PROMsPROMOTINGNCT07061379
Patient Reported Outcome Measurements (PROMs) Impact on Clinical Outcome in firsT Line settIng Non- Small-Cell Lung Cancer (NSCLC) According to Chemo- Immunotherapy reGimen
An observational study of PROMs, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
A multicenter, national pharmacological observational study that has as its overall goal to implement a set of validated and agreed upon European-wide questionnaires (PROMs - patient's reported outcomes) to assess patients' perceptions of aspects of their lives based on the treatment they are receiving. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PROMs
- What is being tested?
- Carboplatin/Cisplatin+Pemetrexed+Pembrolizumab/Cemiplimab for 4 cycles and then maintenance with Pemetrexed+Pembrolizumab/Cemiplimab up to 2 years or disease progression or unacceptable toxicity and Carboplatin/Cisplatin+Pemetrexed+Nivolumab+Ipilimumab for 2 cycles and then maintenance with Nivolumab q21 and Ipilimumab q42 up to 2 years or disease progression or unacceptable toxicity
- How many people
- 144 participants
- Where
- 1 siteItaly
- Study dates
- 24 Jul 2025to Jun 2031
- Phase
- Observational
- 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
Study population: Patients with diagnosis of unresectable or advanced NSCLC eligible for first line chemo- ICI (Cohort A) or double ICI-chemo (Cohort B) regimens. Up to 50 patients with squamous histology, treated with any chemo- immunotherapy scheme will be monitored for QoL parameters as a prospective exploratory observational cohort and will not be included in the sample size calculation.
Who may be able to join
- Age > 18 years
- Diagnosis of Stage IV NSCLC with PD-L1 <50%, without actionable genomic alterations
- Signed Informed Consent Form (ICF) to the study
- Patients eligible to receive first line treatment with combo chemo-immuno treatments as standard of care
Who cannot join
- Patients unable to fill the questionnaires due to neurological comorbidities
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Ospedale San Raffaele
Milan, Italy, 20132
Sara Oresti, Medical Oncologist, 026438195 ext. + 39, oresti.sara@hsr.it
Sara Oresti
About this study
Official title: Patient Reported Outcome Measurements (PROMs) Impact on Clinical Outcome in firsT Line settIng Non- Small-Cell Lung Cancer (NSCLC) According to Chemo- Immunotherapy reGimen (PROMOTING)
A multicenter, national pharmacological observational study that has as its overall goal to implement a set of validated and agreed upon European-wide questionnaires (PROMs - patient's reported outcomes) to assess patients' perceptions of aspects of their lives based on the treatment they are receiving.
Specifically, with the research we present here, we aim to obtain data on patients' health and condition, including quality of life, symptom status, physical function, mental health (anxiety and depression), sleep quality, and sexuality as useful indicators not only of patient well-being but also of the effectiveness of the treatment itself.
Read more
The study involves the following: patients will be asked to complete online questionnaires at the following timepoints: before the start of treatment, after 4 and 8 treatment cycles, and at disease progression.
Data will also be collected regarding the patient's oncological medical history, treatment performed, response to treatment at CT/PET reevaluations, any toxicities that arose during treatment.
Read the detailed description
Patient-reported outcomes measures (PROMs) are tools to assess patients' views on aspects of their health and condition, including health-related quality of life, symptom status, physical function and mental health. In medical oncology, PROMs are emerging as useful indicators not only of patient well-being, but also of treatment efficacy. Measurement of quality of life (QoL) has an intrinsic role in the definition of treatment value and, in the absence of head-to-head comparisons showing differences in overall survival or other traditional endpoints, comparison in terms of QoL can usefully inform the choice among alternative treatment options. The recent availability of alternative strategies in advanced NSCLC, in particular different combination therapies in first line setting, requires models to support clinical decision in tailoring individual treatments. In this model, the integration of PROMs could be essential in promoting a patient-centered approach to cancer care.
EORTC QLQ-C-30, exploring general functioning, and EORTC LC-13, specific for lung cancer are the most used PROMs tools in thoracic oncology.
QoL is a complex and composite outcome, which includes different aspects of patients' well-being, such as anxiety, depression and emotional stress. The latter has been measured in patients with lung cancer using PHQ-9 and Generalized Anxiety Disorder 7-item scales. Of note, a significant association with reduced response and worse survival upon immunotherapy was reported, suggesting an impact of emotional stress on patients' immune system and consequently on treatment outcomes.
Considering the broad effect of immunotherapy on the endocrine system and hormones' functions, it is likely that sexual health and sleep, other nuances of the QoL field, could be also affected by immunotherapy. So far, both sexual and sleep dysfunctions have been poorly explored in clinical trials. Furthermore, "time toxicity" defined as number of days with physical contact with healthcare system, could significantly affect patients' emotional distress sphere and has never been explored in NSCLC upon chemo-immunotherapy combinations.
Based on these assumptions, we believe that chemo-ICI (4 cycles of platinum-based doublet chemotherapy + anti- PD-1 followed by single agent chemo and immunotherapy maintenance) or double-ICI chemo (2 cycles of platinum-based doublet chemotherapy + anti-PD-1 and anti-CTLA-4, followed by maintenance with combo immunotherapy) regimens may have distinct effects on several QoL domains. This could be due to the intrinsic differences in the drugs used (i.e. addition of anti-CTLA-4 agents), treatment related toxicities and different tumor shrinkage activity.
The present study aims to compare QoL by validated questionnaires (EORTC QLQ-C-30, EORTC LC13) in the two above mentioned cohorts of patients with metastatic lung adenocarcinoma, having an additional focus in sexual (EORTC QLQ-SH-22), emotional stress (PHQ-9, Generalized Anxiety Disorder 7-item scale) and sleep disorders (PSQI) as previously reported. Time toxicity will be measured by analyzing the time patients spend in contact with healthcare system, such as visits and treatment. A defined cut off considers time toxicity severe when it exceeds 20% of the total care time.
- Conditions
- PROMs
- Being tested
- Carboplatin/Cisplatin+Pemetrexed+Pembrolizumab/Cemiplimab for 4 cycles and then maintenance with Pemetrexed+Pembrolizumab/Cemiplimab up to 2 years or disease progression or unacceptable toxicity, Carboplatin/Cisplatin+Pemetrexed+Nivolumab+Ipilimumab for 2 cycles and then maintenance with Nivolumab q21 and Ipilimumab q42 up to 2 years or disease progression or unacceptable toxicity
- Keywords
- NSCLC, immunotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carboplatin/Cisplatin+Pemetrexed+Pembrolizumab/Cemiplimab for 4 cycles and then maintenance with Pemetrexed+Pembrolizumab/Cemiplimab up to 2 years or disease progression or unacceptable toxicityDrug
Cohort A: Carboplatin/Cisplatin+Pemetrexed+Pembrolizumab/Cemiplimab (Keynote 189, EmpowerLung 3) for 4 cycles and then maintenance with Pemetrexed+Pembrolizumab/Cemiplimab up to 2 years or disease progression or unacceptable toxicity
Carboplatin/Cisplatin+Pemetrexed+Nivolumab+Ipilimumab for 2 cycles and then maintenance with Nivolumab q21 and Ipilimumab q42 up to 2 years or disease progression or unacceptable toxicityDrug
Cohort B:
Carboplatin/Cisplatin+Pemetrexed+Nivolumab+Ipilimumab (CheckMate9LA) for 2 cycles and then maintenance with Nivolumab q21 and Ipilimumab q42 up to 2 years or disease progression or unacceptable toxicity
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: patient treated with chemo-ICI regimen as first line therapy | Cohort A: Carboplatin/Cisplatin+Pemetrexed+Pembrolizumab/Cemiplimab (Keynote 189, EmpowerLung 3) for 4 cycles and then maintenance with Pemetrexed+Pembrolizumab/Cemiplimab up to 2 years or disease progression or unacceptable toxicity Receives: Drug: Carboplatin/Cisplatin+Pemetrexed+Pembrolizumab/Cemiplimab for 4 cycles and then maintenance with Pemetrexed+Pembrolizumab/Cemiplimab up to 2 years or disease progression or unacceptable toxicity | |
| Cohort B: patient treated with double ICI-chemo regimen as first line therapy | Cohort B:
Carboplatin/Cisplatin+Pemetrexed+Nivolumab+Ipilimumab (CheckMate9LA) for 2 cycles and then maintenance with Nivolumab q21 and Ipilimumab q42 up to 2 years or disease progression or unacceptable toxicity Receives: Drug: Carboplatin/Cisplatin+Pemetrexed+Nivolumab+Ipilimumab for 2 cycles and then maintenance with Nivolumab q21 and Ipilimumab q42 up to 2 years or disease progression or unacceptable toxicity |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate what kind of first line treatment for metastatic lung adenocarcinoma has a better impact on quality of life of the patients
QoL domains assessed by EORTC QLQ-C-30 and LC13 at baseline and after 4 cycles. All questionnaires used in this study are validated questionnaires
Measured: Baseline, after 4 cycles
Secondary outcomes (1)
To assess the impact on overall survival of all the PROMs items under investigation
- QoL domains assessed by EORTC QLQ-C-30 and LC13 after 8 cycles of treatment and at disease progression
- Sleep (PSQI), emotional stress (PHQ-9, GAD 7-item scale), sexual health ((EORTC QLQ-SH- 22) and time toxicity after 4 cycles, 8 cycles, and at disease progression
- Overall Survival
Measured: After 4 cycles, after 8 cycles, and at disease progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start24 Jul 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PROMsStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- A.O.U. Città della Salute e della Scienza, Fondazione Policlinico Campus Bio-Medico, ASST Lariana, Como, IRCCS Istituto Nazionale dei Tumori, ASST Grande Ospedale Metropolitano Niguarda, IRCCS San Gerardo dei Tintori, Monza, Asst Degli Spedali Civili Di Brescia, Policlinico San Matteo Pavia, Humanitas Research Hospital IRCCS, Rozzano-Milan, Ospedale Vincenzo Monaldi
- Responsible party
- Principal investigator, Sara Oresti, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07061379
- Sponsor's protocol ID
- PROMOTING
- Acronym
- PROMOTING
- Status last verified
- Aug 2025
- First submitted
- 20 Jun 2025
- Last updated
- 3 Sep 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Reported Outcome Measurements (PROMs) Impact on Clinical Outcome in firsT Line settIng Non- Small-Cell Lung Cancer (NSCLC) According to Chemo- Immunotherapy reGimen (PROMOTING)
- ClinicalTrials.gov ID
- NCT07061379
- Acronym / sponsor ID
- PROMOTING / PROMOTING
- Conditions
- PROMs
- Keywords
- NSCLC, immunotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Collaborators
- A.O.U. Città della Salute e della Scienza, Fondazione Policlinico Campus Bio-Medico, ASST Lariana, Como, IRCCS Istituto Nazionale dei Tumori, ASST Grande Ospedale Metropolitano Niguarda, IRCCS San Gerardo dei Tintori, Monza, Asst Degli Spedali Civili Di Brescia, Policlinico San Matteo Pavia, Humanitas Research Hospital IRCCS, Rozzano-Milan, Ospedale Vincenzo Monaldi
- Study start
- 24 Jul 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2031 (estimated)
- First posted
- 11 Jul 2025 (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.
A multicenter, national pharmacological observational study that has as its overall goal to implement a set of validated and agreed upon European-wide questionnaires (PROMs - patient's reported outcomes) to assess patients' perceptions of aspects of their lives based on the treatment they are receiving.
Specifically, with the research we present here, we aim to obtain data on patients' health and condition, including quality of life, symptom status, physical function, mental health (anxiety and depression), sleep quality, and sexuality as useful indicators not only of patient well-being but also of the effectiveness of the treatment itself.
The study involves the following: patients will be asked to complete online questionnaires at the following timepoints: before the start of treatment, after 4 and 8 treatment cycles, and at disease progression.
Data will also be collected regarding the patient's oncological medical history, treatment performed, response to treatment at CT/PET reevaluations, any toxicities that arose during treatment.
Detailed description
Patient-reported outcomes measures (PROMs) are tools to assess patients' views on aspects of their health and condition, including health-related quality of life, symptom status, physical function and mental health. In medical oncology, PROMs are emerging as useful indicators not only of patient well-being, but also of treatment efficacy. Measurement of quality of life (QoL) has an intrinsic role in the definition of treatment value and, in the absence of head-to-head comparisons showing differences in overall survival or other traditional endpoints, comparison in terms of QoL can usefully inform the choice among alternative treatment options. The recent availability of alternative strategies in advanced NSCLC, in particular different combination therapies in first line setting, requires models to support clinical decision in tailoring individual treatments. In this model, the integration of PROMs could be essential in promoting a patient-centered approach to cancer care.
EORTC QLQ-C-30, exploring general functioning, and EORTC LC-13, specific for lung cancer are the most used PROMs tools in thoracic oncology.
QoL is a complex and composite outcome, which includes different aspects of patients' well-being, such as anxiety, depression and emotional stress. The latter has been measured in patients with lung cancer using PHQ-9 and Generalized Anxiety Disorder 7-item scales. Of note, a significant association with reduced response and worse survival upon immunotherapy was reported, suggesting an impact of emotional stress on patients' immune system and consequently on treatment outcomes.
Considering the broad effect of immunotherapy on the endocrine system and hormones' functions, it is likely that sexual health and sleep, other nuances of the QoL field, could be also affected by immunotherapy. So far, both sexual and sleep dysfunctions have been poorly explored in clinical trials. Furthermore, "time toxicity" defined as number of days with physical contact with healthcare system, could significantly affect patients' emotional distress sphere and has never been explored in NSCLC upon chemo-immunotherapy combinations.
Based on these assumptions, we believe that chemo-ICI (4 cycles of platinum-based doublet chemotherapy + anti- PD-1 followed by single agent chemo and immunotherapy maintenance) or double-ICI chemo (2 cycles of platinum-based doublet chemotherapy + anti-PD-1 and anti-CTLA-4, followed by maintenance with combo immunotherapy) regimens may have distinct effects on several QoL domains. This could be due to the intrinsic differences in the drugs used (i.e. addition of anti-CTLA-4 agents), treatment related toxicities and different tumor shrinkage activity.
The present study aims to compare QoL by validated questionnaires (EORTC QLQ-C-30, EORTC LC13) in the two above mentioned cohorts of patients with metastatic lung adenocarcinoma, having an additional focus in sexual (EORTC QLQ-SH-22), emotional stress (PHQ-9, Generalized Anxiety Disorder 7-item scale) and sleep disorders (PSQI) as previously reported. Time toxicity will be measured by analyzing the time patients spend in contact with healthcare system, such as visits and treatment. A defined cut off considers time toxicity severe when it exceeds 20% of the total care time.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A: patient treated with chemo-ICI regimen as first line therapy | – | Drug: Carboplatin/Cisplatin+Pemetrexed+Pembrolizumab/Cemiplimab for 4 cycles and then maintenance with Pemetrexed+Pembrolizumab/Cemiplimab up to 2 years or disease progression or unacceptable toxicityCohort A: Carboplatin/Cisplatin+Pemetrexed+Pembrolizumab/Cemiplimab (Keynote 189, EmpowerLung 3) for 4 cycles and then maintenance with Pemetrexed+Pembrolizumab/Cemiplimab up to 2 years or disease progression or unacceptable toxicity |
| Cohort B: patient treated with double ICI-chemo regimen as first line therapy | – | Drug: Carboplatin/Cisplatin+Pemetrexed+Nivolumab+Ipilimumab for 2 cycles and then maintenance with Nivolumab q21 and Ipilimumab q42 up to 2 years or disease progression or unacceptable toxicityCohort B: Carboplatin/Cisplatin+Pemetrexed+Nivolumab+Ipilimumab (CheckMate9LA) for 2 cycles and then maintenance with Nivolumab q21 and Ipilimumab q42 up to 2 years or disease progression or unacceptable toxicity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diagnosis of unresectable or advanced NSCLC eligible for first line chemo- ICI (Cohort A) or double ICI-chemo (Cohort B) regimens. Up to 50 patients with squamous histology, treated with any chemo- immunotherapy scheme will be monitored for QoL parameters as a prospective exploratory observational cohort and will not be included in the sample size calculation.
Key inclusion criteria (4 listed)
- Age > 18 years
- Diagnosis of Stage IV NSCLC with PD-L1 <50%, without actionable genomic alterations
- Signed Informed Consent Form (ICF) to the study
- Patients eligible to receive first line treatment with combo chemo-immuno treatments as standard of care
Key exclusion criteria (1 listed)
- Patients unable to fill the questionnaires due to neurological comorbidities
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 |
|---|---|---|
| Carboplatin/Cisplatin+Pemetrexed+Pembrolizumab/Cemiplimab for 4 cycles and then maintenance with Pemetrexed+Pembrolizumab/Cemiplimab up to 2 years or disease progression or unacceptable toxicityCohort A: Carboplatin/Cisplatin+Pemetrexed+Pembrolizumab/Cemiplimab (Keynote 189, EmpowerLung 3) for 4 cycles and then maintenance with Pemetrexed+Pembrolizumab/Cemiplimab up to 2 years or disease progression or unacceptable toxicity | Drug | Cohort A: patient treated with chemo-ICI regimen as first line therapy |
| Carboplatin/Cisplatin+Pemetrexed+Nivolumab+Ipilimumab for 2 cycles and then maintenance with Nivolumab q21 and Ipilimumab q42 up to 2 years or disease progression or unacceptable toxicityCohort B: Carboplatin/Cisplatin+Pemetrexed+Nivolumab+Ipilimumab (CheckMate9LA) for 2 cycles and then maintenance with Nivolumab q21 and Ipilimumab q42 up to 2 years or disease progression or unacceptable toxicity | Drug | Cohort B: patient treated with double ICI-chemo regimen as first line therapy |
Primary outcome
To evaluate what kind of first line treatment for metastatic lung adenocarcinoma has a better impact on quality of life of the patients
Time frame: Baseline, after 4 cycles
QoL domains assessed by EORTC QLQ-C-30 and LC13 at baseline and after 4 cycles. All questionnaires used in this study are validated questionnaires
1 secondary outcome
To assess the impact on overall survival of all the PROMs items under investigation
Time frame: After 4 cycles, after 8 cycles, and at disease progression
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 3 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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.
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 PROMs, run by IRCCS San Raffaele at 1 site in Italy.
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 1 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 3 Sep 2025. 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 Italy. 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 Sara Oresti, Medical Oncologist (+39 022643 8195, oresti.sara@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate what kind of first line treatment for metastatic lung adenocarcinoma has a better impact on quality of life of the patients (time frame: Baseline, after 4 cycles). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Sep 2025.