Cobolimab
BiologicalCobolimab will be administered.
NCT Number: NCT04655976
This is a multi-center, parallel group treatment, Phase 2/3 open label study evaluating cobolimab in combination with dostarlimab and docetaxel in participants with advanced non-small cell Lung Cancer (NSCLC) who have progressed on prior anti-PD-(L)1 therapy and chemotherapy.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Phase 2 / Phase 3
GSK Investigational Site, Buenos Aires, Argentina
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Cobolimab will be administered.
Dostarlimab will be administered.
Docetaxel will be administered.
Time frame: Up to approximately 234 weeks
OS is defined as the time from the date of randomization to the date of death due to any cause.
Time frame: Up to approximately 234 weeks
OS is defined as the time from the date of randomization to the date of death due to any cause.
Time frame: Up to approximately 234 weeks
OS is defined as the time from the date of randomization to the date of death due to any cause.
Time frame: Up to approximately 234 weeks
ORR is defined as the percentage of participants who have achieved confirmed complete response (CR) or confirmed partial response (PR) as the best overall response based on Investigator assessment, evaluated using Response Evaluation Criteria in Solid Tumors Criteria (RECIST) version 1.1 . PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeters (mm).
Time frame: Up to approximately 234 weeks
PFS is defined as the length of time from randomization to the earliest date of assessment of disease progression based on RECIST v1.1 by Investigator assessment or death by any cause, whichever occurs first. Progressive Disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start. In addition, the sum has an absolute increase from nadir of 5 mm.)
Time frame: Up to approximately 234 weeks
DOR is defined as the time from first documented response (CR/PR) until the time of first documentation of disease progression based on RECIST version 1.1 by Investigator assessment or death, whichever occurs first. PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeters (mm). Progressive Disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start).
Time frame: Up to approximately 234 weeks
TTD in lung cancer is defined as time from randomization to meaningful deterioration on a composite endpoint of dyspnea, chest pain, and cough, from the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 13 item Lung Cancer Module (EORTC-QLQ-LC13).
Time frame: Baseline [Day(D) -1],D1 on Cycle(C)(s) 2,3,4,5,6,9,12,15,18,22,26,30,34,38,42,46,50,54, 58,62,66, End of treatment (EoT- up to approximately(~) 216 weeks), Safety follow up (SFU) at D30 after EOT (~ 220 weeks) & at D90 after EOT (~ 229 weeks)
The EORTC QLQ-C30 includes 30-items with single and multi-item scales. These include five functional scales (physical functioning [PF], role functioning [RF], emotional functioning [EF] cognitive functioning [CF] and social functioning [SF]), three symptom scales (fatigue, nausea/vomiting [N/V] and pain), a global health status (GHS)/ Quality-of-Life (QoL) scale, and six single items (dyspnea, insomnia, appetite loss [AL], constipation, diarrhea and financial difficulties [FD]). Response options are 1 (Not at all) to 4 (Very much). Scores were averaged and transformed to 0 to 100, a high score for functional scales/ GHS/QoL represent better functioning ability or health-related quality-of-life (HRQoL), whereas a high score for symptom scales/ single items represent significant symptomatology. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (D -1),D1 on Cycle(C)(s) 2,3,4,5,6,9,12,15,18,22,26,30,34,38,42,46,50,54, 58,62,66, End of treatment (EoT- up to approximately(~) 216 weeks), Safety follow up (SFU) at D30 after EOT (~ 220 weeks) & at D90 after EOT (~ 229 weeks)
The QLQ-LC13 questionnaire comprises 13 questions assessing lung cancer-associated symptoms (cough, hemoptysis, dyspnea and site-specific pain which includes pain in chest, pain in arm or shoulder and pain in other parts), and treatment-related side effects (sore mouth [SM], dysphagia, peripheral neuropathy [PN] and alopecia). Response options are 1 (Not at all) to 4 (Very much). Scores were averaged and transformed to 0 to 100. Higher scores represent increasing symptom levels. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day-1) up to Cycle 1 Day 1
ECGs were recorded after the participants were in a supine or semi-recumbent position (about 30 degrees of elevation) and rested for approximately 2 minutes. ECG findings are summarized as clinically significant change from baseline worst case hierarchy: Yes > No > Not Applicable (NA).
Time frame: Up to 329 weeks
A TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, or is a congenital anomaly/birth defect, other situations which involved medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs. AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA dictionary).
Time frame: Up to 329 weeks
A TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment.
Time frame: Up to 329 weeks
Number of participants using concomitant medications will be presented.
Time frame: Up to 329 weeks
Blood samples will be collected for the analysis of hematology parameters.
Time frame: Up to 329 weeks
Blood samples will be collected for the analysis of Clinical Chemistry parameters.
Time frame: Up to 329 weeks
Blood samples will be collected for the analysis of thyroid function
Time frame: Up to 329 weeks
Urine samples will be collected to analyze urine specific gravity.
Time frame: Up to 329 weeks
Vital signs will be assessed
Time frame: Baseline (Day -1) and Up to 281 weeks
Vital signs will be assessed and presented
Time frame: Up to 329 weeks
Performance status will be assessed using the ECOG performance status scale.
Time frame: Up to approximately 234 weeks
Number of participants with abnormal physical examinations will be presented
GlaxoSmithKline
Industry
A Randomized, Open Label Phase 2/3 Study Comparing Cobolimab + Dostarlimab + Docetaxel To Dostarlimab + Docetaxel To Docetaxel Alone In Participants With Advanced Non-small Cell Lung Cancer Who Have Progressed On Prior Anti-PD-(L)1 Therapy And Chemotherapy (COSTAR Lung)
Acronym: COSTAR Lung
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06472076
Bronchial Neoplasms, Carcinoma, Bronchogenic
Ocala, Florida, United States
View Trial DetailsNCT05565378
Bronchial Neoplasms, Carcinoma, Bronchogenic
Plantation, Florida, United States
View Trial DetailsNCT04940936
Bronchial Neoplasms, Carcinoma, Bronchogenic
Vejle, Region Syddanmark, Denmark
View Trial DetailsNCT04986670
Bronchial Neoplasms, Carcinoma, Bronchogenic
Boston, Massachusetts, United States
View Trial Details