Liver Directed RT + Chemo-immunotherapy for ES-SCLC
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04923776|
Recruitment Status : Recruiting
First Posted : June 11, 2021
Last Update Posted : April 14, 2022
|Condition or disease||Intervention/treatment||Phase|
|Small-cell Lung Cancer||Drug: Carboplatin Drug: Etoposide Drug: Atezolizumab Radiation: Stereotactic Body Radiation Therapy (SBRT)||Phase 2|
Although the clinical evidence for the combination of radiation therapy and immunotherapy is more limited, numerous case reports, retrospective studies, early stage trials, and ongoing prospective trials highlight the potential for combining radiation with immunotherapy in augmenting the anti-tumor response.
The combination of stereotactic body radiation therapy (SBRT) of liver lesions with immunotherapy has been less well studied. Given the findings that patients with ES-SCLC and liver involvement have a poor prognosis and a limited response to chemo-immunotherapy, the investigators aim to augment the systemic anti-tumor immune response with RT targeted to liver metastases administered in addition to standard of care treatment. Preclinical data and prior clinical studies support the reasoning for these treatment approaches, and the investigators hypothesize that combination RT with chemo-immunotherapy will lead to improved local control and progression free survival in ES-SCLC patients with liver involvement.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Atezolizumab + Carboplatin + Etoposide With Liver-Directed Radiotherapy (RT) in Extensive Stage Small Cell Lung Cancer (ES-SCLC) Patients With Liver Metastases|
|Actual Study Start Date :||September 20, 2021|
|Estimated Primary Completion Date :||February 2024|
|Estimated Study Completion Date :||February 2025|
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.
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.
Other Name: Paraplatin
The dosage for this drug is 100 mg/m2 Intravenous, Days 1-3, every 21 days for 4 cycles. This is standard of care.
Other Name: Vepesid
The dosage for this drug is 1200 mg Intravenous, Day 1, every 21 days until disease progression. This is standard of care.
Other Name: Tecentriq
Radiation: Stereotactic Body Radiation Therapy (SBRT)
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.
- Progression Free Survival (PFS) Rate [ Time Frame: Up to 6 months ]Progression free survival rate at 6 months will be measured to assess the efficacy of liver-directed SBRT when added to standard of care atezolizumab + chemotherapy. 6-month PFS rate will be defined as the proportion of patients that are progression free and alive at 6 months from the start of treatment.
- Overall Survival Rate [ Time Frame: Up to 2 years ]Overall survival (OS) will be defined as the time from treatment start to date of death or last follow up. Patients lost to follow-up at the cut-off date will be censored in the analysis.
- Disease control rate (DCR) [ Time Frame: Up to 2 years ]Disease control rate (DCR) will be defined as the proportion of patients who have a partial (PR) or complete response (CR) or stable disease (SD) after beginning study treatment. Only patients who have received at least one cycle of therapy and have had their disease re-evaluated will be considered evaluable for response.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04923776
|Contact: Brian Henick, MD||212 305 firstname.lastname@example.org|
|Contact: Research Nurse Navigatoremail@example.com|
|United States, New York|
|Columbia University Irving Medical Center, Herbert Irving Comprehensive Cancer Center||Recruiting|
|New York, New York, United States, 10032|
|Contact: Brian Henick, MD|
|Principal Investigator: Brian Henick, MD|
|Principal Investigator:||Brian Henick, MD||Columbia University|