MedTrace Logo

A Phase Ib/II Clinical Study of GH21 Capsules Combined With Osimertinib Mesylate Tablets in Patients With NSCLC

NCT06306456 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2024-07-08

No results posted yet for this study

Summary

This study, including phase Ib , phase IIa and phase IIb, aims to evaluate the safety, tolerability, PK profile, efficacy and to determine the RP2D of GH21 capsules combined with Osimertinib mesylate tablets in NSCLC patients with EGFR mutations.

Conditions

  • Non-Small Cell Lung Cancer With EGFR Mutation

Interventions

DRUG

GH21

Oral, 15mg BIW/6mg QD

DRUG

Tagrisso

Oral, 80mg QD

Sponsors & Collaborators

  • Suzhou Genhouse Bio Co., Ltd.

    lead OTHER

Principal Investigators

  • Caicun Zhou, Doctorate · （86）021-65115006

  • Haidan Wang, Doctorate · （86）0512-86861608

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-05
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT06306456 on ClinicalTrials.gov