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NCT Number: 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

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.

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Key information

Conditions

NSCLC Stage IV Without EGFR/ALK Mutation

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

the second affiliated hospital of Army medical university

Chongqing, Chongqing Municipality, 400037, China

Location status: Recruiting

Location contact

jianguo Sun, Phd

CONTACT

[email protected]

023-68774490

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

benmelstobart combined with chemotherapy

Drug

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.

Other names: Radiotherapy

Benmelstobart combined with Bevacizumab and chemotherapy

Drug

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.

Other names: Radiotherapy

Primary outcomes

  1. 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

    To evaluate the efficacy of Benmelstobart plus different radiotherapy fractionation modes in non-small cell lung cancer (NSCLC) patients with multiple metastases, as measured by the remission rate of abscopal lesions according to RECIST v1.1

Secondary outcomes

  1. 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

    To evaluate the efficacy of Benmelstobart plus different radiotherapy fractionation modes in non-small cell lung cancer (NSCLC) patients with multiple metastases, as measured by progression-free survival rate according to RECIST v1.1

  2. OS

    Time frame: up to 5 years

    To evaluate the efficacy of Benmelstobart plus different radiotherapy fractionation modes in non-small cell lung cancer (NSCLC) patients with multiple metastases, as measured by by overall survival

  3. AE

    Time frame: From date of consent informed until 60 days after the last investigational product administration. Up to approximately 2 years

    The incidence of immune-related adverse events (irAEs) as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Study contacts

Contact information is provided by the study sponsor or research team.

Jianguo Sun, MD

CONTACT

[email protected]

86-13983155736

Sponsors and collaborators

Lead sponsor

Xinqiao Hospital of Chongqing

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 1, 2025
Registry last updated
Jul 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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