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

NCT06114108 | Recruiting DMC

• 1 other identifier: salVage
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 7

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.

Conditions

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

Keywords

Non-small cell lung cancer (NSCLC); Local consolidative treatment (LAT); patient-reported outcome measures (PROMs)

Outcome Measures

Primary Outcomes (2)

• 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.

  up to 24 months after randomization

• 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.

  6 months after randomization

Secondary Outcomes (5)

• Patients undergoing LAT maintain Quality of Life (QoL)

  up to 24 months after randomization

• To assess safety and tolerability of the LAT strategy as compared to standard of care

  from randomization until 30 days after last intervention

• To compare quality-adjusted life years

  up to 24 months after randomization

• To evaluate the economic impact of the LAT approach

  from signing informed consent until 24 months after randomization

• To assess the response of primary tumor and metastases to systemic treatment alone and in combination with LAT (according to (i)RECIST criteria)

  from intervention until 24 month after randomization

Study Arms (2)

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

EXPERIMENTAL

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.

Other: Systemic therapy alone or in combination with LAT (surgery and/or radiotherapy); Other: Surgery; Radiation: Radiotherapy

Control group: Systemic Therapy

ACTIVE COMPARATOR

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

Other: Systemic therapy alone or in combination with LAT (surgery and/or radiotherapy); Radiation: Radiotherapy

Interventions

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

Also known as: Systemic therapy

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

Surgery OTHER

Surgery

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

Radiotherapy RADIATION

Radiotherapy

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 a trial that either does not permit participation in other trials or would result in excessive patient burden if another trial were joined. In such cases, the co-investigators' team and the Patient Advisory Board will decide on participation on an individual basis.

Sponsors & Collaborators

• Swiss Cancer Institute: lead

Study Sites (7)

Kantonspital Aarau

Aarau, 5001, Switzerland

RECRUITING

IOSI Ospedale Regionale di Bellinzona e Valli

Bellinzona, 6500, Switzerland

RECRUITING

Kantonsspital Graubuenden

Chur, CH-7000, Switzerland

RECRUITING

Hôpital Fribourgeois - Hôpital Cantonal

Fribourg, Switzerland

RECRUITING

Hôpitaux Universitaires Genève HUG

Geneva, 1205, Switzerland

RECRUITING

Luzerner Kantonsspital

Lucerne, Switzerland

RECRUITING

Universitätsspital Zürich

Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Surgical Procedures, Operative; Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Isabelle Schmitt-Opitz, Prof

  Universitätsspital Zürich

  STUDY DIRECTOR

Central Study Contacts

Gwendoline Wicki

CONTACT

+41 31 389 91 91; trials@swisscancerinstitute.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, open label, randomized, controlled, international, multicenter interventional clinical trial

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: November 2, 2023
• Study Start: December 21, 2023
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (7)