Clinical trial · Observational
Prospective Evaluation of Immunological, Molecular-genetic, Image-based and Microbial Analyzes to Characterize Tumor Response and Control in Patients With Inoperable Stage III NSCLC Treated With Chemoradiotherapy Followed by Consolidation Therapy With Durvalumab
Prospective Evaluation of Immunological, Molecular-genetic, Image-based and Microbial Analyzes to Characterize Tumor Response and Control in Patients With Inoperable Stage III NSCLC Treated With Chemoradiotherapy Followed by Consolidation Therapy With Durvalumab (PRECISION)
- 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)
This non-interventional single-center explorative biomarker study aims at longitudinal comprehensive characterization (molecular genetics, immunological, morphological, image-based and microbial features) of the patient (host) and tumor as well as changes during standard treatment and in case of recurrent disease in inoperable stage III non-small cell lung cancer (NSCLC). Comprehensive analysis will include peripheral blood cellular and humoral immunophenotyping, circulating tumor DNA and gut/saliva microbiota analyses. 18F-FDG-PET/CT before, 6 weeks, 6- and 12-months after chemoradiotherapy as well as daily in course of radiation treatment cone-beam-CT and/or MRI imaging are included for morphological analysis. This study will provide valuable information of predictive biomarkers in patients with stage III NSCLC treated with durvalumab maintenance treatment after concurrent chemoradiotherapy.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biomarker | — | UNRESOLVED | — |
| Chemoradiotherapy | — | UNRESOLVED | — |
| Durvalumab | — | UNRESOLVED | — |
| NSCLC, Stage III | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Oncology | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Non-interventional | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational group
- description
- In this cohort, 40 NSCLC patients with indication for chemoradiotherapy followed by durvalumab maintenance treatment ("standard of care") will be consecutively recruited. Comprehensive characterization of all patients includes immunophenotyping of peripheral blood mono-nuclear cells, ctDNA as well as gut/saliva microbiome analyses and will be performed before, after 15 fractions of radiotherapy, at the end of concurrent chemoradiotherapy as well as 3-, 6- and 12 months after start of durvalumab. 18F-FDG-PET/CT will be performed 5-10 d before start of radiotherapy, 6 weeks, 6 months,12 and 24 months after the end of radiochemotherapy. Lung function will be asssed before start of radiotherapy, at the end and 6 weeks after chemoradiotherapy as well as 3-, 6- and 12, 18, 24months after start of durvalumab.
- interventionNames
- Other: Non-interventional
Primary outcomes (1)
- measure
- Predictive biomarker for progression-free survival at 12 and 24 months
- timeFrame
- 24 months
- description
- To identify early immunological and morphological biomarkers and their dynamic changes to predict progression-free survival at 12 and 24 months.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient age ≥ 18 years * Histologically/cytologically confirmed diagnosis of non-small-cell lung cancer (NSCLC) * Patients with non-operable NSCLC in tumor stage III A/B/C after UICC 8 * Eligible for platinum-based concurrent chemoradiotherapy followed by durvalumab maintenance treatment * No invasive carcinoma in the last five years. * ECOG Performance Status 0-2 * Lung function parameters (before or after bronchodilation): FEV1 ≥ 1.0 L and/or DLCO-SB ≥ 40% * A maximum of two cycles of induction chemotherapy are permissible before start of chemoradiotherapy Exclusion Criteria: * Simultaneous participation in another clinical trial * Mixed histology of small-cell and non-small-cell lung cancer * Brain metastases confirmed by a contrast enhanced cMRI * Prior receipt of an immunotherapy or investigational medicinal product * Previous exposure to an anti-PD-1 or anti-PD-L1 antibody * Pneumonitis ≥ Grade 2 as a result of prior radio-/chemoradiotherapy * Patients with a non-active disease in the last 5 years can be included, but only after consultation with the responsible investigator of the study or his representative * Primary immunodeficiencies in previous history * Prior Interstitial lung disease (ILD) * Prior autoimmune disease * Previous organ transplantation with subsequent therapeutic immunosuppression
References
Publications (1)
- DERIVEDKasmann L, Taugner J, Eze C, Nieto A, Pelikan C, Florsch B, Kenndoff S, Hofer TP, Nossner E, Schulz C, Unterrainer M, Tufman A, Klauschen F, Jung A, Neumann J, Kumbrink J, Reinmuth N, Bartenstein P, Belka C, Manapov F. Prospective evaluation of immunological, molecular-genetic, image-based and microbial analyses to characterize tumor response and control in patients with unresectable stage III NSCLC treated with concurrent chemoradiotherapy followed by consolidation therapy with durvalumab (PRECISION): protocol for a prospective longitudinal biomarker study. Transl Lung Cancer Res. 2022 Jul;11(7):1503-1509. doi: 10.21037/tlcr-21-1010. PMID 35958344