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Recruiting NCT06953843

Study on the Optimal Combination Pattern of the Combined Treatment of Radiotherapy and Immunotherapy for the Abscopal Effect in Non-Small Cell Lung Cancer (NSCLC) With Multiple Metastases

Phase II Interventional NSCLC Stage IV Without EGFR/ALK Mutation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Benmelstobart combined with chemotherapy, Benmelstobart combined with chemotherapy, Benmelstobart combined with chemotherapy, Benmelstobart combined with chemotherapy.
Who it may be relevant to
Registry conditions: NSCLC Stage IV Without EGFR/ALK Mutation. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

An Umbrella Trial of Combining Different Radiotherapy Fractionation Patterns With Immunotherapy for Multiple Metastases of Non-Small Cell Lung Cancer

Overview

This study aims to conduct a prospective, multicenter, umbrella clinical study to compare the abscopal effects of different radiotherapy fractionation patterns combined with Benmelstobart, and to explore an efficient and low-toxic treatment strategy for non-small cell lung cancer (NSCLC) with multiple metastases. The main objective is to explore and compare the control rates of abscopal lesions in NSCLC patients with multiple metastases when different radiotherapy fractionation patterns are combined with Benmelstobart.

Interventions

  • Drug Benmelstobart combined with chemotherapy
    After 4 cycles of treatment with Benmelstobart combined with chemotherapy, if there is no progression, the patient will receive the treatment of 6-10Gy\*3-6F plus Benmelstobart.
  • Drug Benmelstobart combined with chemotherapy
    After 4 cycles of treatment with Benmelstobart combined with chemotherapy, if there is no progression and the largest lesion measures between 3 cm and 5 cm, the patient will receive the treatment of 3 Gy \* 15 fractions plus Benmelstobart.
  • Drug Benmelstobart combined with chemotherapy
    After 4 cycles of treatment with Benmelstobart combined with chemotherapy, if there is no disease progression and the largest lesion is larger than 5 cm, the patient will receive treatment with Spatial Fractionated Radiotherapy Technique (SFRT) plus Benmelstobart.
  • Drug Benmelstobart combined with chemotherapy
    After 4 cycles of treatment with Benmelstobart combined with chemotherapy, if there is no disease progression, and when the largest lesion is ≤ 3 cm and the patient can maintain the radiotherapy position for 50 minutes, the patient will receive treatment with the hyperfractionated pulsed radiotherapy technique (0.5 Gy \* 16 \* 6 fractions) plus Benmelstobart.
  • Drug Benmelstobart combined with chemotherapy
    After 4 cycles of treatment with Benmelstobart combined with chemotherapy, Benmelstobart is continued for maintenance treatment.
  • Drug Benmelstobart combined with Bevacizumab and chemotherapy
    For eligible subjects who have developed resistance to EGFR-TKI, after 4 cycles of treatment with Benmelstobart combined with Bevacizumab and chemotherapy, if there is no disease progression, they will receive the treatment of 6-10Gy \* 3-6 fractions plus Benmelstobart.

Primary outcome measures

  • The remission rate of abscopal lesions [Time frame: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to approximately 2 years]
Secondary outcome measures (3)
  • PFS [Time frame: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to approximately 2 years]
  • OS [Time frame: up to 5 years]
  • AE [Time frame: From date of consent informed until 60 days after the last investigational product administration. Up to approximately 2 years]

Eligibility criteria

Inclusion criteria

  • Patient must meet all of the following inclusion criteria to be enrolled in this study:
  • Non-small cell lung cancer confirmed by pathological histology.
  • More than 3 metastatic lesions.
  • No brain metastases or stable lesions.
  • Negative for driver genes (including EGFR, ALK, ROS, BRAF, MET, RET).
  • Performance status (PS) score of 0-1, with an expected survival period of more than 3 months.
  • Age between 18 and 75 years old.
  • Assessment by PET-CT (including FDG and FMISO, not mandatory).
  • No contraindications to immunotherapy and radiotherapy.
  • Signed the informed consent form.

Exclusion criteria

  • Patients with any of the following criteria are not eligible for enrollment in this study:
  • Those with severe dysfunction of important vital organs (heart, liver, kidney).
  • Those accompanied by other malignant tumors.
  • Uncontrolled heart diseases or myocardial infarction within the past 6 months.
  • Those with a history of mental illness.
  • Other situations in which the researcher deems it inappropriate for the subject to participate in the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • the second affiliated hospital of Army medical university — Chongqing

Identifiers

NCT: NCT06953843 · XQonc-023

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗