Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06947694

A Study on Exploring the Abscopal Effect Induced by Different Radioimmunotherapy Combination Patterns in the Treatment of Non-Small Cell Lung Cancer With Multiple Metastases

It is planned to carry out a multicenter umbrella study to find the optimal organ combination and the best radioimmunotherapy combination pattern, so as to improve the survival of NSCLC patients with multiple metastases. At the same time, by using multimodal omics data, machine learning will be employed to construct a prediction model for the abscopal effect, and explore the immunoregulation of organ-specific radiotherapy and biomarkers of the abscopal effect. The main objective is to find the optimal organ combination and the best radioimmunotherapy combination pattern.

Recruiting

Interested in participating?

Request Info

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 diagnosed initially through pathological histology.
  • There are 3-6 metastatic lesions.
  • No brain metastasis or the lesions are stable.
  • Negative for driver genes (including EGFR, ALK, ROS, BRAF, MET, RET genes. Note: The above English terms are all gene names).
  • ECOG (Eastern Cooperative Oncology Group) score: 0-1 point, with an expected, survival period of more than 3 months.
  • Aged between 18 and 75 years old.
  • Evaluated by PET-CT (including FDG and FMISO, not mandatory).
  • No contraindications for immunotherapy and radiotherapy.
  • The informed consent form has been signed.

Exclusion criteria

  • Patients with any of the following criteria are not eligible for enrollment in this study:
  • Those with severe dysfunction of vital organs (heart, liver, kidney).
  • Those accompanied by other malignant tumors.
  • Those with uncontrolled heart diseases or having experienced a myocardial infarction within the past six months.
  • Those with a history of mental illness.
  • And other situations in which the researchers deem it inappropriate for the subjects to participate in the study.

Treatment and study plan

chemotherapy + PD-1 inhibitors

Drug

The patient receives 4 cycles of treatment with "chemotherapy + PD-1 inhibitors". If there is no disease progression, the patient will receive radiotherapy (radiation dose: 5-8Gy * 3-10 fractions) for pulmonary lesions, lymph node lesions and visceral lesions in combination with the PD-1 inhibitors . During the follow-up, the PD-1 inhibitors will be maintained until the disease progresses or the toxicity is intolerable. The maximum duration of immunotherapy shall not exceed 2 years.

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 2 approximately years

    The remission rate of abscopal lesions. Immunotherapy is administered within less than 1 week after the start of radiotherapy. The time point for determining the abscopal effect is set as ≤ 4 cycles of immunotherapy. The assessment is carried out in accordance with the RECIST 1.1 (Appendix 1) and iPERCIST criteria.

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 2 approximately years

  2. OS

    Time frame: up to 5 years

  3. ORR

    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 2 approximately years

  4. DOR

    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 2 approximately years

  5. irAE

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

    Adverse reactions related to immunotherapy

  6. QoF

    Time frame: up to 2 years

Study contacts

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

Jianguo Sun, MD

CONTACT

[email protected]

023-68774490

Sponsors and collaborators

Lead sponsor

Xinqiao Hospital of Chongqing

Other

Registry information

Official study title

A Prospective, Multicenter, Umbrella Design Clinical Study on the Abscopal Effect Induced by Different Radioimmunotherapy Combination Patterns in the Treatment of Non-Small Cell Lung Cancer With Multiple Metastases

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 27, 2025
Registry last updated
Jul 22, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.