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Clinical Trial NCT06953843 for NSCLC Stage IV Without EGFR/ALK Mutation is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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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 Phase 2 366 Immunotherapy

Recruiting
Clinical Trial NCT06953843 is designed to study Treatment for NSCLC Stage IV Without EGFR/ALK Mutation. It is a Phase 2 interventional study that is recruiting, having started on July 9, 2025, with plans to enroll 366 participants. Led by Xinqiao Hospital of Chongqing, it is expected to complete by December 31, 2027. The latest data from ClinicalTrials.gov was last updated on July 14, 2025.
Brief Summary
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...Show More
Official Title

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

Conditions
NSCLC Stage IV Without EGFR/ALK Mutation
Other Study IDs
  • XQonc-023
NCT ID Number
NCT06953843
Start Date (Actual)
2025-07-09
Last Update Posted
2025-07-14
Completion Date (Estimated)
2027-12-31
Enrollment (Estimated)
366
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
Non-Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalGroup A
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.
ExperimentalGroup B
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.
ExperimentalGroup C
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.
ExperimentalGroup D
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.
ExperimentalGroup E
Benmelstobart combined with chemotherapy
After 4 cycles of treatment with Benmelstobart combined with chemotherapy, Benmelstobart is continued for maintenance treatment.
ExperimentalGroup F
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.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
The remission rate of abscopal lesions
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
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
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
PFS
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
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
OS
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
up to 5 years
AE
The incidence of immune-related adverse events (irAEs) as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
From date of consent informed until 60 days after the last investigational product administration. Up to approximately 2 years
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All

  • Patient must meet all of the following inclusion criteria to be enrolled in this study:

    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.

  • 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.
Xinqiao Hospital of Chongqing logoXinqiao Hospital of Chongqing
Study Responsible Party
Jianguo Sun, Principal Investigator, Prof, Xinqiao Hospital of Chongqing
Study Central Contact
Contact: Jianguo Sun, MD, 86-13983155736, [email protected]
1 Study Locations in 1 Countries

Chongqing Municipality

the second affiliated hospital of Army medical university, Chongqing, Chongqing Municipality, 400037, China
jianguo Sun, Phd, Contact, 023-68774490, [email protected]
Recruiting