Advanced Non-small Cell Lung Cancer (NSCLC)INNOVA-LUNGNCT07649629
Impact of Liquid Biopsy on the Therapeutic Pathway for Lung Cancer: Advancing the Molecular Characterization of Patients With Advanced Lung Adenocarcinoma by Integrating Liquid Biopsy Into the Early Stages of the Diagnostic and Therapeutic Pathway
An observational study of Advanced Non-small Cell Lung Cancer (NSCLC), run by Regina Elena Cancer Institute at 1 site in Italy.
Trial summary
This multicenter pilot observational study aims to assess the feasibility of introducing liquid biopsy at an early stage of the diagnostic pathway for patients with suspected advanced non-small cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Non-small Cell Lung Cancer (NSCLC)
- What is being tested?
- Plasma-based liquid biopsy
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2025to 1 Mar 2027
- 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: The study population includes adult patients with radiological suspicion of locally advanced lung cancer not suitable for locoregional treatment or metastatic lung cancer. Participants are enrolled before completion of the standard diagnostic pathway, when tissue biopsy or cytological sampling is planned but not yet performed, or has already been performed without an available histopathological diagnosis of NSCLC. Eligible patients are recruited at participating centers during thoracic surgery assessment or the first oncology visit and undergo plasma-based liquid biopsy while continuing the standard diagnostic pathway.
Who may be able to join
- Age ≥ 18 years.
- Radiological suspicion of locally advanced lung cancer not amenable to locoregional treatment or metastatic lung cancer (stage III-IV).
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
- Tissue biopsy and/or cytological sampling planned but not yet performed, or already performed without an available histopathological diagnosis of non-small cell lung cancer (NSCLC).
- Written informed consent for study participation and personal data processing obtained before any study-specific procedure.
Who cannot join
- Previous or current history of non-small cell lung cancer (NSCLC).
- Histopathological diagnosis of NSCLC already available following tissue biopsy.
- Eligibility for surgical removal of tumor tissue.
- Ongoing or previous systemic oncological treatment for lung cancer.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Simonetta Buglioni, Biology contact
Italy1 site, 1 recruiting
- Recruiting
IFO-IRE, Istituto Nazionale Tumori Regina Elena
Roma, RM, 00144
Maristella Giammaruco, MD, +39 06 5266 5698, maristella.giammaruco@ifo.it
Simonetta Buglioni, Biology, +39 06 5266 2923, simonetta.buglioni@ifo.it
About this study
Official title: Impatto Della Biopsia Liquida Sul Percorso Terapeutico Del Tumore al Polmone: Anticipare la Caratterizzazione Molecolare Dei Pazienti Con Adenocarcinoma Del Polmone in Stadio Avanzato Integrando la Biopsia Liquida Nella Fase Iniziale Del Percorso Diagnostico-terapeutico
This multicenter pilot observational study aims to assess the feasibility of introducing liquid biopsy at an early stage of the diagnostic pathway for patients with suspected advanced non-small cell lung cancer (NSCLC).
Liquid biopsy is a minimally invasive blood test that can detect tumor-related genetic alterations in circulating nucleic acids. The study will evaluate whether this approach can provide molecular information more rapidly than standard tissue-based testing and how closely the results obtained from blood samples match those obtained from tumor tissue.
Read more
Approximately 70 adult patients with radiological evidence of locally advanced or metastatic lung cancer will be enrolled. Participants will undergo a blood draw for liquid biopsy and will continue to follow the standard diagnostic pathway, including tissue biopsy or cytological sampling when indicated.
The results generated within the study are intended for research purposes and will not replace standard diagnostic procedures or independently determine treatment decisions. The findings will be used to identify practical and methodological issues and to support the design of future clinical studies on the plasma-first approach.
Read the detailed description
Molecular characterization is an essential step in the management of advanced non-small cell lung cancer (NSCLC), as the identification of actionable genomic alterations may guide the selection of targeted therapies. However, tissue-based molecular testing may be delayed or limited by insufficient or poor-quality biological material.
Liquid biopsy allows the analysis of circulating tumor-derived nucleic acids from a peripheral blood sample and may provide molecular information earlier in the diagnostic pathway. The plasma-first approach consists of performing liquid biopsy at an early stage, while the patient continues the standard diagnostic process.
This is a multicenter, prospective, non-pharmacological pilot observational study involving adult patients with radiological suspicion of locally advanced NSCLC not suitable for locoregional treatment or metastatic NSCLC. Eligible patients must have a tissue biopsy or cytological sampling planned but not yet performed, or already performed without an available histopathological diagnosis of NSCLC at the time of enrollment.
Each participant will undergo a peripheral blood draw for liquid biopsy within one week of the first clinical assessment. Plasma-derived circulating nucleic acids will be analyzed using next-generation sequencing (NGS). Participants will then continue the standard diagnostic pathway of the enrolling center, including tissue biopsy or cytological sampling, histopathological diagnosis, PD-L1 assessment, and standard tissue-based molecular profiling.
The study will assess the feasibility of the plasma-first approach and will generate a structured dataset to support the design of future prospective studies. Secondary objectives include evaluating:
- the turnaround time of plasma-based and tissue-based molecular testing;
- the proportion of informative liquid biopsy results;
- the concordance between molecular alterations detected in plasma and tissue samples;
- the performance of different NGS-based approaches for the detection of genomic alterations;
- the tumor fraction in plasma samples and its relationship with molecular and clinical variables;
- the potential organizational and economic implications of integrating liquid biopsy into the diagnostic pathway.
For participants enrolled at the coordinating center, additional exploratory analyses will be performed to estimate tumor fraction and compare two NGS-based analytical approaches.
The results of the liquid biopsy performed within this pilot study are collected for research purposes. They will not replace standard diagnostic procedures and will not independently determine the initiation of treatment. Treatment decisions will remain based on the standard diagnostic and clinical assessment performed according to current clinical practice.
The study plans to enroll approximately 70 participants over a 6-month recruitment period, with an observation period of 12 months and an overall estimated study duration of 18 months.
- Being tested
- Plasma-based liquid biopsy
- Keywords
- Lung Cancer, Liquid biopsy, Plasma-first approach, Non-small cell lung cancer, NSCLC, ctDNA, ctRNA, NGS, Molecular profiling, Tumor fraction, Actionable genomic alterations, Targeted therapy, Biomarkers
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma-based liquid biopsyDiagnostic test
Participants will undergo a peripheral blood draw for plasma-based liquid biopsy within one week of the first clinical assessment. Circulating cell-free nucleic acids extracted from plasma will be analyzed using next-generation sequencing (NGS) to identify molecular alterations and evaluate turnaround time, concordance with tissue-based molecular profiling, and tumor fraction.
The liquid biopsy is performed for research purposes within this pilot observational study. Participants will continue the standard diagnostic pathway of the enrolling center, including tissue biopsy or cytological sampling, histopathological diagnosis, PD-L1 assessment, and standard tissue-based molecular testing. The study procedure will not independently determine treatment decisions.
| Study group | Role | What they receive |
|---|---|---|
| Prospective Plasma-First NSCLC Cohort | Adult patients with radiological suspicion of locally advanced non-small cell lung cancer (NSCLC) not suitable for locoregional treatment, or metastatic NSCLC, will be enrolled before completion of the standard diagnostic pathway.
Participants will undergo a peripheral blood draw for liquid biopsy within one week of the first clinical assessment. Plasma-derived circulating nucleic acids will be analyzed using next-generation sequencing (NGS) to evaluate molecular alterations, turnaround time, concordance with tissue-based profiling, and tumor fraction.
All participants will continue the standard diagnostic pathway of the enrolling center, including tissue biopsy or cytological sampling, histopathological diagnosis, PD-L1 assessment, and tissue-based molecular testing. No investigational treatment is assigned, and study procedures will not independently determine treatment decisions. Receives: Diagnostic Test: Plasma-based liquid biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of establishing a structured plasma-first molecular profiling dataset
Proportion of enrolled participants with a complete structured dataset including liquid biopsy results, tissue-based diagnostic and molecular profiling results, and relevant clinical data required for the feasibility assessment of the plasma-first approach.
Measured: Up to 18 months
Secondary outcomes (5)
Turnaround time for plasma-based molecular profiling
Time in days from peripheral blood collection to availability of the liquid biopsy molecular profiling report.
Measured: Up to 7 days from blood collection
Proportion of participants with informative liquid biopsy results
Proportion of enrolled participants in whom plasma-based molecular profiling identifies at least one clinically actionable genomic alteration with established evidence supporting targeted therapy.
Measured: Up to 30 days from enrollment
Concordance between plasma-based and tissue-based molecular profiling
Proportion of participants with concordant molecular profiling results between plasma-derived circulating nucleic acids and matched tissue or cytological samples.
Measured: Up to 30 days from enrollment
Tumor fraction in plasma samples
Distribution of estimated tumor fraction values in plasma samples and proportion of samples with sufficient circulating tumor DNA concentration for molecular analysis.
Measured: Up to 30 days from blood collection
Analytical performance of two NGS-based plasma profiling approaches
Comparison of the ability of amplicon-based and hybrid-capture next-generation sequencing approaches to detect genomic alterations, including low variant allele frequency alterations and gene fusions, in plasma-derived circulating nucleic acids.
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start1 Sep 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Advanced Non-small Cell Lung Cancer (NSCLC)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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regina Elena Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Federico Cappuzzo, MD, Principal investigator, IFO-IRE, Istituto Nazionale Tumori Regina Elena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07649629
- Sponsor's protocol ID
- RS348/2025
- Acronym
- INNOVA-LUNG
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available. Study data will be pseudonymized and managed in accordance with applicable data protection requirements. Any data sharing among participating centers will be limited to the purposes of the study and regulated through appropriate data transfer agreements. Study results may be disseminated in aggregated form. Any future reuse or sharing of individual-level data for compatible research purposes would require specific institutional approval and compliance with applicable ethical, legal, and data protection requirements.
Publications
Low SK, Ariyasu R, Uchibori K, Hayashi R, Chan HT, Chin YM, Akita T, Harutani Y, Kiritani A, Tsugitomi R, Manabe R, Ogusu S, Amino Y, Kitazono S, Yanagitani N, Nakamura Y, Nishio M. Rapid genomic profiling of circulating tumor DNA in non-small cell lung cancer using Oncomine Precision Assay with Genexus integrated sequencer. Transl Lung Cancer Res. 2022 May;11(5):711-721. doi: 10.21037/tlcr-21-981.
PubMed 35693289Husain H, Pavlick DC, Fendler BJ, Madison RW, Decker B, Gjoerup O, Parachoniak CA, McLaughlin-Drubin M, Erlich RL, Schrock AB, Frampton GM, Das Thakur M, Oxnard GR, Tukachinsky H. Tumor Fraction Correlates With Detection of Actionable Variants Across > 23,000 Circulating Tumor DNA Samples. JCO Precis Oncol. 2022 Oct;6:e2200261. doi: 10.1200/PO.22.00261.
PubMed 36265119Rolfo C, Mack P, Scagliotti GV, Aggarwal C, Arcila ME, Barlesi F, Bivona T, Diehn M, Dive C, Dziadziuszko R, Leighl N, Malapelle U, Mok T, Peled N, Raez LE, Sequist L, Sholl L, Swanton C, Abbosh C, Tan D, Wakelee H, Wistuba I, Bunn R, Freeman-Daily J, Wynes M, Belani C, Mitsudomi T, Gandara D. Liquid Biopsy for Advanced NSCLC: A Consensus Statement From the International Association for the Study of Lung Cancer. J Thorac Oncol. 2021 Oct;16(10):1647-1662. doi: 10.1016/j.jtho.2021.06.017. Epub 2021 Jul 8.
PubMed 34246791Garcia-Pardo M, Czarnecka K, Law JH, Salvarrey A, Fernandes R, Fan J, Corke L, Waddell TK, Yasufuku K, Donahoe LL, Pierre A, Le LW, Ghumman N, Liu G, Shepherd FA, Bradbury P, Sacher A, Stockley T, Pal P, Rogalla P, Tsao MS, Leighl NB. Plasma-first: accelerating lung cancer diagnosis and molecular profiling through liquid biopsy. Ther Adv Med Oncol. 2022 Sep 20;14:17588359221126151. doi: 10.1177/17588359221126151. eCollection 2022.
PubMed 36158638
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impatto Della Biopsia Liquida Sul Percorso Terapeutico Del Tumore al Polmone: Anticipare la Caratterizzazione Molecolare Dei Pazienti Con Adenocarcinoma Del Polmone in Stadio Avanzato Integrando la Biopsia Liquida Nella Fase Iniziale Del Percorso Diagnostico-terapeutico
- ClinicalTrials.gov ID
- NCT07649629
- Acronym / sponsor ID
- INNOVA-LUNG / RS348/2025
- Keywords
- Lung Cancer, Liquid biopsy, Plasma-first approach, Non-small cell lung cancer, NSCLC, ctDNA, ctRNA, NGS
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Regina Elena Cancer InstituteUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 16 Jun 2026 (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.
This multicenter pilot observational study aims to assess the feasibility of introducing liquid biopsy at an early stage of the diagnostic pathway for patients with suspected advanced non-small cell lung cancer (NSCLC).
Liquid biopsy is a minimally invasive blood test that can detect tumor-related genetic alterations in circulating nucleic acids. The study will evaluate whether this approach can provide molecular information more rapidly than standard tissue-based testing and how closely the results obtained from blood samples match those obtained from tumor tissue.
Approximately 70 adult patients with radiological evidence of locally advanced or metastatic lung cancer will be enrolled. Participants will undergo a blood draw for liquid biopsy and will continue to follow the standard diagnostic pathway, including tissue biopsy or cytological sampling when indicated.
The results generated within the study are intended for research purposes and will not replace standard diagnostic procedures or independently determine treatment decisions. The findings will be used to identify practical and methodological issues and to support the design of future clinical studies on the plasma-first approach.
Detailed description
Molecular characterization is an essential step in the management of advanced non-small cell lung cancer (NSCLC), as the identification of actionable genomic alterations may guide the selection of targeted therapies. However, tissue-based molecular testing may be delayed or limited by insufficient or poor-quality biological material.
Liquid biopsy allows the analysis of circulating tumor-derived nucleic acids from a peripheral blood sample and may provide molecular information earlier in the diagnostic pathway. The plasma-first approach consists of performing liquid biopsy at an early stage, while the patient continues the standard diagnostic process.
This is a multicenter, prospective, non-pharmacological pilot observational study involving adult patients with radiological suspicion of locally advanced NSCLC not suitable for locoregional treatment or metastatic NSCLC. Eligible patients must have a tissue biopsy or cytological sampling planned but not yet performed, or already performed without an available histopathological diagnosis of NSCLC at the time of enrollment.
Each participant will undergo a peripheral blood draw for liquid biopsy within one week of the first clinical assessment. Plasma-derived circulating nucleic acids will be analyzed using next-generation sequencing (NGS). Participants will then continue the standard diagnostic pathway of the enrolling center, including tissue biopsy or cytological sampling, histopathological diagnosis, PD-L1 assessment, and standard tissue-based molecular profiling.
The study will assess the feasibility of the plasma-first approach and will generate a structured dataset to support the design of future prospective studies. Secondary objectives include evaluating:
- the turnaround time of plasma-based and tissue-based molecular testing;
- the proportion of informative liquid biopsy results;
- the concordance between molecular alterations detected in plasma and tissue samples;
- the performance of different NGS-based approaches for the detection of genomic alterations;
- the tumor fraction in plasma samples and its relationship with molecular and clinical variables;
- the potential organizational and economic implications of integrating liquid biopsy into the diagnostic pathway.
For participants enrolled at the coordinating center, additional exploratory analyses will be performed to estimate tumor fraction and compare two NGS-based analytical approaches.
The results of the liquid biopsy performed within this pilot study are collected for research purposes. They will not replace standard diagnostic procedures and will not independently determine the initiation of treatment. Treatment decisions will remain based on the standard diagnostic and clinical assessment performed according to current clinical practice.
The study plans to enroll approximately 70 participants over a 6-month recruitment period, with an observation period of 12 months and an overall estimated study duration of 18 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective Plasma-First NSCLC Cohort | – | Diagnostic Test: Plasma-based liquid biopsyAdult patients with radiological suspicion of locally advanced non-small cell lung cancer (NSCLC) not suitable for locoregional treatment, or metastatic NSCLC, will be enrolled before completion of the standard diagnostic pathway. Participants will undergo a peripheral blood draw for liquid biopsy within one week of the first clinical assessment. Plasma-derived circulating nucleic acids will be analyzed using next-generation sequencing (NGS) to evaluate molecular alterations, turnaround time, concordance with tissue-based profiling, and tumor fraction. All participants will continue the standard diagnostic pathway of the enrolling center, including tissue biopsy or cytological sampling, histopathological diagnosis, PD-L1 assessment, and tissue-based molecular testing. No investigational treatment is assigned, and study procedures will not independently determine treatment decisions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes adult patients with radiological suspicion of locally advanced lung cancer not suitable for locoregional treatment or metastatic lung cancer. Participants are enrolled before completion of the standard diagnostic pathway, when tissue biopsy or cytological sampling is planned but not yet performed, or has already been performed without an available histopathological diagnosis of NSCLC. Eligible patients are recruited at participating centers during thoracic surgery assessment or the first oncology visit and undergo plasma-based liquid biopsy while continuing the standard diagnostic pathway.
Key inclusion criteria (5 listed)
- Age ≥ 18 years.
- Radiological suspicion of locally advanced lung cancer not amenable to locoregional treatment or metastatic lung cancer (stage III-IV).
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
- Tissue biopsy and/or cytological sampling planned but not yet performed, or already performed without an available histopathological diagnosis of non-small cell lung cancer (NSCLC).
- Written informed consent for study participation and personal data processing obtained before any study-specific procedure.
Key exclusion criteria (4 listed)
- Previous or current history of non-small cell lung cancer (NSCLC).
- Histopathological diagnosis of NSCLC already available following tissue biopsy.
- Eligibility for surgical removal of tumor tissue.
- Ongoing or previous systemic oncological treatment for lung cancer.
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 |
|---|---|---|
| Plasma-based liquid biopsyParticipants will undergo a peripheral blood draw for plasma-based liquid biopsy within one week of the first clinical assessment. Circulating cell-free nucleic acids extracted from plasma will be analyzed using next-generation sequencing (NGS) to identify molecular alterations and evaluate turnaround time, concordance with tissue-based molecular profiling, and tumor fraction. The liquid biopsy is performed for research purposes within this pilot observational study. Participants will continue the standard diagnostic pathway of the enrolling center, including tissue biopsy or cytological sampling, histopathological diagnosis, PD-L1 assessment, and standard tissue-based molecular testing. The study procedure will not independently determine treatment decisions. | Diagnostic test | Prospective Plasma-First NSCLC Cohort |
Primary outcome
Feasibility of establishing a structured plasma-first molecular profiling dataset
Time frame: Up to 18 months
Proportion of enrolled participants with a complete structured dataset including liquid biopsy results, tissue-based diagnostic and molecular profiling results, and relevant clinical data required for the feasibility assessment of the plasma-first approach.
5 secondary outcomes
Turnaround time for plasma-based molecular profiling
Time frame: Up to 7 days from blood collection
Proportion of participants with informative liquid biopsy results
Time frame: Up to 30 days from enrollment
Concordance between plasma-based and tissue-based molecular profiling
Time frame: Up to 30 days from enrollment
Tumor fraction in plasma samples
Time frame: Up to 30 days from blood collection
Analytical performance of two NGS-based plasma profiling approaches
Time frame: Up to 18 months
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 16 Jun 2026.
- Background: PubMed 35693289Low SK, Ariyasu R, Uchibori K, Hayashi R, Chan HT, Chin YM, Akita T, Harutani Y, Kiritani A, Tsugitomi R, Manabe R, Ogusu S, Amino Y, Kitazono S, Yanagitani N, Nakamura Y, Nishio M. Rapid genomic profiling of circulating tumor DNA in non-small cell lung cancer using Oncomine Precision Assay with Genexus integrated sequencer. Transl Lung Cancer Res. 2022 May;11(5):711-721. doi: 10.21037/tlcr-21-981.
- Background: PubMed 36265119Husain H, Pavlick DC, Fendler BJ, Madison RW, Decker B, Gjoerup O, Parachoniak CA, McLaughlin-Drubin M, Erlich RL, Schrock AB, Frampton GM, Das Thakur M, Oxnard GR, Tukachinsky H. Tumor Fraction Correlates With Detection of Actionable Variants Across > 23,000 Circulating Tumor DNA Samples. JCO Precis Oncol. 2022 Oct;6:e2200261. doi: 10.1200/PO.22.00261.
- Background: PubMed 34246791Rolfo C, Mack P, Scagliotti GV, Aggarwal C, Arcila ME, Barlesi F, Bivona T, Diehn M, Dive C, Dziadziuszko R, Leighl N, Malapelle U, Mok T, Peled N, Raez LE, Sequist L, Sholl L, Swanton C, Abbosh C, Tan D, Wakelee H, Wistuba I, Bunn R, Freeman-Daily J, Wynes M, Belani C, Mitsudomi T, Gandara D. Liquid Biopsy for Advanced NSCLC: A Consensus Statement From the International Association for the Study of Lung Cancer. J Thorac Oncol. 2021 Oct;16(10):1647-1662. doi: 10.1016/j.jtho.2021.06.017. Epub 2021 Jul 8.
- Background: PubMed 36158638Garcia-Pardo M, Czarnecka K, Law JH, Salvarrey A, Fernandes R, Fan J, Corke L, Waddell TK, Yasufuku K, Donahoe LL, Pierre A, Le LW, Ghumman N, Liu G, Shepherd FA, Bradbury P, Sacher A, Stockley T, Pal P, Rogalla P, Tsao MS, Leighl NB. Plasma-first: accelerating lung cancer diagnosis and molecular profiling through liquid biopsy. Ther Adv Med Oncol. 2022 Sep 20;14:17588359221126151. doi: 10.1177/17588359221126151. eCollection 2022.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available. Study data will be pseudonymized and managed in accordance with applicable data protection requirements. Any data sharing among participating centers will be limited to the purposes of the study and regulated through appropriate data transfer agreements. Study results may be disseminated in aggregated form. Any future reuse or sharing of individual-level data for compatible research purposes would require specific institutional approval and compliance with applicable ethical, legal, and data protection requirements.
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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.
Simonetta Buglioni, Biology contact
Federico Cappuzzo, MD principal investigator
IFO-IRE, Istituto Nazionale Tumori Regina Elena
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Non-small Cell Lung Cancer (NSCLC), run by Regina Elena Cancer Institute at 1 site in Italy.
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 5 inclusion and 4 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 16 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 1 site in Italy. 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 Maristella Giammaruco, MD (+39 06 5266 5698, maristella.giammaruco@ifo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of establishing a structured plasma-first molecular profiling dataset (time frame: Up to 18 months). 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 NCT07649629, which also lists 4 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 16 Jun 2026.