Trial Comparing Systemic Therapy Alone and With Local Ablative Treatment for Stage IV NSCL Cancer Patients

NCT ID: NCT06114108

Last Updated: 2025-02-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-21
• Study Completion Date: 2027-11-01

Brief 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.

Conditions

Non-small Cell Lung Cancer (NSCLC); Stage IV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention group: Local consolidative treatment (LAT) & Systemic Therapy

All patients undergo standard of care (SoC) first-line systemic therapy according to the results of the molecular analysis obtained from the diagnostic biopsy, as per standard of the respective center.

Patients will undergo additional complete surgical resection of the primary tumor with mediastinal lymph node sampling or radical radiotherapy (preferred stereotactic body radiotherapy (SBRT) to the primary tumor. Surgery and/or SBRT to the metastases will be performed before or after the treatment of the primary tumor according to the clinical need. Thereafter, the treatment will be followed by systemic anticancer treatment as SoC.

Group Type: EXPERIMENTAL

Systemic therapy alone or in combination with LAT (surgery and/or radiotherapy)

Intervention Type: OTHER

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.

Surgery

Intervention Type: OTHER

Surgery

Radiotherapy

Intervention Type: RADIATION

Radiotherapy

Control group: Systemic Therapy

Patients of the control group will receive systemic anticancer treatment alone chemotherapy, chemo-immunotherapy, immunotherapy alone, or targeted treatment).

Group Type: ACTIVE_COMPARATOR

Systemic therapy alone or in combination with LAT (surgery and/or radiotherapy)

Intervention Type: OTHER

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.

Radiotherapy

Intervention Type: RADIATION

Radiotherapy

Interventions

Systemic therapy alone or in combination with LAT (surgery and/or radiotherapy)

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.

Intervention Type: OTHER

Surgery

Surgery

Intervention Type: OTHER

Radiotherapy

Radiotherapy

Intervention Type: RADIATION

Other Intervention Names

Systemic therapy

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Swiss Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Isabelle Schmitt-Opitz, Prof

Role: STUDY_DIRECTOR

Universitätsspital Zürich

Locations

Kantonspital Aarau

Aarau, , Switzerland

Site Status: RECRUITING

IOSI Ospedale Regionale di Bellinzona e Valli

Bellinzona, , Switzerland

Site Status: RECRUITING

Kantonsspital Graubuenden

Chur, , Switzerland

Site Status: RECRUITING

Hôpital Fribourgeois - Hôpital Cantonal

Fribourg, , Switzerland

Site Status: RECRUITING

Hôpitaux Universitaires Genève HUG

Geneva, , Switzerland

Site Status: RECRUITING

Luzerner Kantonsspital

Lucerne, , Switzerland

Site Status: RECRUITING

Universitätsspital Zürich

Zurich, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Gwendoline Wicki

Role: CONTACT

trials@sakk.ch

+41 31 389 91 91

Facility Contacts

Max Lacour, MD

Role: primary

max.lacour@ksa.ch

+41 62 838 45 10

Patrizia Froesch, MD

Role: primary

patrizia.froesch@eoc.ch

+41 91 811 48 40

Michael Thomas Mark, MD

Role: primary

michael.mark@ksgr.ch

+41 (0)81 256 61 11

Alessandra Curioni-Fontecedro, Prof

Role: primary

alessandra.curioni-fontecedro@h-fr.ch

+41 26 306 22 60

Benoît Bédat, MD

Role: primary

benoit.bedat@hcuge.ch

+41 22 372 78 84

Fabrizio Minervini, MD

Role: primary

fabrizio.minervini@luks.ch

+41 41 205 45 01

Isabelle Schmitt-Opitz, Prof

Role: primary

isabelle.schmitt-opitz@usz.ch

+41 44 255 92 99

Other Identifiers

salVage

Identifier Type: -

Identifier Source: org_study_id