Comparing systemic therapy alone versus with local treatment for advanced lung cancer

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

This study is testing if adding local treatments like surgery or radiation to standard therapy can help people with advanced lung cancer live longer and feel better after their initial treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 128 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Swiss Cancer Institute (other)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 7 sites (Aarau and 6 other locations)
• Trial ID: NCT06114108 on ClinicalTrials.gov

What this trial studies

This study investigates whether adding local ablative therapy (LAT), such as surgery or radiation, to standard systemic therapy improves outcomes for patients with stage IV non-small cell lung cancer (NSCLC) who have responded well to initial treatment. The trial will enroll 128 patients from various Swiss hospitals, randomly assigning them to receive either standard therapy alone or standard therapy combined with LAT. The primary focus is on progression-free survival and overall survival, while also assessing the impact on patients' quality of life through patient-reported outcome measures (PROMs). If successful, this study could change the current treatment approach for advanced NSCLC.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with tissue-confirmed stage IV NSCLC who have shown a positive response to initial systemic therapy.

Not a fit: Patients with extensive metastases beyond the defined limits or those not responding to initial therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved survival rates and quality of life for patients with advanced lung cancer.

How similar studies have performed: Other studies have suggested potential benefits of local ablative treatments in similar contexts, but this specific approach is being tested for the first time in this patient population.

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. 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
* 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 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.

Where this trial is running

Aarau and 6 other locations

• Kantonspital Aarau — Aarau, Switzerland (RECRUITING)
• IOSI Ospedale Regionale di Bellinzona e Valli — Bellinzona, Switzerland (RECRUITING)
• Kantonsspital Graubuenden — Chur, Switzerland (RECRUITING)
• Hôpital Fribourgeois - Hôpital Cantonal — Fribourg, Switzerland (RECRUITING)
• Hôpitaux Universitaires Genève HUG — Geneva, Switzerland (RECRUITING)
• Luzerner Kantonsspital — Lucerne, Switzerland (RECRUITING)
• Universitätsspital Zürich — Zurich, Switzerland (RECRUITING)

Study contacts

• Study coordinator: Gwendoline Wicki

Conditions: Non-small Cell Lung Cancer, Stage IV, Non-small cell lung cancer, Local consolidative treatment, patient-reported outcome measures