A Phase Ⅱ Trial of Neoadjuvant Toripalimab Plus Platinum-doublet Chemotherapy in Locally Advanced NSCLC.

Peking University Cancer Hospital & Institute

Status and phase

Invitation-only

Phase 2

Conditions

Locally Advanced NSCLC

Treatments

Drug: Toripalimab combination with platinum-containing dual-drug chemotherapy.

Study type

Interventional

Funder types

Other

Identifiers

NCT04606303

JS001-DN-028

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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