Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT04923776
Study type Interventional
Source Columbia University
Contact Brian Henick, MD
Phone 212 305 3997
Email bh2682@cumc.columbia.edu
Status Recruiting
Phase Phase 2
Start date September 20, 2021
Completion date February 2025

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04242199 - Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors Phase 1
Recruiting NCT05552846 - Phase II Trial of Consolidative Thoracic Radiotherapy for ES-SCLC After Standard Care of Chemo-immunotherapy Phase 2
Terminated NCT04022876 - A Study of ALRN-6924 for the Prevention of Chemotherapy-induced Side Effects (Chemoprotection) Phase 1
Recruiting NCT06022757 - Study of XNW5004 Tablet in Combination With KEYTRUDA® (Pembrolizumab) in Subjects With Advanced Solid Tumors Who Failed Standard Treatments (KEYNOTE F19) Phase 1/Phase 2
Recruiting NCT04168281 - Watchful Observation of Patients With LD-SCLC Instead of the PCI N/A
Completed NCT03239171 - Bioinformation Therapy for Lung Cancer Phase 2/Phase 3
Recruiting NCT06457906 - SRS/SRT/Hypo-RT Versus HA-WBRT for No More Than 10 Brain Metastases in SCLC Phase 3
Recruiting NCT04539977 - PD-L1 Antibody (TQB2450) Plus Chemotherapy for Previously Untreated Limited- Stage Small-cell Lung Cancer Phase 2
Completed NCT03345485 - Study of the Safety, Pharmacokinetics and Efficacy of EDO-S101, in Patients With Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT06103682 - LOcally ABLatIve ThErapy for OligopRogressive Lung And Thoracic MalignanciEs (OBLITERATE) N/A
Recruiting NCT04170946 - Talazoparib and Thoracic RT for ES-SCLC Phase 1
Recruiting NCT03523234 - Neoadjuvant Therapy Combined With Radical Surgery for the Treatment of Small Cell Lung Cancer (SCLC) in II and IIIA Stage N/A
Recruiting NCT05620134 - Study of JK08 in Patients With Unresectable Locally Advanced or Metastatic Cancer Phase 1/Phase 2
Recruiting NCT05578326 - Study of Trilaciclib and Lurbinectidin Phase 2
Recruiting NCT06255197 - Characteristics, Treatment Patterns and Outcomes for Patients With Surgically Resected Lung Cancers
Terminated NCT04610658 - Immune Checkpoint Inhibition With Lurbinectedin Relapsed/Recurrent SCLC Phase 1
Active, not recruiting NCT04116320 - Focused Ultrasound Ablation and PD-1 Antibody Blockade in Advanced Solid Tumors Phase 1
Active, not recruiting NCT05091567 - A Phase III, Open-Label Study of Maintenance Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab in Participants With Extensive-Stage Small-Cell Lung Cancer Phase 3
Terminated NCT04596033 - TiTAN-1: Safety, Proliferation and Persistence of GEN-011 Autologous Cell Therapy Phase 1
Recruiting NCT06160596 - Analyzing and Solving Exceptional Long-term Survivors in Solid Tumors With Poor Prognosis