Extensive-stage Small-cell Lung Cancer Clinical Trial
Official title:
PRophylactic Cerebral Irradiation or Active MAgnetic Resonance Imaging Surveillance in Small-cell Lung Cancer Patients (PRIMALung Study)
In this phase III study, the primary objective is to test with a one-sided significance of 5% whether for the treatment of small cell lung cancer (SCLC) patients, brain MRI surveillance alone is non-inferior in terms of overall survival compared to prophylactic cranial irradiation (PCI) combined with brain MRI surveillance in the entire study population.
The primary objective is to test with a one-sided significance of 5% whether for the treatment of small cell lung cancer (SCLC) patients, brain MRI surveillance alone is non-inferior in terms of overall survival compared to prophylactic cranial irradiation (PCI) combined with brain MRI surveillance in the entire study population under the treatment policy strategy. The secondary objectives are: - To test with a one-sided type I error of 2.5% whether brain MRI surveillance is superior in terms of cognitive failure free survival (CFFS) compared to prophylactic cranial irradiation (PCI) combined with brain MRI surveillance in the study population. - To test with a one-sided type I error of 2.5% whether brain MRI surveillance is superior in terms of global health status/QoL and cognitive functioning according to EORTC QLQ-C30 questionnaire compared to prophylactic cranial irradiation (PCI) combined with brain MRI surveillance in the study population. - To evaluate the frequency and severity of toxicities according to CTCAE v5.0 in the two arms in the treated population (i.e. patients who have started treatment). The exploratory objectives are: - To compare OS and CFFS between the arms within the subgroups of patients with LS and ES disease. - To compare OS and CFFS between the arms within the subgroups: HA-PCI or not, first-line immunotherapy or not, memantine or not. - To compare cognitive failure free survival (CFFS) rate at 12 months after randomization between the arms. - To compare the cumulative incidence of cognitive failures with death as a competing risk between the arms. - To compare brain-metastasis-free survival (BMFS) between the arms. - To compare progression free survival (PFS) between the arms. - To compare time to brain-metastasis-attributed death (TBMAD) between the arms. - To compare other QoL scales according to EORTC QLQ-C30 and QLQ-BN20 questionnaires between arms. - To evaluate the cost-effectiveness of MRI surveillance alone versus MRI surveillance combined with PCI. - To collect blood for biobanking. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04985851 -
To Evaluate the Efficacy of Durvalumab + Anlotinib in Terms of OS and PFS.
|
N/A | |
| Completed |
NCT01987232 -
Phase 1b/2 Study of Carfilzomib, Carboplatin, and Etoposide in Subjects With Previously Untreated Extensive Stage Small-cell Lung Cancer
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT06427369 -
An Investigational Scan (124I-hJAA-F11 PET/CT) for Diagnosing Lung Cancer
|
Phase 1 | |
| Recruiting |
NCT06223711 -
Durvalumab With Consolidative Radiochemotherapy and Ablative Stereotactic Radiotherapy in Oligometastatic ES-SCLC
|
Phase 2 | |
| Completed |
NCT05002868 -
Safety, Pharmacokinetics and Anti-tumor Activity of RP12146, in Patients With Solid Tumors
|
Phase 1 | |
| Withdrawn |
NCT05572476 -
Lurbinectedin Combined With Durvalumab in Pre-treated Patients With Extensive Stage Small-cell Lung Cancer
|
Phase 2 | |
| Recruiting |
NCT05874401 -
Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan
|
Phase 4 | |
| Not yet recruiting |
NCT06008353 -
A Real-World Assessment of the Demographic, Clinical Characteristics and Outcomes of a Brazilian Cohort of Previously Untreated Extensive Stage-Small Cell Lung Cancer Receiving Durvalumab Combined With Platinum-Etoposide in (ES-SCLC) in Brazil
|
||
| Recruiting |
NCT04947774 -
Prophylactic Cranial Irradiation in Extensive-stage Small Cell Lung Cancer
|
||
| Completed |
NCT04902885 -
Phase 3 Study Evaluating Efficacy, Safety and Pharmacokinetics of Trilaciclib In Extensive-Stage Small Cell Lung Cancer Patients Receiving Carboplatin Combined With Etoposide or Topotecan
|
Phase 3 | |
| Active, not recruiting |
NCT05280470 -
Ifinatamab Deruxtecan (I-DXd) in Subjects With Pretreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC)
|
Phase 2 | |
| Recruiting |
NCT05765825 -
Study of Low-Dose Radiotherapy Concurrent Chemotherapy With Serplulimab for Patients With ES-SCLC
|
Phase 2 | |
| Recruiting |
NCT05761977 -
Durvalumab in Combination With Standard Chemotherapy of Patients With Extensive Stage Small Cell Lung Cancer
|
||
| Active, not recruiting |
NCT05092412 -
Low-dose Radiotherapy Combined With Durvalumab, Chemotherapy(EP) in the Treatment of ES-SCLC
|
Phase 2 | |
| Not yet recruiting |
NCT06306560 -
A Study of Adebrelimab Combined With Famitinib and Chemotherapy in the Treatment of ES-SCLC.
|
Phase 2 | |
| Recruiting |
NCT06211036 -
Study Comparing Tarlatamab and Durvalumab Versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following Platinum, Etoposide and Durvalumab
|
Phase 3 | |
| Recruiting |
NCT04894591 -
To Assess the Effectiveness and Safety of Zepzelca in Adult Patients With Extensive Stage Small Cell Lung Cancer (SCLC)
|
||
| Not yet recruiting |
NCT06437509 -
A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Extensive-stage Small Cell Lung Cancer
|
Phase 2 | |
| Not yet recruiting |
NCT06449209 -
Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy
|
Phase 2 | |
| Completed |
NCT04878016 -
A Study of Carboplatin Plus Etoposide With or Without ZKAB001 (Anti-PD-L1 Antibody) in Patients With ES-SCLC
|
Phase 3 |