Clinical trial NCT04606303: A Phase Ⅱ Trial of Neoadjuvant Toripalimab Plus Platinum-doublet Chemotherapy in Locally Advanced NSCLC.
Official title: A Single-center, Prospective, Single-arm Phase Ⅱ Trial of Neoadjuvant Toripalimab Plus Platinum-doublet Chemotherapy in Locally Advanced NSCLC.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Locally Advanced NSCLC
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2020-10-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Major pathological response (MPR) rate
timeFrame: At time of surgery
Secondary outcomes:
measure: Complete pathological response (pCR) rate
timeFrame: At time of surgery
measure: R0 surgical resection rate
timeFrame: At time of surgery
measure: Objective response rate (ORR)
timeFrame: Baseline (Prior to surgery)
measure: Adverse Events (AEs)
timeFrame: Approximately 2 years after the last patient registered.
measure: Event-free survival(EFS)
timeFrame: Approximately 2 years after the last patient registered.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
References: