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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Gwendoline Wicki
• Email: trials@swisscancerinstitute.ch
• Phone: +41 31 389 91 91

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.