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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Locally Advanced NSCLC
• Intervention / Treatment: Drug: Toripalimab combination with platinum-containing dual-drug chemotherapy.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Beijing Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Toripalimab Combined With Platinum-containing Dual-agent.; Toripalimab combined with platinum-containing dual-agent as a neoadjuvant Therapy for Non-small Cell Lung Cancer.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
R0 surgical resection rate	No residual ratio under the microscope after surgical resection	At time of surgery
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
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.
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.

Collaborators and Investigators

• Sponsor: Peking University Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2020
• Primary Completion (Anticipated): May 21, 2023
• Study Completion (Anticipated): May 1, 2024

Study Registration Dates

• First Submitted: October 20, 2020
• First Submitted That Met QC Criteria: October 27, 2020
• First Posted (Actual): October 28, 2020

Study Record Updates

• Last Update Posted (Actual): April 5, 2023
• Last Update Submitted That Met QC Criteria: March 31, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: JS001-DN-028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No