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Neoadjuvant Immunotherapy in EGFR-mutant Localized NSCLC

NCT05244213 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2024-07-08

No results posted yet for this study

Summary

Phase II, single-arm, open-label single center study that assess clinical feasibility and safety of 3 cycles neoadjuvant Sintilimab plus chemotherapy in EGFR-mutant stage IIB-IIIB NSCLC (excluding N3) followed by optional adjuvant treatment upon investigators' decisions.

Conditions

Interventions

BIOLOGICAL

Sintilimab

200mg Q3W

DRUG

Carboplatin

AUC 5, d1 every 3 weeks

DRUG

Nab paclitaxel

260 mg/m2, d1 every 3 weeks

Sponsors & Collaborators

  • Guangdong Provincial People's Hospital

    lead OTHER

Principal Investigators

  • Wen-zhao Zhong, PhD · Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-04
Primary Completion
2024-06-05
Completion
2025-12-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT05244213 on ClinicalTrials.gov