Sac-TMT Plus Bevacizumab as Second-Line Treatment for Advanced Non-Squamous Non-Small Cell Lung Cancer

NCT07244926 | Not Yet Recruiting Phase 2

• 1 other identifier: SKB264-IIT-019
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  up to approximately 60 months

Secondary Outcomes (5)

• Disease control response (DCR)

  up to approximately 60 months

• Duration of response (DOR)

  Until progression or death, up to approximately 60 months

• Progression-free survival (PFS)

  Until progression or death, up to approximately 60 months

• Overall Survival (OS)

  Until death, up to approximately 60 months.

• Incidence and severity of adverse events (AEs)

  up to approximately 60 months

Study Arms (1)

Sac-TMT plus bevacizumab

EXPERIMENTAL

Drug: Sacituzumab tirumotecan plus bevacizumab

Interventions

Sacituzumab tirumotecan plus bevacizumab DRUG

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.

Sac-TMT plus bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.).
• 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.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, China

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Xiubao Ren, MD. Ph.D

  Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

• Liang Liu, MD. Ph.D

  Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiubao Ren, MD. Ph.D

CONTACT

86-22-23340123; liuliang@tjmuch.com

Liang Liu, MD. Ph.D

CONTACT

86-22-23340123; renxiubao@tjmuch.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 24, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

CN (1)