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

NCT ID: NCT06947694

Last Updated: 2025-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

427 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-02

Study Completion Date

2027-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

NSCLC Stage IV Without EGFR/ALK Mutation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group A

Group Type EXPERIMENTAL

chemotherapy + PD-1 inhibitors

Intervention Type 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.

Group B

Group Type EXPERIMENTAL

chemotherapy + PD-1 inhibitors

Intervention Type 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: 5-8 Gy × 3-10 fractions) for pulmonary lesions, lymph node lesions and other lesions in combination with the PD-1 inhibitors. During the follow-up, the PD-1 inhibitors will be continued until the disease progresses or the toxicity becomes intolerable. The maximum duration of immunotherapy shall not exceed 2 years.

Group C

Group Type EXPERIMENTAL

chemotherapy + PD-1 inhibitors

Intervention Type 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 bone metastatic lesions in combination with the PD-1 inhibitors . During the follow-up, the PD-1 inhibitors will be continued until the disease progresses or the toxicity becomes intolerable. The maximum duration of immunotherapy shall not exceed 2 years.

Group D

Group Type EXPERIMENTAL

chemotherapy + PD-1 inhibitors

Intervention Type 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: 5-8 Gy × 3-10 fractions) for pulmonary lesions, visceral lesions and other 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 becomes intolerable. The maximum duration of immunotherapy shall not exceed 2 years.

Group E

Group Type EXPERIMENTAL

chemotherapy + PD-1 inhibitors

Intervention Type 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: 5-8 Gy × 3-10 fractions) for pulmonary lesions, visceral lesions and bone metastatic lesions in combination with the PD-1 inhibitors. During the follow-up, the PD-1 inhibitors will be continued until the disease progresses or the toxicity becomes intolerable. The maximum duration of immunotherapy shall not exceed 2 years.

Group F

Group Type EXPERIMENTAL

chemotherapy + PD-1 inhibitors

Intervention Type 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: 5-8 Gy × 3-10 fractions) for lymph node lesions, visceral lesions and other lesions in combination with the PD-1 inhibitors. During the follow-up, the PD-1 inhibitors will be continued until the disease progresses or the toxicity becomes intolerable. The maximum duration of immunotherapy shall not exceed 2 years.

Group G

Group Type EXPERIMENTAL

chemotherapy + PD-1 inhibitors

Intervention Type 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: 5-8 Gy × 3-10 fractions) for lymph node lesions, visceral lesions and other lesions in combination with the PD-1 inhibitors. During the follow-up, the PD-1 inhibitors will be continued until the disease progresses or the toxicity becomes intolerable. The maximum duration of immunotherapy shall not exceed 2 years.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

chemotherapy + PD-1 inhibitors

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.

Intervention Type DRUG

chemotherapy + PD-1 inhibitors

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: 5-8 Gy × 3-10 fractions) for pulmonary lesions, lymph node lesions and other lesions in combination with the PD-1 inhibitors. During the follow-up, the PD-1 inhibitors will be continued until the disease progresses or the toxicity becomes intolerable. The maximum duration of immunotherapy shall not exceed 2 years.

Intervention Type DRUG

chemotherapy + PD-1 inhibitors

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 bone metastatic lesions in combination with the PD-1 inhibitors . During the follow-up, the PD-1 inhibitors will be continued until the disease progresses or the toxicity becomes intolerable. The maximum duration of immunotherapy shall not exceed 2 years.

Intervention Type DRUG

chemotherapy + PD-1 inhibitors

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: 5-8 Gy × 3-10 fractions) for pulmonary lesions, visceral lesions and other 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 becomes intolerable. The maximum duration of immunotherapy shall not exceed 2 years.

Intervention Type DRUG

chemotherapy + PD-1 inhibitors

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: 5-8 Gy × 3-10 fractions) for pulmonary lesions, visceral lesions and bone metastatic lesions in combination with the PD-1 inhibitors. During the follow-up, the PD-1 inhibitors will be continued until the disease progresses or the toxicity becomes intolerable. The maximum duration of immunotherapy shall not exceed 2 years.

Intervention Type DRUG

chemotherapy + PD-1 inhibitors

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: 5-8 Gy × 3-10 fractions) for lymph node lesions, visceral lesions and other lesions in combination with the PD-1 inhibitors. During the follow-up, the PD-1 inhibitors will be continued until the disease progresses or the toxicity becomes intolerable. The maximum duration of immunotherapy shall not exceed 2 years.

Intervention Type DRUG

chemotherapy + PD-1 inhibitors

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: 5-8 Gy × 3-10 fractions) for lymph node lesions, visceral lesions and other lesions in combination with the PD-1 inhibitors. During the follow-up, the PD-1 inhibitors will be continued until the disease progresses or the toxicity becomes intolerable. The maximum duration of immunotherapy shall not exceed 2 years.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Radiotherapy Radiotherapy Radiotherapy Radiotherapy Radiotherapy Radiotherapy Radiotherapy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Patients with any of the following criteria are not eligible for enrollment in this study:

1. Those with severe dysfunction of vital organs (heart, liver, kidney).
2. Those accompanied by other malignant tumors.
3. Those with uncontrolled heart diseases or having experienced a myocardial infarction within the past six months.
4. Those with a history of mental illness.
5. And other situations in which the researchers deem it inappropriate for the subjects to participate in the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Xinqiao Hospital of Chongqing

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jianguo Sun

prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jianguo Sun, MD

Role: PRINCIPAL_INVESTIGATOR

the second affiliated hospital of Army medical university, Chongqing, Chongqing 40037 Recruiting

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

the second affiliated hospital of Army medical university

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jianguo Sun, MD

Role: CONTACT

023-68774490

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

jianguo Sun, Phd

Role: primary

023-68774490

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

XQonc-024

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.