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Can a bone drug extend life in advanced lung cancer?

NCT ID NCT02129699

Disease control Sponsor: ETOP IBCSG Partners Foundation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time

Summary

This phase III trial tests whether adding denosumab, a drug often used for bone health, to standard chemotherapy helps people with stage IV non-small cell lung cancer live longer. About 595 adults with advanced disease will receive either chemotherapy alone or chemotherapy plus denosumab. Researchers will compare overall survival and how long the cancer stays controlled between the two groups.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
denosumab (XGEVA), a drug that may help strengthen bones and is being added to standard chemotherapy
What this could lead to
If adding denosumab to standard chemotherapy improves survival, it could become a new part of first-line treatment for advanced non-small cell lung cancer.
What could go wrong
This is a phase III trial, but results may still be negative or show only modest benefit. Denosumab can cause side effects like low calcium levels and jaw problems.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

595 people

The number who actually took part.

Started

Jan 2015

Finished

Feb 2020

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

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 or cytologically confirmed advanced stage IV non-small cell lung carcinoma (NSCLC), according to 7th TNM classification * Age ≥ 18 years * ECOG performance status 0-2 * Measurable or evaluable disease (according to RECIST 1.1 criteria) assessed within 28 days from randomization. * Availability of tumour tissue (as assessed by the local pathologist) for translational research: * preferred: FFPE block from primary tumour or metastasis, * alternatively: cell block * if no block available: 10 freshly cut unstained slides. * Adequate haematological function: neutrophils ≥ 1.5 ×109/L, platelets ≥ 100×109/L, and hemoglobin ≥ 9 g/dL * Adequate liver function: * ALT ≤ 3 × ULN ( ≤ 5 × ULN if liver metastasis are present) * Total bilirubin \< 2 x ULN * Adequate renal function: calculated renal creatinine clearance (CrCl) ≥ 30 mL/min (according to the formula of Cockroft-Gault) * Life expectancy of at least 3 months * 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 7 days before enrollment. Pregnancy test has to be repeated within 14 days before treatment start. * All sexually active men and women of childbearing potential must use an effective contraceptive method during the study treatment and for a period of at least 6 months following the last administration of trial treatment * Written Informed Consent must be signed and dated by the patient and the investigator prior to any trial-related intervention for 1. Trial treatment 2. Submission of biomaterial for central testing Exclusion Criteria: * Patients with presence of documented sensitizing EGFR activating mutation or ALK rearrangements (screening following local standards is optional, but strongly encouraged in non-squamous histology) * Patients with documented brain metastases (systematic screening of patients not mandatory; however, if the patient is symptomatic, brain metastases screening is recommended). * Prior chemotherapy or molecular targeted therapy for metastatic disease. Exceptions: * Neoadjuvant or adjuvant chemotherapy or radio-chemotherapy are allowed if terminated more than 6 months before registration. * Previous radical radiotherapy without systemic treatment is allowed. * One previous line of systemic immunotherapy by checkpoint inhibitors is allowed and needs to be documented * Concomitant treatment with immune checkpoint inhibitors * Any investigational agent(s) within 30 days prior to randomisation * Concurrent bisphosphonate administration * Oral/ dental conditions (by visual inspection): * Prior history or current evidence of osteomyelitis / osteonecrosis of the jaw * Active dental or jaw condition which requires oral surgery * Planned invasive dental procedure for the course of the trial * Non-healed dental or oral surgery * Evidence of any medical condition which would impair the ability of the patient to participate in the trial or might preclude therapy with trial drugs (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease, active infection, uncontrolled diabetes mellitus; uncontrolled arterial hypertension ≥ 160/100 mmHg, history of myocardial infarction in the last 3 months) * Documented active infection with Hepatitis B virus or Hepatitis C virus, known infection with human immunodeficiency virus (HIV) * Known hypersensitivity to any of the components of the treatment * Severe, uncorrected hypocalcaemia or hypercalcaemia: * hypercalcaemia: total calcium \>3.1 mmol/l or corrected calcium (with albumin level) \>3 mmol/l * hypocalcaemia: total calcium \<2 mmol/l or corrected calcium (with albumin level) \< 1.9 mmol/l * Legal incapacity or limited legal capacity * Medical or psychological condition, including uncontrolled arterial hypertension (\>160/110) despite adequate medication which in the opinion of the investigator would not permit the patient to complete the trial or sign meaningful informed consent * Women who are pregnant or breastfeeding * Any concurrent malignancy other than adequately treated basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or bladder, in situ breast carcinoma, or prostate cancer Gleason score \< 6. (Patients with a previous malignancy but without evidence of disease for ≥ 2 years will be allowed to enter the trial) * Any previous exposure to denosumab, with the exception of a maximum of 2 previous doses of denosumab (Prolia®) more than 6 month before enrolment for osteoporosis treatment/prevention.

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

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

Lung cancer non-small cell stage IV

Contacts and locations

Locations

  • AKH Wien

    Vienna, Austria

  • ASKLEPIOS - Fachkliniken München - Gauting

    München, Germany

  • Aberdeen Royal Infirmary

    Aberdeen, United Kingdom

  • Assistance Publique-Hôitaux de Marseille

    Marseille, France

  • Beaumont Hospital

    Dublin, Ireland

  • CHBS Lorient

    Lorient, France

  • CHICAS

    Sisteron, France

  • Centre Hospitalier Annecy

    Annecy, France

  • Centre Hospitalier De Beauvais

    Beauvais, 60021, France

  • Centre Hospitalier Intercommunal Creteil

    Créteil, France

  • Centre Hospitalier Regional De La Citadelle

    Liège, 14000, Belgium

  • Centre Hospitalier Universitaire Rennes

    Rennes, France

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, Switzerland

  • Centre Hospitalier de Meaux

    Meaux, France

  • Centre hospitalier universitaire d'Angers

    Angers, France

  • Clinique Mutualiste de l'Estuaire

    Saint-Nazaire, France

  • Clinique et Maternite Sainte Elisabeth

    Namur, 5000, Belgium

  • Complejo Hospitalario de Jaén

    Jaén, Spain

  • Cork University Hospital

    Cork, Ireland

  • GHPSO (Sie de Creil)

    Creil, France

  • H Morales Meseguer

    Murcia, Spain

  • H. U. Insular Gran Canaria

    Las Palmas, Spain

  • HFR Fribourg

    Fribourg, Switzerland

  • Hospital Arnau Vilanova Valencia

    Valencia, Spain

  • Hospital Center Le Mans

    Le Mans, France

  • Hospital De La Santa Creu I Sant Pau

    Barcelona, 08025, Spain

  • Hospital General Castellón

    Castelló, Spain

  • Hospital General de Alicante

    Alicante, Spain

  • Hospital Son Espases

    Palma de Mallorca, Spain

  • Hospital Universitario Miguel Servet

    Zaragoza, Spain

  • Hospital Universitario Reina Sofia

    Córdoba, Spain

  • Hospital Waterford

    Waterford, Ireland

  • Hôpital Louis Pradel

    Lyon, France

  • Hôpital de Villefranche-sur-Saône

    Villefranche-sur-Saône, 69655, France

  • Hôpital du Cluzeau

    Limoges, France

  • Hôpitale de la Cavale Blanche - CHRU de BREST

    Brest, 29606, France

  • IRCCS Azienda Ospedaliera Universitaria San Martino

    Genova, Italy

  • Institut Català d'Oncologia - L'Hospitalet

    Barcelona, Spain

  • Institut Paoli-Calmettes

    Marseille, France

  • Institute of Oncology Ljubljana

    Ljubljana, Slovenia

  • KH der Elisabethinen Linz

    Linz, Austria

  • Kantonsspital Graubünden

    Chur, Switzerland

  • Kantonsspital Luzern

    Lucerne, 6016, Switzerland

  • Kantonsspital Winterthur

    Winterthur, 8401, Switzerland

  • Maria Sklodowska-Curie Memorial Car

    Gliwice, Poland

  • Mater Miscordia University Hospital

    Dublin, Ireland

  • Mater Private Hospital

    Dublin, Ireland

  • Onkologiezentrum Berner Oberland

    Thun, 3600, Switzerland

  • Onze Lieve Vrouw Ziekenhuis

    Aalst, Belgium

  • Ospedale San Gerardo

    Monza, 20900, Italy

  • Otto-Wagner-Spital Department 1

    Vienna, Austria

  • Otto-Wagner-Spital Department 2

    Vienna, Austria

  • Oxford University Hospitals Trust

    Oxford, United Kingdom

  • Pius Hospital

    Oldenburg, Germany

  • Regional Universitario Carlos Haya

    Málaga, Spain

  • S.G Moscati Hospital

    Aversa, Italy

  • San Paolo Hospital

    Milan, Italy

  • St James's Hospital

    Dublin, Ireland

  • The Adelaide and Meath Hospital

    Dublin, Ireland

  • Univ. Klinik für Innere Medizin V

    Innsbruck, Austria

  • University Clinic Golnik

    Golnik, Slovenia

  • University Hospital Galway

    Galway, Ireland

  • University Hospital Limerick

    Limerick, Ireland

  • University Hosptial Ghent

    Ghent, Belgium

  • Universitätsspital Zürich

    Zurich, Switzerland

  • Weston Park Hospital

    Sheffield, United Kingdom

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