NSCLC: Multicenter, Prospective, Real World Study of Camrelizumab in Cross-line Treatment of Non-small Cell Lung Cancer

• Sponsor: Henan Cancer Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05547737
• Collaborator: Jiangsu HengRui Medicine Co., Ltd. (Industry)
• Enrollment: 500
• Anticipated Duration (Months): 36

Study Details

Study Description

Brief Summary

To explore the effectiveness and safety of Camrelizumab based cross-line therapy for patients with advanced NSCLC in the real world

Condition or Disease	Intervention/Treatment	Phase
NSCLC	Drug: Camrelizumab

Study Design

• Study Type: Observational
• Anticipated Enrollment: 500 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Multicenter, Prospective, Real World Study of Camrelizumab in Cross-line Treatment of Non-small Cell Lung Cancer
• Anticipated Study Start Date: Sep 21, 2022
• Anticipated Primary Completion Date: Sep 21, 2025
• Anticipated Study Completion Date: Sep 21, 2025

Outcome Measures

Primary Outcome Measures

1. Objective Response Rate (ORR) in second-line treatment of patients with non-small cell lung cancer based on Camrelizumab regimen [Up to 12 months]

   CR+PR

Secondary Outcome Measures

1. 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]

   Progression free survival (PFS) according to RECIST 1.1

2. Evaluation of second progression-free survival (PFS2) in patients with non-small cell lung cancer based on Camrelizumab regimen [Up to 12 months]

   Evaluation of second progression-free survival (PFS2) in patients with non-small cell lung cancer based on Camrelizumab regimen

3. OS [Up to 12 months]

   Overall survival

4. To evaluate the safety of Camrelizumab based first/second line therapy in patients with non-small cell lung cancer [Up to 12 months]

   according to NCI-CTCAE version 5.0

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All

Inclusion Criteria:

1. Signed informed consent and volunteered to join the study

2. Aged >=18 years

3. Patients with stage IIIb, IV, or relapsed non-small cell lung cancer diagnosed cytologically or histopathologically as EGFR/ALK-

4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1

5. At least one measurable lesion (according to RECIST 1.1)

6. No prior systemic therapy for advanced/metastatic NSCLC

7. contraception

Exclusion Criteria:

1. Those who are allergic to drug treatment；

2. Patients who were also treated with other immunodrugs or therapies；

3. Patients who are participating in other intervention studies；

4. Patients with other malignant tumors at the same time；

5. Pregnant or lactating women；

6. The investigator did not consider the patients eligible to participate in the study under any other circumstances.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Henan Cancer Hospital
• Jiangsu HengRui Medicine Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Henan Cancer Hospital
• ClinicalTrials.gov Identifier: NCT05547737
• Other Study ID Numbers: NSCLC-RWS-001
• First Posted: Sep 21, 2022
• Last Update Posted: Sep 21, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Sep 21, 2022