Lung Cancer Stage IV Clinical Trial
— Re-Induce 2Official title:
Re-induction of a Systemic Immune Response After Initial Response With Immune Therapy With Single-dose Radiotherapy in Metastatic or Locally Recurrent Lung Cancer: A Prospective Phase II Trial (Re-Induce 2)
Patients with metastatic non-small cell lung cancer (NSCLC) who after an initial response to immunotherapy of chemo-immunotherapy show diffuse disease progression are treated with chemotherapy, with a median PFS of about 3 months and a high incidence of important toxicity or by continuation of immune therapy when the growth rate of the tumours is low. In a previous study, it was showed that irradiating a single metastatic lesion and continuation of immune therapy resulted in a median PFS time was 4.9 months (95% CI, 3.0-7.0 months). At three months of follow-up, the PFS rate was 62.5%, at six months 37.5% and at 12 months 17.9%. The median OS for all patients was 14.9 months (95% CI, 12.2-21.5 months). Toxicity was hardly observed. This was obtained with a few fractions of radiotherapy. There is biological rationale to deliver this radiation in a single fraction of 10 Gy. Objective: The primary objective is to investigate if a single fraction of 10 Gy is not inferior to a more fractionated schedule, which would add to the convenience for the patient, even less toxicity and costs. Study design: Prospective, single-arm phase II trial. Study population: Patients with stage IV NSCLC who initially showed a partial or complete remission under immune therapy alone or concurrent immune therapy and chemotherapy and now show progressive disease according to RECIST 1.1 criteria. At least two different lesions should show progressive disease. Patients should be able to continue the same immune therapy (i.e. no adverse events grade 3 or more). Intervention: Patients continue the same immune therapy they already received and get radiotherapy to one progressing lesion. The lesion may or may not be symptomatic. The preferred radiotherapy dose is 10 Gy in 1 fraction, but other fractionation schedules (e.g. 24 Gy/ 3 fractions, 30 Gy/ 10 fractions, 20 Gy/ 5 fractions, 20-24 Gy / 1 fraction for stereotactic radiotherapy for brain metastases), including so-called isotoxic strategies are allowed if these are standard for a certain location or palliative indication in the body. Main study parameters/endpoints: Progression-free survival (PFS).
Status | Not yet recruiting |
Enrollment | 82 |
Est. completion date | December 1, 2026 |
Est. primary completion date | December 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Stage IV NSCLC - An initial partial or complete remission under immune therapy alone or concurrent immune therapy and chemotherapy - Subsequently progressive disease according to RECIST 1.1 criteria - Considered by the treating physician to be able to continue the same immune treatment as standard of care - At least two different lesions should show progressive disease - At least one progressing lesion should be eligible for radiation Exclusion Criteria: - Patients with any grade 3 or higher toxicity from previous therapy - Patients who are not eligible for continuation of the immune therapy according to standard practice - Corticosteroids in a dose above 10 mg prednisone or equivalent per day. Corticoids used as supportive therapy for systemic or radiotherapy are allowed |
Country | Name | City | State |
---|---|---|---|
Netherlands | Maastricht Radiation Oncology (Maastro) | Maastricht |
Lead Sponsor | Collaborator |
---|---|
Maastricht Radiation Oncology |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-free | Progression-free survival (PFS) | 3 months after radiotherapy | |
Secondary | Regression | Number of patients who show regression of the irradiated lesion | 3 months after radiotherapy | |
Secondary | Remission rate | Number of patients who show remission (RECIST 1.1) of the non-irradiated lesion(s) | 3 months after radiotherapy | |
Secondary | Toxicity | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0Toxicity (CTCAE 4.0) of this combination of remission and regression | 3 months after radiotherapy | |
Secondary | Overall survival | Overall survival (OS) | 3 months after radiotherapy | |
Secondary | PFS second course | PFS of patients who received a second course of radiotherapy at the time of disease progression | 3 months after radiotherapy | |
Secondary | Number | Number of patients who received a second course of radiotherapy at the time of disease progression | 3 months after radiotherapy | |
Secondary | Relation between the growth rate of the fastest growing metastasis in the 3 months preceding radiotherapy and PFS | Relation between the growth rate of the fastest growing metastasis in the 3 months preceding radiotherapy and PFS | 3 months after radiotherapy |
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