Lung Cancer
Conditions
Keywords
Neoadjuvant, Non Small Cell Lung Carcinoma
Brief 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.
Interventions
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.
Sponsors
The First Hospital of Jilin University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Event free survival(EFS) | Six months after the surgery | Defined as the time from randomization to the occurrence of any event, including disease progression, discontinuation of treatment for any reason, or death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Six months after the surgery | Defined as the time from the first dose of study drug to death due to any cause. |
| Objective Response Rate (ORR) | Six months after the surgery | Defined as the percentage of participants having complete response or partial response to protocol treatment. Objective response will be measured by RECIST 1.1. |
| Disease-Control Rate (DCR) | Six months after the surgery | Defined as the proportion of patients with complete response, partial response, and stable disease. |
| Pathological complete response rate（PCR） | At the end of 2-3 cycles of neoadjuvant therapy (each cycle is 21 days) | Defined as the absence of residual tumor cells (RVT) in the tumor bed in the pathological response assessment of postoperative specimens after neoadjuvant therapy (the criterion of most studies also includes the absence of tumor residue in the lymph nodes). |
| Major pathological response rate (MPR) | At the end of 2-3 cycles of neoadjuvant therapy (each cycle is 21 days) | Defined as the proportion of residual surviving tumor cells in the tumor bed in the postoperative specimen is less than or equal to 10%. |
Countries
China
Contacts
Primary ContactKewei Ma
Outcome results
None listed