OncologyPRECISIONNCT05027165
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
An observational study of Oncology and Biomarker, run by LMU Klinikum at 1 site in Germany.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncology, Biomarker, NSCLC, Stage III
- What is being tested?
- Non-interventional
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 7 Nov 2020to 31 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will enrol 40 patients with stage III inoperable non-small cell lung cancer (NSCLC) who received standard chemoradiotherapy followed by maintenance therapy with PD-L1 inhibition (durvalumab) at the department of radiation oncology, University Hospital Munich (LMU).
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
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.
Read the detailed description
The study will enrol 40 patients with stage III inoperable non-small cell lung cancer (NSCLC) who received standard chemoradiotherapy followed by maintenance therapy with PD-L1 inhibition (durvalumab) according to the current European Medicines Agency (EMA) approval.
The oncological treatment is carried out according to the international standards of radiation oncology/medical oncology. These are implemented by the department of radiation oncology at the University Hospital Munich (LMU) in their SOPs. Therefore, all patients will be treated with concurrent platinum-based chemoradiotherapy followed by durvalumab maintenance treatment 12 months after the end of chemoradiotherapy at the department of radiation oncology (University Hospital Munich (LMU)). 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 chemoradiotherapy. Lung function will be assessed before start of radiotherapy, at the end and 6 weeks after chemoradiotherapy as well as 3-, 6- and 12, 18, 24 months after start of durvalumab.
Follow-up will be performed by the department of radiation oncology at the University Hospital Munich (LMU) according to the clinical SOPs.
- Conditions
- Oncology, Biomarker, NSCLC, Stage III, Durvalumab, Chemoradiotherapy
- Being tested
- Non-interventional
- Keywords
- NSCLC, Stage III, Biomarker
- Medical subject headings
- Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-interventionalOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Observational group | 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. Receives: Other: Non-interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive biomarker for progression-free survival at 12 and 24 months
To identify early immunological and morphological biomarkers and their dynamic changes to predict progression-free survival at 12 and 24 months.
Measured: 24 months
Secondary outcomes (1)
Predictive biomarkers for progression-free survival, overall survival, response rate, local and distant tumor control
To identify predictive biomarkers for progression-free survival at 6 and 18 months after chemoradiotherapy and overall survival and response rate, local and distant tumor control at 6 weeks, 6-, 12-, 18 and 24 months from the end of chemoradiotherapy.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start7 Nov 2020
- Primary completion31 Jan 2024 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OncologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LMU Klinikum
- Sponsor type
- University, hospital or other
- Collaborators
- Ludwig-Maximilians - University of Munich, Asklepios Lung Clinic, Munich-Gauting, Germany, Immunoanalytics Research Group Tissue Control of Immunocytes, Helmholtz Center Munich, Munich, Germany
- Responsible party
- Principal investigator, Farkhad Manapov, LMU Klinikum
- Investigators
- Farkhad Manapov, PhD MD, Principal investigator, LMU University hospital, Munich, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05027165
- Sponsor's protocol ID
- 20-502
- Acronym
- PRECISION
- Status last verified
- Mar 2023
- First submitted
- 24 Aug 2021
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Data is available on request due to privacy/ethical restrictions.
Publications
Kasmann 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.
PubMed 35958344
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05027165
- Acronym / sponsor ID
- PRECISION / 20-502
- Conditions
- Oncology, Biomarker, NSCLC, Stage III, Durvalumab, Chemoradiotherapy
- Keywords
- NSCLC, Stage III, Biomarker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- LMU KlinikumUniversity, hospital or other
- Collaborators
- Ludwig-Maximilians - University of Munich, Asklepios Lung Clinic, Munich-Gauting, Germany, Immunoanalytics Research Group Tissue Control of Immunocytes, Helmholtz Center Munich, Munich, Germany
- Study start
- 7 Nov 2020 (actual)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 30 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will enrol 40 patients with stage III inoperable non-small cell lung cancer (NSCLC) who received standard chemoradiotherapy followed by maintenance therapy with PD-L1 inhibition (durvalumab) according to the current European Medicines Agency (EMA) approval.
The oncological treatment is carried out according to the international standards of radiation oncology/medical oncology. These are implemented by the department of radiation oncology at the University Hospital Munich (LMU) in their SOPs. Therefore, all patients will be treated with concurrent platinum-based chemoradiotherapy followed by durvalumab maintenance treatment 12 months after the end of chemoradiotherapy at the department of radiation oncology (University Hospital Munich (LMU)). 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 chemoradiotherapy. Lung function will be assessed before start of radiotherapy, at the end and 6 weeks after chemoradiotherapy as well as 3-, 6- and 12, 18, 24 months after start of durvalumab.
Follow-up will be performed by the department of radiation oncology at the University Hospital Munich (LMU) according to the clinical SOPs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational group | – | Other: Non-interventionalIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will enrol 40 patients with stage III inoperable non-small cell lung cancer (NSCLC) who received standard chemoradiotherapy followed by maintenance therapy with PD-L1 inhibition (durvalumab) at the department of radiation oncology, University Hospital Munich (LMU).
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-interventionalNo intervention | Other | Observational group |
Primary outcome
Predictive biomarker for progression-free survival at 12 and 24 months
Time frame: 24 months
To identify early immunological and morphological biomarkers and their dynamic changes to predict progression-free survival at 12 and 24 months.
1 secondary outcome
Predictive biomarkers for progression-free survival, overall survival, response rate, local and distant tumor control
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
- Derived from this study: PubMed 35958344Kasmann 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.
- Individual participant dataSharing planned: No. Data is available on request due to privacy/ethical restrictions.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Farkhad Manapov, PhD MD principal investigator
LMU University hospital, Munich, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oncology and Biomarker, run by LMU Klinikum at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive biomarker for progression-free survival at 12 and 24 months (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05027165, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2023.