinical Trials: A Systematic Review and Meta-Analysis. Front Oncol. 2021 Apr 16;11:562315. doi: 10.3389/fonc.2021.562315. eCollection 2021.
PubMed 33937012Cherukuri AR, Lubner MG, Zea R, Hinshaw JL, Lubner SJ, Matkowskyj KA, Foltz ML, Pickhardt PJ. Tissue sampling in the era of precision medicine: comparison of percutaneous biopsies performed for clinical trials or tumor genomics versus routine clinical care. Abdom Radiol (NY). 2019 Jun;44(6):2074-2080. doi: 10.1007/s00261-018-1702-1.
PubMed 30032384Pincott J, Kanchustambham V. Small Cell Lung Cancer. 2026 Apr 15. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK482458/
PubMed 29494065Braun D, Dana N, Hernan HR, Sahni S, Scribano CM, Johnson C, Vedder L, von Euw E, Zweng J, Wargowski E, Sunil A, Sharma D, Routh J, Rexroad K, Nasreen A, McDonnell P, Jergens V, Costa C, Zuniga R, Toia GV, Patel PM, McGregor S, Martin RCG 2nd, Majeed U, Mukhopadhyay D, Lou Y, Kokabi N, Jakub JW, Hays D, Godwin AK, Giffi V, Gelbard A, Friedl A, Duimstra EK, Dronca RS, Chen R, Chalfin H, Bhattacharya S, Broome B, Babiker HM, Chandra T, Caenepeel S, Hrycyniak LCF, Sood C, Ramos H, Patel P, Advani P, Gierman HJ, Taube J. Prediction of immunotherapy response using live tumor fragments from routine clinical biopsies. Cell Rep Med. 2026 Oct 15:103114. doi: 10.1016/j.xcrm.2026.103114. Online ahead of print.
PubMed 42880280Ramasubramanian TS, Adstamongkonkul P, Scribano CM, Johnson C, Caenepeel S, Hrycyniak LCF, Vedder LC, Dana N, Baltes C, Browning V, Chen YI, Dietz T, Flietner E, Kaplewski N, Kellner A, Korrer M, Liu C, Marhefke N, McDonnell P, Nasreen A, Pope V, Prasad A, Richardson J, Schneider S, Schultz MM, Sood C, Sunil A, Euw EV, Wait E, Wargowski EE, Advani P, Broome B, Bruckbauer A, Godwin A, Kokabi N, Lou Y, Martin RCG 2nd, Robaina M, Toia G, Routh J, Friedl A, Eliceiri K, Szulczewski M, Johnson S, Oliner J, Galon J, Capitini C, Mukhopadhyay D, Taube J, Braun D, Gierman HJ. A live tumor fragment platform to assess immunotherapy response in core needle biopsies while addressing challenges of tumor heterogeneity. J Transl Med. 2026 Jan 3;24(1):18. doi: 10.1186/s12967-025-07378-2.
PubMed 41484629Ramasubramanian TS, Adstamongkonkul P, Scribano CM, Johnson C, Caenepeel S, Hrycyniak LCF, Vedder L, Dana N, Baltes C, Browning T, Chen YI, Dietz T, Flietner E, Kaplewski N, Kellner A, Korrer M, Liu C, Marhefke N, McDonnell P, Nasreen A, Pope V, Prasad A, Richardson J, Schneider S, Schultz M, Sood C, Sunil A, von Euw E, Wait E, Wargowski E, Advani P, Broome B, Bruckbauer A, Godwin A, Kokabi N, Martin R, Robaina M, Toia G, Routh J, Friedl A, Eliceiri K, Szulczewski M, Johnson S, Oliner J, Galon J, Capitini C, Mukhopadhyay D, Taube J, Braun D, Gierman HJ. A live tumor fragment platform to assess immunotherapy response in core needle biopsies while addressing challenges of tumor heterogeneity. bioRxiv [Preprint]. 2025 Jul 18:2025.07.18.663728. doi: 10.1101/2025.07.18.663728.
PubMed 40791544
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Lung Trial to Collect Tissue to Train and Validate a Live Tumor Diagnostic Platform (CYBRID-01)
- ClinicalTrials.gov ID
- NCT05478538
- Acronym / sponsor ID
- ELEPHAS-01 / ELEP-2022-CYBRID-01
- Keywords
- Metastatic NSCLC, NSCLC, Non Small Cell Lung Cancer, Core needle biopsy, Live tumor fragments, Immunotherapy, Immunotherapy prediction, 3D culture
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- ElephasIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 28 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to determine the ex-vivo prognostic accuracy of the Cybrid live tumor diagnostic platform using in-vivo RECIST 1.1 as the reference method.
Detailed description
Cancer is a leading cause of death and despite many new drugs, a major diagnostic challenge remains knowing which drug will work best for a patient. A new class of drugs called immune checkpoint inhibitors (ICIs) have revolutionized cancer treatment. However, current diagnostic methods (e.g. PDL1, MSI and TMB) do not accurately predict which patients will respond.
Elephas is developing a diagnostic platform using small 3D Live Tumor Fragments (LTFs) from participants for accurate prediction of drug response with a focus on ICIs such as Pembrolizumab (Keytruda). These LTFs contain both tumor cells and infiltrating immune cells, which are critical in determining response to ICIs and other immunotherapies.
In this observational clinical trial, 200 Non-Small Cell Lung Cancer (NSCLC) participants will be recruited and their actual clinical response to ICIs (using RECIST 1.1) will be compared to the platform's predictive Artificial Intelligence (AI) score that is based on RNA, clinical data, and 3D microscopy images. The sensitivity and specificity of the platform's score will be determined and compared to current diagnostic methods for ICIs like PDL1, MSI, and TMB.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stage IV or metastatic Non Small Cell Lung Cancer (NSCLC) | – | Procedure: Core Needle, Forceps, or Punch BiopsySubjects suspected of or diagnosed with Stage IV NSCLC and meet one of the following criteria: 1. Subjects who are undiagnosed, have undergone imaging and are suspected to have Stage IV lung cancer. 2. Subjects with a Stage I, II, or III diagnosis of NSCLC, who are being re-biopsied after imaging-confirmed progression to metastatic disease 3. Subjects who have a confirmed diagnosis of NSCLC, and have undergone a SOC biopsy procedure and will undergo a separate procedure for the purposes of this study. 4. Subjects who have a previous Stage IV/metastatic NSCLC diagnosis and have already received first line treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suspected of or diagnosed with metastatic non-small cell lung cancer (NSCLC).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Core Needle, Forceps, or Punch BiopsySubjects must be clinically able, at investigator discretion, to undergo additional core needle, forceps, or punch biopsy during their biopsy. These additional biopsies may either be collected from the primary tumor or a metastatic site amenable to additional passes (e.g., liver or lymph nodes) per the clinician. | Procedure or surgery | Stage IV or metastatic Non Small Cell Lung Cancer (NSCLC) |
Primary outcome
Sensitivity and Specificity of Cybrid Score for Predicting In-Vivo Clinical Response to Immune Checkpoint Inhibitors
Time frame: 3 years
The ex-vivo prognostic accuracy of the Cybrid live tumor diagnostic platform will be determined using in-vivo RECIST 1.1 as the reference method.
1 secondary outcome
Determine the Area Under the Receiver Operating Characteristic Curve (AUC) of Cybrid Score and Compare to the AUCs of Current FDA Approved Predictive Biomarkers PD-L1 and Tumor Mutation Burden (TMB)
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Background: PubMed 19097774Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.
- Background: PubMed 28271869Seymour L, Bogaerts J, Perrone A, Ford R, Schwartz LH, Mandrekar S, Lin NU, Litiere S, Dancey J, Chen A, Hodi FS, Therasse P, Hoekstra OS, Shankar LK, Wolchok JD, Ballinger M, Caramella C, de Vries EGE; RECIST working group. iRECIST: guidelines for response criteria for use in trials testing immunotherapeutics. Lancet Oncol. 2017 Mar;18(3):e143-e152. doi: 10.1016/S1470-2045(17)30074-8. Epub 2017 Mar 2.
- Background: PubMed 33937012Chen S, Zhang Z, Zheng X, Tao H, Zhang S, Ma J, Liu Z, Wang J, Qian Y, Cui P, Huang D, Huang Z, Wu Z, Hu Y. Response Efficacy of PD-1 and PD-L1 Inhibitors in Clinical Trials: A Systematic Review and Meta-Analysis. Front Oncol. 2021 Apr 16;11:562315. doi: 10.3389/fonc.2021.562315. eCollection 2021.
- Background: PubMed 30032384Cherukuri AR, Lubner MG, Zea R, Hinshaw JL, Lubner SJ, Matkowskyj KA, Foltz ML, Pickhardt PJ. Tissue sampling in the era of precision medicine: comparison of percutaneous biopsies performed for clinical trials or tumor genomics versus routine clinical care. Abdom Radiol (NY). 2019 Jun;44(6):2074-2080. doi: 10.1007/s00261-018-1702-1.
- Background: PubMed 29494065Pincott J, Kanchustambham V. Small Cell Lung Cancer. 2026 Apr 15. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK482458/
- Derived from this study: PubMed 42880280Braun D, Dana N, Hernan HR, Sahni S, Scribano CM, Johnson C, Vedder L, von Euw E, Zweng J, Wargowski E, Sunil A, Sharma D, Routh J, Rexroad K, Nasreen A, McDonnell P, Jergens V, Costa C, Zuniga R, Toia GV, Patel PM, McGregor S, Martin RCG 2nd, Majeed U, Mukhopadhyay D, Lou Y, Kokabi N, Jakub JW, Hays D, Godwin AK, Giffi V, Gelbard A, Friedl A, Duimstra EK, Dronca RS, Chen R, Chalfin H, Bhattacharya S, Broome B, Babiker HM, Chandra T, Caenepeel S, Hrycyniak LCF, Sood C, Ramos H, Patel P, Advani P, Gierman HJ, Taube J. Prediction of immunotherapy response using live tumor fragments from routine clinical biopsies. Cell Rep Med. 2026 Oct 15:103114. doi: 10.1016/j.xcrm.2026.103114. Online ahead of print.
- Derived from this study: PubMed 41484629Ramasubramanian TS, Adstamongkonkul P, Scribano CM, Johnson C, Caenepeel S, Hrycyniak LCF, Vedder LC, Dana N, Baltes C, Browning V, Chen YI, Dietz T, Flietner E, Kaplewski N, Kellner A, Korrer M, Liu C, Marhefke N, McDonnell P, Nasreen A, Pope V, Prasad A, Richardson J, Schneider S, Schultz MM, Sood C, Sunil A, Euw EV, Wait E, Wargowski EE, Advani P, Broome B, Bruckbauer A, Godwin A, Kokabi N, Lou Y, Martin RCG 2nd, Robaina M, Toia G, Routh J, Friedl A, Eliceiri K, Szulczewski M, Johnson S, Oliner J, Galon J, Capitini C, Mukhopadhyay D, Taube J, Braun D, Gierman HJ. A live tumor fragment platform to assess immunotherapy response in core needle biopsies while addressing challenges of tumor heterogeneity. J Transl Med. 2026 Jan 3;24(1):18. doi: 10.1186/s12967-025-07378-2.
- Derived from this study: PubMed 40791544Ramasubramanian TS, Adstamongkonkul P, Scribano CM, Johnson C, Caenepeel S, Hrycyniak LCF, Vedder L, Dana N, Baltes C, Browning T, Chen YI, Dietz T, Flietner E, Kaplewski N, Kellner A, Korrer M, Liu C, Marhefke N, McDonnell P, Nasreen A, Pope V, Prasad A, Richardson J, Schneider S, Schultz M, Sood C, Sunil A, von Euw E, Wait E, Wargowski E, Advani P, Broome B, Bruckbauer A, Godwin A, Kokabi N, Martin R, Robaina M, Toia G, Routh J, Friedl A, Eliceiri K, Szulczewski M, Johnson S, Oliner J, Galon J, Capitini C, Mukhopadhyay D, Taube J, Braun D, Gierman HJ. A live tumor fragment platform to assess immunotherapy response in core needle biopsies while addressing challenges of tumor heterogeneity. bioRxiv [Preprint]. 2025 Jul 18:2025.07.18.663728. doi: 10.1101/2025.07.18.663728.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fred Hausheer, MD, FACP study director
Elephas
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NSCLC (Non-small Cell Lung Cancer) and Metastatic NSCLC - Non-Small Cell Lung Cancer, run by Elephas at 7 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?
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: under way, not looking for participants, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and Specificity of Cybrid Score for Predicting In-Vivo Clinical Response to Immune Checkpoint Inhibitors (time frame: 3 years). 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 NCT05478538, which also lists 8 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 29 Jun 2026.