beta
Trial Radar AI
Clinical Trial NCT04973293 for Lung Neoplasm Malignant is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
One study matched filter criteria
Card View
Back to Search

Preoperative Sintilimab Combined With Bevacizumab and Chemotherapy for Resectable Non-Small Cell Lung Cancer 20

Recruiting
Clinical Trial NCT04973293 is an interventional study for Lung Neoplasm Malignant that is recruiting. It started on 1 October 2022 with plans to enroll 20 participants. Led by Ruijin Hospital, it is expected to complete by 31 December 2025. The latest data from ClinicalTrials.gov was last updated on 19 November 2024.
Brief Summary
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...Show More
Detailed Description
Lung cancer is one of the most common malignancies around the world. 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. Bevacizumab targeting VEGF is a widely used antitumor drugs in different types of malignancies, including late-stage NSCLC. Immune checkpoint...Show More
Official Title

The Safety and Feasibility of Preoperative Sintilimab Combined With Bevacizumab and Chemotherapy for Locally Advanced Resectable Non-Small Cell Lung Cancer

Conditions
Lung Neoplasm Malignant
Other Study IDs
  • RTS-014
NCT ID Number
NCT04973293
Start Date (Actual)
2022-10-01
Last Update Posted
2024-11-19
Completion Date (Estimated)
2025-12-31
Enrollment (Estimated)
20
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Non-small cell lung cancer
Neoadjuvant therapy
Immunotherapy
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalNeoadjuvant treatment
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. Pa...Show More
sintilimab
Sintilimab 200 mg, 4 cycles of treatment before surgery
bevacizumab
bevacizumab 15 mg/kg, 4 cycles of treatment before surgery
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Safety (Rate of grade 3 and higher grade treatment-related adverse events)
Adverse events will be evaluated and recorded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 5.0).
From date of treatment allocation until surgery or up to at least 90 days after last dose of preoperative treatment
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Feasibility (Completion rate of neoadjuvant treatment and surgery)
Propotion of participants who complete neoadjuvant treatment and receive surgery within 42 days after preoperative therapies.
From date of treatment allocation until surgery, assessed up to 5 months
Major Pathological Response Rate
Major pathologic response is predefined as no more than 10% of residual viable tumor cells in primary lesions.
Two weeks after surgery
Radiographic Response
Radiographic response will be evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
From date of treatment allocation and during treatment period up to 4 months
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  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.

  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.
Ruijin Hospital logoRuijin Hospital
Study Responsible Party
Hecheng Li M.D., Ph.D, Principal Investigator, Professor, Ruijin Hospital
Study Central Contact
Contact: Hecheng Li, MD, PhD, 0086-021-64370045, [email protected]
Contact: Yuyan Zheng, MD, 0086-15280093677, [email protected]
1 Study Locations in 1 Countries

Shanghai Municipality

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai Municipality, 200025, China
Hecheng Li, MD,PHD, Contact, 0086-021-64370045, [email protected]
Yuyan Zheng, MD, Contact, 0086-15280093677, [email protected]
Hecheng Li, MD,PHD, Principal Investigator
Recruiting