A Phase Ⅱ Trial of Neoadjuvant Toripalimab Plus Platinum-doublet Chemotherapy in Locally Advanced NSCLC.
- Conditions
- Locally Advanced NSCLC
- Interventions
- Registration Number
- NCT04606303
- Lead Sponsor
- Peking University Cancer Hospital & Institute
- Brief Summary
This is a Phase 2, prospective, single-arm, open-Label, single-center study that to find out (1)The effectiveness and safety of toripalimab combined with platinum-doublet chemotherapy as a preoperative neoadjuvant therapy for locally advanced (stage IIB, IIIA, and resectable stage IIIB) NSCLC, (2)The best treatment time for this combination of neoadjuvant therapy before surgery, (3)The effectiveness and safety of combination of neoadjuvant therapy as salvage neoadjuvant therapy after failure of neoadjuvant chemo-only for locally advanced non-small cell lung cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 100
- Sign the informed consent form before starting any trial related procedure.
- 18-80 years old, male or female.
- Non-small cell lung cancer confirmed by cytology or histology. Evaluation by the researchers to confirm resectable stage IIB, IIIA or resectable stage IIIB (CT3-4N2M0) NSCLC patients without any treatment before.
- If the pathological type is adenocarcinoma, genetic testing is required.
- Newly treated patients or patients with failure of traditional preoperative neoadjuvant chemotherapy can be enrolled;
- ECOG PS 0-1.
- Good cardiac function, left ventricular ejection fraction >50%;
- Good respiratory function, able to tolerate radical resection of lung cancer;
- Bone marrow hematopoietic function is good, leukocyte> 4×10^9/l; Hemoglobin> 10g/dl; Platelet > 100×10^9/l;
- Good renal function, glomerular filtration rate>60 ml/min.
- Good liver function, Total bilirubin(TBIL)<1.5ULN, AST<2.5 ULN, ALT<3ULN;
- There must be at least one evaluable focus judged according to recist1.1 standard.
small cell lung cancer confirmed by cytology or histology. Pathologic type was adenocarcinoma with EGFR gene mutation or ALK gene rearrangement.
Advanced lung cancer, or unresectable lung cancer A patient who had received preoperative neoadjuvant radiotherapy for NSCLC. Patients who have a history of active autoimmune disease or potentially recurrent autoimmune disease.
Patients with active hepatitis Allergic to study drug (Toripalimab ,cisplatin, carboplatin, paclitaxel, gemcitabine and pemetrexed) components excipients.
Patients were given antibiotics within 2 weeks. The investigator considered that the subject's comordities or other conditions may affect the compliance with the protocol or are not suitable for participating in this study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Toripalimab Combined With Platinum-containing Dual-agent. Toripalimab combination with platinum-containing dual-drug chemotherapy. Toripalimab combined with platinum-containing dual-agent as a neoadjuvant Therapy for Non-small Cell Lung Cancer.
- Primary Outcome Measures
Name Time Method Major pathological response (MPR) rate At time of surgery MPR rate is defined as the percentage of participants having ≤10% viable tumor cells in the pathological examination of resected specimens.
- Secondary Outcome Measures
Name Time Method R0 surgical resection rate At time of surgery No residual ratio under the microscope after surgical resection
Objective response rate (ORR) Baseline (Prior to surgery) ORR is defined as the percentage of participants having a complete response or a partial response, measured by RECIST 1.1.
Adverse Events (AEs) Approximately 2 years after the last patient registered. Incidence of all grade AE which has been confirmed to be correlated with neoadjuvant treatment.
Complete pathological response (pCR) rate At time of surgery pCR rate is defined as the percentage of participants having no tumor cells in the pathological examination of resected specimens.
Event-free survival(EFS) Approximately 2 years after the last patient registered. Event-free survival was defined as the time from the first treatment to any progression of disease precluding surgery, progression or recurrence of disease after surgery, progression of disease in the absence of surgery, or death from any cause
Trial Locations
- Locations (1)
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China