NSCLC Stage IIIB, NSCLC Stage IIICNCT06829641
Clinical Outcomes of Tislelizumab Combined With Chemotherapy as Induction Therapy in Stage III (cTNM-IIIB/IIIC) NSCLC
An observational study of NSCLC Stage IIIB, NSCLC Stage IIIC, run by West China Hospital.
Trial summary
This is an observational study evaluating the clinical characteristics, treatment patterns, and clinical outcomes in Stage III (cTNM-IIIB/IIIC) Non-Small Cell Lung Cancer.Patients meeting inclusion and exclusion criteria were enrolled, with treatment modalities and clinical outcomes of stage III non-small cell lung… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- NSCLC Stage IIIB, NSCLC Stage IIIC
- What is being tested?
- Tislelizumab Combined with Chemotherapy,
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 9 Aug 2025to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Stage IIIB/IIIC NSCLC patients confirmed by histological or cytological examination based on the 8th edition of the AJCC staging system.
Who may be able to join
- Stage IIIB/IIIC NSCLC patients confirmed by histological or cytological examination based on the 8th edition of the AJCC staging system.
- Patients were negative for EGFR-sensitive mutations or ALK/ROS1 fusion alterations.
- No prior chemotherapy, radiotherapy, surgical intervention, or immunotherapy had been administered.
- ECOG PS scores of the enrolled patients ranged from 0 to 2.
Who cannot join
- Patients with other previous malignancies did not require additional treatment. Patients with incomplete key baseline and treatment information:including clinical stage, pathological type, neoadjuvant treatment, pathological response, imaging response after neoadjuvant.
- Patients included in anti-tumor drug intervention or unblinded clinical trials, in which the treatment being administered is unknown.
- Prior surgery, radiotherapy or systemic therapy for NSCLC, including radiofrequency ablation, etc.
About this study
Official title: A Multicenter Real-World Data Pooled Analysis: The Clinical Outcomes of Tislelizumab Combined With Chemotherapy as Induction Therapy in Stage III (cTNM-IIIB/IIIC) NSCLC
This is an observational study evaluating the clinical characteristics, treatment patterns, and clinical outcomes in Stage III (cTNM-IIIB/IIIC) Non-Small Cell Lung Cancer.Patients meeting inclusion and exclusion criteria were enrolled, with treatment modalities and clinical outcomes of stage III non-small cell lung cancer (NSCLC) patients from multiple tertiary hospitals in real-world settings since August 2020 being collected and analyzed.
Read the detailed description
Key Inclusion Population： Stage IIIB/IIIC NSCLC patients confirmed by histological or cytological examination based on the 8th edition of the AJCC staging system.Patients were negative for EGFR-sensitive mutations or ALK/ROS1 fusion alterations.
No prior chemotherapy, radiotherapy, surgical intervention, or immunotherapy had been administered.ECOG PS scores of the enrolled patients ranged from 0 to 2.
Neoadjuvant/Induction Therapy Regimen:
Tislelizumab combined with platinum-based doublet chemotherapy was administered for at Least Two Cycles , followed by surgical resection or other therapeutic interventions (e.g., radiotherapy/chemotherapy). Real-world clinical outcomes were collected and analyzed based on patients' subsequent treatment pathways.Clinical Stage IIIB-IIIC Non-Small Cell Lung Cancer (AJCC 8th Edition Staging); ECOG PS Score 0-2
Retrospective data collection was conducted for cases prior to site initiation, while prospective collection was implemented for post-initiation cases.
Collected parameters include:
- Patient clinical characteristics
- Treatment patterns
- Treatment compliance
- Safety profiles
- Event-free survival (EFS) and overall survival (OS) tracking
- Conditions
- NSCLC Stage IIIB, NSCLC Stage IIIC
- Being tested
- Tislelizumab Combined with Chemotherapy,
- 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.
Tislelizumab Combined with Chemotherapy,Procedure or surgery
Tislelizumab Combined with Chemotherapy as Induction Therapy
What is being measured
The primary outcome is the main question the study is designed to answer.
major pathological response
viable tumor cell less than 10%
Measured: ;usually 1 week after surgery
Secondary outcomes (6)
R0 resection rate
margin negative resection
Measured: ,usually 1 week after surgery
Down-staging rate
clinical and pathological downstaging
Measured: usually 1 week after surgery
Impact of Neoadjuvant Therapy on Surgical Outcomes
Surgical Rate
Measured: usually 1 week after surgery
The outcome of survival
patterns and Outcomes of Postoperative Disease Recurrence/Progression
Measured: usually 12 month after Induction Therapy
12month event-free survival rate
the time from randomization to any progression of disease precluding surgery, progresson or recurrence of disease after surgery, progression of disease in the absence of surgery, or death from any cases;
Measured: rom date of diagnosis until the date of first documented progression, the rate of recurrence or date of death from any cause, whichever came first, assessed up to 12 months
OS
From diagnosis to the death;
Measured: from date of diagnosis until the date of death from any cause, whichever came first, assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start9 Aug 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC Stage IIIB, NSCLC Stage IIICStudies 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
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhou Qinghua, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06829641
- Sponsor's protocol ID
- CLOG-0004
- Status last verified
- Jun 2025
- First submitted
- 9 Feb 2025
- Last updated
- 27 Jun 2025
- 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 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Real-World Data Pooled Analysis: The Clinical Outcomes of Tislelizumab Combined With Chemotherapy as Induction Therapy in Stage III (cTNM-IIIB/IIIC) NSCLC
- ClinicalTrials.gov ID
- NCT06829641
- Acronym / sponsor ID
- CLOG-0004
- Conditions
- NSCLC Stage IIIB, NSCLC Stage IIIC
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 9 Aug 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 17 Feb 2025 (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 is an observational study evaluating the clinical characteristics, treatment patterns, and clinical outcomes in Stage III (cTNM-IIIB/IIIC) Non-Small Cell Lung Cancer.Patients meeting inclusion and exclusion criteria were enrolled, with treatment modalities and clinical outcomes of stage III non-small cell lung cancer (NSCLC) patients from multiple tertiary hospitals in real-world settings since August 2020 being collected and analyzed.
Detailed description
Key Inclusion Population： Stage IIIB/IIIC NSCLC patients confirmed by histological or cytological examination based on the 8th edition of the AJCC staging system.Patients were negative for EGFR-sensitive mutations or ALK/ROS1 fusion alterations.
No prior chemotherapy, radiotherapy, surgical intervention, or immunotherapy had been administered.ECOG PS scores of the enrolled patients ranged from 0 to 2.
Neoadjuvant/Induction Therapy Regimen:
Tislelizumab combined with platinum-based doublet chemotherapy was administered for at Least Two Cycles , followed by surgical resection or other therapeutic interventions (e.g., radiotherapy/chemotherapy). Real-world clinical outcomes were collected and analyzed based on patients' subsequent treatment pathways.Clinical Stage IIIB-IIIC Non-Small Cell Lung Cancer (AJCC 8th Edition Staging); ECOG PS Score 0-2
Retrospective data collection was conducted for cases prior to site initiation, while prospective collection was implemented for post-initiation cases.
Collected parameters include:
- Patient clinical characteristics
- Treatment patterns
- Treatment compliance
- Safety profiles
- Event-free survival (EFS) and overall survival (OS) tracking
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Stage IIIB/IIIC NSCLC patients confirmed by histological or cytological examination based on the 8th edition of the AJCC staging system.
Key inclusion criteria (4 listed)
- Stage IIIB/IIIC NSCLC patients confirmed by histological or cytological examination based on the 8th edition of the AJCC staging system.
- Patients were negative for EGFR-sensitive mutations or ALK/ROS1 fusion alterations.
- No prior chemotherapy, radiotherapy, surgical intervention, or immunotherapy had been administered.
- ECOG PS scores of the enrolled patients ranged from 0 to 2.
Key exclusion criteria (3 listed)
- Patients with other previous malignancies did not require additional treatment. Patients with incomplete key baseline and treatment information:including clinical stage, pathological type, neoadjuvant treatment, pathological response, imaging response after neoadjuvant.
- Patients included in anti-tumor drug intervention or unblinded clinical trials, in which the treatment being administered is unknown.
- Prior surgery, radiotherapy or systemic therapy for NSCLC, including radiofrequency ablation, etc.
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 |
|---|---|---|
| Tislelizumab Combined with Chemotherapy,Tislelizumab Combined with Chemotherapy as Induction Therapy | Procedure or surgery | – |
Primary outcome
major pathological response
Time frame: ;usually 1 week after surgery
viable tumor cell less than 10%
6 secondary outcomes
R0 resection rate
Time frame: ,usually 1 week after surgery
Down-staging rate
Time frame: usually 1 week after surgery
Impact of Neoadjuvant Therapy on Surgical Outcomes
Time frame: usually 1 week after surgery
The outcome of survival
Time frame: usually 12 month after Induction Therapy
12month event-free survival rate
Time frame: rom date of diagnosis until the date of first documented progression, the rate of recurrence or date of death from any cause, whichever came first, assessed up to 12 months
OS
Time frame: from date of diagnosis until the date of death from any cause, whichever came first, assessed up to 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- 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.
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 NSCLC Stage IIIB, NSCLC Stage IIIC, 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 3 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: opening soon, as of the sponsor's last update on 27 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
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 response (time frame: ;usually 1 week after surgery). 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 27 Jun 2025.