Clinical trial NCT05387512: A Real World Study of Camrelizumab in the Treatment of Advanced Non-squamous Non-small-cell Lung Cancer
Official title: Efficacy，Safety and Cost-effectiveness Evaluation of Camrelizumab Plus Chemotherapy in First-line Treatment of Patients With Non-squamous Non-small-cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Keywords: lung cancer
Lead sponsor: Affiliated Hospital of Nantong University
Sponsor class: OTHER
Collaborators: name: The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China
First posted: 2022-05-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In this study, pathological records and follow-up information of newly treated lung cancer patients in our hospital and four hospitals in Nanjing and Nantong from June 2020 to May 2024 were collected. Patients meeting the criteria of admission were divided into experimental group and control group.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Progression free survival
timeFrame: 2020-2022
Secondary outcomes:
Other outcomes:
Locations:
city: Nantong
country: China
facility: Department of Pharmacy, Affiliated Hospital of Nantong University
state: Jiangsu
Study officials:
affiliation: Affilication Hospital of Nantong University
name: Zhiyuan Tang, Doctor
role: STUDY_DIRECTOR
References: