New combo attack shows promise for Oligo-Metastatic lung cancer
NCT ID NCT03965468
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 Hide 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Non-small cell lung cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Two-Drug combo targets stubborn KRAS lung cancer
- Smaller chest drain may speed recovery after lung cancer surgery
- Gut bacteria may hold clues to why some cancer treatments work better
- Breath-Tracking sensor aims to sharpen lung cancer scans
- Can PET scan signals predict who beats lung cancer with immunotherapy?
- Two-Drug combo takes aim at Hard-to-Treat lung cancer