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

NCT06947694 | Recruiting Phase 2

• 1 other identifier: XQonc-024
• Study Type: interventional
• Target: 427
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

NSCLC Stage IV Without EGFR/ALK Mutation

Outcome Measures

Primary Outcomes (1)

• The remission rate of abscopal lesions

  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.

  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

Secondary Outcomes (6)

• PFS

  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

• OS

  up to 5 years

• ORR

  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

• DOR

  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

• irAE

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

Study Arms (7)

Group A

EXPERIMENTAL

Drug: chemotherapy + PD-1 inhibitors

Group B

EXPERIMENTAL

Drug: chemotherapy + PD-1 inhibitors

Group C

EXPERIMENTAL

Drug: chemotherapy + PD-1 inhibitors

Group D

EXPERIMENTAL

Drug: chemotherapy + PD-1 inhibitors

Group E

EXPERIMENTAL

Drug: chemotherapy + PD-1 inhibitors

Group F

EXPERIMENTAL

Drug: chemotherapy + PD-1 inhibitors

Group G

EXPERIMENTAL

Drug: chemotherapy + PD-1 inhibitors

Interventions

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.

Also known as: Radiotherapy

Group A

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xinqiao Hospital of Chongqing: lead

Study Sites (1)

the second affiliated hospital of Army medical university

Chongqing, Chongqing Municipality, 400037, China

RECRUITING

MeSH Terms

Interventions

Drug Therapy; Immune Checkpoint Inhibitors; Radiotherapy

Intervention Hierarchy (Ancestors)

Therapeutics; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Study Officials

• Jianguo Sun, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianguo Sun, MD

CONTACT

023-68774490; sunjg09@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof

Study Record Dates

• First Submitted: April 20, 2025
• First Posted: April 27, 2025
• Study Start: July 2, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)