Clinical trial · Interventional
Immune Boost In Non-Small Cell Lung Cancer
A Randomized Phase II Study of Radiation Induced Immune Boost in Operable Non-small Cell Lung Cancer
NCT02319408CI-TRIAL-00058671RadImmunecompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Insufficient migration and activation of tumour specific effector T cells seems to be the one important reason for inadequate host anti-tumour immune response. Ionizing radiation can induce a variety of immune responses. The goal of this randomized trial is to assess if a preoperative single fraction low dose radiation is able to improve anti-tumour immune response in operable early stage lung cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Preoperative radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- No radiation
- description
- Lobectomy for lung cancer without preoperative radiation
- type
- EXPERIMENTAL
- label
- Preoperative radiation
- description
- Lobectomy for lung cancer with preoperative radiation
- interventionNames
- Radiation: Preoperative radiation
Primary outcomes (1)
- measure
- Cluster of differentiation (CD)8+ T cells in resected NSCLC
- timeFrame
- 7 days
- description
- Frequencies of CD8+ T cells in resected NSCLC tumors determined by immunohistochemistry
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven clinical stage I to IIA pulmonary adenocarcinoma * Lung tumor is felt to be curatively resectable by the treating physicians * Sufficient pulmonary function for lobectomy according to current guidelines * The patient is free of distant metastases as confirmed by contrast-enhanced chest and upper abdomen CT-scan and by contrast-enhanced CT or MRI of the brain * Age over 50years at the time of consent due to federal radiation protection law * In female patients of childbearing potential there must be a negative pregnancy test * Eastern Cooperative Oncology Group performance status of 0,1, 2 or 3 at the time of randomization * Patients who the investigator believes can and will comply with the requirements of this protocol * Written informed consent according to good clinical practise and national/regional regulations Exclusion Criteria: * The patient shows clinical signs of pneumonia * The patient receives immunosuppressive drugs (alkylating agents, antimetabolites, methotrexate, azathioprine, mercaptopurine, cytotoxic antibodies, ciclosporin, tacrolimus, sirolimus, interferon, mycophenolate, small biological agents) * The patient has been diagnosed with a potential immune mediated disease * Elevated blood leukocyte count or erythrocyte sedimentation rate * Pregnancy * The patient has received any cancer specific treatment, including radiotherapy, immunotherapy, hormonal therapy or chemotherapy * The patient is diagnosed with a concomitant malignancy and/or has a history of malignancy within the past five years or has had a malignancy that has been in complete remission for less than 5 years * The patient needs chronic long term oxygen therapy * The patient has undergone splenectomy * The patient is known to be HIV positive * The patient has an uncontrolled bleeding disorder
References
Publications (2)
- BACKGROUNDKlug F, Prakash H, Huber PE, Seibel T, Bender N, Halama N, Pfirschke C, Voss RH, Timke C, Umansky L, Klapproth K, Schakel K, Garbi N, Jager D, Weitz J, Schmitz-Winnenthal H, Hammerling GJ, Beckhove P. Low-dose irradiation programs macrophage differentiation to an iNOS(+)/M1 phenotype that orchestrates effective T cell immunotherapy. Cancer Cell. 2013 Nov 11;24(5):589-602. doi: 10.1016/j.ccr.2013.09.014. Epub 2013 Oct 24. PMID 24209604
- RESULTSafi S, Beckhove P, Warth A, Benner A, Roeder F, Rieken S, Debus J, Dienemann H, Hoffmann H, Huber PE. A randomized phase II study of radiation induced immune boost in operable non-small cell lung cancer (RadImmune trial). BMC Cancer. 2015 Dec 19;15:988. doi: 10.1186/s12885-015-2006-2. PMID 26686362