Non-small Cell Lung CancerNCT04793139
Efficacy and Safety of Camrelizumab in Real-World Prospective Study
An observational study of Non-small Cell Lung Cancer, run by Guangdong Association of Clinical Trials.
Trial summary
This observational real-world study is designed to evaluate the efficacy and safety of camrelizumab for the treatment of Chinese NSCLC patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Camrelizumab
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2021to 30 Dec 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Total 1000 patients who should accept camrelizumab with NSCLC will be enrolled. The patients should be registered consecutively in each site.
Who may be able to join
- Sign the informed consent and volunteer to participate in the study;
- Non-small cell lung cancer confirmed by histological/cytopathological tests;
- Age ≥18;
- The investigators determined that patients should receive camrelizumab alone or in combination.
Who cannot join
- Patients who are also receiving other immunomedications or therapies;
- Patients participating in other interventional studies;
- Patients complicated with other malignant tumors;
- Women who have been confirmed to be pregnant or lactating;
- The Investigator considers the patient unsuitable for participation in any other condition of the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy and Safety of Camrelizumab for Chinese NSCLC Patients: a Prospective, Observational, Multicenter Real-World Study
This observational real-world study is designed to evaluate the efficacy and safety of camrelizumab for the treatment of Chinese NSCLC patients.
Read the detailed description
Camrelizumab is a humanized antibody for cancer immunotherapy. The National Medical Products Administration (NMPA, China) approved camrelizumab as a first-line treatment of certain patients with NSCLC. This is a multicenter non-interventional study, NSCLC patients who have been treated with camrelizumab will be included. The main objective of this study is to evaluate the efficacy and safety of camrelizumab in the clinical practice.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Camrelizumab
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CamrelizumabDrug
Also called SHR-1210
Camrelizumab-treated advanced NSCLC Patients with advanced non-small cell lung cancer treated with camrelizumab. Dosage form, dosage, frequency and duration of camrelizumab is determined according to the investigator's actual clinical practice.
What is being measured
The primary outcome is the main question the study is designed to answer.
AE,Grade 3-5
Safety of the general population:Serious Adverse Events (AE)，Grade 3-5.
Measured: From April 1, 2021 to Septeember 30, 2024
Secondary outcomes (6)
pCR
Neoadjuvant therapy population: pathological complete response rate (pCR).
Measured: From April 1, 2021 to December 30, 2024
MPR
Neoadjuvant population: main pathological response rate (MPR)
Measured: From April 1, 2021 to December 30, 2024
R0 resection rate
Neoadjuvant therapy population: R0 resection rate.
Measured: From April 1, 2021 to December 30, 2022
ORR
Advanced non-small cell lung cancer: objective response rate (ORR).
Measured: From April 1, 2021 to December 30, 2022
PFS
Advanced non-small cell lung cancer: progression-free survival.
Measured: From April 1, 2021 to December 30, 2022
OS
Advanced non-small cell lung cancer: Overall survival.
Measured: From April 1, 2021 to December 30, 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start1 Apr 2021 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Association of Clinical Trials
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yilong Wu, Principal investigator, Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04793139
- Sponsor's protocol ID
- CTONG2007
- Status last verified
- Mar 2021
- First submitted
- 8 Mar 2021
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Camrelizumab for Chinese NSCLC Patients: a Prospective, Observational, Multicenter Real-World Study
- ClinicalTrials.gov ID
- NCT04793139
- Acronym / sponsor ID
- CTONG2007
- Conditions
- Non-small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Guangdong Association of Clinical TrialsUniversity, hospital or other
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 11 Mar 2021 (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.
This observational real-world study is designed to evaluate the efficacy and safety of camrelizumab for the treatment of Chinese NSCLC patients.
Detailed description
Camrelizumab is a humanized antibody for cancer immunotherapy. The National Medical Products Administration (NMPA, China) approved camrelizumab as a first-line treatment of certain patients with NSCLC. This is a multicenter non-interventional study, NSCLC patients who have been treated with camrelizumab will be included. The main objective of this study is to evaluate the efficacy and safety of camrelizumab in the clinical practice.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Total 1000 patients who should accept camrelizumab with NSCLC will be enrolled. The patients should be registered consecutively in each site.
Key inclusion criteria (4 listed)
- Sign the informed consent and volunteer to participate in the study;
- Non-small cell lung cancer confirmed by histological/cytopathological tests;
- Age ≥18;
- The investigators determined that patients should receive camrelizumab alone or in combination.
Key exclusion criteria (5 listed)
- Patients who are also receiving other immunomedications or therapies;
- Patients participating in other interventional studies;
- Patients complicated with other malignant tumors;
- Women who have been confirmed to be pregnant or lactating;
- The Investigator considers the patient unsuitable for participation in any other condition of the study.
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 |
|---|---|---|
| CamrelizumabAlso: SHR-1210Camrelizumab-treated advanced NSCLC Patients with advanced non-small cell lung cancer treated with camrelizumab. Dosage form, dosage, frequency and duration of camrelizumab is determined according to the investigator's actual clinical practice. | Drug | – |
Primary outcome
AE,Grade 3-5
Time frame: From April 1, 2021 to Septeember 30, 2024
Safety of the general population:Serious Adverse Events (AE)，Grade 3-5.
6 secondary outcomes
pCR
Time frame: From April 1, 2021 to December 30, 2024
MPR
Time frame: From April 1, 2021 to December 30, 2024
R0 resection rate
Time frame: From April 1, 2021 to December 30, 2022
ORR
Time frame: From April 1, 2021 to December 30, 2022
PFS
Time frame: From April 1, 2021 to December 30, 2022
OS
Time frame: From April 1, 2021 to December 30, 2022
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- Individual participant dataSharing planned: Undecided
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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.
Yilong Wu principal investigator
Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer, run by Guangdong Association of Clinical Trials.
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 4 inclusion and 5 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 11 Mar 2021. 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 Chongrui Xu, Doctor (+8618696164925, xucr001@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AE,Grade 3-5 (time frame: From April 1, 2021 to Septeember 30, 2024). 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 11 Mar 2021.