A Real World Study of Camrelizumab in the Treatment of Advanced Non-squamous Non-small-cell Lung Cancer

Affiliated Hospital of Nantong University

Status: Enrolling

Conditions: Lung Cancer

Treatments: Drug: Camrelizumab

Study type: Observational

Funder types: Other

Identifiers

NCT05387512

2022-K002-01

Details and patient eligibility

About

To provide sufficient scientific evidence for rational drug use of camrelizumab in the treatment of advanced non-squamous non-small cell lung cancer in China, efficacy，safety and cost-effectiveness of camrelizumab plus chemotherapy versus chemotherapy alone or chemotherapy plus antiangiogenic therapy in the first-line treatment of patients with advanced non-squamous non-small-cell lung cancer will be evaluated. Based on real world, the Markov Model was established to analyze the incremental cost-effectiveness in experimental group(camrelizumab plus chemotherapy), compared with control group (chemotherapy alone or chemotherapy plus antiangiogenic therapy). Deterministic sensitivity analysis and probabilistic sensitivity analysis will be performed.

Full description

1. Study on the safety and effectiveness of camrelizumab combined with chemotherapy in patients with EGFR mutation negative and ALK negative advanced non-squamous non-small cell lung cancer.
2. Safety and effectiveness of standard chemotherapy alone or chemotherapy plus antiangiogenic therapy in first-line treatment of EGFR mutation negative and ALK negative patients with advanced non-squamous non-small cell lung cancer.
3. Pharmacoeconomic evaluation of camrelizumab combined with chemotherapy in patients with EGFR mutation negative and ALK negative advanced non-squamous non-small cell lung cancer.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. Histopathological diagnosis of non-squamous non-small cell lung cancer; 2) EGFR gene mutation negative and ALK negative, and did not receive systematic chemotherapy; 3) Older than 18 years of age; 4) Pathological stage IIIB or IV; 5) ECOG (Eastern Oncology Collaboration group) score 0-1; 4) Ecg and liver and kidney function are normal; 6) No second primary tumor disease or serious complications.

Exclusion criteria

• 1. Patients with lung squamous cell carcinoma diagnosed by histopathology; (2) Patients with serious cardiovascular disease, active gastrointestinal bleeding, obvious coagulopathy, complicated with other malignant tumors, and drug allergy were excluded; 3) Patients with poor treatment compliance and incomplete case data.

Trial design

100 participants in 2 patient groups

Camrelizumab treatment group

Description:

The primary treatment is Camrelizumab combined with Pemetrexed and Platinum, secondary treatment with standard chemotherapy after progression. Reference regimen of Camrelizumab 200mg/3 weeks; Carboplatin reference regimen was AUC = 5 mg/mL/min; Cisplatin reference regimen was 75 mg/m2; Pemetrexed reference regimen was 500 mg/m2; paclitaxel liposome reference regimen is 135-175 mg/m2.

Treatment:

Drug: Camrelizumab

Control treatment group

Description:

The primary treatment is Pemetrexed and Platinum plus anti-angiogenic drugs, Secondary treatment is standard chemotherapy regimens after progression. Reference regimen of Carilizumab 200mg/3 weeks; Carboplatin reference regimen was AUC = 5 mg/mL/min; Cisplatin reference regimen was 75 mg/m2; Pemetrexed reference regimen was 500 mg/m2; paclitaxel liposome reference regimen is 135-175 mg/m2.

Treatment:

Drug: Camrelizumab