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

NCT04606303 | Unknown Phase 2

• 1 other identifier: JS001-DN-028
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Locally Advanced NSCLC

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Complete pathological response (pCR) rate

  At time of surgery

• R0 surgical resection rate

  At time of surgery

• Objective response rate (ORR)

  Baseline (Prior to surgery)

• Adverse Events (AEs)

  Approximately 2 years after the last patient registered.

• Event-free survival(EFS)

  Approximately 2 years after the last patient registered.

Study Arms (1)

Toripalimab Combined With Platinum-containing Dual-agent.

EXPERIMENTAL

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.

Interventions

Toripalimab combination with platinum-containing dual-drug chemotherapy. DRUG

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.

Toripalimab Combined With Platinum-containing Dual-agent.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sign the informed consent form before starting any trial related procedure.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Related Publications (2)

• Liu B, Tao Y, Zhuo M, Xu LD, Cheng X, Tao W, Xie Z, Lv C, Wang Y, Li S, Zhang S, Huang M, Wang Y, Li X, Zhu Y, Cui X, Zhou X, Han B, Zhang E, Huang YS, Chen W, Wang J, Yan S, Wu N. The role of dynamic monitoring of plasma cell-free DNA methylation in predicting pathological response in resectable stage IIB-IIIB non-small cell lung cancer: biomarker analyses from a prospective phase II trial. BMC Med. 2025 Nov 5;23(1):611. doi: 10.1186/s12916-025-04419-x.

  PMID: 41194150 DERIVED

• Tao Y, Li X, Liu B, Wang J, Lv C, Li S, Wang Y, Chen J, Yan S, Wu N. Association of early immune-related adverse events with treatment efficacy of neoadjuvant Toripalimab in resectable advanced non-small cell lung cancer. Front Oncol. 2023 May 15;13:1135140. doi: 10.3389/fonc.2023.1135140. eCollection 2023.

  PMID: 37256186 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department

Study Record Dates

• First Submitted: October 20, 2020
• First Posted: October 28, 2020
• Study Start: December 18, 2020
• Primary Completion: May 21, 2023
• Study Completion: May 1, 2024
• Last Updated: April 5, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)