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New combo attack shows promise for Oligo-Metastatic lung cancer

NCT ID NCT03965468

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Aug 18, 2026 · Updated 3 times

Summary

This phase II trial tests a combination of immunotherapy (durvalumab), chemotherapy (carboplatin and paclitaxel), and targeted radiation to metastatic spots, followed by surgery or radiation to the main lung tumor. The goal is to see if this aggressive approach can keep the cancer from growing for at least a year in people with non-small cell lung cancer that has spread to only a few other sites. The study enrolled 96 participants and is no longer recruiting.

What this could mean

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

Active substance
Durvalumab (Imfinzi), Carboplatin, Paclitaxel
What this could lead to
If successful, this combination approach could improve control of advanced lung cancer that has spread to a few other sites, potentially extending life without progression.
What could go wrong
This is a mid-stage trial with only 96 participants and no comparison group, so results may not be definitive. Side effects from chemotherapy, immunotherapy, and radiation can be significant.

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 96 people

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

Started

Nov 2019

Expected to finish

Dec 2026

An estimate. End dates often move.

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 confirmed non-small cell lung cancer * Synchronous oligo-metastatic stage IV disease: maximum of three distant metastases, one of which must be extra-cerebral for stereotactic body radiotherapy (SBRT); Initial mediastinal staging is recommended (except for lymph nodes \<1 cm on CT and PET-negative) preferentially by endobronchial ultrasound (EBUS); Neurosurgical resection of one single central nervous system (CNS) metastasis or laparoscopic resection of one adrenal metastasis before study inclusion is allowed (one extra-cerebral metastasis must be available for SBRT) * Able to understand and give written informed consent and comply with study procedures * Age ≥18 years * ECOG Performance Status 0-1 * Availability of tumour tissue for translational research * Adequate haematological, renal and liver function Exclusion Criteria: * Prior chemotherapy, radiotherapy or therapeutic surgery for NSCLC (an exception is the resection of one single CNS or adrenal metastasis, as above) * Activating driver mutation: epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), proto-oncogene receptor tyrosine kinase (ROS1) * More than three distant metastases * Brain metastases not amendable for radiosurgery or neurosurgery * Extracranial metastatic locations such as malignant ascites, pleural or pericardial effusion, diffuse lymphangiomatosis of skin or lung, diffuse bone marrow metastasis, abdominal masses/abdominal organomegaly, identified by physical exam that is not measurable by reproducible imaging techniques. * Primary lung cancer not suitable for radical therapy (pneumonectomy excluded) * History of leptomeningeal carcinomatosis * Major surgery or significant traumatic injury from which the patient has not recovered at least 28 days before enrolment * Any uncontrolled intercurrent illness, including but not limited to: ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease or serious chronic gastrointestinal conditions associated with diarrhea, which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardise compliance with the protocol * Known active hepatitis infection, positive hepatitis C virus (HCV) antibody, hepatitis B virus (HBV) surface antigen (HBsAg) or HBV core antibody (anti-HBc) at screening. * Known positivity for human immunodeficiency virus (positive HIV 1/2 antibodies) or active tuberculosis infection (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice) * Active autoimmune disease requiring systemic treatment * Severe or uncontrolled cardiac disease requiring treatment * History of active primary immunodeficiency * History of allogeneic organ transplant * Receipt of live attenuated vaccines within 30 days prior to enrolment * Known allergies or hypersensitivity to trial drugs or to any excipient. * Women who are pregnant or in the period of lactation. * Sexually active men and women of childbearing potential who are not willing to use a highly effective contraceptive method during the trial and up to 90 days after last dose of durvalumab monotherapy or 180 days after the last dose of durvalumab and tremelimumab combination therapy

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Centre Hospitalier Universitaire Vaudois (CHUV)

    Lausanne, Switzerland

  • Erasmus Medical Centre

    Rotterdam, Netherlands

  • Geneva University Hospital

    Geneva, Switzerland

  • Hosp. De la Santa Creu i Sant Pau

    Barcelona, Spain

  • Hosp. Sanchinarro- Centro Integral Oncología Clara Campal

    Madrid, Spain

  • Hosp. Uni. Politécnico La Fe

    Valencia, Spain

  • Hosp. Uni. Virgen de las Nieves

    Granada, Spain

  • IRCCS Istituto Nazionale Tumori Regina Elena

    Roma, Italy

  • Inselspital Bern

    Bern, Switzerland

  • Istituto Oncologico Veneto - Irccs

    Padova, Italy

  • Kantonsspital Winterthur

    Winterthur, Switzerland

  • Maastricht University Medical Center

    Maastricht, Netherlands

  • University Hospital Zurich

    Zurich, Switzerland

  • Vall d'Hebron University Hospital

    Madrid, Spain

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