Advanced Lung CarcinomaBREATHNCT06374160
Exercise in Patients With Advanced Non-small Cell Lung Cancer
A study testing Exercise intervention in people with Advanced Lung Carcinoma and First Line Treatment, run by University Hospital, Essen at 1 site in Germany.
Trial summary
Lung cancer is one of the most common types of cancer in Germany, with 56,839 new cases and 45,072 deaths annually. Approximately 70% of patients with non-small cell lung cancer (NSCLC) are diagnosed at an advanced stage and suffer from comorbidities and symptoms such as fatigue, tiredness, and loss of strength. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Lung Carcinoma, First Line Treatment, Second Line Treatment
- What is being tested?
- Exercise intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteGermany
- Study dates
- 1 May 2024to 31 Aug 2026
- Phase
- Interventional
- 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
Who may be able to join
- Patients with histologically confirmed non-small cell lung carcinoma in UICC stages IIIB and IV
- First- or second-line therapy (inclusion up to 28 days after the first cycle) in palliative intention
- Age ≥ 18 years
- Signed informed consent
Who cannot join
- Severe cardiopulmonary disease (EF<30%)
- Newly occurring or progressive uncontrolled CNS (central nervous system) metastases
- Expected life expectancy < 3 months
- Bone metastases with acute risk of fracture
- ECOG (Eastern Cooperative Oncology Group) performance status > 2
- Acute pulmonary embolism
Show all 11Show fewer
- Acute myocardial infarction
- Requiring surgery for aortic aneurysm
- Tension pneumothorax
- Lack of proficiency in the German language
- Active infection
Trial locations and contacts
1 site in 1 country.
Germany1 site
West German Cancer Center (Department of Palliative medicine and Department of Medical Oncology), University Hospital Essen
Essen, North Rhine-Westphalia, 45147
Mitra Tewes, PD. Dr., mitra.tewes@uk-essen.de
Nico De Lazzari, M. Sc., +49 201 723-82035, nico.delazzari@uk-essen.de
About this study
Official title: Better Symptom Control With Exercise in Patients With Advanced Non-small Cell Lung Cancer
Lung cancer is one of the most common types of cancer in Germany, with 56,839 new cases and 45,072 deaths annually. Approximately 70% of patients with non-small cell lung cancer (NSCLC) are diagnosed at an advanced stage and suffer from comorbidities and symptoms such as fatigue, tiredness, and loss of strength. The standard first-line treatment for metastatic NSCLC includes platinum-based chemoimmunotherapy followed by immunotherapy maintenance. Exercise can have positive effects on symptoms such as shortness of breath, fatigue, quality of life, and physical fitness. However, there is a lack of current scientific evidence for the effectiveness of exercise in advanced lung cancer patients. No current trial investigated exercise in advanced NSCLC receiving immunotherapy so far.
The BREATH-study is a prospective 3-arm randomized controlled trial (RCT). In total, the investigators plan to recruit 104 patients. A 2:1:1 randomization will be performed with three study groups: a control group and two exercise therapy groups (strength+endurance exercise/only endurance exercise). One group receives individual endurance training and the other group a combination of individual endurance and strength training. Both treatment groups will be treated twice a week for 12 weeks. The control group will initially receive standard treatment without exercise for 12 weeks and will then be randomized into one of the other two study groups with exercise twice a week for 12 weeks. This approach allows for a sufficiently large sample for comparisons between exercise therapy and the control group, as well as between the two exercise therapy approaches.
The primary aim is to investigate the impact of exercise on V02peak. Secondarily endpoints aim to investigate changes in physical function, patient related outcomes and cardiac function before and after exercise.
- Conditions
- Advanced Lung Carcinoma, First Line Treatment, Second Line Treatment, NSCLC Stage IV, NSCLC Stage IIIB, Palliative Treatment
- Being tested
- Exercise intervention
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise interventionBehavioural
Exercise
| Study group | Role | What they receive |
|---|---|---|
| Arm A (endurance training + strength training) | Experimental | Frequency: 2 supervised exercise sessions per week.
Session Breakdown:
Duration: 60 minutes per session. Aerobic Endurance Training: 20 minutes. Strength Training: 40 minutes.
Aerobic Interval Training:
Set at 50% of maximal workload based on spiroergometry. Five sets of 2 minutes of exertion; 5 sets of 1 minute of recovery; Total exertion time: 20 minutes
Strength Training:
Muscle Groups Targeted: Major muscle groups. Sets and Repetitions: 2 sets with 8-12 repetitions.
Training Intensity:
Range: 50-80% of 1-RM (1-repetition maximum) Receives: Behavioral: Exercise intervention |
| Arm B (endurance exercise) | Experimental | Frequency: 2 supervised exercise sessions per week.
Session Breakdown:
Duration: Approximately 30 minutes. Focus: Aerobic endurance training. Followed by 10 minutes of Respiratory therapy.
Endurance Training:
Method: Intervals for a balance between exertion and recovery. Intensity: Set at 50% of maximal workload based on spiroergometry. Receives: Behavioral: Exercise intervention |
| Arm C (Usual Care) | No intervention | The control group receives a one-time sports consultation with general information about daily activities and sports participation, as well as individual training recommendations. After the 12 weeks, the control group will be randomized into one of the exercise therapies. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum oxygen uptake (VO2 peak [ml/min/kg])
The primary goal is to achieve an improvement in performance (VO2 peak[ml/min/kg]) from T0 (enrolment) to T1 (12 weeks) through exercise compared to the standard treatment. The one-sided alternative hypothesis of a larger improvement in the two treatment groups compared to the control group will be tested statistically as a confirmatory analysis.
Measured: assessed at Baseline, after 12 weeks and 24 weeks of enrolment
Secondary outcomes (29)
Functional Assessment of Chronic Illness Therapy - Fatigue (FACT-F)
The FACT-F is a 13-item questionnaire to assess fatigue in cancer patients. Subscale are physical well-being, social/family well-being, emotional well-being, functional well-being and the fatigue subscale. Based on the subscale the FACIT-F trial outcome index (TOI) Score range 0-108, FACT-G total score (Score range 0-108) and FACIT-F total score (Score range 0-160) can be calculated. The higher the score, the better the Quality of Life.
Measured: assessed at baseline, after 12 weeks and 24 weeks of enrolment
European Organisation for Research and Treatment of Cancer (EORTC QLQ C30)
The EORTC QLQ Core Questionnaire is a 30-item instrument meant to assess some of the different aspects that define the quality of life of cancer patients (e.g., physical function, emotional function, symptom scales, and Quality of Life). High scores for functional scales (score 0-100) represent a high level of functioning, high scores for the global health status represent a high quality of life (score 0-100), high scores for symptom scales (score 0-100) represent a high level of symptomatology.
Measured: assessed at baseline after 12 weeks and 24 weeks of enrolment
European Organisation for Research and Treatment of Cancer Lung cancer module (EORTC-LC13)
The LC13 is a modular supplement to the EORTC-C30 for assessment of symptoms in clinical lung. cancer trials. The scoring range is between 0 to 100, a high score indicating a high level of symptomatology.
Measured: assessed at baseline, after 12 weeks and 24 weeks of enrolment
Arterial blood pressure
Change during study participation (mmHg)
Measured: assessed at Baseline, after 12 weeks and 24 weeks of enrolment
Change in ECG
Changes in 12-lead resting ECG, including PQ [ms], QRS [ms], and QT [ms] intervals
Measured: assessed at baseline, after 12 weeks and 24 weeks of enrolment
Adherence to exercise intervention
The exercise physiologist monitored adherence to the supervised sessions. Based on the absolute numbers of scheduled exercise sessions, both absolute and percentage-based adherence can be calculated and compared between study arms.
Measured: Through study completion, an average of 12 weeks
Drop-out rate
All withdrawals will be considered as dropouts, with reasons noted. Compare the total number of dropouts in each study arm. This provides a straightforward comparison of the raw dropout counts between groups. Also, calculate the percentage of participants who dropped out in each study arm relative to the total number of participants initially assigned to that arm. This allows for a comparison of dropout rates relative to the initial sample size and compared between study arms.
Measured: Through study completion, an average of 12 weeks
Recruitment rate
The recruitment rate quantifies the speed of participant enrollment for a study.
Measured: At Baseline
Serious Adverse Event/Adverse Events
Safety analyses will be based on Adverse Events (AEs), Serious Adverse Events (SAEs) after the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Measured: Through study completion, an average of 12 weeks
Therapy response
Therapy response in the next computer tomography (analogous to RECIST v1.1)
Measured: Baseline and after 12 weeks
Treatment Toxicity
Treatment toxicity encompasses the adverse effects experienced by individuals undergoing chemotherapy and exercise regimens concurrently. These effects may manifest as physical symptoms such as fatigue, nausea, muscle weakness, and decreased immune function, which can impact overall well-being and treatment adherence. Monitoring and managing toxicity levels are crucial to ensure patient safety and optimize treatment outcomes. Additionally, integrating exercise interventions alongside chemotherapy may pose unique challenges, as physical activity can exacerbate certain side effects or interact with treatment efficacy. Therefore, careful monitoring and personalized exercise prescriptions are essential to mitigate toxicity risks and enhance the overall tolerability and effectiveness of combined therapy approaches. Toxicity will be reported with CTCAE v5.0
Measured: assessed at baseline after 12 weeks and 24 weeks of enrolment
Treatment scheme
Change in dose or frequency during trial participation
Measured: assessed at baseline after 12 weeks and 24 weeks of enrolment
NT-pro-BNP
Concentration of N-terminal prohormone of brain natriuretic peptide (NT-pro-BNP), measured in picograms per milliliter (pg/mL) of blood
Measured: Up to 24 weeks
High sensitive troponin I
Concentration of troponin I in nanograms per milliliter [ng/mL] of blood.
Measured: Up to 24 weeks
Erythrocytes
The amount of Erythrocytes per liter [/pl]
Measured: Up to 24 weeks
Hemoglobin
Concentration of hemoglobin in the blood, measured in grams per deciliter (g/dL)
Measured: Up to 24 weeks
Leukocytes
Count of leukocytes per nanoliter [ /nl]
Measured: Up to 24 weeks
Lymphocytes
Count of lymphocytes per nanoliter [ /nl]
Measured: Up to 24 weeks
Neutrophils
Count of neutrophils per nanoliter [ /nl]
Measured: Up to 24 weeks
CRP
Concentration of C-reactive protein (CRP) in the blood, measured in milligrams per deciliter [mg/dL]
Measured: Up to 24 weeks
CYRFRA 21-1
Concentration of cytokeratin-19 fragment (CYFRA 21-1) in nanograms per milliliter [ng/mL] of blood
Measured: Up to 24 weeks
Physical function (Hypothetical One-repetition maximum)
Leg press [kg.], Latissimus pulldown [kg.], bench press [kg.], Crunch [kg.], Leg curl [kg.], Back extension [kg.]
Measured: assessed at baseline after 12 weeks and 24 weeks of enrolment
Blood gas analysis pH value
pH value
Measured: assessed at baseline, after 12 weeks and 24 weeks of enrolment
Blood gas analysis (PAO2)
Partial pressure of oxygen in arterial blood (PAO2 [mmHg])
Measured: assessed at baseline, after 12 weeks and 24 weeks of enrolment
Blood gas analysis (SaO2)
Arterial oxygen saturation, measured as a percentage (SaO2 [%])
Measured: assessed at baseline, after 12 weeks and 24 weeks of enrolment
Blood gas analysis (PCO2)
Partial pressure of carbon dioxide in arterial blood PCO2 [mmHg]
Measured: assessed at baseline, after 12 weeks and 24 weeks of enrolment
Blood gas analysis (BE)
Base excess (BE) represents the amount of excess or deficit of base (primarily bicarbonate, HCO3-) in the blood [mmol/l]
Measured: assessed at baseline, after 12 weeks and 24 weeks of enrolment
Blood gas analysis (HCO3)
Bicarbonate concentration in the blood HCO3 [mmol/l]
Measured: assessed at baseline, after 12 weeks and 24 weeks of enrolment
Blood gas analysis (SBCe)
Bicarbonate Concentration in the extracellular fluid SBCe [mmol/l]
Measured: assessed at baseline, after 12 weeks and 24 weeks of enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start1 May 2024 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion31 Aug 2026 (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 Advanced Lung CarcinomaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- BREATH is a prospective 3-arm 2:1:1 randomized controlled trial (RCT). The first arm represents the control group, which will receive the standard treatment for the first 12 weeks (recommendations for physical activity during cancer treatment). The other two arms represent the exercise groups, one group will receive individualized endurance training and the other group a combination of individualized endurance and strength training. All arms will be treated for 12 weeks. Afterwards, the patients in the control group are randomized to one of the other two study arms and then also treated twice for 12 weeks.
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Collaborators
- German Cancer Aid
- Responsible party
- Sponsor
- Investigators
- Mitra Tewes, PD. Dr., Principal investigator, Department of Palliative Medicine, University Hospital Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06374160
- Sponsor's protocol ID
- 70115371
- Acronym
- BREATH
- Status last verified
- Apr 2024
- First submitted
- 10 Apr 2024
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will publish a study protocol, including the statistical analysis plan, at an international peer-reviewed journal
Publications
De Lazzari N, Wiesweg M, Gotte M, Franco J, Mincu RI, Jager J, Huessler EM, Kuklik N, Stang A, Totzeck M, Tewes M. Improving aerobic capacity in patients with advanced non-small cell lung cancer: study protocol of the 3-armed randomized controlled BREATH trial. Trials. 2026 Jan 17;27(1):88. doi: 10.1186/s13063-025-09416-2.
PubMed 41546104
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Better Symptom Control With Exercise in Patients With Advanced Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06374160
- Acronym / sponsor ID
- BREATH / 70115371
- Conditions
- Advanced Lung Carcinoma, First Line Treatment, Second Line Treatment, NSCLC Stage IV, NSCLC Stage IIIB, Palliative Treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Collaborators
- German Cancer Aid
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 18 Apr 2024 (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.
Lung cancer is one of the most common types of cancer in Germany, with 56,839 new cases and 45,072 deaths annually. Approximately 70% of patients with non-small cell lung cancer (NSCLC) are diagnosed at an advanced stage and suffer from comorbidities and symptoms such as fatigue, tiredness, and loss of strength. The standard first-line treatment for metastatic NSCLC includes platinum-based chemoimmunotherapy followed by immunotherapy maintenance. Exercise can have positive effects on symptoms such as shortness of breath, fatigue, quality of life, and physical fitness. However, there is a lack of current scientific evidence for the effectiveness of exercise in advanced lung cancer patients. No current trial investigated exercise in advanced NSCLC receiving immunotherapy so far.
The BREATH-study is a prospective 3-arm randomized controlled trial (RCT). In total, the investigators plan to recruit 104 patients. A 2:1:1 randomization will be performed with three study groups: a control group and two exercise therapy groups (strength+endurance exercise/only endurance exercise). One group receives individual endurance training and the other group a combination of individual endurance and strength training. Both treatment groups will be treated twice a week for 12 weeks. The control group will initially receive standard treatment without exercise for 12 weeks and will then be randomized into one of the other two study groups with exercise twice a week for 12 weeks. This approach allows for a sufficiently large sample for comparisons between exercise therapy and the control group, as well as between the two exercise therapy approaches.
The primary aim is to investigate the impact of exercise on V02peak. Secondarily endpoints aim to investigate changes in physical function, patient related outcomes and cardiac function before and after exercise.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- BREATH is a prospective 3-arm 2:1:1 randomized controlled trial (RCT). The first arm represents the control group, which will receive the standard treatment for the first 12 weeks (recommendations for physical activity during cancer treatment). The other two arms represent the exercise groups, one group will receive individualized endurance training and the other group a combination of individualized endurance and strength training. All arms will be treated for 12 weeks. Afterwards, the patients in the control group are randomized to one of the other two study arms and then also treated twice for 12 weeks.
| Arm | Type | Receives |
|---|---|---|
| Arm A (endurance training + strength training) | Experimental | Behavioral: Exercise interventionFrequency: 2 supervised exercise sessions per week. Session Breakdown: Duration: 60 minutes per session. Aerobic Endurance Training: 20 minutes. Strength Training: 40 minutes. Aerobic Interval Training: Set at 50% of maximal workload based on spiroergometry. Five sets of 2 minutes of exertion; 5 sets of 1 minute of recovery; Total exertion time: 20 minutes Strength Training: Muscle Groups Targeted: Major muscle groups. Sets and Repetitions: 2 sets with 8-12 repetitions. Training Intensity: Range: 50-80% of 1-RM (1-repetition maximum) |
| Arm B (endurance exercise) | Experimental | Behavioral: Exercise interventionFrequency: 2 supervised exercise sessions per week. Session Breakdown: Duration: Approximately 30 minutes. Focus: Aerobic endurance training. Followed by 10 minutes of Respiratory therapy. Endurance Training: Method: Intervals for a balance between exertion and recovery. Intensity: Set at 50% of maximal workload based on spiroergometry. |
| Arm C (Usual Care) | No intervention | –The control group receives a one-time sports consultation with general information about daily activities and sports participation, as well as individual training recommendations. After the 12 weeks, the control group will be randomized into one of the exercise therapies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with histologically confirmed non-small cell lung carcinoma in UICC stages IIIB and IV
- First- or second-line therapy (inclusion up to 28 days after the first cycle) in palliative intention
- Age ≥ 18 years
- Signed informed consent
Key exclusion criteria (11 listed)
- Severe cardiopulmonary disease (EF<30%)
- Newly occurring or progressive uncontrolled CNS (central nervous system) metastases
- Expected life expectancy < 3 months
- Bone metastases with acute risk of fracture
- ECOG (Eastern Cooperative Oncology Group) performance status > 2
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 |
|---|---|---|
| Exercise interventionExercise | Behavioural | Arm A (endurance training + strength training), Arm B (endurance exercise) |
Primary outcome
Maximum oxygen uptake (VO2 peak [ml/min/kg])
Time frame: assessed at Baseline, after 12 weeks and 24 weeks of enrolment
The primary goal is to achieve an improvement in performance (VO2 peak[ml/min/kg]) from T0 (enrolment) to T1 (12 weeks) through exercise compared to the standard treatment. The one-sided alternative hypothesis of a larger improvement in the two treatment groups compared to the control group will be tested statistically as a confirmatory analysis.
29 secondary outcomes
Functional Assessment of Chronic Illness Therapy - Fatigue (FACT-F)
Time frame: assessed at baseline, after 12 weeks and 24 weeks of enrolment
European Organisation for Research and Treatment of Cancer (EORTC QLQ C30)
Time frame: assessed at baseline after 12 weeks and 24 weeks of enrolment
European Organisation for Research and Treatment of Cancer Lung cancer module (EORTC-LC13)
Time frame: assessed at baseline, after 12 weeks and 24 weeks of enrolment
Arterial blood pressure
Time frame: assessed at Baseline, after 12 weeks and 24 weeks of enrolment
Change in ECG
Time frame: assessed at baseline, after 12 weeks and 24 weeks of enrolment
Adherence to exercise intervention
Time frame: Through study completion, an average of 12 weeks
Drop-out rate
Time frame: Through study completion, an average of 12 weeks
Recruitment rate
Time frame: At Baseline
Serious Adverse Event/Adverse Events
Time frame: Through study completion, an average of 12 weeks
Therapy response
Time frame: Baseline and after 12 weeks
Treatment Toxicity
Time frame: assessed at baseline after 12 weeks and 24 weeks of enrolment
Treatment scheme
Time frame: assessed at baseline after 12 weeks and 24 weeks of enrolment
NT-pro-BNP
Time frame: Up to 24 weeks
High sensitive troponin I
Time frame: Up to 24 weeks
Erythrocytes
Time frame: Up to 24 weeks
Hemoglobin
Time frame: Up to 24 weeks
Leukocytes
Time frame: Up to 24 weeks
Lymphocytes
Time frame: Up to 24 weeks
Neutrophils
Time frame: Up to 24 weeks
CRP
Time frame: Up to 24 weeks
CYRFRA 21-1
Time frame: Up to 24 weeks
Physical function (Hypothetical One-repetition maximum)
Time frame: assessed at baseline after 12 weeks and 24 weeks of enrolment
Blood gas analysis pH value
Time frame: assessed at baseline, after 12 weeks and 24 weeks of enrolment
Blood gas analysis (PAO2)
Time frame: assessed at baseline, after 12 weeks and 24 weeks of enrolment
Blood gas analysis (SaO2)
Time frame: assessed at baseline, after 12 weeks and 24 weeks of enrolment
Blood gas analysis (PCO2)
Time frame: assessed at baseline, after 12 weeks and 24 weeks of enrolment
Blood gas analysis (BE)
Time frame: assessed at baseline, after 12 weeks and 24 weeks of enrolment
Blood gas analysis (HCO3)
Time frame: assessed at baseline, after 12 weeks and 24 weeks of enrolment
Blood gas analysis (SBCe)
Time frame: assessed at baseline, after 12 weeks and 24 weeks of enrolment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Derived from this study: PubMed 41546104De Lazzari N, Wiesweg M, Gotte M, Franco J, Mincu RI, Jager J, Huessler EM, Kuklik N, Stang A, Totzeck M, Tewes M. Improving aerobic capacity in patients with advanced non-small cell lung cancer: study protocol of the 3-armed randomized controlled BREATH trial. Trials. 2026 Jan 17;27(1):88. doi: 10.1186/s13063-025-09416-2.
- Individual participant dataSharing planned: No. We will publish a study protocol, including the statistical analysis plan, at an international peer-reviewed journal
Related trials for Advanced Lung Carcinoma
RecruitingPhase 3
A Study of Calderasib (MK-1084) Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004/KANDLELIT-004)
Non-small Cell Lung Cancer
RecruitingPhase 1/2
Efficacy and Safety of Ivonescimab Plus Pemetrexed and Platinum-Based Chemotherapy in Advanced Malignant Pleural Mesothelioma
Malignant Pleural Mesothelioma, Advanced
Active, not recruitingPhase 3
Testing the Timing of Pembrolizumab Alone or With Chemotherapy as First Line Treatment and Maintenance in Non-small Cell Lung Cancer
Lung Non-Squamous Non-Small Cell Carcinoma, Stage IIIB Lung Cancer AJCC v8
RecruitingPhase 3
A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)
Non-small Cell Lung Cancer
RecruitingPhase 1
A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations
Cancer, PDAC - Pancreatic Ductal Adenocarcinoma
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.
Mitra Tewes, PD. Dr. principal investigator
Department of Palliative Medicine, University Hospital Essen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise intervention in people with Advanced Lung Carcinoma and First Line Treatment, run by University Hospital, Essen 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 4 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 18 Apr 2024. 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?
Contact Nico De Lazzari, M. Sc. (+49 201 / 723-82035, nico.delazzari@uk-essen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum oxygen uptake (VO2 peak [ml/min/kg]) (time frame: assessed at Baseline, after 12 weeks and 24 weeks of enrolment). 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 NCT06374160, 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 18 Apr 2024.