Clinical Trials Logo
  1. Home
  2. Small Cell Lung Cancer
  3. NCT05223647

Chemo-immunotherapy Plus Thoracic Radiotherapy in Extensive Stage Small-cell Lung Cancer — TRIPLEX  

Small-cell Lung Cancer Clinical Trial

Official title:
Randomized Phase III Trial Investigating the Survival Benefit of Adding Thoracic Radiotherapy to Durvalumab (MEDI4736) Immunotherapy Plus Chemotherapy in Extensive Stage Small-cell Lung Cancer

Clinical Trial Summary

Studies have shown that combining chemotherapy and immune checkpoint inhibitors (ICI) prolongs survival compared with chemotherapy alone in extensive stage small-cell lung cancer (ES SCLC), but the survival benefit is modest. The main aim of this trial is to investigate whether there is a synergistic/additive effect of concurrent thoracic radiotherapy in ES SCLC patients receiving carboplatin/etoposide/durvalumab.

Clinical Trial Description

Studies show that adding ICI therapy to standard chemotherapy prolongs survival in ES SCLC. The survival benefit, however, is modest, and there is a need for more effective therapy. It has been hypothesized that there is a synergistic effect of combining ICI with radiotherapy. In this randomized phase III study, the main aim is to investigate whether concurrent thoracic radiotherapy of 30 Gy/10 fractions improves survival in ES SCLC patients receiving carboplatin/etoposide/durvalumab. It is currently not possible to classify the patients who benefit from ICIs in SCLC. In this study, biological material (tissue, blood, feces) which will be analyzed for potential predictive and prognostic biomarkers. Prophylactic cranial irradiation in ES SCLC is debated, mainly due to the potentially detrimental effect on cognition. Thus, frequency and timing of brain metastases and cognitive function will be assessed before, during and after study treatment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05223647
Study type Interventional
Source Norwegian University of Science and Technology
Contact Bjørn H Grønberg, MD, PhD
Phone 47297878
Email bjorn.h.gronberg@ntnu.no
Status Recruiting
Phase Phase 3
Start date January 11, 2022
Completion date October 2029
View Details
See also
  Status Clinical Trial Phase
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 NCT04923776 - Liver Directed RT + Chemo-immunotherapy for ES-SCLC 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 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 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
Completed NCT03547804 - A Prospective, Single-center, One-arm Clinical Study of Apatinib Combined With Chemotherapy for Pretreated Patients With Advanced Small Cell Lung Cancer Phase 2