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

Locally Advanced NSCLC Clinical Trial

Official title:

A Single-center, Prospective, Single-arm Phase Ⅱ Trial of Neoadjuvant Toripalimab Plus Platinum-doublet Chemotherapy in Locally Advanced NSCLC.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04606303
• Other study ID #: JS001-DN-028
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: December 18, 2020
• Est. completion date: May 1, 2024

Study information

• Verified date: March 2023
• Source: Peking University Cancer Hospital & Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: May 1, 2024
• Est. primary completion date: May 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Locally Advanced NSCLC

Intervention

Drug:
• Toripalimab combination with platinum-containing dual-drug chemotherapy.
cisplatin + paclitaxel/ albumin-bound paclitaxel/ gemcitabine/ Pemetroxel+ Toripalimab (cisplatin 75mg/m2 (D1), paclitaxel 175mg/m2 (D1), or albumin-bound paclitaxel 260mg/m2 (D1), or gemcitabine 1250mg/m2 (D1, D8), or Pemetroxel 500mg/m2 (D1)), Toripalimab 240mg D1, Q3W. If the patient is SD or PD, Toripalimab combined with platinum-containing dual-drug chemotherapy in the third cycle will continue, and a total of 4 cycles can be carried out at most, and the therapeutic effect will be evaluated after each cycle of treatment. If the patient is PR or CR at any time during the treatment (after treatment in the third or fourth cycle), the surgical treatment will be entered. If PR or CR is still not reached after treatment in the fourth cycle, the endpoint of the trial will be reached, theobservation of the patient will be finished, and the subsequent treatment will be decided by the clinician.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Cancer Hospital & Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major pathological response (MPR) rate	MPR rate is defined as the percentage of participants having =10% viable tumor cells in the pathological examination of resected specimens.	At time of surgery
Secondary	Complete pathological response (pCR) rate	pCR rate is defined as the percentage of participants having no tumor cells in the pathological examination of resected specimens.	At time of surgery
Secondary	R0 surgical resection rate	No residual ratio under the microscope after surgical resection	At time of surgery
Secondary	Objective response rate (ORR)	ORR is defined as the percentage of participants having a complete response or a partial response, measured by RECIST 1.1.	Baseline (Prior to surgery)
Secondary	Adverse Events (AEs)	Incidence of all grade AE which has been confirmed to be correlated with neoadjuvant treatment.	Approximately 2 years after the last patient registered.
Secondary	Event-free survival(EFS)	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	Approximately 2 years after the last patient registered.