NSCLCPhase 2NCT07643350

Efficacy and Safety of Induction Benmelstobart Plus Anlotinib and Chemotherapy Followed by Concurrent Chemoradiotherapy and Benmelstobart Maintenance Versus Concurrent Chemoradiotherapy Followed by Benmelstobart Maintenance in Patients With Unresectable Stage III NSCLC

A Phase 2 study testing Benmelstobart and benmelstobart combined with chemotherapy and anlotinib in people with NSCLC, run by The Third Xiangya Hospital of Central South University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: NSCLC
What is being tested?: Benmelstobart and benmelstobart combined with chemotherapy and anlotinib
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 152 participants
Where: 1 siteChina
Study dates: 15 May 2026to 15 May 2031
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

1. Voluntary signing of a written ICF.
2. Age at enrollment: 18-75 years; both sexes are eligible.
3. Eastern Cooperative Oncology Group (ECOG) performance status score: 0 or 1.
4. Expected survival: ≥3 months.
5. Histologically or cytologically confirmed stage III NSCLC (classified according to the International Union Against Cancer and the American Joint Committee on Cancer's 9th edition of the lung cancer TNM staging system).
6. Definitively determined as unresectable after MDT discussion.

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7. The primary driver genes must not harbor sensitive mutations (including EGFR (exon 19 deletion, exon 21 L858R point mutation, exon 20 insertion, etc.), ALK fusion, ROS1 fusion, MET exon 14 skipping mutation, HER2 exon 20 mutation, BRAF V600E mutation, RET fusion, NTRK fusion). For non-squamous NSCLC, a prior tissue-based common genetic testing report must be provided; otherwise, tumor tissue samples (archived or fresh, primary or metastatic) must be collected prior to enrollment for genetic mutation status assessment (at a local laboratory or central laboratory). For squamous NSCLC subjects with a smoking history or current smoking status, if the prior primary driver gene mutation status is unknown, no corresponding testing is required prior to enrollment, and the status shall be considered negative.
8. No prior systemic antitumor therapy or chest radiotherapy for NSCLC.
9. At least one measurable lesion according to RECIST v1.1, and such lesions must be suitable for repeated accurate measurement per RECIST v1.1 criteria. -10. Subjects must provide tumor tissue samples diagnosed as locally advanced tumors at the time of diagnosis or thereafter, including archived or freshly obtained uncolored formalin-fixed paraffin-embedded (FFPE) pathological sections (preferably recently obtained tumor tissue samples), approximately 10-25 sections (of which approximately 10-15 sections are required for EGFR and ALK testing, and approximately 10 sections for PD-L1 expression testing; however, additional sections must be provided if the central laboratory determines that the sample is insufficient for testing), or fresh tumor tissue specimens (frozen in liquid nitrogen for omics research). Tumor lesions used for fresh biopsy should not be designated as RECIST v1.1 target lesions unless the lesion is the only measurable lesion. For archived samples, collection must occur after the last systemic treatment, and the collection site must not have undergone radiotherapy. Note: If a subject's archived sample does not meet the above requirements, the investigator may determine that the biopsy does not serve the subject's best interests and may, after discussion with the project team, permit the use of the archived sample.
11.Fertile female subjects must have undergone a urine or serum pregnancy test within 7 days prior to the first medication administration (if the urine pregnancy test result is not negative, a serum pregnancy test must be performed, with the serum result serving as the definitive determination), and the result must be negative. If a fertile female subject has sexual intercourse with an unmarried male partner, she must have used an acceptable contraceptive method since the start of screening and must agree to continue using contraception for 120 days after the last administration of the antitumor drug; whether contraception should be discontinued after this period should be discussed with the investigator.
12. If an unmarried male subject has sexual intercourse with a fertile female partner, he must have used an effective contraceptive method from the start of screening until 120 days after the last administration; whether contraception should be discontinued after this time point should be discussed with the investigator.
13. The subject must be willing and able to comply with all scheduled visits, treatment regimens, laboratory tests, and other study requirements.

Who cannot join

1. Histopathological presence of any small cell carcinoma components, as well as specific types such as salivary gland type and SMARCA4 deletion.
2. Except for NSCLC, the subject had suffered from other malignancies within the preceding 5 years. Subjects who have been cured of other tumors through local treatment (e.g., basal or squamous cell carcinoma of the skin, superficial bladder cancer, cervical or breast carcinoma in situ) are not excluded.
3. Concurrent enrollment in another clinical study, unless it is an observational, non-interventional clinical study or a follow-up phase of an intervention study.
4. Previous local treatments targeting the tumor lesion, such as thoracic radiotherapy or radiofrequency ablation.
5. Receiving nonspecific immunomodulatory therapy (e.g., interleukins, interferons, thym peptides, tumor necrosis factor, etc., excluding IL-11 for thrombocytopenia) within 2 weeks prior to the first dose; or receiving herbal or proprietary Chinese medicines with antitumor indications within 1 week prior to the first dose.
6. Suffering from an active autoimmune disease requiring systemic treatment within the past two years (e.g., treatment with disease-modifying drugs, corticosteroids, or immunosuppressants). Alternative therapies (e.g., thyroxine, insulin, or physiological corticosteroid replacement for adrenal or pituitary insufficiency) are not considered systemic treatments.

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7. History of immunodeficiency; positive HIV antibody test; or current long-term use of systemic corticosteroids or other immunosuppressants.
8. Subjects with known active tuberculosis (TB) or suspected active TB require clinical examination for exclusion; known active syphilis infection.
9. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
10. Non-infectious pneumonia/interstitial lung disease requiring systemic glucocorticoid therapy within the past 5 years or currently.
11.Severe infections occurring within 4 weeks prior to the first dose, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia; active infections treated with systemic anti-infective therapy within 2 weeks prior to the first dose (excluding antiviral therapy for hepatitis B or hepatitis C).
12.Subjects with active Hepatitis B (Hepatitis B surface antigen [HBsAg] positive AND Hepatitis B virus DNA [HBVDNA] >1,000 copies/mL [200IU/mL] or above the lower limit of detection); note that HBsAg-positive subjects are required to receive antiviral therapy against Hepatitis B during the study treatment period. Subjects with active Hepatitis C (Hepatitis C virus [HCV] antibody positive AND HCV RNA levels above the lower limit of detection).
13Has undergone major surgical procedures or sustained severe trauma within 30 days prior to the first dose administration, or plans to undergo major surgery within 30 days after the first dose (as determined by the investigator); has undergone minor local surgeries within 3 days prior to the first dose administration (excluding peripheral venous catheterization and intravenous infusion port implantation).
14. The tumor invades or compresses surrounding vital organs (e.g., aorta, heart and pericardium, superior vena cava, trachea, esophagus) or carries a risk of esophageal-tracheal fistula or esophageal-plenic fistula; mediastinal lymph node metastasis involves the trachea or main bronchi with a risk of bronchial fistula.
15. Currently has uncontrolled comorbid conditions, including but not limited to decompensated cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders, severe active peptic ulcer disease or gastritis, or psychiatric/social conditions that may limit the subject's adherence to study requirements or affect their capacity to provide written informed consent.
16. Has a history of myocarditis, cardiomyopathy, or malignant arrhythmias; experienced unstable angina, myocardial infarction, congestive heart failure, or vascular diseases (e.g., aneurysm with rupture risk) requiring hospitalization within 12 months prior to the first dose; or has other cardiac injuries that may affect the safety evaluation of antineoplastic agents.
17. History of esophageal and gastric varices, severe ulcers, non-healed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months prior to the first dose; or acute exacerbation of chronic obstructive pulmonary disease within 1 month prior to the first dose.
18. History of any arterial thromboembolic event, venous thromboembolic event of grade 3 or higher per NCI CTCAE 5.0 criteria, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 6 months prior to the first dose; or current hypertension with systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg despite oral antihypertensive therapy.
19.Patients with a history of severe bleeding tendency or coagulation disorders; those with clinically significant hemoptysis (defined as coughing up or expectorating ≥ 1 teaspoon of fresh blood or small blood clots or only blood without sputum, patients with blood in sputum are allowed to be enrolled) within 1 month before the first administration; those with imaging findings during the screening period showing that the tumor encircles important blood vessels or has obvious necrosis or cavities, and the investigator determines that participation in the study would pose a risk of bleeding.
20. Received a live vaccine within 30 days prior to the first dose, or plans to receive a live vaccine during the study period.
21. Known hypersensitivity to any component of any antineoplastic agent; history of severe hypersensitivity reactions to other monoclonal antibodies.
22. Known history of mental illness, drug abuse, alcoholism, or substance use.
23. Women who are pregnant or breastfeeding.
24. Any past or current medical conditions, treatments, or laboratory abnormalities that may confound study results, compromise the participant's ability to complete the study, or make participation potentially detrimental to the participant's best interests.
25. Localized or systemic diseases not caused by malignancies, or tumor-related conditions or symptoms, that may pose significant medical risks and/or uncertainty in survival assessment, such as tumor-associated leukemic response (white blood cell count>20 × 10⁹/L) or cachectic manifestations (e.g., known weight loss exceeding 10% within three months prior to screening).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xuewen Liu contact

+8618711033808

aveinliu@163.com

China1 site

ThirdXiangyaHCSU
Changsha, Hunan
Xuewen Liu, +8618711033808, aveinliu@163.com

Other trials in China

About this study

Official title: Comparison of the Efficacy and Safety of Induction Benmelstobart Plus Anlotinib and Chemotherapy Followed by Concurrent Chemoradiotherapy and Benmelstobart Maintenance Versus Concurrent Chemoradiotherapy Followed by Benmelstobart Maintenance in Patients With Unresectable Stage III NSCLC: A Randomized, Controlled, Multicenter Phase II Clinical Study

The goal of this clinical trial is to compare the efficacy and safety of induction Benmelstobart plus Anlotinib and chemotherapy followed by concurrent chemoradiotherapy (CCRT) and subsequent Benmelstobart maintenance versus CCRT followed by Benmelstobart maintenance in patients with unresectable stage III NSCLC. Additionally, high-throughput sequencing and multi-omics analysis will be performed on patient-derived tissue and blood samples. By integrating baseline characteristics with clinical data, we aim to identify key determinants of treatment efficacy and prognosis, thereby establishing a precision evaluation system for therapeutic outcomes.

Conditions: NSCLC
Being tested: Benmelstobart, benmelstobart combined with chemotherapy and anlotinib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BenmelstobartBiological
Group B:radical concurrent chemoradiotherapy → Maintenance therapy with Benmelstobart (for up to 1 year)
benmelstobart combined with chemotherapy and anlotinibDrug
Group A:Benmelstobart + Anlotinib + platinum-based dual-drug chemotherapy (2 cycles of induction therapy) → radical concurrent chemoradiotherapy (Benmelstobart and anlotinib discontinued during radiotherapy) → Benmelstobart maintenance therapy (for up to 1 year)。

Study groups in NCT07643350
Study group	Role	What they receive
Group A:Benmelstobart + Anlotinib+chemotherapy	Experimental	Benmelstobart + Anlotinib + platinum-based dual-drug chemotherapy (2 cycles of induction therapy) → radical concurrent chemoradiotherapy (Benmelstobart and anlotinib discontinued during radiotherapy) → Benmelstobart maintenance therapy (for up to 1 year) Receives: Drug: benmelstobart combined with chemotherapy and anlotinib
Group B：radical concurrent chemoradiotherapy	Experimental	radical concurrent chemoradiotherapy → Maintenance therapy with Benmelstobart (for up to 1 year) Receives: Biological: Benmelstobart

What is being measured

The primary outcome is the main question the study is designed to answer.

Progression-Free Survival (PFS)
Measured: The duration from initiation of antitumor therapy until the documentation of disease progression (according to RECIST v1.1) or death from any cause (whichever occurs first).Up to 60 months from randomization

Secondary outcomes (3)

Objective Response Rate (ORR)
Measured: Primary efficacy assessment at Week 6 after randomization for the first 12 months, followed by every 3 months until disease progression, death or withdrawal of consent
Disease Control Rate (DCR)
Measured: The proportion of subjects who achieved optimal overall response confirmed as CR, PR, or SD (according to the RECIST v1.1 )，Primary efficacy assessment at Week 6 after randomization for the first 12 months, followed by every 3 months
OS
Measured: Time to death from any cause at the initiation of antitumor therapy, up to 60 months from randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 May 202615 May 2031

First posted11 Jun 2026
Study start15 May 2026 (estimated)
Primary completion15 May 2029 (estimated)
Study completion15 May 2031 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for NSCLCStudies of the same condition, open and under way.
More trials run by The Third Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
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: 152 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07643350
Sponsor's protocol ID: R26036
Status last verified: May 2026
First submitted: 17 May 2026
Last updated: 11 Jun 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Li Y, Juergens RA, Finley C, Swaminath A. Current and Future Treatment Options in the Management of Stage III NSCLC. J Thorac Oncol. 2023 Nov;18(11):1478-1491. doi: 10.1016/j.jtho.2023.08.011. Epub 2023 Aug 11.
PubMed 37574133
Ganti AK, Klein AB, Cotarla I, Seal B, Chou E. Update of Incidence, Prevalence, Survival, and Initial Treatment in Patients With Non-Small Cell Lung Cancer in the US. JAMA Oncol. 2021 Dec 1;7(12):1824-1832. doi: 10.1001/jamaoncol.2021.4932.
PubMed 34673888
Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.
PubMed 38572751
Xia C, Dong X, Li H, Cao M, Sun D, He S, Yang F, Yan X, Zhang S, Li N, Chen W. Cancer statistics in China and United States, 2022: profiles, trends, and determinants. Chin Med J (Engl). 2022 Feb 9;135(5):584-590. doi: 10.1097/CM9.0000000000002108.
PubMed 35143424
Song Z, Ma S, Zhang X, Liu X. Efficacy and safety of induction benmelstobart plus anlotinib and chemotherapy followed by concurrent chemoradiotherapy and benmelstobart consolidation versus concurrent chemoradiotherapy followed by benmelstobart consolidation in patients with unresectable stage III NSCLC: a randomized, controlled, multicenter phase II trial protocol (BEAM-LUNG). Front Immunol. 2026 Sep 25;17:1915557. doi: 10.3389/fimmu.2026.1915557. eCollection 2026.
PubMed 42857095

Study at a glance

From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of the Efficacy and Safety of Induction Benmelstobart Plus Anlotinib and Chemotherapy Followed by Concurrent Chemoradiotherapy and Benmelstobart Maintenance Versus Concurrent Chemoradiotherapy Followed by Benmelstobart Maintenance in Patients With Unresectable Stage III NSCLC: A Randomized, Controlled, Multicenter Phase II Clinical Study
ClinicalTrials.gov ID: NCT07643350
Acronym / sponsor ID: R26036
Conditions: NSCLC
Phase: Phase 2
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 152 participants (estimated)
Lead sponsor: The Third Xiangya Hospital of Central South UniversityUniversity, hospital or other
Study start: 15 May 2026 (estimated)
Primary completion: 15 May 2029 (estimated)
Study completion: 15 May 2031 (estimated)
First posted: 11 Jun 2026 (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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group A:Benmelstobart + Anlotinib+chemotherapy	Experimental	Drug: benmelstobart combined with chemotherapy and anlotinibBenmelstobart + Anlotinib + platinum-based dual-drug chemotherapy (2 cycles of induction therapy) → radical concurrent chemoradiotherapy (Benmelstobart and anlotinib discontinued during radiotherapy) → Benmelstobart maintenance therapy (for up to 1 year)
Group B：radical concurrent chemoradiotherapy	Experimental	Biological: Benmelstobartradical concurrent chemoradiotherapy → Maintenance therapy with Benmelstobart (for up to 1 year)

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

1. Voluntary signing of a written ICF.
2. Age at enrollment: 18-75 years; both sexes are eligible.
3. Eastern Cooperative Oncology Group (ECOG) performance status score: 0 or 1.
4. Expected survival: ≥3 months.
5. Histologically or cytologically confirmed stage III NSCLC (classified according to the International Union Against Cancer and the American Joint Committee on Cancer's 9th edition of the lung cancer TNM staging system).

Key exclusion criteria (25 listed)

1. Histopathological presence of any small cell carcinoma components, as well as specific types such as salivary gland type and SMARCA4 deletion.
2. Except for NSCLC, the subject had suffered from other malignancies within the preceding 5 years. Subjects who have been cured of other tumors through local treatment (e.g., basal or squamous cell carcinoma of the skin, superficial bladder cancer, cervical or breast carcinoma in situ) are not excluded.
3. Concurrent enrollment in another clinical study, unless it is an observational, non-interventional clinical study or a follow-up phase of an intervention study.
4. Previous local treatments targeting the tumor lesion, such as thoracic radiotherapy or radiofrequency ablation.
5. Receiving nonspecific immunomodulatory therapy (e.g., interleukins, interferons, thym peptides, tumor necrosis factor, etc., excluding IL-11 for thrombocytopenia) within 2 weeks prior to the first dose; or receiving herbal or proprietary Chinese medicines with antitumor indications within 1 week prior to the first dose.

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
BenmelstobartGroup B:radical concurrent chemoradiotherapy → Maintenance therapy with Benmelstobart (for up to 1 year)	Biological	Group B：radical concurrent chemoradiotherapy
benmelstobart combined with chemotherapy and anlotinibGroup A:Benmelstobart + Anlotinib + platinum-based dual-drug chemotherapy (2 cycles of induction therapy) → radical concurrent chemoradiotherapy (Benmelstobart and anlotinib discontinued during radiotherapy) → Benmelstobart maintenance therapy (for up to 1 year)。	Drug	Group A:Benmelstobart + Anlotinib+chemotherapy

Primary outcome

Progression-Free Survival (PFS)
Time frame: The duration from initiation of antitumor therapy until the documentation of disease progression (according to RECIST v1.1) or death from any cause (whichever occurs first).Up to 60 months from randomization

3 secondary outcomes

Objective Response Rate (ORR)
Time frame: Primary efficacy assessment at Week 6 after randomization for the first 12 months, followed by every 3 months until disease progression, death or withdrawal of consent
Disease Control Rate (DCR)
Time frame: The proportion of subjects who achieved optimal overall response confirmed as CR, PR, or SD (according to the RECIST v1.1 )，Primary efficacy assessment at Week 6 after randomization for the first 12 months, followed by every 3 months
OS
Time frame: Time to death from any cause at the initiation of antitumor therapy, up to 60 months from randomization

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 11 Jun 2026.
Results publication: PubMed 37574133Li Y, Juergens RA, Finley C, Swaminath A. Current and Future Treatment Options in the Management of Stage III NSCLC. J Thorac Oncol. 2023 Nov;18(11):1478-1491. doi: 10.1016/j.jtho.2023.08.011. Epub 2023 Aug 11.
Results publication: PubMed 34673888Ganti AK, Klein AB, Cotarla I, Seal B, Chou E. Update of Incidence, Prevalence, Survival, and Initial Treatment in Patients With Non-Small Cell Lung Cancer in the US. JAMA Oncol. 2021 Dec 1;7(12):1824-1832. doi: 10.1001/jamaoncol.2021.4932.
Results publication: PubMed 38572751Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.
Results publication: PubMed 35143424Xia C, Dong X, Li H, Cao M, Sun D, He S, Yang F, Yan X, Zhang S, Li N, Chen W. Cancer statistics in China and United States, 2022: profiles, trends, and determinants. Chin Med J (Engl). 2022 Feb 9;135(5):584-590. doi: 10.1097/CM9.0000000000002108.
Derived from this study: PubMed 42857095Song Z, Ma S, Zhang X, Liu X. Efficacy and safety of induction benmelstobart plus anlotinib and chemotherapy followed by concurrent chemoradiotherapy and benmelstobart consolidation versus concurrent chemoradiotherapy followed by benmelstobart consolidation in patients with unresectable stage III NSCLC: a randomized, controlled, multicenter phase II trial protocol (BEAM-LUNG). Front Immunol. 2026 Sep 25;17:1915557. doi: 10.3389/fimmu.2026.1915557. eCollection 2026.
Individual participant dataSharing planned: Undecided

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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.

Xuewen Liu contact

+8618711033808

aveinliu@163.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 12 inclusion and 25 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: opening soon, as of the sponsor's last update on 11 Jun 2026. 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 Xuewen Liu (+8618711033808, aveinliu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) (time frame: The duration from initiation of antitumor therapy until the documentation of disease progression (according to RECIST v1.1) or death from any cause (whichever occurs first).Up to 60 months from randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07643350, which also lists 5 linked publications.

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 11 Jun 2026.