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

Efficacy，Safety and Cost-effectiveness Evaluation of Camrelizumab Plus Chemotherapy in First-line Treatment of Patients With Non-squamous Non-small-cell Lung Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Drug: Camrelizumab

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Zhiyuan Tang, Doctor; Phone Number: 18862804577; Email: tina2951@sina.com

Study Locations

• China
  • Jiangsu
    • Nantong, Jiangsu, China, 226000
      • Recruiting
      • Department of Pharmacy, Affiliated Hospital of Nantong University
      • Contact: Zhiyuan Tang, Doctor; Phone Number: 18862804577; Email: tina2951@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Camrelizumab treatment group; 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.	Drug: Camrelizumab; Patients with EGFR-mutation-negative and ALK-negative advanced non-squamous non-small cell lung cancer were treated with first-line chemotherapy in combination with camrelizumab.; Other Names: Airuika, S20190027
Control treatment group; 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.	Drug: Camrelizumab; Patients with EGFR-mutation-negative and ALK-negative advanced non-squamous non-small cell lung cancer were treated with first-line chemotherapy in combination with camrelizumab.; Other Names: Airuika, S20190027

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression free survival	Kaplan-meier method was used to estimate median PFS and its 95%CI, and survival curves were plotted. Log-rank test was used to compare PFS between groups, and COX proportional risk model was used to estimate the HR and 95%CI between groups. Random forebrain metastases (yes/no) and number of metastases (≤3 metastases / >3 metastases) were considered as important covariables in the model.	2020-2022

Collaborators and Investigators

• Sponsor: Affiliated Hospital of Nantong University
• Collaborators: The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China
• Investigators: Study Director: Zhiyuan Tang, Doctor, Affilication Hospital of Nantong University

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2022
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: May 19, 2022
• First Submitted That Met QC Criteria: May 19, 2022
• First Posted (Actual): May 24, 2022

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: lung cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 2022-K002-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No