Non-small Cell Lung Cancer Stage ⅢANCT06394427
Neoadjuvant Chemoimmunotherapy in Stage IIIA- N2IIIB Non-small Cell Lung Cancer
An observational study of Non-small Cell Lung Cancer Stage ⅢA and Non-small Cell Lung Cancer Stage IIIB, run by West China Hospital.
Trial summary
to explore the impact of preoperative neoadjuvant immunotherapy on perioperative outcomes and long-term prognosis of locally advanced NSCLC in the real world Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-small Cell Lung Cancer Stage ⅢA, Non-small Cell Lung Cancer Stage IIIB
- What is being tested?
- cycles of neoadjuvant therapy and duration of waiting for surgery
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- May 2024to Aug 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: locally advanced NSCLC meeting the above crateria
Who may be able to join
- Confirmed as primary lung cancer through cytology or histological examination;
- ECOG score of 0 or 1; ③ 18 years old or above;
- Received imaging examination, with a preliminary clinical staging of stage III;
- Received genetic testing and tested negative for EGFR mutations, ALK or ROS-1 fusion; ⑥ Accepting preoperative neoadjuvant immunotherapy combined with chemotherapy; ⑦ Receive surgical treatment after completion of neoadjuvant therapy; ⑧ The postoperative specimens were sent to the pathology department of our hospital for pathological testing, and a complete pathological report is available.
Who cannot join
- Patients with combined small cell lung cancer; ② Patients with severe liver/kidney dysfunction, cardiovascular disease, or systemic immune disorders;
- Accept other neoadjuvant treatments; ④ Patients participating in any clinical trial.
About this study
Official title: Influence of Neoadjuvant Chemoimmunotherapy on Treatment Response in Stage IIIA- N2IIIB Non-small Cell Lung Cancer
to explore the impact of preoperative neoadjuvant immunotherapy on perioperative outcomes and long-term prognosis of locally advanced NSCLC in the real world
- Being tested
- cycles of neoadjuvant therapy and duration of waiting for surgery
- 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.
cycles of neoadjuvant therapy and duration of waiting for surgeryOther
We intended to explore the cycles of neoadjuvant therapy and duration of waiting for surgery on the perioperative outcomes and long-term prognosis of locally advanced NSCLC in the real world
| Study group | Role | What they receive |
|---|---|---|
| chemoimmunotherapy group 1 | patients received different cycles of neoadjuvant chemoimmunotherapy Receives: Other: cycles of neoadjuvant therapy and duration of waiting for surgery | |
| chemoimmunotherapy group 2 | the duration of before patients received surgery after neoadjuvant chemoimmunotherapy Receives: Other: cycles of neoadjuvant therapy and duration of waiting for surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
major pathological remission
proportion of patients with no more than 10% residual viable tumor cells; patients who showed no viable tumor in the lung primary setting but lymph nodes show viable metastatic carcinoma were also classified as MPR
Measured: one month
pathological complete remission
proportion of patients without residual viable tumor cell on evaluation of resected lung cancer specimens including all sampled regional lymph nodes
Measured: one month
survival time
time since diagnosed with NSCLC
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study startMay 2024 (estimated)
- Primary completionAug 2024 (estimated)
- Study completionAug 2025 (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 Cancer Stage ⅢAStudies of the same condition, open and under way.
- More trials run by West China 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pengfei Li, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06394427
- Sponsor's protocol ID
- 2024-674
- Status last verified
- Apr 2024
- First submitted
- 28 Apr 2024
- Last updated
- 1 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets are available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Neoadjuvant Chemoimmunotherapy on Treatment Response in Stage IIIA- N2IIIB Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06394427
- Acronym / sponsor ID
- 2024-674
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- May 2024 (estimated)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 1 May 2024 (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 impact of preoperative neoadjuvant immunotherapy on perioperative outcomes and long-term prognosis of locally advanced NSCLC in the real world
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chemoimmunotherapy group 1 | – | Other: cycles of neoadjuvant therapy and duration of waiting for surgerypatients received different cycles of neoadjuvant chemoimmunotherapy |
| chemoimmunotherapy group 2 | – | Other: cycles of neoadjuvant therapy and duration of waiting for surgerythe duration of before patients received surgery after neoadjuvant chemoimmunotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- locally advanced NSCLC meeting the above crateria
Key inclusion criteria (4 listed)
- Confirmed as primary lung cancer through cytology or histological examination;
Key exclusion criteria (2 listed)
- Patients with combined small cell lung cancer; ② Patients with severe liver/kidney dysfunction, cardiovascular disease, or systemic immune disorders;
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 |
|---|---|---|
| cycles of neoadjuvant therapy and duration of waiting for surgeryWe intended to explore the cycles of neoadjuvant therapy and duration of waiting for surgery on the perioperative outcomes and long-term prognosis of locally advanced NSCLC in the real world | Other | chemoimmunotherapy group 1, chemoimmunotherapy group 2 |
Primary outcome
major pathological remission
Time frame: one month
proportion of patients with no more than 10% residual viable tumor cells; patients who showed no viable tumor in the lung primary setting but lymph nodes show viable metastatic carcinoma were also classified as MPR
pathological complete remission
Time frame: one month
proportion of patients without residual viable tumor cell on evaluation of resected lung cancer specimens including all sampled regional lymph nodes
survival time
Time frame: 5 years
time since diagnosed with NSCLC
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Individual participant dataSharing planned: No. The datasets are available upon reasonable request.
Related trials for Non-small Cell Lung Cancer Stage ⅢA
Active, not recruitingPhase 2
Neoadjuvant Therapy of Pembrolizumab + Ramucirumab for PD-L1 Positive Stage IB-IIIA Lung Cancer (EAST ENERGY)
Non-small Cell Lung Cancer Stage IB, Non-small Cell Lung Cancer Stage II
Active, not recruitingPhase 2
Clinical Study of Neoadjuvant Chemotherapy and Immunotherapy Combined With Probiotics in Patients With Resectable NSCLC
Non-small Cell Lung Cancer Stage II, Non-small Cell Lung Cancer Stage ⅢA
RecruitingPhase 2
Adjuvant Chemotherapy Combined With Camrelizumab for ⅡA -ⅢA NSCLC Patients
Immunotherapy, Chemotherapy
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer Stage ⅢA and Non-small Cell Lung Cancer Stage IIIB, run by West China 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 4 inclusion and 2 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 1 May 2024. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
major pathological remission (time frame: one month). The study lists 3 primary outcomes in all. 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 1 May 2024.