Trial Comparing Systemic Therapy Alone and With Local Ablative Treatment for Stage IV NSCL Cancer Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSwiss Cancer Institute
About this trial
Unfortunately, most patients are already at a very advanced stage when they are diagnosed with lung cancer, i.e. the cancer has already spread outside the lungs forming metastases. The current standard of care therapy at this advanced stage of lung cancer includes systemic anti-cancer therapy such as chemotherapy, immunotherapy to boost the body's immune response, or targeted therapy that directly hinders tumor growth. In this study, the aim is to find out whether it is better if, after a good response to the standard therapy, the remains of main tumor and the metastases are additionally treated by surgery and/or radiation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The inclusion criteria are irrespective from the tumor burden at the time of primary diagnosis before initiation of first line systemic therapy. Treatment of brain metastases upfront or after an induction phase of standard systemic therapy is done according to the standard practice of the treating center.
Adults (18 years or older)
Tissue confirmed, pre-treatment clinical stage IV NSCLC
ECOG performance status ≤ 1
Disqualifiers
Serious concomitant disorder that would compromise patient safety during LAT
Unresolved complications from initial systemic anticancer treatment, higher than CTCAE grade 2
Metastatic locations such as malignant ascites, malignant pleural or malignant pericardial effusion, diffuse lymphangiosis of skin or lung, diffuse bone marrow metastasis, abdominal masses/abdominal organomegaly, identified by physical exam that is not measurable by reproducible imaging techniques, leptomeningeal carcinomatosis
Women who are pregnant or breast feeding
Trial design
Design model
Parallel
Treatments tested in this trial
Systemic therapy alone or in combination with LAT (surgery and/or radiotherapy)
Other interventionThe choice of LAT intervention for the primary tumor and all metastases (surgery or SBRT) and the sequence of the treatment (primary tumor vs metastases) will be decided at the local MDT according to the medical need and patient counseling during interdisciplinary clinic visits.
Surgery
Other interventionSurgery
Radiotherapy
RadiationRadiotherapy
Treatment groups
128 Participants
are divided into 2 treatment groupsGroup A: Intervention group: Local consolidative treatment (LAT) & Systemic TherapyExperimental treatment 3 interventions
Group B: Control group: Systemic TherapyActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Progression-Free Survival (PFS) l in the Local Ablative Therapy (LAT) arm is superior to Standard of Care (SoC)
Progression free survival (PFS) will be assessed by regular clinical examinations of the patients and based on imaging modalities such as (PET)-CT scans and brain MRIs.
Time frame
up to 24 months after randomization2
Quality of life (QoL) in the LAT arm is non-inferior to the control arm as measured with the European Quality of Life 5 Dimensions 3 Level (EQ-5D-5L) questionnaire-based score at 6 months after randomization
To show that QoL in the LAT arm is non-inferior to the control arm, mobility the European Quality of Life 5 Dimensions 3 Level (EQ-5D-5L) questionnaire will be used. The questionnaire uses an 1 (no problem) to 5 (extreme problems) scale.
Time frame
6 months after randomizationSecondary outcomes
1
Patients undergoing LAT maintain Quality of Life (QoL)
Patients undergoing LAT maintain Quality of Life (QoL) as measured by using the EQ-5D-5L on different time points of the trial.
Time frame
up to 24 months after randomization2
To assess safety and tolerability of the LAT strategy as compared to standard of care
Safety to study interventions will be evaluated by measuring counts of serious adverse events from randomization until 30 days after last intervention or progression, whichever occurs first. Serious adverse events will be evaluated based on CTCAE v5.0.from randomization up until 30 days after last intervention.
Time frame
from randomization until 30 days after last intervention3
To compare quality-adjusted life years
Quality-adjusted life years will be calculated based on the EQ-5D-5L scores and compared between treatment groups, as accrued during the trial observation period across all time points
Time frame
up to 24 months after randomization4
To evaluate the economic impact of the LAT approach
The economic impact of the LAT approach will be calculated based on the costs of the LAT intervention and on the costs of healthcare utilization outside of the hospital. For the calculation of healthcare utilization costs, patients will be asked on scheduled visits about the healthcare services they have been using outside of the hospital.
Time frame
from signing informed consent until 24 months after randomizationSponsors and contacts
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Source ClinicalTrials.gov