Multicenter, Prospective, Real World Study of Camrelizumab in Cross-line Treatment of Non-small Cell Lung Cancer
NSCLC
1 other identifier
observational
500
0 countries
N/A
Brief Summary
To explore the effectiveness and safety of Camrelizumab based cross-line therapy for patients with advanced NSCLC in the real world
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2022
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 28, 2022
CompletedFirst Posted
Study publicly available on registry
September 21, 2022
CompletedStudy Start
First participant enrolled
September 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 21, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 21, 2025
CompletedSeptember 21, 2022
May 1, 2022
3 years
June 28, 2022
September 19, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Objective Response Rate (ORR) in second-line treatment of patients with non-small cell lung cancer based on Camrelizumab regimen
CR+PR
Up to 12 months
Secondary Outcomes (4)
Evaluation of Progression Free survival (PFS) in patients with non-small cell lung cancer based on first-line/second-line treatment with Camrelizumab
Up to 36 months
Evaluation of second progression-free survival (PFS2) in patients with non-small cell lung cancer based on Camrelizumab regimen
Up to 12 months
OS
Up to 12 months
To evaluate the safety of Camrelizumab based first/second line therapy in patients with non-small cell lung cancer
Up to 12 months
Interventions
Cross - line treatment of Camrelizumab in non-small cell lung cancer
Eligibility Criteria
Patients with stage IIIb, IV, or relapsed non-small cell lung cancer diagnosed cytologically or histopathologically as EGFR/ALK-
You may qualify if:
- Signed informed consent and volunteered to join the study
- Aged \>=18 years
- Patients with stage IIIb, IV, or relapsed non-small cell lung cancer diagnosed cytologically or histopathologically as EGFR/ALK-
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- At least one measurable lesion (according to RECIST 1.1)
- No prior systemic therapy for advanced/metastatic NSCLC
- contraception
You may not qualify if:
- Those who are allergic to drug treatment;
- Patients who were also treated with other immunodrugs or therapies;
- Patients who are participating in other intervention studies;
- Patients with other malignant tumors at the same time;
- Pregnant or lactating women;
- The investigator did not consider the patients eligible to participate in the study under any other circumstances.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Henan Cancer Hospitallead
- Jiangsu HengRui Medicine Co., Ltd.collaborator
MeSH Terms
Interventions
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2022
First Posted
September 21, 2022
Study Start
September 21, 2022
Primary Completion
September 21, 2025
Study Completion
September 21, 2025
Last Updated
September 21, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share