NSCLC Stage IV Without EGFR/ALK MutationPhase 2NCT06953843
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
A Phase 2 study testing Benmelstobart combined with chemotherapy and Benmelstobart combined with Bevacizumab and chemotherapy in people with NSCLC Stage IV Without EGFR/ALK Mutation, run by Xinqiao Hospital of Chongqing at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NSCLC Stage IV Without EGFR/ALK Mutation
- What is being tested?
- Benmelstobart combined with chemotherapy and Benmelstobart combined with Bevacizumab and chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 366 participants
- Where
- 1 siteChina
- Study dates
- 9 Jul 2025to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must meet all of the following inclusion criteria to be enrolled in this study:
- Non-small cell lung cancer confirmed by pathological histology.
- More than 3 metastatic lesions.
- No brain metastases or stable lesions.
- Negative for driver genes (including EGFR, ALK, ROS, BRAF, MET, RET).
- Performance status (PS) score of 0-1, with an expected survival period of more than 3 months.
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- Age between 18 and 75 years old.
- Assessment by PET-CT (including FDG and FMISO, not mandatory).
- No contraindications to immunotherapy and radiotherapy.
- Signed the informed consent form.
Who cannot join
- Patients with any of the following criteria are not eligible for enrollment in this study:
- Those with severe dysfunction of important vital organs (heart, liver, kidney).
- Those accompanied by other malignant tumors.
- Uncontrolled heart diseases or myocardial infarction within the past 6 months.
- Those with a history of mental illness.
- Other situations in which the researcher deems it inappropriate for the subject to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the second affiliated hospital of Army medical university
Chongqing, Chongqing Municipality, 400037
jianguo Sun, Phd, 023-68774490, sunjg09@aliyun.com
About this study
Official title: An Umbrella Trial of Combining Different Radiotherapy Fractionation Patterns With Immunotherapy for Multiple Metastases of Non-Small Cell Lung Cancer
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.
- Conditions
- NSCLC Stage IV Without EGFR/ALK Mutation
- Being tested
- Benmelstobart combined with chemotherapy, Benmelstobart combined with Bevacizumab and chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Benmelstobart combined with chemotherapyDrug
Also called Radiotherapy
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.
Benmelstobart combined with chemotherapyDrug
Also called Radiotherapy
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.
Benmelstobart combined with chemotherapyDrug
Also called Radiotherapy
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.
Benmelstobart combined with chemotherapyDrug
Also called Radiotherapy
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.
Benmelstobart combined with chemotherapyDrug
After 4 cycles of treatment with Benmelstobart combined with chemotherapy, Benmelstobart is continued for maintenance treatment.
Benmelstobart combined with Bevacizumab and chemotherapyDrug
Also called Radiotherapy
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Drug: Benmelstobart combined with chemotherapy |
| Group B | Experimental | Not described Receives: Drug: Benmelstobart combined with chemotherapy |
| Group C | Experimental | Not described Receives: Drug: Benmelstobart combined with chemotherapy |
| Group D | Experimental | Not described Receives: Drug: Benmelstobart combined with chemotherapy |
| Group E | Experimental | Not described Receives: Drug: Benmelstobart combined with chemotherapy |
| Group F | Experimental | Not described Receives: Drug: Benmelstobart combined with Bevacizumab and chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 outcomes (3)
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
Measured: 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
Measured: 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
Measured: From date of consent informed until 60 days after the last investigational product administration. Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start9 Jul 2025 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC Stage IV Without EGFR/ALK MutationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 366 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xinqiao Hospital of Chongqing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianguo Sun, Xinqiao Hospital of Chongqing
- Investigators
- Jianguo Sun, MD, Principal investigator, the second affiliated hospital of Army medical university, Chongqing, Chongqing 40037 Recruiting
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06953843
- Sponsor's protocol ID
- XQonc-023
- Status last verified
- Jul 2025
- First submitted
- 20 Apr 2025
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Umbrella Trial of Combining Different Radiotherapy Fractionation Patterns With Immunotherapy for Multiple Metastases of Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06953843
- Acronym / sponsor ID
- XQonc-023
- Conditions
- NSCLC Stage IV Without EGFR/ALK Mutation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 366 participants (estimated)
- Lead sponsor
- Xinqiao Hospital of ChongqingUniversity, hospital or other
- Study start
- 9 Jul 2025 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 1 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Benmelstobart combined with chemotherapy |
| Group B | Experimental | Drug: Benmelstobart combined with chemotherapy |
| Group C | Experimental | Drug: Benmelstobart combined with chemotherapy |
| Group D | Experimental | Drug: Benmelstobart combined with chemotherapy |
| Group E | Experimental | Drug: Benmelstobart combined with chemotherapy |
| Group F | Experimental | Drug: Benmelstobart combined with Bevacizumab and chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient must meet all of the following inclusion criteria to be enrolled in this study:
Key exclusion criteria (6 listed)
- Patients with any of the following criteria are not eligible for enrollment in this study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Benmelstobart combined with chemotherapyAlso: RadiotherapyAfter 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. | Drug | Group A |
| Benmelstobart combined with chemotherapyAlso: RadiotherapyAfter 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. | Drug | Group B |
| Benmelstobart combined with chemotherapyAlso: RadiotherapyAfter 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. | Drug | Group C |
| Benmelstobart combined with chemotherapyAlso: RadiotherapyAfter 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. | Drug | Group D |
| Benmelstobart combined with chemotherapyAfter 4 cycles of treatment with Benmelstobart combined with chemotherapy, Benmelstobart is continued for maintenance treatment. | Drug | Group E |
| Benmelstobart combined with Bevacizumab and chemotherapyAlso: RadiotherapyFor 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. | Drug | Group F |
Primary outcome
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 approximately 2 years
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
3 secondary outcomes
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 approximately 2 years
OS
Time frame: up to 5 years
AE
Time frame: From date of consent informed until 60 days after the last investigational product administration. Up to approximately 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jianguo Sun, MD principal investigator
the second affiliated hospital of Army medical university, Chongqing, Chongqing 40037 Recruiting
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Benmelstobart combined with chemotherapy and Benmelstobart combined with Bevacizumab and chemotherapy in people with NSCLC Stage IV Without EGFR/ALK Mutation, run by Xinqiao Hospital of Chongqing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jianguo Sun, MD (86-13983155736, sunjg09@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 approximately 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.