Exploratory Phase II Clinical Study of Toripalimab Plus Radiotherapy Versus Toripalimab Plus Chemotherapy for the Neoadjuvant Treatment of Operable Stage II-IIIA (N+) Non-small Cell Lung Cancer (NSCLC)

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

This randomized phase II trial is to explore the clinical efficacy, safety and feasibility of neoadjuvant immunotherapy plus radiotherapy compared with neoadjuvant immunotherapy plus chemotherapy in operable stage II-IIIA (N+) non small cell lung cancer (NSCLC) and the optimal radiotherapy pattern.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Age 18 to 75 years old, gender is not limited.

• ECOG performance status 0-1.

• non-small cell lung cancer diagnosed by pathology.

• sufficient tumor tissue available for biomarker analysis.

• clinical staging of cT1-2N1-2M0 or T3N1M0, stage II-IIIA (8th UICC staging criteria).

• Patients with distant metastases ruled out by CT or PET/CT and physically assessed as acceptable for radical lung cancer surgery.

• histomolecular pathology confirming the absence of classic driver oncogene mutations in EGFR, ALK, or ROS1.

• Basic normal function of all organs (laboratory test results within 1 week prior to enrollment).

‣ Bone marrow function: absolute neutrophil count (ANC) ≥ 1.5x109 /L, platelet count ≥ 100x109 /L, hemoglobin ≥ 9g/dL.

⁃ Liver: serum total bilirubin ≤ 1.5 times the upper limit of normal; ALT and AST ≤ 2.5 times the upper limit of normal.

⁃ Kidney: blood creatinine level ≤ 1.5 times the upper limit of normal or creatinine clearance ≥ 60 ml/min and urea nitrogen ≤ 200 mg/L.

⁃ Urine protein \<+, if urine protein + then total 24 hour protein must be \<500mg.

⁃ Blood glucose: within normal range and/or with diabetic patients on treatment but with stable blood glucose control.

⁃ Pulmonary function: baseline FEV1 of at least 2L; if baseline FEV1 \< 2L then FEV1 \> 800ml is expected after surgery as assessed by a surgical specialist.

⁃ Cardiac function: no myocardial infarction within 1 year; no unstable angina; no symptomatic severe arrhythmia; no cardiac insufficiency.

• Voluntarily participated in this study and signed the informed consent form by himself or his agent

Locations
Other Locations
China
Shanghai Chest Hospital
RECRUITING
Shanghai
Contact Information
Primary
Xiaolong Fu, MD
xlfu1964@126.com
862122200000
Backup
Wen Feng, MD
fengwen412@126.com
862122200000
Time Frame
Start Date: 2025-02-20
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 124
Treatments
Experimental: Arm A
Radiation: primary tumor SBRT, DT: 24Gy/3Fx, d1-3; positive lymph nodes LDRT, DT: 2Gy/2Fx, d1-2, d22-23 (2 cycles) ; Drug: toripalimab 240mg ivgtt d4, d24 (2 cycles)
Active_comparator: Arm B
Drug: Chemotherapy + toripalimab 240mg ivgtt d1, d22 (2 cycles)~Chemotherapy regimen:~Non-squamous carcinoma: pemetrexed + platinum or paclitaxel + platinum. Squamous carcinoma: paclitaxel + platinum or gemcitabine + platinum
Sponsors
Collaborators: Shanghai Junshi Bioscience Co., Ltd.
Leads: Shanghai Chest Hospital

This content was sourced from clinicaltrials.gov