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Neoadjuvant Toripalimab for Non-squamous NSCLC With EGFR Mutation

NCT05962021 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2023-08-01

No results posted yet for this study

Summary

This study was designed to investigate the efficacy and safety of neoadjuvant Toripalimab (anti-PD1) plus chemotherapy for patients with resectable II-IIIB non-squamous NSCLC harboring EGFR mutation, and to explore the potential predictive and prognostic biomarkers, aiming to provide more abundant evidences for the preoperative treatment decision of non-squamous NSCLC patients.

Conditions

  • Non Squamous Non Small Cell Lung Cancer
  • EGFR Positive Non-small Cell Lung Cancer

Interventions

DRUG

Toripalimab plus Chemotherapy

Therapy was administered on a 21-day regimen for 3 cycles, with Toripalimab (240mg, d1), carboplatin (AUC=5, d1) + pemetrexed (500 mg/m2, d1) for patients with lung adenocarcinoma and carboplatin (AUC=5, d1) + albumin-bound paclitaxel (260 mg/m2, d1) for patients with other subtypes.

Sponsors & Collaborators

  • Shanghai Junshi Bioscience Co., Ltd.

    collaborator OTHER

  • Peking University People's Hospital

    lead OTHER

Principal Investigators

  • Fan Yanf, M.D. · Peking University People's Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
17 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2026-06-30
Completion
2026-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05962021 on ClinicalTrials.gov