Liver Directed RT + Chemo-immunotherapy for ES-SCLC

Part of paid clinical trials in New York, New York.

Sponsor
Brian Henick, MD
Study ID
NCT04923776
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
    The dosage for this drug is area under the curve (AUC) 5 mg/ml/min intravenous, Day 1, every 21 days for 4 cycles. This is standard of care.
  • Etoposide — DRUG
    The dosage for this drug is 100 mg/m2 Intravenous, Days 1-3, every 21 days for 4 cycles. This is standard of care.
  • Atezolizumab — DRUG
    The dosage for this drug is 1200 mg Intravenous, Day 1, every 21 days until disease progression. This is standard of care.
  • Stereotactic Body Radiation Therapy (SBRT) — RADIATION
    This radiotherapy is given within +/-3 days of cycle 2, 10 Gy 3 doses on alternating days. This is not standard of care and considered interventional.

Study Details

The purpose of this study is to evaluate whether radiation treatment directed at liver metastases can be safely added to standard of care treatment for extensive stage small cell lung cancer (ES-SCLC). The current standard treatment for people who have ES-SCLC is chemotherapy including drugs called carboplatin and etoposide, that is combined with a type of immunotherapy called atezolizumab. However, patients with liver involvement of their ES-SCLC don't respond as well to this treatment. The study aims to answer whether adding radiation directed at liver metastases can improve responses to standard chemo-immunotherapy in this patient population. All study participants will get the same study intervention, which will be chemo-immunotherapy and radiation therapy.

Key Dates

Start date
Sep 20, 2021
Status verified
Dec 2024
Primary completion
Sep 13, 2023
Completion
Dec 23, 2023

Study Design

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

Arms

  • Experimental: Experimental: Chemotherapy+SBRT
    Addition of SBRT, directed at liver metastases, to standard of care (SOC) treatment atezolizumab+chemotherapy in SCLC. All patients must undergo a mandatory biopsy of a liver lesion prior to chemotherapy initiation. Cycle 1 of chemoimmunotherapy will be administered as per standard of care, with radiation planning to be done subsequently in anticipation of liver-directed SBRT.

Primary Outcome Measure

Progression Free Survival (PFS) Rate [ Time Frame: Up to 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Irving Medical Center, Herbert Irving Comprehensive Cancer CenterNew YorkNew York10032-

Find similar trials in New York, NY

By research site
Columbia University Irving Medical Center, Herbert Irving Comprehensive Cancer Center· New York, NY

Related Studies