Re-induction of a Systemic Immune Response in Metastatic or Locally Recurrent Lung Cancer

NCT06024941 | Withdrawn Phase 2 DMC

• 1 other identifier: Re-Induce 2
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Lung Cancer Stage IV

Outcome Measures

Primary Outcomes (1)

• Progression-free

  Progression-free survival (PFS)

  3 months after radiotherapy

Secondary Outcomes (7)

• Regression

  3 months after radiotherapy

• Remission rate

  3 months after radiotherapy

• Toxicity

  3 months after radiotherapy

• Overall survival

  3 months after radiotherapy

• PFS second course

  3 months after radiotherapy

Study Arms (1)

Radiation

EXPERIMENTAL

Radiation to one progressive lesion

Radiation: Radiation

Interventions

Radiation RADIATION

Radiation to one or more progressive lesions. Preferably 1x10Gy, but also 3x8Gy, 10x 3Gy, 5x4Gy or 1x20-24Gy is possible.

Radiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht Radiation Oncology: lead

Study Sites (1)

Maastricht Radiation Oncology (Maastro)

Maastricht, 6229 ET, Netherlands

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Radiation

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Officials

• Dirk De Ruysscher, MD, PhD

  Maastro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: September 6, 2023
• Study Start: December 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-03

Locations

NL (1)