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Status unknownNCT05547737NSCLCUpdated Sep 21, 2022

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

An observational study in NSCLC, sponsored by Henan Cancer Hospital. Status unknown. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-09-21.

Sponsored by Henan Cancer Hospital · Observational

The sponsor has not verified this record recently (last verified May 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
500
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • NSCLC
03

In context

Lead sponsor

Henan Cancer Hospital is the lead sponsor of 234 studies on the registry; 130 are open to participants now.

Browse Henan Cancer Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No

Interventions

  • DrugCamrelizumab

    Cross - line treatment of Camrelizumab in non-small cell lung cancer

06

What researchers measure

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

    Time frame: Up to 12 months

Secondary outcomes

  1. Evaluation of Progression Free survival (PFS) in patients with non-small cell lung cancer based on first-line/second-line treatment with Camrelizumab

    Progression free survival (PFS) according to RECIST 1.1

    Time frame: Up to 36 months

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

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

    Time frame: Up to 12 months

  3. OS

    Overall survival

    Time frame: Up to 12 months

  4. To evaluate the safety of Camrelizumab based first/second line therapy in patients with non-small cell lung cancer

    according to NCI-CTCAE version 5.0

    Time frame: Up to 12 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2022; primary completion for Sep 2025, 36 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 28, 2022
First posted
Sep 21, 2022
StartEst.
Sep 21, 2022
Primary completionEst.
Sep 21, 2025
CompletionEst.
Sep 21, 2025
Last update
Sep 21, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05547737
Lead sponsor
Henan Cancer Hospital
Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Responsible party
Sponsor
First posted
Sep 21, 2022
Start date
Sep 21, 2022 (estimated)
Primary completion
Sep 21, 2025 (estimated)
Completion
Sep 21, 2025 (estimated)
Last update
Sep 21, 2022

Study contacts

Qi Ming Wang, Doctor's degree
Contact
qimingwang1006@126.com
13783590691
zhen He, Doctor's degree
Contact
13523530961@126.com
13523530961

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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