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Efficacy and Safety of JMT101 Combined Wth Docetaxel / HB1801 in Patients With Squamous Cell Non-Small Cell Lung Cancer

NCT06319313 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 534

Last updated 2024-03-20

No results posted yet for this study

Summary

This study is a phase II/III, randomized, controlled, open-label, multi-center study with safety run-in to evaluate the efficacy and safety of JMT101 combined with docetaxel/ HB1801 in Patients with Squamous cell non-small cell lung cancer （sqNSCLC）.

Conditions

  • Squamous Cell Non-small Cell Lung Cancer

Interventions

DRUG

JMT101

JMT101, 6 mg/kg, IV infusion once every 2 weeks (one treatment cycle is 4 weeks). or 9 mg/kg, IV infusion once every 3 weeks.

DRUG

docetaxel

50 mg/m2, IV infusion once every 2 weeks (one treatment cycle is 4 weeks). Or 75 mg/m2, IV infusion once every 3 weeks.

DRUG

HB1801

75 mg/m2, IV infusion once every 2 weeks (one treatment cycle is 4 weeks). Or 100 mg/m2, IV infusion once every 3 weeks.

Sponsors & Collaborators

  • Shanghai JMT-Bio Inc.

    lead INDUSTRY

Principal Investigators

  • Li Zhang, M.D. · Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2026-07-01
Completion
2027-12-01

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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 NCT06319313 on ClinicalTrials.gov