A Prospective Cohort Study of Chemotherapy Plus Immunotherapy Combined With Stereotactic Body Radiotherapy as Neoadjuvant Therapy for Patients With Resectable Non-small Cell Lung Cancer

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug, Radiation
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

In this study, patients with EGFR/ALK wild-type, resectable locally advanced NSCLC are expected to receive 1 cycle of chemoimmunotherapy as neoadjuvant therapy, followed by SBRT to the primary lung lesion, and chemoimmunotherapy for 2 cycles. Surgical treatment will be given within 4-6 weeks after the last cycle of chemoimmunotherapy, then immunotherapy maintenance for 1 year.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Histologically or pathologically confirmed, newly diagnosed non-small cell lung cancer patients;

• Age ≥18 years;

• (Eastern Cooperative Oncology Group, ECOG) (Performance Status, PS) score 0-1;

• According to the 8th-9th edition of (American Joint Committee on Cancer, AJCC) (stage II-IIIA, for stage IIIB included T3-4N2, T4 only included tumor \> 7cm);

• Puncture or biopsy samples were tested EGFR/ALK negative;

• Surgically or potentially resectable after discussion by multidisciplinary team (MDT);

• Who has not received systemic antitumor therapy and has not received chest radiotherapy;

• Evaluable lesions in the lung or mediastinum;

• The organ function level should meet the following criteria one week before enrollment: 1) Bone marrow function: hemoglobin ≥80g/L, white blood cell count ≥4.0\*10\^9/L or neutrophil count ≥1.5\*10\^9/L, platelet count ≥100\*10\^9/L; 2) Liver: total serum bilirubin level ≤1.5 times the normal upper limit, when serum total bilirubin level \> 1.5 times the normal upper limit, direct bilirubin level ≤ normal upper limit, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times the normal upper limit; 3) Kidney: blood creatinine level \< 1.5 times the normal upper limit or creatinine clearance ≥50ml/min, urea nitrogen ≤200mg/L; Serum albumin ≥30g/L;

⁃ Male/female of childbearing age agrees to use contraception during the trial period (surgical ligation or oral contraceptives/IUDs + condom contraception);

⁃ Sign informed consent.

Locations
Other Locations
China
Department of Thoracic Oncology, Hangzhou Cancer Hospital
RECRUITING
Hangzhou
Contact Information
Primary
Yi Tang
Beebee24@163.com
86-15068763710
Time Frame
Start Date: 2024-04-24
Estimated Completion Date: 2029-04-30
Participants
Target number of participants: 40
Treatments
Experimental: Treatment group
Treatment group
Sponsors
Leads: First People's Hospital of Hangzhou

This content was sourced from clinicaltrials.gov