Efficacy and safety of Sintilimab combined with pegylated recombinant human granulocyte colony stimulating factor in the treatment of metastatic NSCLC

Efficacy and safety of Sintilimab combined with pegylated recombinant human granulocyte colony stimulating factor in the treatment of locally advanced or metastatic NSCLC

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200063209

Enrollment

Unknown

Registered

2022-09-01

Start date

2022-09-01

Completion date

Unknown

Last updated

2023-04-17

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

Conditions

Lung cancer

Interventions

experimental group:Carrelizumab 200mg, paclitaxel 135mg/m2, cisplatin 75mg/m2 or carboplatin AUC5 intravenous drip, combined with pegylated recombinant human granulocyte stimulating factor 6mg subcuta

control group:Carrelizumab 200mg, paclitaxel 135mg/m2, cisplatin 75mg/m2 or carboplatin AUC5 were administered intravenously once every 3 weeks

Eligibility

Sex/Gender

All

Age

18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Chinese lung squamous cell carcinoma with stage IIIB or IV confirmed by histology or cytology; 2. Aged <= 80 years, life expectancy more than 3 months; 3. ECOG PS score 0-1; 4. There are evaluable lesions, and the evaluation standard is according to the imrecist standard; 5. Complete CPS scoring test; 6. Have not received any systematic anti-tumor treatment for advanced diseases in the past; 7. Patients who have previously received platinum containing adjuvant chemotherapy, neoadjuvant chemotherapy, neoadjuvant immunotherapy, and whose disease progresses to phase IV and occurs more than 6 months after the end of the last treatment.

Exclusion criteria

Exclusion criteria: 1. Patients with brain metastasis or cancerous meningitis; 2. Patients with endocrine system diseases; 3. Patients with other malignant tumors; 4. Those who have received lung radiotherapy of > 30gy in recent 6 months; 5. Pegylated recombinant human granulocyte stimulating factor (PEG rhG CSF) or carrelizumab or chemotherapy intolerance.

Design outcomes

Primary

Measure	Time frame
Overall Survival;	—

Secondary

Measure	Time frame
Progression Free Survival;Objective Response Rate;	—

Countries

China

Contacts

Public ContactZhang Weike

the Eighth People's Hospital of Jinan

dapentidehama@outlook.com+86 13506340918

Outcome results

None listed

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