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A Trial With Chemotherapy, Immunotherapy, and Radiotherapy for Patients With Newly Diagnosed Stage IV Small Cell Lung Cancer

NCT04951115 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2024-11-26

Study results available
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Summary

This study is for subjects with untreated Stage IV small cell lung cancer. Subjects will be given radiation therapy for five days, followed by standard of care chemo-immunotherapy (etoposide + carboplatin or cisplatin + durvalumab) for 4 cycles. Subjects may continue to receive durvalumab after 4 cycles have been completed until disease progression.

Conditions

  • Small-cell Lung Cancer

Interventions

DRUG

Carboplatin

AUC = 5-6 mg/mL per min on Day 1 of each 21-day cycle, for 4 cycles

DRUG

Cisplatin

75-80 mg/m2 on Day 1 of each 21-day cycle, for 4 cycles

DRUG

Etoposide

80-100 mg/m2 on Day 1, Day 2, and Day 3 of each 21-day cycle, for 4 cycles

DRUG

Durvalumab

1500 mg on Day 1 of each 21-day cycle, for 4 cycles. Following this, 1500 mg once every 4 weeks until disease progression

RADIATION

Stereotactic Body Radiotherapy

6 Gy of radiotherapy targeting multiple sites of intrathoracic disease on Days 1-5 of cycle 1.

Sponsors & Collaborators

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Ashish Saxena, MD · Weill Medical College of Cornell University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-12
Primary Completion
2024-01-17
Completion
2024-01-17
FDA Drug
Yes

Countries

  • United States

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 NCT04951115 on ClinicalTrials.gov