Impact of eHealth Monitoring on Overall Survival in Patients With Metastatic NSCLC / Extensive-stage SCLC / Advanced TNBC Under First-line Treatment With Atezolizumab Plus Chemotherapy
- Conditions
- Stage IV Non-small Cell Lung CancerExtensive-stage Small Cell Lung CancerAdvanced (Locally Advanced and Inoperable or Metastatic), PD-L1 IC-positive TNBC
- Registration Number
- NCT03911219
- Lead Sponsor
- iOMEDICO AG
- Brief Summary
The current study is aimed to test the benefit of a web-based application tool in NSCLC, SCLC and TNBC patients during the recently approved first-line treatment strategy with atezolizumab in combination with chemotherapy.
- Detailed Description
Checkpoint inhibitors represent new, promising treatment opportunities in the palliative lung cancer setting. Among programmed cell death-1 (PD-1) and programmed cell death ligand-1 (PD-L1) inhibitors, atezolizumab (Tecentriq® ), a PD-L1 inhibitor, has been shown to ameliorate outcomes for NSCLC patients with metastatic disease: The open-label phase II multicenter studies POPLAR and BIRCH revealed an improved overall response rate and a benefit in overall survival (OS) under atezolizumab monotherapy. The open-label, randomized phase III OAK trial led to atezolizumab approval as monotherapy for patients with metastatic NSCLC whose disease progressed during or following platinumcontaining chemotherapy regardless of PD-L1 status.
Despite these developments, platinum-based chemotherapy regimens are still standard of care for lung cancer without druggable alterations. Lately combining conventional chemotherapeutics with immunotherapy showed promising results: A phase I study of first-line atezolizumab plus chemotherapy demonstrated efficacy regardless of PD-L1 status and an acceptable safety profile in multiple tumor types. Accordingly, ongoing phase III trials address potential benefits of platinum-based immunotherapy combinations in comparison to standard platinum-containing regimens in first-line NSCLC and SCLC. If additional bevacizumab might further enhance atezolizumab efficacy by inhibiting vascular Endothelial Growth Factor (VEGF)-related immunosuppression is currently investigated in the IMpower150 trial.
Patients under intensive care for advanced cancers develop symptoms due to cancer progression and, possibly, due to therapy-related sideeffects. These symptoms are often not detected promptly by the treating physician leading to functional impairment and deconditioning of the patient's status with potential implications for the general outcome. Improved symptom control in late-stage cancer under exhaustive therapy regimens was achieved through intensified symptom management. Systematic collection of symptom information by electronic patientreported outcomes (ePROs) in addition to clinical routine provides an attractive basis for intensified symptom management. However, despite new, intriguing results, the proof of a significant benefit (defined as primary outcome measure) under first-line treatment is still limited in oncology trials.
In the palliative setting of lung cancer, routine treatment monitoring includes imaging at certain intervals. However, as approaching imaging assessments clarify the patient's fate, they are often a source for anxiety and concern. Additionally, patients with emerging symptoms often wait until the next routinely scheduled consultation with their treating oncologist. As a consequence, tumor progression without therapeutic hindrance over several weeks may occur and naturally shorten the patient's survival time. Clinical monitoring via self-assessed symptom-based approaches endows several benefits. Remarkably, 75-95% of relapses in lung cancer patients come with symptoms and, thus, a direct PRO measurement might be useful in the detection of an early disease progression. Easily accessible web-based application tools such as CANKADO were developed to report PROs more frequently compared to routine assessment. These tools help to strengthen the connection between patient and treating physician and to reduce patients' anxiety. Of note, even during treatment with toxic chemotherapy, most patients are willing and able to self-report via the web. Physicians appreciate PROs and trust in patient-reported information. In line with this, several promising studies confirmed a benefit from proactive, web-based monitoring programs. If symptoms occurred or worsened, the respective physician was informed earlier what resulted n improved OS, quality of life (QoL) and also in economic advantages due to less unnecessary routine check-ups. So far, these studies were performed on heterogeneous patient populations during chemotherapy. The current study is aimed to test the benefit of a web-based application tool in NSCLC, SCLC and TNBC patients during the recently approved first-line treatment strategy with atezolizumab in combination with chemotherapy.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 154
Not provided
- Prior treatment for stage IV non-squamous NSCLC (prior TKI therapy is allowed for EGFR mutant or ALK-positive NSCLC) or prior systemic treatment for extensive-stage SCLC or prior systemic chemotherapy for advanced TNBC
- History of severe (or known) hypersensitivity to chimeric or humanized antibodies or fusion proteins or any component of atezolizumab formulation
- Pregnant or breast-feeding women
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall Survival (OS) 72 months Time from randomization to death from any cause. Patients not experiencing an event (i.e., patients alive at their individual end of study) will be censored with the last date the patient was known to be alive.
- Secondary Outcome Measures
Name Time Method Disease control rate (DCR) 72 months The proportion of patients showing a best overall response of CR, PR, or SD (as assessed by the treating physician).
Progression Free Survival (PFS) 72 months The time from randomization to tumor progression or death from any cause, whatever occurs first. Patients being event-free (i.e., alive and progression-free) by the time of analysis or starting a new antineoplastic therapy before progression, will be censored at the date of the last adequate tumor assessment.
Time to deterioration in global health scale score 72 months To compare patient-reported outcomes (PROs) on quality of life (QoL) of the two study arms: Time to deterioration (TTD) by ≥ 10 points in the global health scale score
Alerts 72 months Frequency and total number of eHealth Support system (EHSS) alerts.
Change from baseline in the functional/symptom scores 72 months To compare patient-reported outcomes (PROs) on quality of life (QoL) of the two study arms: Change from baseline in the functional/symptom scores
Sensitivity of alerts 72 months Ratio of alert-initiated visits that result in detection of tumor progression and/or action-requiring symptom management (as evaluated by the oncologist) and all visits which result in detection of tumor progression and/or action-requiring symptom management.
Progression-detection rate 72 months The proportion of individuals who test positive for a first tumor progression during atezolizumab therapy in a specific type of tumor assessment (i.e., alert-triggered vs. non-alert-triggered), compared to the total number of first detected progressions during atezolizumab therapy (i.e., progressions detected in all tumor assessments during scheduled as well as unscheduled visits).
Relative dose intensity of first-line atezolizumab 72 months Relative dose intensity of first-line atezolizumab (including maintenance therapy)
Subscale scores and single item responses 72 months To compare patient-reported outcomes (PROs) on quality of life (QoL) of the two study arms Subscale scores and single item responses in Patient Reported Outcomes on QoL in both arms
Best response 72 months The best documented response (in terms of complete response \[CR\], partial response \[PR\], stable disease \[SD\], or progressive disease \[PD\]) per patient, as assessed by the treating physician.
Overall response rate (ORR) 72 months The proportion of patients showing a best overall response of CR or PR (as assessed by the treating physician).
Time to deterioration in functional/symptom scores 72 months To compare patient-reported outcomes (PROs) on quality of life (QoL) of the two study arms: Time to deterioration (TTD) by ≥ 10 points in the functional/symptom scores
Negative predictive value of alerts 72 months Ratio of non-alert-initiated visits with no result (i.e., neither detected tumor progression nor action-requiring symptom management) and all non-alert-initiated visits.
Patient compliance 72 months Intensity of use of application tool (defined as number of utilizations per week over the total observation time).
Change from baseline in the global health scale score 72 months To compare patient-reported outcomes (PROs) on quality of life (QoL) of the two study arms: Change from baseline in the global health scale score
Specifity of alerts 72 months Ratio of non-alert-initiated visits with neither detected tumor progression nor action-requiring symptom management (as evaluated by the oncologist) and all visits with neither detected tumor progression nor action-requiring symptom management.
Positive predictive value of alerts 72 months Ratio of alert-initiated visits that resulted in detection of tumor progression and/or action-requiring symptom management and all alert-initiated visits.
Safety and tolerability 72 months Frequency and severity of (serious) adverse events ((S)AEs) coded by the Medical Dictionary for Regulatory Activities (MedDRA), summarized by Preferred Term and System Organ Class and graded according to CTCAE v5.0.
Frequency and severity of (serious) adverse drug reactions ((S)ADRs) with causal relationship to bevacizumab and/or atezolizumab coded by the MedDRA, summarized by Preferred Term and System Organ Class and graded according to CTCAE v5.0.Treatment duration of first-line atezolizumab 72 months Treatment duration of first-line atezolizumab (including maintenance therapy)
Treatment duration of each combined first-line antineoplastic therapy substance 72 months Treatment duration of each combined first-line antineoplastic therapy substance
Relative dose intensity of each combined first-line antineoplastic therapy substance 72 months Relative dose intensity of each combined first-line antineoplastic therapy substance
Treatment modifications of first-line atezolizumab and all combined antineoplastic substances 72 months Therapy details and subsequent therapy lines based on Treatment modifications of first-line atezolizumab and all combined antineoplastic substances
Subsequent antineoplastic therapy lines 72 months Therapy details and subsequent antineoplastic therapy lines
Treatment duration of combined first-line bevacizumab 72 months Treatment duration of combined first-line bevacizumab (including maintenance therapy)
Trial Locations
- Locations (88)
Onkologische Praxis im St. Marien-Krankenhaus
🇩🇪Ahaus, Germany
Gesundheitszentrum St. Marien
🇩🇪Amberg, Germany
Klinikum Arnsberg, Karolinen Hospital
🇩🇪Arnsberg, Germany
MVZ am Klinikum Aschaffenburg
🇩🇪Aschaffenburg, Germany
Klinikum Augsburg, II. Medizinische Klinik
🇩🇪Augsburg, Germany
Gemeinschaftspraxis Dr. Heinrich, Prof. Dr. Bangerter
🇩🇪Augsburg, Germany
Klinikum Bayreuth GmbH
🇩🇪Bayreuth, Germany
Facharztpraxis am VPH Bensberg, Onkologie und Hämatologie
🇩🇪Bergisch Gladbach, Germany
Onkologisches Versorgungszentrum Friedrichshain
🇩🇪Berlin, Germany
Praxiskooperation Bonn-Euskirchen
🇩🇪Bonn, Germany
Scroll for more (78 remaining)Onkologische Praxis im St. Marien-Krankenhaus🇩🇪Ahaus, Germany