Lung CancerPhase 2NCT07244926
Sac-TMT Plus Bevacizumab as Second-Line Treatment for Advanced Non-Squamous Non-Small Cell Lung Cancer
A Phase 2 study testing Sacituzumab tirumotecan plus bevacizumab in people with Lung Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
In this single-arm, phase II study, we aimed to evaluate the efficacy and safety of sac-TMT plus bevacizumab in patients with advanced non-squamous NSCLC who showed disease progression on or after first-line ICI plus platinum-based chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Sacituzumab tirumotecan plus bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteChina
- Study dates
- Dec 2025to Jun 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old, regardless of gender
- Histologically or cytologically confirmed locally advanced or metastatic non-squamous NSCLC (stage IIIB/C or IV not amenable to curative treatment)
- Negative for EGFR sensitizing mutations [no exon 19 deletion (19-Del) or exon 21 point mutation (L858R mutation)] and ALK fusion gene, and no known actionable gene alterations in ROS1, NTRK, BRAF, MET, KRAS, HER2, or RET.
- Disease progression after first-line platinum-based chemotherapy combined with anti-PD-(L)1 therapy.
- At least one measurable lesion according to RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 within 7 days prior to administration.
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- Expected life expectancy ≥ 12 weeks.
- Adequate organ and bone marrow function.
- Agreement to use effective medical contraception methods from the time of signing the informed consent form until 6 months after the last dose for female subjects of childbearing potential and male subjects with partners of childbearing potential.
- Join the study voluntarily, signs the informed consent form, and is able to comply with the visits and related procedures stipulated in the protocol.
Who cannot join
- Histologically or cytologically confirmed squamous cell NSCLC or mixed with small cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma components.
- Previously received any of the following treatments (including in the adjuvant or neoadjuvant setting): a) Therapy targeting TROP2. b) Any drug therapy containing a topoisomerase I inhibitor, including Antibody-Drug Conjugate (ADC) therapy. c) Anti-angiogenic agents.
- Requirement for strong inhibitors or inducers of Cytochrome P450 3A4 (CYP3A4) within 2 weeks prior to the first dose or during the study period.
- Documented severe dry eye syndrome, severe meibomian gland disease and/or blepharitis, or history of corneal disease that prevents/delays corneal healing.
- Known leptomeningeal metastasis, brainstem metastasis, spinal cord metastasis and/or compression, or active central nervous system (CNS) metastases. Subjects with brain metastases previously treated with local therapy can participate if they are clinically stable for at least 4 weeks prior to dosing and do not require corticosteroids or anticonvulsants for at least 14 days; subjects with untreated asymptomatic brain metastases may be enrolled after investigator assessment.
- History of other malignancies within 3 years prior to dosing (except for tumors cured with local therapy, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, etc.).
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- Presence of severe cardiovascular or cerebrovascular diseases or risk factors.
- Uncontrolled systemic diseases, as judged by the investigator.
- Urinalysis shows urine protein ≥ ++ and confirmed 24-hour urine protein quantification > 1.0 g.
- History of (non-infectious) interstitial lung disease (ILD) or non-infectious pneumonitis requiring steroid treatment, current ILD or non-infectious pneumonitis, or suspected ILD or non-infectious pneumonitis that cannot be ruled out by imaging at screening.
- Clinically severe pulmonary impairment due to concurrent pulmonary diseases.
- Subjects with active chronic inflammatory bowel disease, gastrointestinal obstruction, severe ulcer, gastrointestinal perforation, intra-abdominal abscess, or acute gastrointestinal bleeding.
- Tumor invasion or compression of surrounding vital organs and blood vessels accompanied by related symptoms (e.g., superior vena cava syndrome), or risk of esophagotracheal fistula or esophagopleural fistula.
- History of bleeding tendency or coagulation disorder and/or clinically significant bleeding symptoms or risks within 4 weeks prior to the first dose.
- Use of aspirin (>325 mg/day) or treatment with dipyridamole or clopidogrel within 2 weeks prior to the first dose.
- Use of full-dose oral or intravenous anticoagulants or thrombolytic agents within 2 weeks prior to the first dose.
- Biopsy or other minor surgery (excluding placement of vascular access devices) within 7 days prior to the first dose.
- Toxicity from previous anti-tumor therapy has not recovered to ≤ Grade 1 or the level specified in the eligibility criteria (except for toxicities judged by the investigator to pose low safety risks, such as alopecia, fatigue, etc.).
- Known active tuberculosis. Subjects suspected of having active tuberculosis require clinical evaluation to exclude it.
- History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Active Hepatitis B or Hepatitis C. Note: Subjects who are HBsAg positive are required to receive anti-hepatitis B virus therapy during the study treatment period.
- Positive human immunodeficiency virus (HIV) test or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection.
- Known allergy to the investigational drug or any of its components, history of severe hypersensitivity reactions to other biological agents.
- Major surgery within 4 weeks prior to dosing or anticipated need for major surgery during the study period.
- Severe infection within 4 weeks prior to dosing, active infection requiring systemic anti-infective therapy within 2 weeks prior to dosing.
- Non-specific immunomodulatory therapy within 2 weeks prior to dosing.
- Radiation therapy to lung lesions with a total dose > 30 Gy within 6 months prior to dosing; non-thoracic radiotherapy with a total dose > 30 Gy or extensive radiotherapy (including radionuclide therapy such as Strontium-89) within 4 weeks prior to dosing; palliative radiotherapy for symptom control is allowed but must be completed at least 2 weeks before the first dose.
- Administration of live vaccines within 30 days prior to dosing, or planned administration of live vaccines during the study period.
- Rapid deterioration of condition during the screening period prior to dosing.
- Pregnant or lactating women.
- Local or systemic diseases caused by non-malignant conditions, or diseases or symptoms secondary to the tumor, that could lead to high medical risk and/or uncertainty in survival assessment.
- Any condition that, in the investigator's judgment, interferes with the evaluation of the investigational product, subject safety, or interpretation of study results, or any other situation where the investigator considers the subject unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Sacituzumab Tirumotecan (Sac-TMT) Plus Bevacizumab in Second-line Treatment of Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC) Without Actionable Gene Alterations: a Single-arm, Phase II Trial
In this single-arm, phase II study, we aimed to evaluate the efficacy and safety of sac-TMT plus bevacizumab in patients with advanced non-squamous NSCLC who showed disease progression on or after first-line ICI plus platinum-based chemotherapy.
- Conditions
- Lung Cancer
- Being tested
- Sacituzumab tirumotecan plus bevacizumab
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacituzumab tirumotecan plus bevacizumabDrug
The eligible patients will receive intravenous sac-TMT 4mg/kg every 2 weeks plus intravenous bevacizumab 10mg/kg every 2 weeks until disease progression, death, unacceptable toxicity, or another treatment discontinuation criterion is met.
| Study group | Role | What they receive |
|---|---|---|
| Sac-TMT plus bevacizumab | Experimental | Not described Receives: Drug: Sacituzumab tirumotecan plus bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
ORR is defined as the proportion of patients with a confirmed complete (CR) or partial response (PR) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the investigator.
Measured: up to approximately 60 months
Secondary outcomes (5)
Disease control response (DCR)
DCR is defined as the proportion of patients with the best overall response of CR, PR, and stable disease (SD) Per RECIST 1.1 as assessed by the investigator.
Measured: up to approximately 60 months
Duration of response (DOR)
DOR is defined as first documented evidence of a CR or PR until PD or death
Measured: Until progression or death, up to approximately 60 months
Progression-free survival (PFS)
PFS is defined as the time from the initial treatment to the first occurrence of disease progression or death (whichever occurs first)
Measured: Until progression or death, up to approximately 60 months
Overall Survival (OS)
OS is defined as the time from the initial treatment to the date of death due to any cause.
Measured: Until death, up to approximately 60 months.
Incidence and severity of adverse events (AEs)
Measured: up to approximately 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study startDec 2025 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiubao Ren, MD. Ph.D, Principal investigator, Tianjin Medical University Cancer Institute and HospitalLiang Liu, MD. Ph.D, Principal investigator, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07244926
- Sponsor's protocol ID
- SKB264-IIT-019
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sacituzumab Tirumotecan (Sac-TMT) Plus Bevacizumab in Second-line Treatment of Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC) Without Actionable Gene Alterations: a Single-arm, Phase II Trial
- ClinicalTrials.gov ID
- NCT07244926
- Acronym / sponsor ID
- SKB264-IIT-019
- Conditions
- Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 24 Nov 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.
In this single-arm, phase II study, we aimed to evaluate the efficacy and safety of sac-TMT plus bevacizumab in patients with advanced non-squamous NSCLC who showed disease progression on or after first-line ICI plus platinum-based chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sac-TMT plus bevacizumab | Experimental | Drug: Sacituzumab tirumotecan plus bevacizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥18 years old, regardless of gender
- Histologically or cytologically confirmed locally advanced or metastatic non-squamous NSCLC (stage IIIB/C or IV not amenable to curative treatment)
- Negative for EGFR sensitizing mutations [no exon 19 deletion (19-Del) or exon 21 point mutation (L858R mutation)] and ALK fusion gene, and no known actionable gene alterations in ROS1, NTRK, BRAF, MET, KRAS, HER2, or RET.
- Disease progression after first-line platinum-based chemotherapy combined with anti-PD-(L)1 therapy.
- At least one measurable lesion according to RECIST v1.1.
Key exclusion criteria (32 listed)
- Histologically or cytologically confirmed squamous cell NSCLC or mixed with small cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma components.
- Previously received any of the following treatments (including in the adjuvant or neoadjuvant setting): a) Therapy targeting TROP2. b) Any drug therapy containing a topoisomerase I inhibitor, including Antibody-Drug Conjugate (ADC) therapy. c) Anti-angiogenic agents.
- Requirement for strong inhibitors or inducers of Cytochrome P450 3A4 (CYP3A4) within 2 weeks prior to the first dose or during the study period.
- Documented severe dry eye syndrome, severe meibomian gland disease and/or blepharitis, or history of corneal disease that prevents/delays corneal healing.
- Known leptomeningeal metastasis, brainstem metastasis, spinal cord metastasis and/or compression, or active central nervous system (CNS) metastases. Subjects with brain metastases previously treated with local therapy can participate if they are clinically stable for at least 4 weeks prior to dosing and do not require corticosteroids or anticonvulsants for at least 14 days; subjects with untreated asymptomatic brain metastases may be enrolled after investigator assessment.
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 |
|---|---|---|
| Sacituzumab tirumotecan plus bevacizumabThe eligible patients will receive intravenous sac-TMT 4mg/kg every 2 weeks plus intravenous bevacizumab 10mg/kg every 2 weeks until disease progression, death, unacceptable toxicity, or another treatment discontinuation criterion is met. | Drug | Sac-TMT plus bevacizumab |
Primary outcome
Objective response rate (ORR)
Time frame: up to approximately 60 months
ORR is defined as the proportion of patients with a confirmed complete (CR) or partial response (PR) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the investigator.
5 secondary outcomes
Disease control response (DCR)
Time frame: up to approximately 60 months
Duration of response (DOR)
Time frame: Until progression or death, up to approximately 60 months
Progression-free survival (PFS)
Time frame: Until progression or death, up to approximately 60 months
Overall Survival (OS)
Time frame: Until death, up to approximately 60 months.
Incidence and severity of adverse events (AEs)
Time frame: up to approximately 60 months
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 24 Nov 2025.
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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.
Xiubao Ren, MD. Ph.D principal investigator
Tianjin Medical University Cancer Institute and Hospital
Liang Liu, MD. Ph.D principal investigator
Tianjin Medical University Cancer Institute and Hospital
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 Sacituzumab tirumotecan plus bevacizumab in people with Lung Cancer, run by Tianjin Medical University Cancer Institute and Hospital 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 32 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 24 Nov 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 Xiubao Ren, MD. Ph.D (86-22-23340123 ext. 3173, liuliang@tjmuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: up to approximately 60 months). 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 24 Nov 2025.