Clinical trial · Interventional
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
NCT06114108CI-TRIAL-00107171salVagerecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer (NSCLC) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
| Stage IV | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiotherapy | Radiation | — | UNRESOLVED |
| Surgery | Other | — | UNRESOLVED |
| Systemic therapy alone or in combination with LAT (surgery and/or radiotherapy) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention group: Local consolidative treatment (LAT) & Systemic Therapy
- description
- 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.
- interventionNames
- Other: Systemic therapy alone or in combination with LAT (surgery and/or radiotherapy)
- Other: Surgery
- Radiation: Radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- Control group: Systemic Therapy
- description
- Patients of the control group will receive systemic anticancer treatment alone chemotherapy, chemo-immunotherapy, immunotherapy alone, or targeted treatment).
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.