NCT05547737

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

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 21, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

September 21, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2025

Completed
Last Updated

September 21, 2022

Status Verified

May 1, 2022

Enrollment Period

3 years

First QC Date

June 28, 2022

Last Update Submit

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

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

MeSH Terms

Interventions

camrelizumab

Central Study Contacts

Qi Ming Wang, Doctor's degree

CONTACT

zhen He, Doctor's degree

CONTACT

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