Efficacy and safety of PEG-rhG-CSF Combined with Camrelizumab and Chemotherapy in the Treatment of advanced squamous non-small cell lung cancer

The Efficacy and Safety of Pegylated Recombinant Human Granulocyte Colony-Stimulating Factor or Placebo Combined with Camrelizumab, Paclitaxel and Platinum-based Chemotherapy in the First-line Treatment of Advanced Squamous Cell Carcinoma of the Lung: A Phase II Randomized Controlled Trial

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400094635

Enrollment

Unknown

Registered

2024-12-25

Start date

2022-06-01

Completion date

Unknown

Last updated

2025-01-06

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:Carelizumab 200 mg, paclitaxel 135 mg/m2, cisplatin 75 mg/m2, or carboplatin AUC5 intravenously, in combination with pegylated recombinant human granulocyte-stimulating factor 6 mg

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 80 Years

Inclusion criteria

Inclusion criteria: 1.This study is mainly focused on Chinese patients with histologically or cytologically confirmed stage IV lung squamous cell carcinoma. 2.Age <= 80 years old, with an expected lifespan of more than 3 months. 3.ECOG PS score is 0 - 1. 4.There are evaluable lesions, and the evaluation criteria follow the imRECIST criteria. 5.Complete the CPS score detection. 6.Have not received any systemic anti-tumor therapy for advanced diseases previously. 7.For patients who have previously received platinum-containing adjuvant chemotherapy, neoadjuvant chemotherapy, or neoadjuvant immunotherapy, if the disease progresses to stage IV and this occurs more than 6 months after the end of the last treatment..

Exclusion criteria

Exclusion criteria: (1) Patients with an expected survival period of less than 3 months; (2) Patients with brain metastases or carcinomatous meningitis; (3) Patients with comorbid endocrine system diseases; (4) Patients with other concurrent malignant tumors; (5) Patients who have received pulmonary radiotherapy of more than 30 Gy within the past 6 months; (6) Patients intolerant to PEG-rhG-CSF, camrelizumab, or chemotherapy.

Design outcomes

Primary

Measure	Time frame
OS;	—

Secondary

Measure	Time frame
ORR;PFS;TTP;	—

Countries

China

Contacts

Public ContactZhang Weike

Jinan Eighth People's Hospital

dapentidehama@outlook.com+86 135 0634 0918

Outcome results

None listed

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