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

Part of paid clinical trials in Brooklyn, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT04951115
Phase
PHASE2
Status
Terminated

Conditions

  • Small-cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Carboplatin — DRUG
    AUC = 5-6 mg/mL per min on Day 1 of each 21-day cycle, for 4 cycles
  • Cisplatin — DRUG
    75-80 mg/m2 on Day 1 of each 21-day cycle, for 4 cycles
  • Etoposide — DRUG
    80-100 mg/m2 on Day 1, Day 2, and Day 3 of each 21-day cycle, for 4 cycles
  • Durvalumab — DRUG
    1500 mg on Day 1 of each 21-day cycle, for 4 cycles. Following this, 1500 mg once every 4 weeks until disease progression
  • Stereotactic Body Radiotherapy — RADIATION
    6 Gy of radiotherapy targeting multiple sites of intrathoracic disease on Days 1-5 of cycle 1.

Study Details

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.

Key Dates

Start date
Jul 12, 2021
Status verified
Nov 2024
Primary completion
Jan 17, 2024
Completion
Jan 17, 2024

Study Design

Enrollment
6 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Radiation + Chemo-Immunotherapy

Primary Outcome Measure

Number of Toxicities Grade 3 or Above Related to Therapy [ Time Frame: Up to 29 months ]

Locations (3)

FacilityCityStateZIPSite coordinators
New York-Presbyterian Brooklyn Methodist HospitalBrooklynNew York11215-
New York-Presbyterian QueensFlushingNew York11355-
Weill Cornell MedicineNew YorkNew York10065-

Find similar trials in Brooklyn, NY

By research site
New York-Presbyterian Brooklyn Methodist Hospital· Brooklyn, NYNew York-Presbyterian Queens· Flushing, NYWeill Cornell Medicine· New York, NY

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