Detection of Minimal Residual Disease in Resectable Stage II-IIIB Non-small Cell Lung Cancer

NCT ID: NCT06267144

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-20
• Study Completion Date: 2025-12-17

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.

Conditions

Lung Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

immunotherapy and chemotherapy

Participants received two to three cycles of neoadjuvant chemoimmunotherapy before surgery. Adjuvant chemotherapy was also administered for 2-3 cycles after surgery. In addition, MRD was detected within 30 days before surgery, 1 week after surgery, 1 month ±7days after surgery, 6 months after surgery.

Sintilimab plus chemotherapy

Intervention Type: DRUG

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.

Interventions

Sintilimab plus chemotherapy

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.

Intervention Type: DRUG

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Hospital of Jilin University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Hospital Of Jilin University

Changchun, Jilin, China

Site Status: RECRUITING

Countries

China

Central Contacts

Kewei Ma

Role: CONTACT

makw@jlu.edu.cn

0431-88782179

Facility Contacts

Ma Kewei

Role: primary

0431-88782222

Other Identifiers

23K237-001

Identifier Type: -

Identifier Source: org_study_id