Clinical Trials Logo

Clinical Trial Summary

This phase I trial aims to determine if it is safe to use palliative radiotherapy and lurbinectedin at the same time to treat small cell lung cancer that has spread outside of the chest and that has grown after being treated with chemotherapy (extensive stage). Lurbinectedin kills tumor cells by blocks a process called transcription that small cell lung cancer relies on to survive. It also damages the deoxyribonucleic acid (DNA) of tumor cells, which is similar to the way radiation kills tumor cells. Palliative radiotherapy is a routine medical treatment for patients who have lung cancer that has spread to other parts of the body (metastatic), and is used to relieve symptoms caused by cancer or to patients from developing symptoms. This trial may help doctors understand if treating patients with lurbinectedin and palliative radiotherapy at the same time would make them both work better than either one alone or if they could cause more side effects for patients when given together.


Clinical Trial Description

PRIMARY OBJECTIVE: I. To describe the safety in terms of palliative radiation therapy (RT) in combination with uninterrupted lurbinectedin in patients with extensive stage-lung small cell carcinoma (ES-SCLC). SECONDARY OBJECTIVES: I. To determine the feasibility of delivering palliative RT in combination with lurbinectedin. II. To evaluate the preliminary efficacy of RT plus (+) lurbinectedin, as assessed by: IIa. Radiographic response rates. IIb. Pain response rates. IIc. Progression free survival (PFS). IId. Overall survival (OS). III. To assess patient-reported toxicities to palliative RT + lurbinectedin. EXPLORATORY OBJECTIVE: I. To explore the dose-volume relationships between irradiated bone marrow and hematologic toxicity. OUTLINE: Patients undergo palliative RT over 5 or 10 treatment fractions at the discretion of the treating physician daily for 21 days. Patients also receive lurbinectedin intravenously (IV) over 1 hour on day 1 of each cycle. Cycles of lurbinectedin repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of palliative RT, patients are followed up at 1, 3, 6, and 12 months. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05244239
Study type Interventional
Source Emory University
Contact Kristin Higgins, MD
Phone 404.778.3473
Email Kristin.higgins@emory.edu
Status Recruiting
Phase Phase 1
Start date July 27, 2022
Completion date January 28, 2025

See also
  Status Clinical Trial Phase
Withdrawn NCT04267913 - Testing of TAK228 (MLN0128, Sapanisertib) Plus Docetaxel to the Usual Standard of Care for Advanced Squamous Cell Lung Cancer (A Lung-MAP Treatment Trial) Phase 2
Recruiting NCT04151940 - PET/CT Changes During Chemoimmunotherapy and Radiation Therapy in Patients With Stage IV Non-small Cell Lung Cancer N/A
Terminated NCT03707925 - Bronchoscopic Laser Ablation of Peripheral Lung Tumors N/A
Active, not recruiting NCT04081688 - Atezolizumab and Varlilumab in Combination With Radiation Therapy for NSCLC Phase 1
Recruiting NCT04929041 - Testing the Addition of Radiation Therapy to Immunotherapy for Stage IV Non-Small Cell Lung Cancer Patients Who Are PD-L1 Negative Phase 2/Phase 3
Active, not recruiting NCT04250545 - Testing of the Anti Cancer Drugs CB-839 HCl (Telaglenastat) and MLN0128 (Sapanisertib) in Advanced Stage Non-small Cell Lung Cancer Phase 1
Terminated NCT04396535 - Docetaxel With or Without Bintrafusp Alfa for the Treatment of Advanced Non-small Cell Lung Cancer Phase 2
Active, not recruiting NCT04514497 - Testing the Addition of an Anti-cancer Drug, BAY 1895344, to Usual Chemotherapy for Advanced Stage Solid Tumors, With a Specific Focus on Patients With Small Cell Lung Cancer, Poorly Differentiated Neuroendocrine Cancer, and Pancreatic Cancer Phase 1
Withdrawn NCT05161533 - Hypofractionated Radiation Therapy After Durvalumab and Chemotherapy for the Treatment of Stage IV Extensive Stage Small Cell Lung Cancer, CASPIAN-RT Trial Phase 2
Recruiting NCT04919369 - All-Trans Retinoic Acid (ATRA) and Atezolizumab for the Treatment of Recurrent or Metastatic Non-Small Cell Lung Cancer Phase 1
Terminated NCT03662074 - Subsequent Line Gemcitabine and Nivolumab in Treating Participants With Metastatic Small Cell Lung Cancer Phase 2
Recruiting NCT04073745 - Single Fraction Stereotactic Body Radiation Therapy After Surgery in Treating Patients With Non-small Cell Lung Cancer Phase 1
Withdrawn NCT04186988 - [18F]-AraG for the Detection of T-Cell Activation in Advanced Non-small Cell Lung Cancer Patients Undergoing PD-1/PD-L1-Directed Therapy Early Phase 1
Active, not recruiting NCT03600701 - Atezolizumab and Cobimetinib in Treating Patients With Metastatic, Recurrent, or Refractory Non-small Cell Lung Cancer Phase 2
Active, not recruiting NCT03637816 - Anamorelin Hydrochloride in Reducing Anorexia in Patients With Advanced Non-small Cell Lung Cancer Phase 2/Phase 3
Active, not recruiting NCT04514484 - Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and HIV Phase 1
Recruiting NCT05234307 - PBF-1129 and Nivolumab for the Treatment of Recurrent or Metastatic Non-Small Cell Lung Cancer Phase 1
Recruiting NCT06122064 - A Tool for Improving the Shared Decision-making Process in Patients With Non-small Cell Lung Cancer N/A
Active, not recruiting NCT04533451 - Testing the Effects of MK-3475 (Pembrolizumab) With or Without the Usual Chemotherapy Treatment for Patients 70 Years of Age and Older With Advanced Non-small Cell Lung Cancer Phase 2
Active, not recruiting NCT03776253 - Conquer Fear SUPPORT Intervention in Supporting Patients With Stage III-IV Lung or Gynecologic Cancer N/A