RecruitingNot ApplicableNCT06114108

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

Phase III Randomized Controlled Trial Comparing Maintenance Systemic Therapy Alone With Systemic Therapy Plus Local Ablative Treatment for Patients With Advanced Stage IV Non-small Cell Lung Cancer

Sponsor

Swiss Cancer Institute

Enrollment

128 participants

Start Date

Dec 21, 2023

Study Type

INTERVENTIONAL

Conditions

Non-small Cell Lung Cancer (NSCLC)Stage IV

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria8

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 Criteria5

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

Interventions

OTHERSystemic 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.

OTHERSurgery

Surgery

RADIATIONRadiotherapy

Radiotherapy