[M23-721] Study to Evaluate Adverse Events, Optimal Dose, and Change in Disease Activity, with Livmoniplimab in Combination with Budigalimab Plus Chemotherapy Versus IV Infused Pembrolizumab Plus Chemotherapy in Adult Participants with Untreated Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

JRCT ID: jRCT2031240062

Registered date:07/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Non-Small Cell Lung Cancer
• Date of first enrollment: 24/04/2024
• Target sample size: 840
• Countries of recruitment: United States,Japan,Israel,Japan
• Study type: Interventional

Intervention(s)

Stage 1 (Cohort 1): Livmoniplimab Dose A
Participants will receive livmoniplimab (dose A)+ budigalimab, + chemotherapy for 4 cycles followed by livmoniplimab + budigalimab + pemetrexed.
Stage 1 (Cohort 2): Livmoniplimab Dose B
Participants will receive livmoniplimab (dose B) + budigalimab, + chemotherapy for 4 cycles followed by livmoniplimab + budigalimab + pemetrexed.
Stage 1 (Cohort 3): Budigalimab
Participants will receive budigalimab + chemotherapy for 4 cycles followed by budigalimab + pemetrexed.
Stage 1 (Cohort 4): Pembrolizumab
Participants will receive pembrolizumab + chemotherapy for 4 cycles followed by pembrolizumab + pemetrexed.

Stage 2 (Arm 1): Livmoniplimab (Dose Optimized)
Participants will receive livmoniplimab (dose optimized) + budigalimab + chemotherapy for 4 cycles followed by livmoniplimab + budigalimab + pemetrexed.
Stage 2 (Arm 2): Placebo
Participants will receive placebo + pembrolizumab + chemotherapy for 4 cycles followed by pembrolizumab + pemetrexed.

Outcome(s)

Primary Outcome

Stage 1: Best Overall Response (BOR) of Complete Response (CR)/Partial Response (PR) [ Time Frame: Up to 21 Months ]
BOR of CR/PR is defined as achieving CR or PR according to response evaluation criteria in solid tumors (RECIST) v1.1 as determined by investigators at any time prior to subsequent anticancer therapy. Objective response rate (ORR), defined as the percentage of participants with a BOR of CR/PR, will be summarized.

Stage 2: Overall Survival (OS) [ Time Frame: Up to 55 Months ]
OS is defined as the time measured from randomization until death from any cause.

Secondary Outcome

Stage 1: Progression Free Survival (PFS) [ Time Frame: Up to 21 Months ]
PFS is defined as the time measured from randomization until the first documentation of progressive disease (PD) according to RECIST 1.1 as determined by investigators or death from any cause, whichever occurs first.

Stage 1: Duration of Response (DOR) [ Time Frame: Up to 21 Months ]
DOR is defined as the time from first CR/PR until the first documentation of PD according to RECIST 1.1 as determined by investigators or death from any cause, whichever occurs first.

Stage 1: OS [ Time Frame: Up to 21 Months ]
OS is defined as the time measured from randomization until death from any cause.

Stage 2: PFS [ Time Frame: Up to 55 Months ]
PFS is defined as the time measured from randomization until the first documentation of progressive disease according to RECIST 1.1 as determined by blinded independent central review (BICR) or death from any cause, whichever occurs first.

Stage 2: BOR of CR/PR [ Time Frame: Up to 55 Months ]
BOR of CR/PR is defined as achieving CR or PR according to RECIST 1.1 as determined by investigators at any time prior to subsequent anticancer therapy. ORR, defined as the percentage of participants with a BOR of CR/PR, will be summarized.

Stage 2: Change from Baseline in Physical Functioning (PF) as measured by the PF domain of European Organization for Research Treatment of Cancer Quality of Life Questionnaire 17 (EORTC QLQ-F17) [ Time Frame: Up to 55 Months ]
The EORTC QLQ-F17, a shorter, 17-item version that includes only the functional scales and the Global Health Status / Quality of Life scale of the EORTC QLQ-C30. QLQ-F17 includes the Physical (PF), Role (RF), Emotional (EF), Cognitive (CF) and Social Functioning (SF) scales as well as the Global Health Status/Quality of Life (QL) scale in their original wording. Participants rate items on a 4 point scale ranging form 1 to 4 (1- Not at All, 2= A Little, 3 = Quite a Bit, and 4= Very Much).

Stage 2: Change from Baseline in Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) [ Time Frame: Up to 55 Months ]
The NSCLC -SAQ scale with seven items assessing 5 symptoms of NSCLC (cough, pain, dyspnea, fatigue and poor appetites). The recall period is "over the last 7 days." Each item has a 5-point verbal rating scale from either 0 "No <symptom> at All" to 4 "Very severe <symptom>" or from 0 "Never" to 4 "Always," depending on the item's format.

Stage 2: Change from Baseline in Quality of Life as Measured by the Global Health Status/Quality of Life Domain of the EORTC QLQ-F17 [ Time Frame: Up to 55 Months ]
The EORTC QLQ-F17, a shorter, 17-item version that includes only the functional scales and the Global Health Status / Quality of Life scale of the EORTC QLQ-C30. QLQ-F17 includes the Physical (PF), Role (RF), Emotional (EF), Cognitive (CF) and Social Functioning (SF) scales as well as the Global Health Status/Quality of Life (QL) scale in their original wording. Participants rate items on a 4 point scale ranging form 1 to 4 (1- Not at All, 2= A Little, 3 = Quite a Bit, and 4= Very Much).

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Diagnosis of histologically or cytologically confirmed metastatic nonsquamous non-small cell lung cancer (NSCLC) with no known epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK) mutation, or other genomic aberration for which a locally approved targeted therapy is available.
- Must have at least 1 measurable lesion per response evaluation criteria in solid tumors (RECIST) v1.1 as determined by the local site Investigator/radiology assessment.
- Life expectancy of at least 3 months and adequate organ function.

• Exclude criteria: - Received prior systemic therapy for the treatment of metastatic NSCLC.

Related Information

• Primary Sponsor: Chika Yamagishi
• Secondary ID(s): NCT06236438