To hear about similar clinical trials, please enter your email below
Trial Title:
Detection of Minimal Residual Disease in Resectable Stage II-IIIB Non-small Cell Lung Cancer
NCT ID:
NCT06267144
Condition:
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Conditions: Keywords:
Neoadjuvant
Non Small Cell Lung Carcinoma
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Sintilimab plus chemotherapy
Description:
Sintilimab: 200 mg via intravenous infusion on Day 1 of each 21-day cycle for 2-3 cycles
in the neoadjuvant therapy and the maintenance therapy.
Chemotherapy drugs: carboplatin/cisplatin+Pemetrexed/gemcitabine/albuminpaclitaxel.
Carboplatin: AUC 5 via intravenous infusion, administered in 3-week (21 days) cycles for
2-3 cycles before and after surgery respectly.
Cisplatin: 75 mg/m2 via intravenous infusion, administered in 3-week (21 days) cycles for
2-3 cycles before and after surgery respectly.
Pemetrexed: 500mg/m2 via intravenous infusion, administered in 3-week (21 days) cycles
for 2-3 cycles before and after surgery respectly.
Gemcitabine:1.0g/m2 via intravenous infusion in day1 and day8, administered in 3-week (21
days) cycles for 2-3 cycles before and after surgery respectly. Albuminpaclitaxel: 260
mg/m2 via intravenous infusion, administered in 3-week (21 days) cycles for 2-3 cycles
before and after surgery respectly.
Arm group label:
immunotherapy and chemotherapy
Summary:
Predicting relapse and overall survival in potentially resectable Stage IIIA-IIIB
Non-small Cell Lung Cancer (NSCLC) patients remains challenging. It is now widely
recognized that patients with detectable MRD have a worse prognosis than those with
undetectable MRD. Therefore, investigators performed this prospective clinical trial to
evaluate the predictive value of MRD with increased risk of relapse and improves
prediction of outcome in potentially resectable Stage IIIA-IIIB NSCLC with neoadjuvant
chemoimmunotherapy. In this study, investigators will pay more attention to the long-term
follow-up time and dynamic monitoring of MRD. The predictive value of MRD with
Disease-free survival (DFS) rate was observed as the primary endpoint. Besides that, the
correlation of MRD with major pathologic response (MPR) rate, pathologic complete
response (pCR) rate，event-free survival(EFS) rate and overall survival (OS) were observed
as the second endpoints. Investigators hope it will provide a new insight for these
potentially resectable Stage IIA-IIIB NSCLC with neoadjuvant chemoimmunotherapy.
Criteria for eligibility:
Study pop:
Patient initially diagnosed with resectable stage III-IIIA/IIIB non-small cell lung
cancer t the First Hospital of Jilin University.
Sampling method:
Non-Probability Sample
Criteria:
Key Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 2.
- Have previously untreated and histological examination confirms resectable stage
II-IIIA/IIIB non-small cell lung cancer (according to the 8th edition of the AJCC
TNM staging criteria), and the pathological type of squamous cell carcinoma and
non-squamous cell carcinoma needs to be distinguished, and EGFR, ALK, and ROS1
should be negative for non-squamous non-small cell lung cancer
- Adequate organ function and expected survival time ≥ 12 weeks;
- Evidence of post-menopausal status or negative urinary or serum pregnancy test for
female pre-menopausal patients.
Key Exclusion Criteria:
- Presence of mixed carcinoma component on histology.
- Patients with other active malignancies within 5 years prior to enrollment.
- Known active autoimmune diseases.
- Currently participate in an interventional clinical study treatment or have been
treated with another drug or investigational device within 4 weeks prior to the
first dose.
- Use of immunosuppressive agents within 14 days prior to the first dose of study
treatment.
- Presence of other uncontrolled serious medical conditions.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Hospital Of Jilin University
Address:
City:
Changchun
Zip:
130000
Country:
China
Status:
Recruiting
Contact:
Last name:
Ma Kewei
Phone:
0431-88782222
Start date:
January 20, 2024
Completion date:
December 17, 2025
Lead sponsor:
Agency:
The First Hospital of Jilin University
Agency class:
Other
Source:
The First Hospital of Jilin University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06267144
