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

NCT ID: NCT06953843

Last Updated: 2025-07-14

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

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

366 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-09

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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NSCLC Stage IV Without EGFR/ALK Mutation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

Group Type EXPERIMENTAL

Benmelstobart combined with chemotherapy

Intervention Type 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.

Group B

Group Type EXPERIMENTAL

Benmelstobart combined with chemotherapy

Intervention Type DRUG

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.

Group C

Group Type EXPERIMENTAL

Benmelstobart combined with chemotherapy

Intervention Type DRUG

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.

Group D

Group Type EXPERIMENTAL

Benmelstobart combined with chemotherapy

Intervention Type DRUG

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.

Group E

Group Type EXPERIMENTAL

Benmelstobart combined with chemotherapy

Intervention Type DRUG

After 4 cycles of treatment with Benmelstobart combined with chemotherapy, Benmelstobart is continued for maintenance treatment.

Group F

Group Type EXPERIMENTAL

Benmelstobart combined with Bevacizumab and chemotherapy

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Benmelstobart combined with chemotherapy

After 4 cycles of treatment with Benmelstobart combined with chemotherapy, Benmelstobart is continued for maintenance treatment.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Radiotherapy Radiotherapy Radiotherapy Radiotherapy Radiotherapy

Eligibility Criteria

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Inclusion Criteria

1. Non-small cell lung cancer confirmed by pathological histology.
2. More than 3 metastatic lesions.
3. No brain metastases or stable lesions.
4. Negative for driver genes (including EGFR, ALK, ROS, BRAF, MET, RET).
5. Performance status (PS) score of 0-1, with an expected survival period of more than 3 months.
6. Age between 18 and 75 years old.
7. Assessment by PET-CT (including FDG and FMISO, not mandatory).
8. No contraindications to immunotherapy and radiotherapy.
9. Signed the informed consent form.

Exclusion Criteria

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

1. Those with severe dysfunction of important vital organs (heart, liver, kidney).
2. Those accompanied by other malignant tumors.
3. Uncontrolled heart diseases or myocardial infarction within the past 6 months.
4. Those with a history of mental illness.
5. Other situations in which the researcher deems it inappropriate for the subject to participate in the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xinqiao Hospital of Chongqing

OTHER

Sponsor Role lead

Responsible Party

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Jianguo Sun

Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jianguo Sun, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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the second affiliated hospital of Army medical university

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jianguo Sun, MD

Role: CONTACT

86-13983155736

Facility Contacts

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jianguo Sun, Phd

Role: primary

023-68774490

Other Identifiers

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XQonc-023

Identifier Type: -

Identifier Source: org_study_id

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