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Blood test may personalize lung cancer therapy

NCT ID NCT06917573

Disease control Sponsor: Fundación GECP Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a simple blood test (ctDNA) can help doctors decide if adding chemotherapy to the immunotherapy drug cemiplimab works better for advanced lung cancer. About 63 people with stage IV or stage IIIB/C non-small cell lung cancer that hasn't been treated before will join. The goal is to see if this personalized approach helps people live longer.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 63 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histologically confirmed stage IV or stage IIIB/C not candidates for definitive chemo/radiotherapy or surgical resection non-small cell lung cancer (NSCLC) per the 8th edition TNM with no prior systemic anti-cancer therapy * PDL1 ≥50% * ECOG performance status 0-1 * Patients aged ≥ 18 years * Prior adjuvant or neoadjuvant chemotherapy for early stage is permitted if completed at least 6 months prior to enrolment * Presence of at least one measurable lesion by CT-scan per RECIST version 1.1 * Anticipated life expectancy \>12 weeks * Correct hematological, hepatic and renal function * Patient consent must be obtained in the appropriate manner as established in the applicable local and regulatory requirements * Patients must be accessible for treatment and follow-up * Women of childbearing potential, including women who had their last menstrual period in the last 2 years, must have a negative serum or urine pregnancy test within 3 days before enrolment. * All sexually active men and women of childbearing potential must use a highly effective contraceptive method during the study treatment and for a period of at least 4 months following the last administration of trial drugs Exclusion Criteria: * Patients whose tumors harbor an activating mutation in EGFR, ALK translocation, or ROS Proto-Oncogene 1 (ROS1) rearrangements sensitive to available targeted inhibitor therapy * Patients with grade ≥2 neuropathy * Pregnant or breastfeeding women * Patients with a weight loss \>10% within the previous 3 months * Patients with carcinomatous meningitis * Patients with a history of other malignant diseases within the past 3 years * Patients must have recovered from a major surgery at least 14 days prior to enrolment * Patients with active or uncontrolled infections or with serious medical conditions or disorders that may not allow patient management as established in the protocol * Prior treatment with antineoplasic drugs or thoracic radiotherapy for any reason different from the ones specific in the inclusion criteria * Patients who have received prior neo-adjuvant, adjuvant chemotherapy, radiotherapy, or chemo-radiotherapy with curative intent for non-metastatic disease less than 6 months before enrollment since the last chemotherapy, radiotherapy, or chemo-radiotherapy * Patients with a combination of small cell lung cancer and non-small cell lung cancer, a carcinoid lung tumor or large cell neuroendocrine carcinoma * Has known allergy or hypersensitivity to components of study drug * Significant comorbidities that preclude the administration of chemotherapy according to the investigator's criteria * Ongoing or recent evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments * Untreated brain metastasis(es) that may be considered active * Immunosuppressive corticosteroid doses within 4 weeks prior to the first dose of cemiplimab * Uncontrolled infection with hepatitis B or hepatitis C or human immunodeficiency virus; or diagnosis of immunodeficiency * History of interstitial lung disease or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management. * History of documented allergic reactions or acute hypersensitivity reactions attributed to antibody treatments * Patients with a history of solid organ transplant * Receipt of live vaccines within 30 days of first study treatment * Women of childbearing potential, or sexually active men, who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment prior to the start of the first treatment, during the study, and for at least 4 months after the last dose.

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Conditions

The condition(s) this trial relates to.

lung disorder neoplasm of thorax non-small cell lung carcinoma respiratory tract neoplasm Thoracic Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lung diseases Non-small cell lung cancer metastatic Respiratory tract neoplasms Stage III non-small cell lung cancer Stage IV non-small cell lung cancer Thoracic neoplasms

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    20 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital Clínico San Carlos

    RECRUITING

    Madrid, Madrid, 28040, Spain

  • Hospital De Basurto

    RECRUITING

    Bilbao, Bilbao, 48013, Spain

  • Hospital Dr. Josep Trueta

    RECRUITING

    Girona, Girona, 17007, Spain

  • Hospital General de Alicante

    RECRUITING

    Alicante, Alicante, 03010, Spain

  • Hospital General de Elche

    RECRUITING

    Elche, Alicante, 03203, Spain

  • Hospital General de Valencia

    RECRUITING

    Valencia, Valencia, 46014, Spain

  • Hospital Puerta de Hierro

    RECRUITING

    Madrid, Madrid, 28222, Spain

  • Hospital Universitari Son Llatzer

    RECRUITING

    Palma de Mallorca, Palma de Mallorca, 07198, Spain

  • Hospital Universitari Vall d' Hebron

    RECRUITING

    Barcelona, Barcelona, 08035, Spain

  • Hospital Universitario Dr. Negrín

    RECRUITING

    Las Palmas de Gran Canaria, Las Palmas, 35010, Spain

  • Hospital Universitario Fundación Jiménez Díaz

    RECRUITING

    Madrid, Madrid, 28040, Spain

  • Hospital Universitario Jerez De La Frontera

    NOT_YET_RECRUITING

    Jerez de la Frontera, Cádiz, 11407, Spain

  • Hospital Universitario Regional de Málaga

    RECRUITING

    Málaga, Málaga, 29010, Spain

  • Hospital Universitario Salamanca

    RECRUITING

    Salamanca, Salamanca, 37007, Spain

  • Hospital Universitario Severo Ochoa

    RECRUITING

    Leganés, Madrid, 28911, Spain

  • Hospital Universitario Son Espases

    RECRUITING

    Palma de Mallorca, Mallorca, 07120, Spain

  • Hospital de la Santa Creu i Sant Pau

    RECRUITING

    Barcelona, Barcelona, 08041, Spain

  • Hospitalario Universitario A Coruña

    RECRUITING

    A Coruña, La Coruña, 15006, Spain

  • ICO Badalona, Hospital Germans Trias i Pujol

    RECRUITING

    Badalona, Barcelona, 08916, Spain

  • ICO Hospitalet

    RECRUITING

    L'Hospitalet de Llobregat, Barcelona, 08908, Spain

More trials for these conditions

Other studies related to the condition(s) this trial covers.