NSCLCNSCLCNCT05547737
Multicenter, Prospective, Real World Study of Camrelizumab in Cross-line Treatment of Non-small Cell Lung Cancer
An observational study of NSCLC, run by Henan Cancer Hospital.
Trial summary
To explore the effectiveness and safety of Camrelizumab based cross-line therapy for patients with advanced NSCLC in the real world Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NSCLC
- What is being tested?
- Camrelizumab
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 21 Sep 2022to 21 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Study population: Patients with stage IIIb, IV, or relapsed non-small cell lung cancer diagnosed cytologically or histopathologically as EGFR/ALK-
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
To explore the effectiveness and safety of Camrelizumab based cross-line therapy for patients with advanced NSCLC in the real world
- Conditions
- NSCLC
- Being tested
- Camrelizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CamrelizumabDrug
Cross - line treatment of Camrelizumab in non-small cell lung cancer
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) in second-line treatment of patients with non-small cell lung cancer based on Camrelizumab regimen
CR+PR
Measured: 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
Progression free survival (PFS) according to RECIST 1.1
Measured: Up to 36 months
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
Measured: Up to 12 months
OS
Overall survival
Measured: Up to 12 months
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
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start21 Sep 2022 (estimated)
- Primary completion21 Sep 2025 (estimated)
- Study completion21 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05547737
- Sponsor's protocol ID
- NSCLC-RWS-001
- Acronym
- NSCLC
- Status last verified
- May 2022
- First submitted
- 28 Jun 2022
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Prospective, Real World Study of Camrelizumab in Cross-line Treatment of Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05547737
- Acronym / sponsor ID
- NSCLC / NSCLC-RWS-001
- Conditions
- NSCLC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- 21 Sep 2022 (estimated)
- Primary completion
- 21 Sep 2025 (estimated)
- Study completion
- 21 Sep 2025 (estimated)
- First posted
- 21 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To explore the effectiveness and safety of Camrelizumab based cross-line therapy for patients with advanced NSCLC in the real world
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with stage IIIb, IV, or relapsed non-small cell lung cancer diagnosed cytologically or histopathologically as EGFR/ALK-
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (6 listed)
- 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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CamrelizumabCross - line treatment of Camrelizumab in non-small cell lung cancer | Drug | – |
Primary outcome
Objective Response Rate (ORR) in second-line treatment of patients with non-small cell lung cancer based on Camrelizumab regimen
Time frame: Up to 12 months
CR+PR
4 secondary outcomes
Evaluation of Progression Free survival (PFS) in patients with non-small cell lung cancer based on first-line/second-line treatment with Camrelizumab
Time frame: Up to 36 months
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
OS
Time frame: Up to 12 months
To evaluate the safety of Camrelizumab based first/second line therapy in patients with non-small cell lung cancer
Time frame: Up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of NSCLC, run by Henan Cancer Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qi Ming Wang, Doctor's degree (13783590691, qimingwang1006@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) in second-line treatment of patients with non-small cell lung cancer based on Camrelizumab regimen (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2022.