(22615 SOHO-02) A Phase 3 open-label, randomized, active-controlled, multicenter trial to evaluate the efficacy and safety of orally administered BAY 2927088 compared with standard of care as a first-line therapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with HER2-activating mutations

Conditions

Advanced non-small cell lung cancer with HER2 (ERBB2) mutation

Brief summary

Progression free survival (PFS) per RECIST 1.1 as assessed by blinded independent central review (BICR)

Detailed description

Overall survival (OS), Objective response rate (ORR) per RECIST 1.1 as assessed by BICR, PFS per RECIST 1.1 as assessed by the investigator, ORR per RECIST 1.1 as assessed by the investigator, Disease control rate (DCR) per RECIST 1.1 as assessed by BICR, DCR per RECIST 1.1 as assessed by the investigator, Duration of response (DOR) as assessed by BICR, DOR as assessed by the investigator, Adverse events per CTCAE v 5.0 (eg. TEAEs, TESAEs) categorized by severity, Change from baseline in Non-small cell lung cancer Symptom Assessment Questionnaire (NSCLC-SAQ) total score, Change from baseline in NSCLC-SAQ individual domain scores (cough, pain, dyspnea, fatigue, appetite), Time to deterioration in NSCLC-SAQ total score, Time to deterioration in NSCLC-SAQ individual domain scores (cough, pain, dyspnea, fatigue, appetite), Time to deterioration in EORTC QLQ-C30 physical functioning domain score, Change from baseline in EORTC QLQ-C30 physical functioning domain score, Change from baseine in EORTC QLQ-C30 global health status/QoL

Related papers

No related papers found yet.

Interventions

DRUGCisplatin Hikma 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGBAY 2927088 Bayer

DRUGBAY 2927088

DRUGBAY 2927088 Bayer (CM)

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGCarboplatin Kabi 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGPemetrexed Fresenius Kabi 25 mg/ml concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression free survival (PFS) per RECIST 1.1 as assessed by blinded independent central review (BICR)	—

Secondary

Measure	Time frame
Overall survival (OS), Objective response rate (ORR) per RECIST 1.1 as assessed by BICR, PFS per RECIST 1.1 as assessed by the investigator, ORR per RECIST 1.1 as assessed by the investigator, Disease control rate (DCR) per RECIST 1.1 as assessed by BICR, DCR per RECIST 1.1 as assessed by the investigator, Duration of response (DOR) as assessed by BICR, DOR as assessed by the investigator, Adverse events per CTCAE v 5.0 (eg. TEAEs, TESAEs) categorized by severity, Change from baseline in Non-small cell lung cancer Symptom Assessment Questionnaire (NSCLC-SAQ) total score, Change from baseline in NSCLC-SAQ individual domain scores (cough, pain, dyspnea, fatigue, appetite), Time to deterioration in NSCLC-SAQ total score, Time to deterioration in NSCLC-SAQ individual domain scores (cough, pain, dyspnea, fatigue, appetite), Time to deterioration in EORTC QLQ-C30 physical functioning domain score, Change from baseline in EORTC QLQ-C30 physical functioning domain score, Change from baseine in	—

Measure

Time frame

Overall survival (OS), Objective response rate (ORR) per RECIST 1.1 as assessed by BICR, PFS per RECIST 1.1 as assessed by the investigator, ORR per RECIST 1.1 as assessed by the investigator, Disease control rate (DCR) per RECIST 1.1 as assessed by BICR, DCR per RECIST 1.1 as assessed by the investigator, Duration of response (DOR) as assessed by BICR, DOR as assessed by the investigator, Adverse events per CTCAE v 5.0 (eg. TEAEs, TESAEs) categorized by severity, Change from baseline in Non-small cell lung cancer Symptom Assessment Questionnaire (NSCLC-SAQ) total score, Change from baseline in NSCLC-SAQ individual domain scores (cough, pain, dyspnea, fatigue, appetite), Time to deterioration in NSCLC-SAQ total score, Time to deterioration in NSCLC-SAQ individual domain scores (cough, pain, dyspnea, fatigue, appetite), Time to deterioration in EORTC QLQ-C30 physical functioning domain score, Change from baseline in EORTC QLQ-C30 physical functioning domain score, Change from baseine in

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Countries

Austria, Belgium, Bulgaria, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Portugal, Romania, Slovakia, Spain, Sweden

Outcome results

None listed