Safety and Tolerability Evaluation of Low-dose Radiation in Combination With CS1001 in Relapsed SCLC Patients

NCT04421352 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2024-03-07

No results posted yet for this study

Summary

A Phase Ia/Ib Safety and Tolerability Evaluation of Low-dose Radiation in Combination with CS1001 in relapsed SCLC patients

Conditions

  • Relapsed Small Cell Lung Cancer

Interventions

DRUG

CS1001

low-dose radiation+CS1001 1200mg Q3W. In the dose escalation part, the dose levels will be escalated following a modified 3+3 dose escalation scheme. Dose A: 3Gy/1f; Dose B: 9Gy/3f; Dose C: 15Gy/5f; In the dose expansion part, more SCLC patients will be assigned.

Sponsors & Collaborators

Principal Investigators

  • You Lu, MD · West China 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
2021-01-12
Primary Completion
2023-12-22
Completion
2023-12-22

Countries

  • China

Study Locations

More Related Trials

Entities

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 NCT04421352 on ClinicalTrials.gov