A Multicenter, Randomized, Open-label, Phase 2 Study Evaluating the Safety and Efficacy of BMS-986504 Monotherapy in Participants with Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) with Homozygous MTAP Deletion After Progression on Prior Therapies

Conditions

Advanced or Metastatic Non-small Cell Lung Cancer

Brief summary

Number of participants who achieve Objective Response (OR) utilizing the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Detailed description

Number of participants who achieve disease control (DC) as assessed by RECIST v1.1, Duration of response (DOR) as assessed by RECIST v1.1, Progression-free survival (PFS) as assessed by RECIST v1.1, Time to objective response (TTOR) as assessed by RECIST v1.1, Number of participants with adverse events (AE), Number of participants with Serious AEs (SAEs), Number of participants with AEs leading to dose interruption, reduction, or discontinuation, Number of participants who achieve Objective Response (OR) as assessed by RECIST v1.1, Overall Survival, Change from baseline in cancer-related symptoms and health-related quality of life as assessed by the Non-small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) total score and symptom score, Change from baseline in cancer-related symptoms and health-related quality of life as assessed by the EORTC-QLQ-F17 quality-of-life (QoL) functional scale score

Related papers

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Interventions

DRUGMRTX1719

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Number of participants who achieve Objective Response (OR) utilizing the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1	—

Secondary

Measure	Time frame
Number of participants who achieve disease control (DC) as assessed by RECIST v1.1, Duration of response (DOR) as assessed by RECIST v1.1, Progression-free survival (PFS) as assessed by RECIST v1.1, Time to objective response (TTOR) as assessed by RECIST v1.1, Number of participants with adverse events (AE), Number of participants with Serious AEs (SAEs), Number of participants with AEs leading to dose interruption, reduction, or discontinuation, Number of participants who achieve Objective Response (OR) as assessed by RECIST v1.1, Overall Survival, Change from baseline in cancer-related symptoms and health-related quality of life as assessed by the Non-small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) total score and symptom score, Change from baseline in cancer-related symptoms and health-related quality of life as assessed by the EORTC-QLQ-F17 quality-of-life (QoL) functional scale score	—

Measure

Time frame

Number of participants who achieve disease control (DC) as assessed by RECIST v1.1, Duration of response (DOR) as assessed by RECIST v1.1, Progression-free survival (PFS) as assessed by RECIST v1.1, Time to objective response (TTOR) as assessed by RECIST v1.1, Number of participants with adverse events (AE), Number of participants with Serious AEs (SAEs), Number of participants with AEs leading to dose interruption, reduction, or discontinuation, Number of participants who achieve Objective Response (OR) as assessed by RECIST v1.1, Overall Survival, Change from baseline in cancer-related symptoms and health-related quality of life as assessed by the Non-small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) total score and symptom score, Change from baseline in cancer-related symptoms and health-related quality of life as assessed by the EORTC-QLQ-F17 quality-of-life (QoL) functional scale score

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Countries

France, Germany, Italy, Poland, Romania, Spain, Sweden

Outcome results

None listed