New lung cancer combo aims to boost treatment completion
NCT ID NCT06102057
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new way to give radiation therapy for stage III lung cancer that cannot be removed by surgery. It combines a smaller, faster radiation field with standard chemotherapy and an immunotherapy drug called durvalumab. The goal is to see if this approach helps more patients finish their treatment with fewer side effects. About 110 adults will take part.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 110 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2024
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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: * Written informed consent * Patients irrespective of sex and gender, aged 18 years or older at the time of signing the ICF * Patients must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study as determined by the investigator * Patients with histologically or cytologically documented NSCLC who present with locally advanced, unresectable (Stage III) disease (according to version 8 of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology (IASLC Staging Manual in Thoracic Oncology 2016)) * Patients fit for simultaneous chemoradiotherapy and consolidation immunotherapy according to interdisciplinary consensus * Histologically proven PD-L1-expression of ≥ 1% (tumor proportion score; TPS) in tumor sample as assessed in routine staging using a validated test such as Ventana SP236 assay * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at enrolment * Tumor assessment by FDG-PET CT within 21 days prior to start of chemoradiotherapy. * Adequate pulmonary function test results * Pre- or post-bronchodilator forced expiratory volume 1 of 1.0 L or \>40% of predicted AND * Diffusing capacity of the lung for carbon monoxide (DLCO) \>30% of predicted * Adequate bone marrow and organ function at enrolment * Hemoglobin ≥9.0 g/dL * Absolute neutrophil count \>1.5 × 109/L * Platelet count \>100 × 109/L * Serum bilirubin ≤1.5 × upper limit of normal (ULN) * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN * Measured creatinine clearance (CrCl) \>40 mL/min or calculated CL \>40 mL/min as determined by Cockcroft-Gault (using actual body weight) * Body weight of \>30 kg at enrolment * Evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they are amenorrhoic for 12 months or more without an alternative medical cause. The following age-specific requirements apply: * Women \<50 years old would be considered post-menopausal if they have been amenorrhoic for 12 months or more following cessation of exogenous hormonal treatments with luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution * Women ≥50 years old would be considered post-menopausal if they have been amenorrhoic for 12 months or more following cessation of all exogenous hormonal treatments, radiation-induced oophorectomy with last menses \>1 year ago, chemotherapy-induced menopause with \>1 year interval since last menses, or surgical sterilization (bilateral oophorectomy or hysterectomy) * Women of childbearing potential (WOCBP) and male patients with partners of childbearing potential must agree to always use a highly effective form of contraception according to the Clinical Trials Facilitation and Coordination Group during the treatment phase of this study and for at least 90 days after the last dose durvalumab or 6 months after the last dose of chemotherapy, whichever occurs last Exclusion Criteria: * Mixed small cell and NSCLC histology * Neuroendocrine tumor * Distant metastases * Malignant pleural effusion or pericardial effusion * Acute superior vena cava obstruction * Receipt of prior or current cancer treatment for NSCLC, including but not limited to, surgical resection, radiation therapy, investigational agents, chemotherapy, and monoclonal antibodies (mAbs). Exception: Prior surgical resection of limited metachronous NSCLC (i.e., stage I or II) is permitted. * Receipt of live attenuated vaccine within 30 days prior to the start of therapy. Note: Patients, if enrolled, should not receive live vaccine during treatment phase and up to 30 days end of treatment * Major surgical procedure (as defined by the Investigator) within 28 days prior start of treatment. * Prior exposure to immune-mediated therapy, including but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1 (including durvalumab), and anti-PD-L2 antibodies, including therapeutic anticancer vaccines * Current use of ongoing long-term immunosuppressive medication. The following are exceptions to this criterion * Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection) * Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent * Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) * History of allogeneic organ transplantation * Active or prior documented autoimmune or inflammatory disorders including inflammatory bowel disease \[e.g., colitis or Crohn's disease\], diverticulitis \[with the exception of diverticulosis\], systemic lupus erythematosus, Sarcoidosis syndrome, Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.\]). The following are exceptions to this criterion: * Patients with vitiligo or alopecia * Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement * Any chronic skin condition that does not require systemic therapy * Patients without active disease in the last 5 years at randomization may be included but only after consultation with the local study physician * Patients with celiac disease controlled by diet alone * Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, ILD, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs, or compromise the ability of the patient to give written informed consent * Patients with oxygen dependence * Acute inflammation of mediastinal lymph nodes/mediastinal lymphadenopathy in the context of active pneumoconiosis, sarcoidosis or tuberculosis * History of another primary malignancy, except for * Basal cell carcinoma of the skin * Second malignancy diagnosed \> 2 years prior to NSCLC diagnosis if after curative treatment without persistence or progression at baseline. Patients with a previous history of radiation therapy are eligible provided field overlap is minimal and the risk of toxicity to tissues in the overlapping region(s) is deemed to be acceptable by treating radiation oncologist. * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease * Adequately treated carcinoma in situ without evidence of disease * History of leptomeningeal carcinomatosis * Positive diagnostic test for hepatitis B (hepatitis B surface antigen) or hepatitis C (hepatitis C antibody or hepatitis C RNA) * Known active infection of tuberculosis or human immunodeficiency virus * Known allergy or hypersensitivity to concomitant chemotherapy and durvalumab or any of the excipients * Any medical contraindication to treatment with platinum-based doublet chemotherapy as listed in the applying SmPCs * Patients who have disease considered for surgical treatment as part of their care plan, such as Pancoast or superior sulcus tumors. * Concurrent enrolment in another clinical study, unless it is an observational (noninterventional) clinical study or the follow-up period of an interventional study * Participation in another clinical study with an investigational product during the 4 weeks prior to enrolment * Pregnancy or breast-feeding
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
11 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Kliniken Maria Hilf GmbH Mönchengladbach
RECRUITINGMönchengladbach, 41063, Germany
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Klinikum der Universitaet Muenchen AöR, Department of Radiotherapy and Radiation Oncology
RECRUITINGMünchen, 81377, Germany
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Medical Center - University Of Freiburg, Department of Radiation Oncology
RECRUITINGFreiburg im Breisgau, 79106, Germany
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Pius-Hospital Oldenburg, Hematology and Oncology
RECRUITINGOldenburg, 26121, Germany
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Universität des Saarlandes, Klinik für Strahlentherapie und Radioonkologie
RECRUITINGHomburg, 66421, Germany
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Universitätsklinik Carl Gustav Carus der Technischen Universität Dresden
RECRUITINGDresden, 01307, Germany
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Universitätsklinikum Essen - Klinik für Strahlentherapie
NOT_YET_RECRUITINGEssen, 45122, Germany
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Universitätsmedizin Göttingen, Department for Radiotherapy and Radiooncology
RECRUITINGGöttingen, 37075, Germany
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Universitätsspital Zürich
RECRUITINGZurich, 8091, Switzerland
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Vinzenz Von Paul Kliniken gGmbH, Klinik für Strahlentherapie und Palliativmedizin
RECRUITINGStuttgart, 70199, Germany
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Überörtliche Berufsausübungsgemeinschaft Troisdorf
RECRUITINGTroisdorf, 53840, Germany
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Other studies related to the condition(s) this trial covers.
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- Glowing drug reveals why lung cancer immunotherapy fails
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- New drug cocktail targets Hard-to-Treat liver cancer