Clinical Trials Logo

Clinical Trial Summary

Patients with small cell lung cancer that had metastatic lesions after been treated with definitive surgery or chemoradiotherapy are being asked to participate in this study.

1. To observe immunity-mediated tumor response outside the radiation field (abscopal effect) after chemoradiotherapy of a metastatic site in metastatic small cell lung cancer patients.

2. To induce the efficacy (effectiveness) of a new combination of therapy, chemoradiotherapy and thymalfasin for heavily pretreated, metastatic small cell lung cancer patients;

3. To explore the role of PET/CT scanning to assess tumor response/abscopal effect.

This study will help find out what abscopal effects (good or bad) the combination of radiotherapy and thymalfasin has on metastatic small cell lung cancer.


Clinical Trial Description

1. To observe immunity-mediated tumor response outside the radiation field (abscopal effect) after chemoradiotherapy of a metastatic site in metastatic small cell lung cancer patients.

2. To induce the efficacy (effectiveness) of a new combination of therapy, chemoradiotherapy and thymalfasin for heavily pretreated, metastatic small cell lung cancer patients;

3. To explore the role of PET/CT scanning to assess tumor response/abscopal effect.

Eligible are patients with metastatic small cell lung cancer who have achieved stable disease or have disease progression after systemic therapy (surgery or definitive chemoradiotherapy) and have at least three separate measurable sites of metastatic lesions. Extent of metastatic disease is recorded both at CT and PET/CT scanning. Radiation is given during combined therapy to one of the lesions, 35Gy in 10 fractions over a two week interval, conformally to maximally spare normal tissue or organ. Thymalfasin treatment is given twice a week with an interval of 3-4 days each week. At day 22 radiation is re-started and the same radiation dose is delivered to a second metastatic site, again with thymalfasin. Abscopal response is evaluated by assessing clinical and PET/CT response in the non-irradiated measurable metastatic sites. A Phase II clinical trial based on an optimum two-stage Phase II Simon design is used to conduct this pilot study. Ten patients will be treated in Stage one; if there are no abscopal responses, the trial will be terminated. If there are one or more abscopal responses in Stage One, the trial will proceed to enroll an additional 19 patients. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02542137
Study type Interventional
Source Zhejiang Provincial People’s Hospital
Contact
Status Withdrawn
Phase Phase 2
Start date September 2015
Completion date December 2019

See also
  Status Clinical Trial Phase
Not yet recruiting NCT03651219 - Mesylate Apatinib Combined With Irinotecan in Treatment of Recurrent Small Cell Lung Cancer Phase 3
Active, not recruiting NCT03958045 - Combination Rucaparib With Nivolumab in Small Cell Lung Carcinoma Phase 2
Completed NCT04381910 - Irinotecan Hydrochloride Liposome Injection (LY01610) For Small Cell Lung Cancer Phase 2
Active, not recruiting NCT04885998 - AMG 757 and AMG 404 in Subjects With Small Cell Lung Cancer (SCLC) Phase 1
Active, not recruiting NCT03703297 - Study of Durvalumab + Tremelimumab, Durvalumab, and Placebo in Limited Stage Small-Cell Lung Cancer in Patients Who Have Not Progressed Following Concurrent Chemoradiation Therapy Phase 3
Recruiting NCT05903092 - MOnaliZumab in Combination With durvAlumab (MEDI4736) Plus Platinum-based chemotheRapy for First-line Treatment of Extensive Stage Small Cell Lung Cancer Phase 2
Completed NCT03652077 - A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies Phase 1
Terminated NCT04422210 - A Study Evaluating The Safety, Tolerability, Pharmacokinetics, And Efficacy Of Venetoclax In Combination With Atezolizumab, Carboplatin, And Etoposide In Participants With Untreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC). Phase 1
Not yet recruiting NCT02875457 - Apatinib as the Maintenance Therapy for Extensive Stage Small Cell Lung Cancer After Combined With Etoposide/Cisplatin Phase 3
Recruiting NCT02605811 - Temozolomide in Preventing Brain Metastases in Small Cell Lung Cancer Phase 2
Recruiting NCT02577627 - Multi-Indication, Retrospective Oncological Study to Validate the Accuracy in Predicting TTP by PrediCare in Patients Under SOC N/A
Completed NCT02551432 - Pembrolizumab and Paclitaxel in Refractory Small Cell Lung Cancer Phase 2
Recruiting NCT02262897 - The Efficacy and Safety of Nab-paclitaxel in Pretreated Patients With Extensive Disease of Small Cell Lung Cancer Phase 2
Terminated NCT00969306 - Chloroquine as an Anti-Autophagy Drug in Stage IV Small Cell Lung Cancer (SCLC) Patients Phase 1
Completed NCT01943578 - Value of Physical Capacity Tests in Lung Cancer N/A
Completed NCT01831089 - Phase I Study of Lurbinectedin (PM01183) in Combination With Paclitaxel, With or Without Bevacizumab, in Selected Advanced Solid Tumors Phase 1
Completed NCT01497873 - A Randomized Study to Compare the Efficacy and Safety of Belotecan and Topotecan as Monotherapy for Sensitive-Relapsed Small Cell Lung Cancer Phase 2
Terminated NCT00958022 - Carboplatin and Etoposide Plus LBH589 for Small Cell Lung Cancer Phase 1
Completed NCT00930891 - Bevacizumab in Extensive Small Cell Lung Cancer Phase 2/Phase 3
Terminated NCT00702962 - Carboplatin and Etoposide in Combination With Vorinostat for Patients With Extensive Stage Small Cell Lung Cancer Phase 1/Phase 2