NSCLC, Stage IIIAPhase 2NCT06614231
Neoajuvant Tislelizumab Combined with Chemotherapy for Initially Unresectable Stage IIIA/N2 Non-small Cell Lung Cancer
A Phase 2 study testing Tislelizumab Combined With Chemotherapy in people with NSCLC, Stage IIIA and NSCLC (non-small Cell Lung Cancer), run by Sun Yat-sen University.
Trial summary
To investigate the efficacy and safety of neoadjuvant treatment with Tislelizumab combined with chemotherapy for initially unresectable N2/III non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC, Stage IIIA, NSCLC (non-small Cell Lung Cancer)
- What is being tested?
- Tislelizumab Combined With Chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2024to 8 Sep 2028
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with initially untreated, unresectable stage III NSCLC (according to the International Association for the Study of Lung Cancer IASLC 8th Thoracic Tumor Stage) with non-small cell lung cancer
- All patients received baseline PET/CT (or neck, upper thoracic and abdominal CT+ cranial MR) for clinical staging
- Cytology/histology (mediastinoscopy or EBUS, etc.) confirmed N2 non-small cell lung cancer
- For non-squamous cell carcinoma patients, if EGFR/ALK mutation status is unknown, tissue samples should be provided for EGFR/ALK gene testing before enrollment; For patients with squamous cell carcinoma, if EGFR/ALK mutation status is unknown, testing is not required during screening
- ECOG (Performance status, PS) score 0-1
- Hematology testings meet the following requirements
Show all 17Show fewer
- neutrophil ≥1.5*109/L
- Platelets ≥100*109/L
- Hemoglobin \> 9.0 g/dL
- Serum creatinine ≤1.5ULN or creatinine clearance (Ccr) ≥40mL/min
- AST/ALT≤ 3ULN
- Total bilirubin ≤1.5ULN
- FEV1≥1.2L or \> 40% of the estimated value
- INR/APTT within normal range
- The patient is over 18 years old
- Measurable lesions (according to the RECIST 1.1 version)
- Subject must understand and voluntarily sign informed consent prior to any study-related evaluation
Who cannot join
- The patient presents with a confirmed or suspected autoimmune disorder.
- Note: Patients with vitiligo, type I diabetes mellitus, or Hashimoto\'s thyroiditis who are hypothyroid but require only hormone replacement therapy may be included in the study if there are no obvious signs of relapse
- Patients must have undergone systemic corticosteroid treatment (≥10mg prednisolone [or equivalent]/day) or received other immunosuppressive medications within 14 days prior to enrollment.
- Note: Inhaled or topical corticosteroids and adrenal hormone replacement therapy (≥10mg prednisolone [or equivalent]/day) can also be accepted for individuals lacking clear evidence of autoimmune disorders
- Patients with grade 3 or 4 interstitial lung disease
- Have other malignant tumors and need anti-tumor therapy
Show all 13Show fewer
- Patients with previous malignancies (except skin malignancies other than melanoma, and in situ cancers of the following sites (bladder, stomach, colorectal, endometrial, cervix, melanoma, or breast) were not included in the study. Unless the malignancy has been in complete remission for two years or more and no additional antitumor therapy is required during the study period
- The investigator believes that the patient is medically, psychologically, or physically incapable of completing this study or of understanding the patient handbook information
- Previously received anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA, and other drugs targeting T-cell co-stimulation or immune regulatory pathways
- Presence of active Hepatitis B or C
- HIV-positive or diagnosed with Acquired Immune Deficiency Disease (AIDS)
- Allergy to the study drug
- Women who are pregnant or breastfeeding
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective Phase II Trial of Neoajuvant Tislelizumab Combined with Chemotherapy for Initially Unresectable Stage IIIA/N2 Non-small Cell Lung Cancer
To investigate the efficacy and safety of neoadjuvant treatment with Tislelizumab combined with chemotherapy for initially unresectable N2/III non-small cell lung cancer.
Read the detailed description
This study is a prospective, single-arm, single-center phase II clinical trial to investigate the efficacy and safety of neoadjuvant treatment with tirilizumab in combination with chemotherapy in patients with initially inoperable stage III/N2 non-small cell lung cancer.
Patients with stage III/N2 non-small cell lung cancer that is initially inoperable and clearly staged and meets the enrollment criteria will receive 3 cycles of tirilizumab (200 mg) in combination with chemotherapy and will be evaluated by imaging of their tumor status. After MDT evaluation patients will either undergo surgery or be withdrawn from the study and receive a combination of radiotherapy and chemotherapy, with postoperative adjuvant therapy at the discretion of the physician. The primary endpoint of this study is the surgical conversion rate; secondary endpoints include MPR, pCR, safety, and EFS.
- Being tested
- Tislelizumab Combined With Chemotherapy
- Keywords
- Unresectable stage III NSCLC, Tirellizumab, Neoadjuvant treatment
- 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 ChemotherapyDrug
Also called Platinum-containing
Tislelizumab 200mg Q3W，Platinum-containing dual drug chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Tislelizumab | Experimental | Tislelizumab 200mg Q3W Receives: Drug: Tislelizumab Combined With Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical conversion rate
After 3 cycles of Tislelizumab combined with chemotherapy, the number of patients who underwent surgical resection/number of patients enrolled
Measured: Within 4-6 weeks (+7 days) after the third cycle of Tislelizumab combined with chemotherapy
Secondary outcomes (2)
Major pathologic response(MPR)
Less than 10% of tumor cells remained in the pathological excision specimen
Measured: Within one week after surgery
Pathologic Complete response（pCR）
No tumor cells were observed in pathological excision specimens
Measured: Within one week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start20 Sep 2024 (estimated)
- Primary completion8 Sep 2028 (estimated)
- Study completion8 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC, Stage IIIAStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xue Hou, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06614231
- Sponsor's protocol ID
- B2024-446-01
- Status last verified
- Sep 2024
- First submitted
- 12 Sep 2024
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: publish an article
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Phase II Trial of Neoajuvant Tislelizumab Combined with Chemotherapy for Initially Unresectable Stage IIIA/N2 Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06614231
- Acronym / sponsor ID
- B2024-446-01
- Keywords
- Unresectable stage III NSCLC, Tirellizumab, Neoadjuvant treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 20 Sep 2024 (estimated)
- Primary completion
- 8 Sep 2028 (estimated)
- Study completion
- 8 Sep 2028 (estimated)
- First posted
- 26 Sep 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 investigate the efficacy and safety of neoadjuvant treatment with Tislelizumab combined with chemotherapy for initially unresectable N2/III non-small cell lung cancer.
Detailed description
This study is a prospective, single-arm, single-center phase II clinical trial to investigate the efficacy and safety of neoadjuvant treatment with tirilizumab in combination with chemotherapy in patients with initially inoperable stage III/N2 non-small cell lung cancer.
Patients with stage III/N2 non-small cell lung cancer that is initially inoperable and clearly staged and meets the enrollment criteria will receive 3 cycles of tirilizumab (200 mg) in combination with chemotherapy and will be evaluated by imaging of their tumor status. After MDT evaluation patients will either undergo surgery or be withdrawn from the study and receive a combination of radiotherapy and chemotherapy, with postoperative adjuvant therapy at the discretion of the physician. The primary endpoint of this study is the surgical conversion rate; secondary endpoints include MPR, pCR, safety, and EFS.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tislelizumab | Experimental | Drug: Tislelizumab Combined With ChemotherapyTislelizumab 200mg Q3W |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patients with initially untreated, unresectable stage III NSCLC (according to the International Association for the Study of Lung Cancer IASLC 8th Thoracic Tumor Stage) with non-small cell lung cancer
- All patients received baseline PET/CT (or neck, upper thoracic and abdominal CT+ cranial MR) for clinical staging
- Cytology/histology (mediastinoscopy or EBUS, etc.) confirmed N2 non-small cell lung cancer
- For non-squamous cell carcinoma patients, if EGFR/ALK mutation status is unknown, tissue samples should be provided for EGFR/ALK gene testing before enrollment; For patients with squamous cell carcinoma, if EGFR/ALK mutation status is unknown, testing is not required during screening
- ECOG (Performance status, PS) score 0-1
Key exclusion criteria (13 listed)
- The patient presents with a confirmed or suspected autoimmune disorder.
- Patients must have undergone systemic corticosteroid treatment (≥10mg prednisolone [or equivalent]/day) or received other immunosuppressive medications within 14 days prior to enrollment.
- Patients with grade 3 or 4 interstitial lung disease
- Have other malignant tumors and need anti-tumor therapy
- Patients with previous malignancies (except skin malignancies other than melanoma, and in situ cancers of the following sites (bladder, stomach, colorectal, endometrial, cervix, melanoma, or breast) were not included in the study. Unless the malignancy has been in complete remission for two years or more and no additional antitumor therapy is required during the study period
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 ChemotherapyAlso: Platinum-containingTislelizumab 200mg Q3W，Platinum-containing dual drug chemotherapy | Drug | Tislelizumab |
Primary outcome
Surgical conversion rate
Time frame: Within 4-6 weeks (+7 days) after the third cycle of Tislelizumab combined with chemotherapy
After 3 cycles of Tislelizumab combined with chemotherapy, the number of patients who underwent surgical resection/number of patients enrolled
2 secondary outcomes
Major pathologic response(MPR)
Time frame: Within one week after surgery
Pathologic Complete response（pCR）
Time frame: Within one week after surgery
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 26 Sep 2024.
- Individual participant dataSharing planned: Yes. publish an article
Related trials for NSCLC, Stage IIIA
RecruitingPhase 3
Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment for Early-Stage Non-Small Cell Lung Cancer, INSIGHT Trial
Lung Non-Small Cell Carcinoma, Stage II Lung Cancer AJCC v8
Not yet recruitingPhase 2
A Prospective Cohort Study of PD-1 Monoclonal Antibody Combined With Ipilimumab N01 and Chemotherapy in Perioperative Treatment of Resectable Non-small Cell Lung Cancer
NSCLC Stage IIIA/B, NSCLC Stage II
RecruitingPhase 3
Testing the Addition of a Type of Drug Called Immunotherapy to the Usual Chemotherapy Treatment for Non-small Cell Lung Cancer, an ALCHEMIST Treatment Trial (Chemo-IO [ACCIO])
Lung Non-Small Cell Carcinoma, Lung Non-Small Cell Squamous Carcinoma
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
RecruitingPhase 2
Cemiplimab and Fianlimab Before Surgery for the Treatment of Stage IB-IIIB Non-Small Cell Lung Cancer
Lung Non-Small Cell Carcinoma, Stage IB Lung Cancer AJCC v8
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tislelizumab Combined With Chemotherapy in people with NSCLC, Stage IIIA and NSCLC (non-small Cell Lung Cancer), run by Sun Yat-sen University.
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 17 inclusion and 13 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 26 Sep 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Xue Hou, MD (+86-13570569436, houxue@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical conversion rate (time frame: Within 4-6 weeks (+7 days) after the third cycle of Tislelizumab combined with chemotherapy). 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 26 Sep 2024.