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.

NCT04606303•Peking University Cancer Hospital & Institute

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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

Age

18 - 80 years

Sex

ALL

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.
+2 more criteria

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

Locations (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

December 18, 2020

Primary Completion Date

May 21, 2023

Completion Date

May 1, 2024

Last Updated

April 5, 2023

Enrollment

100

ESTIMATED participants

Conditions

Locally Advanced NSCLC

Interventions

Toripalimab combination with platinum-containing dual-drug chemotherapy.

DRUG

Study of Inupadenant (EOS100850) With Chemotherapy as Second Line Treatment for Nonsquamous Non-small Cell Lung Cancer

NCT05403385

Metastatic NSCLC - Non-Small Cell Lung CancerLocally Advanced NSCLC - Non-Small Cell Lung Cancer

View study

ACTIVE_NOT_RECRUITINGPHASE2

Concomitant Radiotherapy, Tremelimumab & Durvalumab for Advanced NSCLC Patients Progressing on First-line Immunotherapy

NCT05000710

Metastatic or Locally Advanced NSCLC

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 5, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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