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

Plain English Summary

Trial Comparing Systemic Therapy Alone and With Local Ablative Treatment for Stage IV NSCL Cancer Patients is a Not Applicable clinical trial sponsored by Swiss Cancer Institute studying Non-small Cell Lung Cancer (NSCLC), Stage IV. This trial tests if adding surgery or radiation to standard lung cancer treatment improves outcomes for patients with advanced (Stage IV) non-small cell lung cancer. It is for adults (18+) with Stage IV non-small cell lung cancer that has spread but has a limited number of metastases, and who have responded well to initial standard treatment. Participation involves receiving standard treatment, and then potentially undergoing surgery and/or radiation to remaining tumors and metastases. Patients will be randomly assigned to receive either standard treatment alone or standard treatment plus local treatment. Alternatives include standard systemic therapy (chemotherapy, immunotherapy, targeted therapy) alone, or palliative care if standard treatments are not tolerated or effective. The trial aims to enroll 128 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you are 18 or older, have confirmed Stage IV non-small cell lung cancer, and your cancer has responded to initial treatment with limited remaining tumors. You cannot join if you have serious health issues that would make local treatment unsafe, unresolved complications from previous treatment, or certain widespread metastatic locations. Women who are pregnant or breastfeeding cannot participate. Patients must be able to understand and follow trial procedures. This trial is studying Non-small Cell Lung Cancer (NSCLC), Stage IV, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

Progression-Free Survival means how long patients live without their cancer getting worse, which is a key measure of how well the treatment is working. The specific primary outcome measures are: Progression-Free Survival (PFS) l in the Local Ablative Therapy (LAT) arm is superior to Standard of Care (SoC) (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 (6 months after randomization). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial addresses a gap in treating advanced lung cancer by investigating if local treatments can improve outcomes for patients with limited spread after initial systemic therapy. This research targets Non-small Cell Lung Cancer (NSCLC), Stage IV, where improved treatment options are needed.

Investor Insight

This trial targets a significant portion of advanced lung cancer patients, a large market where improved treatment strategies are sought, suggesting potential for significant clinical impact if succes

Is This Trial Right for Me?

Ask your doctor if your cancer has a limited number of metastases and if you might be a candidate for this trial. Understand that you will be randomly assigned to one of two groups: standard treatment alone or standard treatment plus local treatment (surgery/radiation). Be prepared for regular clinic visits for treatment, imaging scans, and to report any side effects or changes in your health. This trial is currently recruiting participants. The trial is being conducted at 7 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 128 participants

Interventions

• OTHER: Systemic 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.
• OTHER: Surgery — Surgery
• RADIATION: Radiotherapy — Radiotherapy

Primary Outcomes

• Progression-Free Survival (PFS) l in the Local Ablative Therapy (LAT) arm is superior to Standard of Care (SoC) (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 (6 months after randomization)

Secondary Outcomes

• 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)

Full 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.

Trial Locations

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

Frequently Asked Questions

Related Conditions

• Non-small Cell Lung Cancer
• Stage IV Lung Cancer
• Metastatic Lung Cancer
• Lung Adenocarcinoma
• Squamous Cell Lung Cancer
• Chemotherapy
• Immunotherapy
• Targeted Therapy
• Radiation Therapy
• Surgical Oncology

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