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CM082 and JS001 in Patients With Advanced Small-cell Lung Cancer (SCLC)

NCT03904719 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-07-09

No results posted yet for this study

Summary

This study was a single-arm, multi-center, phase II study, which is aimed to evaluate the efficacy and safety of CM082 combined with JS001 as the second-line treatment of advanced small cell lung cancer. Eligible patients will receive CM082 tablets 150mg once daily orally in combination with JS001 (240mg, intravenously) every 21 days. Treatment continues until disease progresses , intolerable toxicity, or withdraw.

Conditions

Interventions

DRUG

CM082 plus JS001

CM082: 150mg once a day orally (taken within half an hour after breakfast) JS001: An intravenous infusion of a solution having a concentration of 1-3mg/ml was prepared with 0.9% physiological saline, and administered once every three weeks. Using an inline filter (0.2 or 0.22 μm), the drug was diluted with physiological saline and intravenously administered within 60 minutes.

Sponsors & Collaborators

  • AnewPharma

    lead INDUSTRY

Principal Investigators

  • Yuankai Shi, MD · National Cancer Center/Cancer 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
2019-09-18
Primary Completion
2021-06-30
Completion
2021-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

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 NCT03904719 on ClinicalTrials.gov