Clinical trial · Interventional
Preoperative Sintilimab Combined With Bevacizumab and Chemotherapy for Resectable Non-Small Cell Lung Cancer
The Safety and Feasibility of Preoperative Sintilimab Combined With Bevacizumab and Chemotherapy for Locally Advanced Resectable Non-Small Cell Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Neoadjuvant chemotherapy followed by surgery has been recommended as the standard treatment for locally advanced and resectable non-small cell lung cancer (NSCLC). However, its efficacy remains to be improved. Drugs targeting PD-1/PD-L1 pathway have been proven to be effective for late-stage NSCLC, and anti-angiogenesis agents targeting VEGF (bevacizumab) has also been used for the first line treatment of advanced or metastatic NSCLC. Therefore, we conduct this single-arm clinical trial, which aims to investigate the safety and feasibility of neoadjuvant sintilimab combined with bevacizumab and chemotherapy followed by surgery in treating locally advanced and resectable NSCLC.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Neoplasm Malignant | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bevacizumab | Drug | Bevacizumab | ALIAS |
| sintilimab | Drug | Sintilimab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Neoadjuvant treatment
- description
- Participants will receive 4 doses of sintilimab (200 mg, IV) and bevacizumab (15 mg/kg, IV) every 3 weeks (Q3W). Participants will also receive 4 doses of carboplatin (AUC=5, IV) and pemetrexed (500 mg/m2, IV) Q3W. Surgery will be performed within 4 to 6 weeks after completion of preoperative therapy. After the second dose of sintilimab, bevacizumab and chemotherapy, contrast-enhanced chest CT will be performed. Patients with progression disease will receive surgery without the last 2 doses of treatment.
- interventionNames
- Drug: sintilimab
- Drug: bevacizumab
Primary outcomes (1)
- measure
- Safety (Rate of grade 3 and higher grade treatment-related adverse events)
- timeFrame
- From date of treatment allocation until surgery or up to at least 90 days after last dose of preoperative treatment
- description
- Adverse events will be evaluated and recorded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 5.0).
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically or cytologically confirmed, previously untreated and surgically resectable non-small cell lung cancer (stage II-IIIA, patients with squamous cell carcinoma or EGFR mutation should not be included); 2. Eastern Cooperative Oncology Group (ECOG) performance status 0-1; 3. Satisfactory preoperative laboratory testing and adequate pulmonary function for surgery; 4. Patients approve and sign the informed consent. Exclusion Criteria: 1. Pancoast tumor, squamous cell carcinoma, large-cell carcinoma and sarcomatoid carcinoma; 2. Patients with active autoimmune disease or history of autoimmune disease; 3. Patients who have a condition requiring systemic treatment with either prednisone or other immunosuppressive medications; 4. Patients with a history of symptomatic interstitial lung disease; 5. History of allergy to study drug components; 6. Women must not be pregnant or breast-feeding; 7. Men with female partners that are not willing to use contraception; 8. Patients who have received prior chemotherapy, anti-angiogenesis therapy and immunotherapy for this malignancy or for any other past malignancy; 9. Patients who have received prior treatment for non-small cell lung cancer; 10. Any mental or psychological condition which would not permit the patient to complete the study or understand the patient information; 11. Patients who have major hemoptysis within the past 4 weeks, tumor has invasion or is close to great vessels; 12. Patients with high risk of major bleeding; 13. Patients who have arterial thrombotic events, esophageal varices, peptic ulcers, wounds or bone fractures; 14. Patients who have prior malignancies; 15. HIV, HBV, HCV infection or active pulmonary tuberculosis; 16. Underlying medical conditions that, in the Investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity or adverse events.
References
Publications (0)
Data not yet available