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A prospective, multicenter, phase II study of carrilizumab in combination with apatinib and fluzoparil for second-line treatment of advanced NSCLC after chemotherapy combined with immunotherapy

A prospective, multicenter, phase II study of carrilizumab in combination with apatinib and fluzoparil for second-line treatment of advanced NSCLC after chemotherapy combined with immunotherapy

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200057534
Enrollment
Unknown
Registered
2022-03-14
Start date
2022-04-01
Completion date
Unknown
Last updated
2023-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-small cell lung cancer (NSCLC)

Interventions

Experimental group:Camrelizumab + Apatinib + Fluzoparib

Sponsors

301 Hospital, General Hospital of the People's Liberation Army
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Subjects aged 18-75 years at the time of signing the informed consent, no gender limit; 2. Locally advanced (stage IIIB/ stage IIIC) and stage IV non-small cell lung cancer with histopathological or cytological evidence that is inoperable and cannot be treated with radical chemoradiotherapy; 3. Negative gene mutation; 4. Previous first-line chemotherapy combined with immunization regimen; 5. ECOG score; 0 and 1; 6. According to RECIST v1.1, subjects must have measurable target lesions examined by CT or MRI; 7. Normal function of major organs; 8. Subjects of childbearing age must agree to use adequate contraception throughout the study period and for 6 months after the end of treatment; 9. Signed the written informed consent, and expected to have good compliance with the research program.

Exclusion criteria

Exclusion criteria: 1. Histologically or cytologically confirmed mixed NSCLC, including NSCLC subjects with small-cell lung cancer components; 2. Subjects with active BMS (subjects with stable symptoms after treatment with BMS can be included if the symptoms remain stable for at least 4 weeks); 3. Imaging evidence of tumor cavity, tumor surrounding or invasion of large vessels; 4. Use of immunosuppressive drugs within 28 days before first use of carrilizumab; 5. Received Chinese herbal medicine with anti-tumor indications or immunomodulatory drugs within 28 weeks prior to initial administration; 6. Administer live attenuated vaccine within 30 days of the first administration or expected during the study period; 7. Subjects with uncontrolled pleural effusion, pericardial effusion, or ascites as determined by the investigator, or who had received serosal effusion drainage for therapeutic purposes within 4 weeks prior to treatment; 8. Subjects with severe infection within 1 month before enrollment; 9. Active autoimmune disease or immunodeficiency; 10. The subject received systemic treatment such as bronchodilator and was not satisfied with asthma control; 11. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); 12. Receiving CYP3A4 inhibitors; 13. The subject has received or plans to receive a solid organ or blood system transplant (other than a corneal transplant) during the study period; 14. Subjects with a history of other malignant tumors within 5 years; 15. Have high blood pressure that is not well controlled by antihypertensive medications (systolic blood pressure >=140 mmHg or diastolic blood pressure >=90 mmHg); 16. Clinical symptoms or diseases of the heart that are not well controlled; 17. Abnormal coagulation function; 18. Clinically significant blood or daily hemoptysis of more than half a teaspoon (2.5ml) or more occurred within 2 months before enrollment; 19. Currently participating in interventional clinical research and treatment; 20. Have a clear history of allergy; 21. Those who have a history of psychotropic substance abuse and cannot abstain or have mental disorders; 22. Increased risks associated with study or investigational drug participation and, in the investigator's judgment, other conditions in which the subject may not be eligible for study inclusion.

Design outcomes

Primary

MeasureTime frame
Progression-free survival;

Secondary

MeasureTime frame
Overall survival;Objective response rate;Disease control rate;Duration of response;

Countries

China

Contacts

Public ContactYang Bo

301 Hospital, General Hospital of the People's Liberation Army

shybomb@126.com+86 18845768635

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026