NSCLC Stage IV Without EGFR/ALK MutationPhase 2NCT06947694
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
A Phase 2 study testing chemotherapy + PD-1 inhibitors in people with NSCLC Stage IV Without EGFR/ALK Mutation, run by Xinqiao Hospital of Chongqing at 1 site in China.
Trial 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. 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?
- chemotherapy + PD-1 inhibitors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 427 participants
- Where
- 1 siteChina
- Study dates
- 2 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 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.
Show all 10Show fewer
- 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.
Who cannot join
- 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.
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: A Prospective, Multicenter, Umbrella Design Clinical Study on the Abscopal Effect Induced by Different Radioimmunotherapy Combination Patterns in the Treatment of Non-Small Cell Lung Cancer With Multiple Metastases
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
- Being tested
- chemotherapy + PD-1 inhibitors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chemotherapy + PD-1 inhibitorsDrug
Also called Radiotherapy
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.
chemotherapy + PD-1 inhibitorsDrug
Also called Radiotherapy
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.
chemotherapy + PD-1 inhibitorsDrug
Also called Radiotherapy
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.
chemotherapy + PD-1 inhibitorsDrug
Also called Radiotherapy
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.
chemotherapy + PD-1 inhibitorsDrug
Also called Radiotherapy
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.
chemotherapy + PD-1 inhibitorsDrug
Also called Radiotherapy
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.
chemotherapy + PD-1 inhibitorsDrug
Also called Radiotherapy
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Drug: chemotherapy + PD-1 inhibitors |
| Group B | Experimental | Not described Receives: Drug: chemotherapy + PD-1 inhibitors |
| Group C | Experimental | Not described Receives: Drug: chemotherapy + PD-1 inhibitors |
| Group D | Experimental | Not described Receives: Drug: chemotherapy + PD-1 inhibitors |
| Group E | Experimental | Not described Receives: Drug: chemotherapy + PD-1 inhibitors |
| Group F | Experimental | Not described Receives: Drug: chemotherapy + PD-1 inhibitors |
| Group G | Experimental | Not described Receives: Drug: chemotherapy + PD-1 inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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 2 approximately years
Secondary outcomes (6)
PFS
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 2 approximately years
OS
Measured: up to 5 years
ORR
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 2 approximately years
DOR
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 2 approximately years
irAE
Adverse reactions related to immunotherapy
Measured: From date of consent informed until 60 days after the last investigational product administration. Up to 2 approximately years
QoF
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start2 Jul 2025
- Primary completion31 Dec 2026 (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
- 427 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
- NCT06947694
- Sponsor's protocol ID
- XQonc-024
- Status last verified
- Jul 2025
- First submitted
- 20 Apr 2025
- Last updated
- 22 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 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Umbrella Design Clinical Study on the Abscopal Effect Induced by Different Radioimmunotherapy Combination Patterns in the Treatment of Non-Small Cell Lung Cancer With Multiple Metastases
- ClinicalTrials.gov ID
- NCT06947694
- Acronym / sponsor ID
- XQonc-024
- Conditions
- NSCLC Stage IV Without EGFR/ALK Mutation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 427 participants (estimated)
- Lead sponsor
- Xinqiao Hospital of ChongqingUniversity, hospital or other
- Study start
- 2 Jul 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Apr 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 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 |
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 |
|---|---|---|
| chemotherapy + PD-1 inhibitorsAlso: RadiotherapyThe 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. | Drug | Group A |
| chemotherapy + PD-1 inhibitorsAlso: RadiotherapyThe 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. | Drug | Group B |
| chemotherapy + PD-1 inhibitorsAlso: RadiotherapyThe 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. | Drug | Group C |
| chemotherapy + PD-1 inhibitorsAlso: RadiotherapyThe 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. | Drug | Group D |
| chemotherapy + PD-1 inhibitorsAlso: RadiotherapyThe 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. | Drug | Group E |
| chemotherapy + PD-1 inhibitorsAlso: RadiotherapyThe 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. | Drug | Group F |
| chemotherapy + PD-1 inhibitorsAlso: RadiotherapyThe 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. | Drug | Group G |
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 2 approximately years
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.
6 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 2 approximately years
OS
Time frame: up to 5 years
ORR
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 2 approximately years
DOR
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 2 approximately years
irAE
Time frame: From date of consent informed until 60 days after the last investigational product administration. Up to 2 approximately years
QoF
Time frame: up to 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 22 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 chemotherapy + PD-1 inhibitors 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 22 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 (023-68774490, 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 2 approximately 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 22 Jul 2025.