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Non Small Cell Lung Cancer (NSCLC)LOLA-PROJECTNCT06997458

Liquid BiOpsy, Lung and Colon Cancer in AndaluciA

An observational study of Non Small Cell Lung Cancer (NSCLC) and Colorectal Cancer (CRC), run by Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental at 1 site in Spain.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

The objective of the LOLA Project is to analyse the impact of adopting xF liquid biopsy panel, in the real world of the Andalusian Health Public System in terms of impact on clinical practice and cost through the assessment of clinical impact, duration of turnaround time (TAT) of xF test vs standard of care and the… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
xF Tempus assay
Type of treatment
Injection or infusion
How many people
500 participants
Where
1 siteSpain
Study dates
1 Aug 2024to 30 Jul 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: Metastatic adenocarcinoma (NSCLC: 250 and CRC: 250)

Who may be able to join

  • General criteria:
  • More than 18 years old
  • Both genders
  • Ability to provide written informed consent
  • Specific criteria:
  • NSCLC
Show all 17Show fewer
  • Patients diagnosed with the 8th Edition of the Tumor, Node, Metastasis (TNM) staging system for Lung Cancer approved by International Association for the Study of Lung Cancer (IASLC) and the American Joint Committee on Cancer (AJCC): IV (Any T, Any N, M1a-c)
  • Histologically confirmed NSCLC (adenocarcinoma)
  • Performance status of 0-2 (ECOG PS) ○ Estimated life expectancy ≥3 months
  • Treatment naïve patients (chemotherapy, immunotherapy, targeted therapy, radiotherapy).
  • Smokers or Non-Smokers
  • CRC
  • Patients diagnosed with the Tumor, Node, Metastasis (TNM) staging system for Colorectal Cancer approved by the American Joint Committee on Cancer (AJCC): IV (Any T, Any N, M1a-c)
  • Histologically confirmed CRC (adenocarcinoma)
  • Performance status of 0-2 (ECOG PS)
  • Estimated life expectancy ≥3 months
  • Treatment naïve patients (chemotherapy, immunotherapy, targeted therapy, radiotherapy).

Who cannot join

  • General: History of any other cancer within the previous 5 years, except non-melanoma skin cancer
  • General: Absence of Informed consent. > Pregnant or nursing women. > Small cell 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.

Spain1 site

  • Centre for Genomics and Oncological Research - Pfizer - University of Granada - Andalusian Regional Government (GENyO)

    Granada, Andalusia, 18016

Other trials in Spain

About this study

Official title: Clinical Implementation of Liquid Biopsy in Cancer Through Next Generation Sequencing (NGS) Panels in the Andalusian Public Health System

The objective of the LOLA Project is to analyse the impact of adopting xF liquid biopsy panel, in the real world of the Andalusian Health Public System in terms of impact on clinical practice and cost through the assessment of clinical impact, duration of turnaround time (TAT) of xF test vs standard of care and the analysis of resource utilisation.

Being tested
xF Tempus assay
Keywords
Liquid Biopsy, cfDNA, ctDNA, Metastatic Cancer, NGS
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Neoplasm Metastasis

What participants receive

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

  • xF Tempus assayDiagnostic test

    The blood will be collected and sent to Tempus Labs using the standard sample collection kit containing all the necessary elements to guarantee shipment to Tempus Labs. Two Streck tubes with 8.5mL of blood per tube will be sent to Tempus Labs.

    The ctDNA isolation and automatic library preparation will be performed using TEMPUS technology (Finkel et al 2021).

    The NGS analyses will be developed using the xF Tempus assay. This assay involves a panel with hybrid gene capture that detects actionable oncologic targets in four variant classes: single-nucleotide variants (SNVs), insertions/deletions (indels), copy number variants (CNVs), and gene rearrangements. The NGS sequencing is performed using NovaSeq 6000Dx Sequencing System (Illumina, Inc) equipment, according to Tempus protocols. (Finkel et al 2021).

Study groups in NCT06997458
Study groupRoleWhat they receive
Patients with radiologic evidence of metastatic (stage IV) NSCLC* Patients diagnosed with the 8th Edition of the Tumor, Node, Metastasis (TNM) staging system for Lung Cancer approved by International Association for the Study of Lung Cancer (IASLC) and the American Joint Committee on Cancer (AJCC): IV (Any T, Any N, M1a-c) * Histologically confirmed NSCLC (adenocarcinoma) * Performance status of 0-2 (ECOG PS) * Estimated life expectancy ≥3 months * Treatment naïve patients (chemotherapy, immunotherapy, targeted therapy, radiotherapy). * Smokers or Non-Smokers
Receives: Diagnostic Test: xF Tempus assay
Patients with radiologic evidence of metastatic (stage IV) CRC* Patients diagnosed with the Tumor, Node, Metastasis (TNM) staging system for Colorectal Cancer approved by the American Joint Committee on Cancer (AJCC): IV (Any T, Any N, M1a-c). * Histologically confirmed CRC (adenocarcinoma). * Performance status of 0-2 (ECOG PS) * Estimated life expectancy ≥3 months * Treatment naïve patients (chemotherapy, immunotherapy, targeted therapy, radiotherapy).
Receives: Diagnostic Test: xF Tempus assay

What is being measured

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

  1. To analyse the impact of adopting large (TEMPUS) NGS panels in the real world of the Andalusian Health Public System in terms of impact on clinical practice and cost.

    Proportion of patients with at least one actionable variant (%)

    Measured: through study completion, an average of 3 year

Timeline

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

  1. First posted30 May 2025
  2. Study start1 Aug 2024
  3. Primary completion30 Jul 2025 (estimated)
  4. Study completion30 Jul 2026 (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
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06997458
Sponsor's protocol ID
LCI2024-2027
Acronym
LOLA-PROJECT
Status last verified
May 2025
First submitted
25 Apr 2025
Last updated
30 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Rolfo C, Cardona AF, Cristofanilli M, Paz-Ares L, Diaz Mochon JJ, Duran I, Raez LE, Russo A, Lorente JA, Malapelle U, Gil-Bazo I, Jantus-Lewintre E, Pauwels P, Mok T, Serrano MJ; ISLB. Challenges and opportunities of cfDNA analysis implementation in clinical practice: Perspective of the International Society of Liquid Biopsy (ISLB). Crit Rev Oncol Hematol. 2020 Jul;151:102978. doi: 10.1016/j.critrevonc.2020.102978. Epub 2020 May 5.

    PubMed 32428812

  • Rolfo C, Denninghoff V. Globalization of precision medicine programs in lung cancer: a health system challenge. Lancet Reg Health Eur. 2023 Dec 12;36:100819. doi: 10.1016/j.lanepe.2023.100819. eCollection 2024 Jan. No abstract available.

    PubMed 38170059

  • Pisapia P, Costa JL, Pepe F, Russo G, Gragnano G, Russo A, Iaccarino A, de Miguel-Perez D, Serrano MJ, Denninghoff V, Quagliata L, Rolfo C, Malapelle U. Next generation sequencing for liquid biopsy based testing in non-small cell lung cancer in 2021. Crit Rev Oncol Hematol. 2021 May;161:103311. doi: 10.1016/j.critrevonc.2021.103311. Epub 2021 Mar 26.

    PubMed 33781866

  • Finkle JD, Boulos H, Driessen TM, Lo C, Blidner RA, Hafez A, Khan AA, Lozac'hmeur A, McKinnon KE, Perera J, Zhu W, Dowlati A, White KP, Tell R, Beaubier N. Validation of a liquid biopsy assay with molecular and clinical profiling of circulating tumor DNA. NPJ Precis Oncol. 2021 Jul 2;5(1):63. doi: 10.1038/s41698-021-00202-2.

    PubMed 34215841

  • Malapelle U, Pisapia P, Addeo A, Arrieta O, Bellosillo B, Cardona AF, Cristofanilli M, De Miguel-Perez D, Denninghoff V, Duran I, Jantus-Lewintre E, Nuzzo PV, O'Byrne K, Pauwels P, Pickering EM, Raez LE, Russo A, Serrano MJ, Gandara DR, Troncone G, Rolfo C. Liquid biopsy from research to clinical practice: focus on non-small cell lung cancer. Expert Rev Mol Diagn. 2021 Nov;21(11):1165-1178. doi: 10.1080/14737159.2021.1985468. Epub 2021 Oct 11.

    PubMed 34570988

Questions about this trial

What is this clinical trial studying?

An observational study of Non Small Cell Lung Cancer (NSCLC) and Colorectal Cancer (CRC), run by Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental at 1 site in Spain.

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 17 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 30 May 2025. 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 Spain. 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?

To analyse the impact of adopting large (TEMPUS) NGS panels in the real world of the Andalusian Health Public System in terms of impact on clinical practice and cost. (time frame: through study completion, an average of 3 year). 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 NCT06997458, which also lists 5 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 30 May 2025.

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