Trial Title:
Trial Comparing Systemic Therapy Alone and With Local Ablative Treatment for Stage IV NSCL Cancer Patients
NCT ID:
NCT06114108
Condition:
Non-small Cell Lung Cancer (NSCLC)
Stage IV
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords:
Non-small cell lung cancer (NSCLC)
Local consolidative treatment (LAT)
patient-reported outcome measures (PROMs)
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Prospective, open label, randomized, controlled, multicenter interventional clinical
trial
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Systemic therapy alone or in combination with LAT (surgery and/or radiotherapy)
Description:
The 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.
Arm group label:
Control group: Systemic Therapy
Arm group label:
Intervention group: Local consolidative treatment (LAT) & Systemic Therapy
Other name:
Systemic therapy
Intervention type:
Other
Intervention name:
Surgery
Description:
Surgery
Arm group label:
Intervention group: Local consolidative treatment (LAT) & Systemic Therapy
Intervention type:
Radiation
Intervention name:
Radiotherapy
Description:
Radiotherapy
Arm group label:
Control group: Systemic Therapy
Arm group label:
Intervention group: Local consolidative treatment (LAT) & Systemic Therapy
Summary:
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.
Detailed description:
In this study, the aim is to find out whether, after a good response to standard therapy,
it is better if the main tumor and metastases are additionally removed by surgery and/or
radiation. This intervention is referred to as local ablative therapy (LAT). There is
evidence to suggest that this additional intervention may prolong the average time to
possible cancer recurrence (PFS: Progression-free survival) or lead to longer survival on
average. Therefore, the question is to know if these treatments prolong life, and if so,
by how much and with what implications. Currently, patients who respond to initial
standard therapy are not routinely offered LAT. If the results of this study are
positive, it will lead to a fundamental change in the current standard of practice.
The benefit of a therapy is not solely determined by the extension of PFS or overall
survival but also heavily influenced by how the therapy impacts patient's quality of
life. Medication side effects, pain, fatigue, nausea or extended hospital stays can
significantly diminish the perceived positive effects of a treatment from the patient's
viewpoint, even if it appears favorable from a medical standpoint. Therefore, the
assessment of quality of life through patient-reported outcome measures (PROMs) is a
central aspect of this study.
This study will enroll 128 patients from different Swiss hospitals, randomly assigning
them to either the intervention group (LAT) or a control group (standard therapy). The
study is expected to span approximately two years for each patient.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
Patients fulfilling all of the following inclusion criteria at screening may be enrolled
in the trial.
- The inclusion criteria are irrespective from the tumor burden at the time of primary
diagnosis before initiation of first line systemic therapy. Neurosurgical diagnostic
resection of one single CNS metastasis or laparoscopic resection of one adrenal
metastasis before trial inclusion is allowed.
- Adults (18 years or older)
- Tissue confirmed, pre-treatment clinical stage IV NSCLC
- ECOG performance status ≤ 1
- Patients responding after 3 cycles (4th bridging cycle up until randomization is
allowed) or 3 months of first line SoC systemic therapy with PR or SD in restaging
imaging, and presenting with (induced) oligometastatic or oligopersistent NSCLC
defined as a maximum of 5 residual extracranial, distant metastases
- Patients may have up to 5 cranial metastases in addition to the oligoresidual
extracranial metastases as long as they are amenable for radiotherapy or surgery.
- The primary tumor and all oligopersistent metastases must be amenable for radical
LAT (surgery or radiotherapy)
- Patients of reproductive age agree to use double contraception during the study
- Patient is able to understand trial procedures and is able/willing to adhere to
trial procedures as confirmed by signature
Exclusion Criteria:
The presence of any one of the following exclusion criteria at screening will lead to
exclusion of the participant:
- 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
- Patient is currently involved in another trial if either: interventional trial that
aims to improve survival, not permitted by other trial, would result in too much
patient burden
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Kantonspital Aarau
Address:
City:
Aarau
Zip:
5001
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Max Lacour, MD
Phone:
+41 62 838 45 10
Email:
max.lacour@ksa.ch
Investigator:
Last name:
Max Lacour, MD
Email:
Principal Investigator
Facility:
Name:
IOSI Ospedale Regionale di Bellinzona e Valli
Address:
City:
Bellinzona
Zip:
6500
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Patrizia Froesch, MD
Phone:
+41 91 811 48 40
Email:
patrizia.froesch@eoc.ch
Investigator:
Last name:
Patrizia Froesch, MD
Email:
Principal Investigator
Facility:
Name:
Kantonsspital Graubuenden
Address:
City:
Chur
Zip:
CH-7000
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Michael Thomas Mark, MD
Phone:
+41 (0)81 256 61 11
Email:
michael.mark@ksgr.ch
Investigator:
Last name:
Michael Thomas Mark, MD
Email:
Principal Investigator
Facility:
Name:
Hôpital Fribourgeois - Hôpital Cantonal
Address:
City:
Fribourg
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Alessandra Curioni-Fontecedro, Prof
Phone:
+41 26 306 22 60
Email:
alessandra.curioni-fontecedro@h-fr.ch
Investigator:
Last name:
Alessandra Curioni-Fontecedro, Prof
Email:
Principal Investigator
Facility:
Name:
Hôpitaux Universitaires Genève HUG
Address:
City:
Geneva
Zip:
1205
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Benoît Bédat, MD
Phone:
+41 22 372 78 84
Email:
benoit.bedat@hcuge.ch
Investigator:
Last name:
Benoît Bédat, MD
Email:
Principal Investigator
Facility:
Name:
Centre Hôspitalier Universitaire Vaudois CHUV
Address:
City:
Lausanne
Zip:
1011
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Thorsten Krüger, MD
Phone:
+41 21 314 24 02
Email:
thorsten.krueger@chuv.ch
Investigator:
Last name:
Thorsten Krüger, MD
Email:
Principal Investigator
Facility:
Name:
Luzerner Kantonsspital
Address:
City:
Luzern
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Fabrizio Minervini, MD
Phone:
+41 41 205 45 01
Email:
fabrizio.minervini@luks.ch
Investigator:
Last name:
Fabrizio Minervini, MD
Email:
Principal Investigator
Facility:
Name:
Universitätsspital Zürich
Address:
City:
Zürich
Zip:
8091
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Isabelle Schmitt-Opitz, Prof
Phone:
+41 44 255 92 99
Email:
isabelle.schmitt-opitz@usz.ch
Investigator:
Last name:
Isabelle Schmitt-Opitz, Prof
Email:
Principal Investigator
Start date:
December 21, 2023
Completion date:
November 1, 2027
Lead sponsor:
Agency:
Swiss Group for Clinical Cancer Research
Agency class:
Other
Source:
Swiss Group for Clinical Cancer Research
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06114108
