Lung CancerNCT05053997
Navigate - Improving Survival and Quality of Life in Vulnerable Lung Cancer Patients
A study testing NAVIGATE in people with Lung Cancer, run by Zealand University Hospital at 6 sites in Denmark.
Trial summary
Half of patients with lung cancer face a limited life span of one-year survival, which is characterized by severe physical and psychological symptoms. Differences in stage, comorbidity but also treatment may explain a large proportion of the social inequality in lung cancer survival. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- NAVIGATE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 6 sitesDenmark
- Study dates
- 1 Mar 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Age ≥ 18 years of age
- Diagnosed with NSCLC at all stages regardless of treatment intension at the participating departments
- Performance status ≤ 2
- Vulnerable according to pre-defined criteria
Who cannot join
- Severe untreated psychiatric disorder (e.g. psychosis) or cognitive problems (e.g. dementia) preventing informed consent
- Not able to receive treatment
- Not able to read and understand Danish -
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Denmark6 sites, 6 recruiting
- Recruiting
Aalborg University Hospital
Aalborg
Tine Krogh Mcculloch, tine.mcculloch@rn.dk
- Recruiting
Gødstrup Hospital
Herning
Hanne Linnet, hansin@rm.dk
- Recruiting
Odense University Hospital
Odense
Christian Borbjerg Laursen, Christian.B.Laursen@rsyd.dk
Line Larsen, Line.Larsen2@rsyd.dk
- Recruiting
Zealand University Hospital
Roskilde
Mads Nordahl Svendsen, mnsv@regionsjaelland.dk
- Recruiting
Sønderborg Sygehus
Sønderborg
Kim Wedervang
Kim.Wedervang@rsyd.dk
- Recruiting
Vejle Sygehus
Vejle
Ole Hilberg, Ole.Hilberg@rsyd.dk
Kirsten Jones, Kirsten.Jones@rsyd.dk
About this study
Official title: NAVIGATE - Improving Survival and Quality of Life in Vulnerable Lung Cancer Patients Through Nurse Navigation, Symptom Monitoring and Exercise: Study Protocol for a Multicenter Randomized Controlled Trial
Half of patients with lung cancer face a limited life span of one-year survival, which is characterized by severe physical and psychological symptoms. Differences in stage, comorbidity but also treatment may explain a large proportion of the social inequality in lung cancer survival. Some vulnerable patients may not receive first line treatment as planned either due to poor performance status or if they are not able to adhere to treatment appointments. Knowing how to navigate the health system may be a barrier preventing vulnerable patients in receiving optimal treatment. The primary aim of this randomised, controlled trial is to test whether a nurse-led individually tailored program including systematic screening of symptoms using PROs and a physical training program will significantly improve a composite outcome of survival and quality of life as the primary outcome among vulnerable lung cancer patients compared with standard care. Secondary outcomes include adherence to cancer treatment, symptom burden and overall survival.
Read the detailed description
During a period of 3 years and 10 months, consecutive newly diagnosed (< 1 week) lung cancer patients will be pre-screened for eligibility and invited to participate at departments of oncology or respiratory medicine in Denmark. Participants (N=250) will be randomized (1:1) to standard treatment plus the intervention (intervention group) or standard treatment (control group) and followed for 1 year. Patients randomized to the control group will receive standard treatment and care consisting of a nurse and a physician, who sees the patient at treatment schedules and during follow-up, i.e. every 3 months for the first 2 years and subsequently annually up to 5 years.
Data will be collected from the intervention and the control group at baseline within 6 weeks after diagnosis, and 3, 6 months and 12 months after diagnosis. Physical tests will be performed at baseline and after 3 and 6 months. Baseline physical tests will be allowed after randomization if patients have difficulties in attending the physiotherapy department within 6 weeks after their diagnosis. Considering that participating patients are vulnerable with limited resources we will proactively support patients in responding to questionnaires electronically, on paper or via telephone as per patient's preference allowing evaluation of the primary and secondary outcomes as well as covariates and mechanisms. The treatment factors will be obtained from the lung cancer clinical database and individual medical journals. In order to develop cost utility analyses, information on use of health services will be retrieved from the national registers.
- Conditions
- Lung Cancer
- Being tested
- NAVIGATE
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NAVIGATEBehavioural
Patients' symptoms are systematically monitored by use of bi-weekly patient reported outcomes and nurse navigators will initiate appropriate actions in terms of medical treatment or guidance of self-management strategies. Nurse navigators will motivate and support patients in health behavior changes and in selfmanaging their treatment and symptoms, and, if relevant, refer to existing rehabilitation services at the hospital or at the local rehabilitation center. Physiotherapists will supervise a training program aimed at improving patients' physical function and thus potentially surgery and overall treatment adherence and outcomes.
| Study group | Role | What they receive |
|---|---|---|
| NAVIGATE intervention arm | Experimental | Nurse navigation Receives: Behavioral: NAVIGATE |
| Navigate control arm | No intervention | Standard treatment and care |
What is being measured
The primary outcome is the main question the study is designed to answer.
A hierarchical composite outcome of survival and global quality of life
Measured from death from all causes and the Global Health Status (a subscale of EORTC QLQ-C30)
Measured: 3 months from randomization
Secondary outcomes (24)
Overall survival
Measured by death from all causes
Measured: 3 months from randomization
Overall survival
Measured by death from all causes
Measured: 6 months from randomization
Overall survival
Measured from death from all causes
Measured: 12 months from randomization
Adherence to cancer treatment
Measured by date of skipped treatments or delays if any, and dose administered
Measured: 3 months from randomization
Adherence to cancer treatment
Measured by date of skipped treatments or delays if any, and dose administered
Measured: 6 months from randomization
Adherence to cancer treatment
Measured by date of skipped treatments or delays if any, and dose administered
Measured: 12 months from randomization
Symptom burden and health related quality of life
Measured by EORTC Questionnaire Core 30 (QLQ-C30) and the lung module (QLQ-LC13).
The QLQ-C30 questionnaire consists of 30 questions with five functional scales (physical, role, cognitive, emotional and social), three symptom scales, a global health status / QoL scale, and six single items.
The QLQ-LC13 module comprises both multi-item and single-item measures of lung cancer-associated symptoms (coughing, haemoptysis, dyspnoea and pain) and side-effects from conventional chemo- and radiotherapy (hair loss,neuropathy, sore mouth and dysphagia).
All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
Measured: 3 months from randomization
Symptom burden and health related quality of life
Measured by EORTC Questionnaire Core 30 (QLQ-C30) and the lung module (QLQ-LC13).
The QLQ-C30 questionnaire consists of 30 questions with five functional scales (physical, role, cognitive, emotional and social), three symptom scales, a global health status / QoL scale, and six single items.
The QLQ-LC13 module comprises both multi-item and single-item measures of lung cancer-associated symptoms (coughing, haemoptysis, dyspnoea and pain) and side-effects from conventional chemo- and radiotherapy (hair loss, neuropathy, sore mouth and dysphagia).
All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
Measured: 6 months from randomization
Symptom burden and health related quality of life
Measured by EORTC Questionnaire Core 30 (QLQ-C30) and the lung module (QLQ-LC13).
The QLQ-C30 questionnaire consists of 30 questions with five functional scales (physical, role, cognitive, emotional and social), three symptom scales, a global health status / QoL scale, and six single items.
The QLQ-LC13 module comprises both multi-item and single-item measures of lung cancer-associated symptoms (coughing, haemoptysis, dyspnoea and pain) and side-effects from conventional chemo- and radiotherapy (hair loss,neuropathy, sore mouth and dysphagia).
All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
Measured: 12 months from randomization
Quality of life (QOL) measured by EuroQol EQ-5D-5L
EQ-5D-5L measures individual generic health status using 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, and each dimension has 5 levels depending on severity of symptoms (1 no problems, 5 extreme problems) and a VAS (visual analogue scale). The scores can then be converted into a single index number. The index value will be used for calculation of quality-adjusted life years (QALYs) for a health economic analysis of the intervention.
Measured: 3 months from randomization
Quality of life (QOL) measured by EuroQol EQ-5D-5L
EQ-5D-5L measures individual generic health status using 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, and each dimension has 5 levels depending on severity of symptoms (1 no problems, 5 extreme problems) and a VAS (visual analogue scale). The scores can then be converted into a single index number. The index value will be used for calculation of quality-adjusted life years (QALYs) for a health economic analysis of the intervention.
Measured: 6 months from randomization
Quality of life (QOL) measured by EuroQol EQ-5D-5L
EQ-5D-5L measures individual generic health status using 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, and each dimension has 5 levels depending on severity of symptoms (1 no problems, 5 extreme problems) and a VAS (visual analogue scale). The scores can then be converted into a single index number. The index value will be used for calculation of quality-adjusted life years (QALYs) for a health economic analysis of the intervention.
Measured: 12 months from randomization
Health behavior
Measured by single-items questions related to physical activity, alcohol consumption and smoking behavior
Measured: 3 months from randomization
Health behavior
Measured by single-items questions related to physical activity, alcohol consumption and smoking behavior.
Measured: 6 months from randomization
Health behavior
Measured by single-items questions related to physical activity, alcohol consumption and smoking behavior.
Measured: 12 months from randomization
Self-efficacy and self-activation
Measured by single items from Patient Activation Measure (PAM) and Health Education Impact Questionnaire (HEIQ)
Measured: 3 months from randomization
Self-efficacy and self-activation
Measured by single items from Patient Activation Measure (PAM) and Health Education Impact Questionnaire (HEIQ)
Measured: 6 months from randomization
Self-efficacy and self-activation
Measured by single items from Patient Activation Measure (PAM) and Health Education Impact Questionnaire (HEIQ)
Measured: 12 months from randomization
Rehabilitation services
Measured by single item question
Measured: 3 months from randomization
Rehabilitation services
Measured by single item question
Measured: 6 months from randomization
Rehabilitation services
Measured by single item question
Measured: 12 months from randomization
Process evaluation
Evaluation by participant-observations during training and patient sessions with subsequent qualitative semi-structured interviews with participants about their experience of the intervention components; however, only among participants who provide informed consent for this. Focus group interviews with nurse navigators and physiotherapists will be conducted about their perceptions of the intervention (facilitators and barriers).
Additionally, evaluation of intervention components will be measured using quantitative single-items questions
Measured: 3 months from evaluation
Process evaluation
Evaluation by participant-observations during training and patient sessions with subsequent qualitative semi-structured interviews with participants about their experience of the intervention components; however, only among participants who provide informed consent for this. Focus group interviews with nurse navigators and physiotherapists will be conducted about their perceptions of the intervention (facilitators and barriers).
Additionally, evaluation of intervention components will be measured using quantitative single-items questions.
Measured: 12 months from evaluation
Cost-effectiveness
Evaluation by health care costs and QALYs (Quality Adjusted Life Years) between the two groups.
Measured: 12 months from randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2021
- Study start1 Mar 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Cancer Society, Odense University Hospital, Vejle Hospital, Hospital of Southern Jutland
- Responsible party
- Principal investigator, Susanne Dalton, Zealand University Hospital
- Investigators
- Susanne O Dalton, Professor, Principal investigator, Zealand University HospitalPernille E Bidstrup, PhD, Principal investigator, Danish Cancer SocietyErik Jakobsen, PhD, Principal investigator, The Danish Lung Cancer Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05053997
- Sponsor's protocol ID
- NAVIGATE
- Status last verified
- Dec 2025
- First submitted
- 13 Sep 2021
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Langballe R, Svendsen L, Jakobsen E, Dalton SO, Karlsen RV, Iachina M, Freund KM, Leclair A, Jorgensen LB, Skou ST, Ehlers JH, Torenholt R, Svendsen MN, Envold Bidstrup P. Nurse navigation, symptom monitoring and exercise in vulnerable patients with lung cancer: feasibility of the NAVIGATE intervention. Sci Rep. 2023 Dec 20;13(1):22744. doi: 10.1038/s41598-023-50161-w.
PubMed 38123657Langballe R, Dalton SO, Jakobsen E, Karlsen RV, Iachina M, Freund KM, Leclair A, Nielsen AS, Andersen EAW, Rosthoj S, Jorgensen LB, Skou ST, Bidstrup PE. NAVIGATE: improving survival in vulnerable patients with lung cancer through nurse navigation, symptom monitoring and exercise - study protocol for a multicentre randomised controlled trial. BMJ Open. 2022 Oct 31;12(10):e060242. doi: 10.1136/bmjopen-2021-060242.
PubMed 36316074
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NAVIGATE - Improving Survival and Quality of Life in Vulnerable Lung Cancer Patients Through Nurse Navigation, Symptom Monitoring and Exercise: Study Protocol for a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05053997
- Acronym / sponsor ID
- NAVIGATE
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Collaborators
- Danish Cancer Society, Odense University Hospital, Vejle Hospital, Hospital of Southern Jutland
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Sep 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.
Half of patients with lung cancer face a limited life span of one-year survival, which is characterized by severe physical and psychological symptoms. Differences in stage, comorbidity but also treatment may explain a large proportion of the social inequality in lung cancer survival. Some vulnerable patients may not receive first line treatment as planned either due to poor performance status or if they are not able to adhere to treatment appointments. Knowing how to navigate the health system may be a barrier preventing vulnerable patients in receiving optimal treatment. The primary aim of this randomised, controlled trial is to test whether a nurse-led individually tailored program including systematic screening of symptoms using PROs and a physical training program will significantly improve a composite outcome of survival and quality of life as the primary outcome among vulnerable lung cancer patients compared with standard care. Secondary outcomes include adherence to cancer treatment, symptom burden and overall survival.
Detailed description
During a period of 3 years and 10 months, consecutive newly diagnosed (< 1 week) lung cancer patients will be pre-screened for eligibility and invited to participate at departments of oncology or respiratory medicine in Denmark. Participants (N=250) will be randomized (1:1) to standard treatment plus the intervention (intervention group) or standard treatment (control group) and followed for 1 year. Patients randomized to the control group will receive standard treatment and care consisting of a nurse and a physician, who sees the patient at treatment schedules and during follow-up, i.e. every 3 months for the first 2 years and subsequently annually up to 5 years.
Data will be collected from the intervention and the control group at baseline within 6 weeks after diagnosis, and 3, 6 months and 12 months after diagnosis. Physical tests will be performed at baseline and after 3 and 6 months. Baseline physical tests will be allowed after randomization if patients have difficulties in attending the physiotherapy department within 6 weeks after their diagnosis. Considering that participating patients are vulnerable with limited resources we will proactively support patients in responding to questionnaires electronically, on paper or via telephone as per patient's preference allowing evaluation of the primary and secondary outcomes as well as covariates and mechanisms. The treatment factors will be obtained from the lung cancer clinical database and individual medical journals. In order to develop cost utility analyses, information on use of health services will be retrieved from the national registers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NAVIGATE intervention arm | Experimental | Behavioral: NAVIGATENurse navigation |
| Navigate control arm | No intervention | –Standard treatment and care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years of age
- Diagnosed with NSCLC at all stages regardless of treatment intension at the participating departments
- Performance status ≤ 2
- Vulnerable according to pre-defined criteria
Key exclusion criteria (3 listed)
- Severe untreated psychiatric disorder (e.g. psychosis) or cognitive problems (e.g. dementia) preventing informed consent
- Not able to receive treatment
- Not able to read and understand Danish -
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 |
|---|---|---|
| NAVIGATEPatients' symptoms are systematically monitored by use of bi-weekly patient reported outcomes and nurse navigators will initiate appropriate actions in terms of medical treatment or guidance of self-management strategies. Nurse navigators will motivate and support patients in health behavior changes and in selfmanaging their treatment and symptoms, and, if relevant, refer to existing rehabilitation services at the hospital or at the local rehabilitation center. Physiotherapists will supervise a training program aimed at improving patients' physical function and thus potentially surgery and overall treatment adherence and outcomes. | Behavioural | NAVIGATE intervention arm |
Primary outcome
A hierarchical composite outcome of survival and global quality of life
Time frame: 3 months from randomization
Measured from death from all causes and the Global Health Status (a subscale of EORTC QLQ-C30)
24 secondary outcomes
Overall survival
Time frame: 3 months from randomization
Overall survival
Time frame: 6 months from randomization
Overall survival
Time frame: 12 months from randomization
Adherence to cancer treatment
Time frame: 3 months from randomization
Adherence to cancer treatment
Time frame: 6 months from randomization
Adherence to cancer treatment
Time frame: 12 months from randomization
Symptom burden and health related quality of life
Time frame: 3 months from randomization
Symptom burden and health related quality of life
Time frame: 6 months from randomization
Symptom burden and health related quality of life
Time frame: 12 months from randomization
Quality of life (QOL) measured by EuroQol EQ-5D-5L
Time frame: 3 months from randomization
Quality of life (QOL) measured by EuroQol EQ-5D-5L
Time frame: 6 months from randomization
Quality of life (QOL) measured by EuroQol EQ-5D-5L
Time frame: 12 months from randomization
Health behavior
Time frame: 3 months from randomization
Health behavior
Time frame: 6 months from randomization
Health behavior
Time frame: 12 months from randomization
Self-efficacy and self-activation
Time frame: 3 months from randomization
Self-efficacy and self-activation
Time frame: 6 months from randomization
Self-efficacy and self-activation
Time frame: 12 months from randomization
Rehabilitation services
Time frame: 3 months from randomization
Rehabilitation services
Time frame: 6 months from randomization
Rehabilitation services
Time frame: 12 months from randomization
Process evaluation
Time frame: 3 months from evaluation
Process evaluation
Time frame: 12 months from evaluation
Cost-effectiveness
Time frame: 12 months from randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Derived from this study: PubMed 38123657Langballe R, Svendsen L, Jakobsen E, Dalton SO, Karlsen RV, Iachina M, Freund KM, Leclair A, Jorgensen LB, Skou ST, Ehlers JH, Torenholt R, Svendsen MN, Envold Bidstrup P. Nurse navigation, symptom monitoring and exercise in vulnerable patients with lung cancer: feasibility of the NAVIGATE intervention. Sci Rep. 2023 Dec 20;13(1):22744. doi: 10.1038/s41598-023-50161-w.
- Derived from this study: PubMed 36316074Langballe R, Dalton SO, Jakobsen E, Karlsen RV, Iachina M, Freund KM, Leclair A, Nielsen AS, Andersen EAW, Rosthoj S, Jorgensen LB, Skou ST, Bidstrup PE. NAVIGATE: improving survival in vulnerable patients with lung cancer through nurse navigation, symptom monitoring and exercise - study protocol for a multicentre randomised controlled trial. BMJ Open. 2022 Oct 31;12(10):e060242. doi: 10.1136/bmjopen-2021-060242.
- Individual participant dataSharing planned: No
Related trials for Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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.
Susanne O Dalton, Professor principal investigator
Zealand University Hospital
Pernille E Bidstrup, PhD principal investigator
Danish Cancer Society
Erik Jakobsen, PhD principal investigator
The Danish Lung Cancer Research Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NAVIGATE in people with Lung Cancer, run by Zealand University Hospital at 6 sites in Denmark.
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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rikke Langballe, PhD (+45 35 25 79 72, ril@cancer.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A hierarchical composite outcome of survival and global quality of life (time frame: 3 months from randomization). 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 NCT05053997, which also lists 2 linked publications.
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 29 Dec 2025.