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Phase II clinical study of camrelizumab combined with fluzopab in maintenance treatment of stage IV NSCLC

Phase II clinical study of camrelizumab combined with fluzopab in maintenance treatment of stage IV NSCLC

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200059716
Enrollment
Unknown
Registered
2022-05-09
Start date
2022-06-01
Completion date
Unknown
Last updated
2024-03-25

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

Conditions

NSCLC

Interventions

experimental group:camrelizumab, 200 mg, 1 time per 3 weeks, intravenous drip + researchers selected chemotherapy 4 to 6 cycles
Maintenance stage: camrelizumab recommended dose of 200 mg, 1 time every 3 weeks, intravenous drip, Q3W up to 31 cycle + fluzopab (150 mg C1 ~ C31, BID)

Sponsors

The First Affiliated Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18-75 years old, male or female; 2. Patients with untreated stage IV non-small cell lung cancer confirmed by histopathology or cytology; 3. According to the RECIST1.1 standard, the subject must have a measurable target lesion through CT or MRI examination, and the tumor imaging evaluation should be carried out within 28 days before the first medication; 4. No known target driver gene mutation; 5. ECOGPS score 0-1 points; 6. Expected survival period >= 6 months.

Exclusion criteria

Exclusion criteria: 1. Those who have been confirmed to be allergic to the test drug and/or its excipients; 2. Subjects who have received or are receiving additional chemotherapy, radiation therapy, targeted or immunotherapy; 3. Suffering from any active autoimmune disease or history of autoimmune disease; 4. Suffering from congenital or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBVDNA >= 500 IU/mL), hepatitis C (hepatitis C antibody positive, and HCV-RNA is higher than the analysis the lower limit of detection of the method) or co-infection with hepatitis B and C; or a history of organ transplantation; 5. Have clinical symptoms or diseases of the heart that cannot be well controlled, such as: (1) Heart failure above NYHA level 2; (2) Unstable angina; (3) Myocardial infarction occurred within 1 year; 6. Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
progression-free survival;

Countries

China

Contacts

Public ContactZhang Congjun

The First Affiliated Hospital of Anhui Medical University

352653531@qq.com+86 13856019578

Outcome results

None listed

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