A Study of Tobemstomig Plus Platinum-Based Chemotherapy v... | NCT05775289

Label	Type	Description	Intervention Names
Arm A: Tobemstomig + Platinum-Based Chemotherapy	Experimental	Participants with non-squamous (NSQ) NSCLC will receive induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin, all on Day 1 every 3 weeks (Q3W) for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig together with pemetrexed until disease progression or treatment discontinuation. Participants with squamous (SQ) NSCLC will receive blinded tobemstomig in combination with paclitaxel and carboplatin, all on Day 1 Q3W for four 21 day cycles, followed by blinded tobemstomig (on Day 1) Q3W until disease progression or treatment discontinuation.	Drug: Tobemstomig Drug: Paclitaxel Drug: Pemetrexed Drug: Carboplatin
Arm B: Pembrolizumab + Platinum-Based Chemotherapy	Active Comparator	Participants with NSQ NSCLC will receive induction treatment with blinded pembrolizumab in combination with pemetrexed and carboplatin, all on Day 1 Q3W for four 21-day cycles, followed by a maintenance therapy with blinded pembrolizumab together with pemetrexed Q3W until disease progression or treatment discontinuation. Participants with SQ NSCLC will receive blinded pembrolizumab in combination with paclitaxel and carboplatin, all on Day 1 Q3W for four 21-day cycles, followed by blinded pembrolizumab (on Day 1) Q3W until disease progression or treatment discontinuation.	Drug: Pembrolizumab Drug: Paclitaxel Drug: Pemetrexed Drug: Carboplatin

Name	Type	Description	Arm Group Labels	Other Names
Tobemstomig	Drug	Participants will receive intravenous (IV) tobemstomig for four 21-day cycles	Arm A: Tobemstomig + Platinum-Based Chemotherapy

Measure	Description	Time Frame
Progression-Free Survival (PFS)	PFS is defined as the time from randomization to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.	Randomization to date of first documented disease progression or death (up to approximately 15 months)
Objective Response Rate (ORR)	ORR is defined as the percentage of participants who experience a complete reponse or partial response on two consecutive occasions at least 4 weeks apart as determined by the investigator according to RECIST v1.1.	Up to approximately 15 months

Measure	Description	Time Frame
Overall Survival (OS)	OS is defined as the time from randomization to death from any cause.	From randomization to death from any cause (up to approximately 15 months)
Duration of Response (DOR)

Name	Affiliation	Role
Clinical Trials	Hoffmann-LaRoche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Henry Ford Health System		Detroit	Michigan	48202-2689	United States
Renown Regional Medical Center Hospital

ID	Title	Description
FG000	Pembro + Chemotherapy (Squamous)	Participants with squamous non small-cell lung cancer (NSCLC) received blinded pembrolizumab (pembro) in combination with paclitaxel and carboplatin on Day 1 every three weeks (Q3W) for four 21-day cycles, followed by blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Nov 9, 2024

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Progression-Free Survival (PFS)

PFS is defined as the time from randomization to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

The analysis population included all participants that were randomized.

Posted

Median

95% Confidence Interval

Months

Randomization to date of first documented disease progression or death (up to approximately 15 months)

ID	Title	Description
OG000	Pembro + Chemotherapy	Participants with squamous or non-squamous NSCLC received induction treatment with blinded pembro in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by maintenance therapy with blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.
OG001	Tobe + Chemotherapy	Participants with squamous or NSQ NSCLC received induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig with pemetrexed until disease progression or treatment discontinuation for a maximum of 24 months of treatment.

Units	Counts
Participants	OG00091 OG00190

Title

Denominators

Categories

Title	Measurements
	OG0007.13(5.59 to NA)Value is NA due to insufficient number of participants with the event. OG0017.62(5.62 to NA)Value is NA due to insufficient number of participants with the event.

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank		0.9705		Hazard Ratio (HR)	0.99			2-Sided	95	0.63	1.56					Superiority

Primary

Objective Response Rate (ORR)

ORR is defined as the percentage of participants who experience a complete reponse or partial response on two consecutive occasions at least 4 weeks apart as determined by the investigator according to RECIST v1.1.

The analysis population was all randomized participants with measurable disease at baseline.

Posted

Number

95% Confidence Interval

Percent of participants

Up to approximately 15 months

ID	Title	Description
OG000	Pembro + Chemotherapy	Participants with squamous or non-squamous NSCLC received induction treatment with blinded pembro in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by maintenance therapy with blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.
OG001	Tobe + Chemotherapy	Participants with squamous or NSQ NSCLC received induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig with pemetrexed until disease progression or treatment discontinuation for a maximum of 24 months of treatment.

Secondary

Overall Survival (OS)

OS is defined as the time from randomization to death from any cause.

The efficacy analysis population consisted of all participants.

Posted

Median

95% Confidence Interval

Months

From randomization to death from any cause (up to approximately 15 months)

ID	Title	Description
OG000	Pembro + Chemotherapy	Participants with squamous or non-squamous NSCLC received induction treatment with blinded pembro in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by maintenance therapy with blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.
OG001	Tobe + Chemotherapy	Participants with squamous or NSQ NSCLC received induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig with pemetrexed until disease progression or treatment discontinuation for a maximum of 24 months of treatment.

Units	Counts
Participants

Secondary

Duration of Response (DOR)

DOR is defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first.

The DOR analysis population consisted of participants who achieved an objective response to study treatment.

Posted

Median

95% Confidence Interval

Months

From the first occurrence of a confirmed objective response to disease progression or death from any cause (whichever occurs first) (up to approximately 15 months)

ID	Title	Description
OG000	Pembro + Chemotherapy	Participants with squamous or non-squamous NSCLC received induction treatment with blinded pembro in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by maintenance therapy with blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.
OG001	Tobe + Chemotherapy	Participants with squamous or NSQ NSCLC received induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig with pemetrexed until disease progression or treatment discontinuation for a maximum of 24 months of treatment.

Secondary

PFS in Participants With PD-L1 Expression

Not Posted

Up to 28 months

Participants

Secondary

OS for Participants With PD-L1 Expression

Not Posted

Up to 28 months

Participants

Secondary

Change in Participant-reported Outcomes as Assessed by the European Organisation for Research and Treatment (EORTC): Physical Functioning

The EORTC Item Library 17 (IL17) physical functioning scale measures a participant's ability to perform a variety of physical activities. Raw scores are calculated by estimating the average of the items that contribute to the scale. Linear transformation is then used to standardize the raw score to a total score range of 0-100. Higher scores for this measure indicate better outcomes.

The analysis population for patient-reported outcomes (PROs) includes all randomized participants. Baseline PRO measurements were taken prior to Cycle 1 Day 1, resulting in few or no data points for that timepoint.

Posted

Median

Full Range

Scores on a scale

Baseline to week 12

ID	Title	Description
OG000	Pembro + Chemotherapy	Participants with squamous or non-squamous NSCLC received induction treatment with blinded pembro in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by maintenance therapy with blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.
OG001	Tobe + Chemotherapy	Participants with squamous or NSQ NSCLC received induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig with pemetrexed until disease progression or treatment discontinuation for a maximum of 24 months of treatment.

Secondary

Change in Participant-reported Outcomes as Assessed by the EORTC: Global Health Status/Quality of Life (GHS/QoL)

The EORTC Item Library 17 (IL17) Global Health Status/Quality of Life (GHS/QoL) scale measures the participant's overall health and quality of health over the last week. Raw scores are calculated by estimating the average of the items that contribute to the scale. Linear transformation is then used to standardize the raw score to a total score range of 0-100. Higher scores for this measure indicate a higher quality of life.

Posted

Median

Full Range

Scores on a scale

Baseline to week 12

ID	Title	Description
OG000	Pembro + Chemotherapy	Participants with squamous or non-squamous NSCLC received induction treatment with blinded pembro in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by maintenance therapy with blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.
OG001	Tobe + Chemotherapy	Participants with squamous or NSQ NSCLC received induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig with pemetrexed until disease progression or treatment discontinuation for a maximum of 24 months of treatment.

Secondary

Change in Participant-reported Outcomes as Assessed by the EORTC: Role Functioning

The EORTC Item Library 17 (IL17) role functioning scale measures the degree to which disease or treatment interferes with the participant's work or daily activities. Raw scores are calculated by estimating the average of the items that contribute to the scale. Linear transformation is then used to standardize the raw score to a total score range of 0-100. Higher scores for this measure indicate better outcomes.

Posted

Median

Full Range

Scores on a scale

Baseline to week 12

ID	Title	Description
OG000	Pembro + Chemotherapy	Participants with squamous or non-squamous NSCLC received induction treatment with blinded pembro in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by maintenance therapy with blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.
OG001	Tobe + Chemotherapy	Participants with squamous or NSQ NSCLC received induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig with pemetrexed until disease progression or treatment discontinuation for a maximum of 24 months of treatment.

Secondary

Change in Participant-reported Outcomes as Assessed by the EORTC: Lung Cancer Symptoms/How Much Did You Cough

The EORTC IL 85 lung cancer symptoms/how much did you cough measure assesses the severity and frequency of coughing over the past week. The single item is scored on a scale of 1-4, with higher scores indicating worse outcomes.

Posted

Median

Full Range

Scores on a scale

Baseline to week 12

ID	Title	Description
OG000	Pembro + Chemotherapy	Participants with squamous or non-squamous NSCLC received induction treatment with blinded pembro in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by maintenance therapy with blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.
OG001	Tobe + Chemotherapy	Participants with squamous or NSQ NSCLC received induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig with pemetrexed until disease progression or treatment discontinuation for a maximum of 24 months of treatment.

Secondary

Change in Participant-reported Outcomes as Assessed by the EORTC: Short of Breath When Rested

The EORTC IL 85 short of breath when rested measure assesses the degree of difficulty breathing while resting over the past week. The single item is scored on a scale of 1-4, with higher scores indicating worse outcomes.

Posted

Median

Full Range

Scores on a scale

Baseline to week 12

ID	Title	Description
OG000	Pembro + Chemotherapy	Participants with squamous or non-squamous NSCLC received induction treatment with blinded pembro in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by maintenance therapy with blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.
OG001	Tobe + Chemotherapy	Participants with squamous or NSQ NSCLC received induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig with pemetrexed until disease progression or treatment discontinuation for a maximum of 24 months of treatment.

Secondary

Change in Participant-reported Outcomes as Assessed by the EORTC: Short of Breath When Walked

The EORTC IL 85 short of breath when walked measure assesses the degree of difficulty breathing while walking over the past week. The single item is scored on a scale of 1-4, with higher scores indicating worse outcomes.

Posted

Median

Full Range

Scores on a scale

Baseline to week 12

ID	Title	Description
OG000	Pembro + Chemotherapy	Participants with squamous or non-squamous NSCLC received induction treatment with blinded pembro in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by maintenance therapy with blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.
OG001	Tobe + Chemotherapy	Participants with squamous or NSQ NSCLC received induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig with pemetrexed until disease progression or treatment discontinuation for a maximum of 24 months of treatment.

Secondary

Change in Participant-reported Outcomes as Assessed by the EORTC: Short of Breath Climbed Stairs

The EORTC IL 85 short of breath climbed stairs measure assesses the degree of difficulty breathing while climbing stairs over the past week. The single item is scored on a scale of 1-4, with higher scores indicating worse outcomes.

Posted

Median

Full Range

Scores on a scale

Baseline to week 12

ID	Title	Description
OG000	Pembro + Chemotherapy	Participants with squamous or non-squamous NSCLC received induction treatment with blinded pembro in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by maintenance therapy with blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.
OG001	Tobe + Chemotherapy	Participants with squamous or NSQ NSCLC received induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig with pemetrexed until disease progression or treatment discontinuation for a maximum of 24 months of treatment.

Secondary

Change in Participant-reported Outcomes as Assessed by the EORTC: Pain in Chest

The EORTC IL 85 pain in chest measure assesses the severity of chest pain over the past week. The single item is scored on a scale of 1-4, with higher scores indicating worse outcomes.

Posted

Median

Full Range

Scores on a scale

Baseline to week 12

ID	Title	Description
OG000	Pembro + Chemotherapy	Participants with squamous or non-squamous NSCLC received induction treatment with blinded pembro in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by maintenance therapy with blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.
OG001	Tobe + Chemotherapy	Participants with squamous or NSQ NSCLC received induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig with pemetrexed until disease progression or treatment discontinuation for a maximum of 24 months of treatment.

Secondary

Change in Participant-reported Outcomes as Assessed by the EORTC: Need to Rest

The EORTC IL 132 need to rest measure assesses how often the participant felt the need to rest over the past week. The single item is scored on a scale of 1-4, with higher scores indicating worse outcomes.

Posted

Median

Full Range

Scores on a scale

Baseline to week 12

ID	Title	Description
OG000	Pembro + Chemotherapy	Participants with squamous or non-squamous NSCLC received induction treatment with blinded pembro in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by maintenance therapy with blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.
OG001	Tobe + Chemotherapy	Participants with squamous or NSQ NSCLC received induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig with pemetrexed until disease progression or treatment discontinuation for a maximum of 24 months of treatment.

Secondary

Change in Participant-reported Outcomes as Assessed by the EORTC: Felt Weak

The EORTC IL 132 felt weak measure assesses how often the participant felt weak over the past week. The single item is scored on a scale of 1-4, with higher scores indicating worse outcomes.

Posted

Median

Full Range

Scores on a scale

Baseline to week 12

ID	Title	Description
OG000	Pembro + Chemotherapy	Participants with squamous or non-squamous NSCLC received induction treatment with blinded pembro in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by maintenance therapy with blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.
OG001	Tobe + Chemotherapy	Participants with squamous or NSQ NSCLC received induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig with pemetrexed until disease progression or treatment discontinuation for a maximum of 24 months of treatment.

Secondary

Change in Participant-reported Outcomes as Assessed by the EORTC: Tired

The EORTC IL 132 tired measure assesses how often the participant felt tired over the past week. The single item is scored on a scale of 1-4, with higher scores indicating worse outcomes.

Posted

Median

Full Range

Scores on a scale

Baseline to week 12

ID	Title	Description
OG000	Pembro + Chemotherapy	Participants with squamous or non-squamous NSCLC received induction treatment with blinded pembro in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by maintenance therapy with blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.
OG001	Tobe + Chemotherapy	Participants with squamous or NSQ NSCLC received induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig with pemetrexed until disease progression or treatment discontinuation for a maximum of 24 months of treatment.

Secondary

Change in Participant-reported Outcomes as Assessed by the EORTC: Aches/Pain in Bones

The EORTC IL 188 aches/pain in bones measure assessesthe severity of bone pain over the past week. The single item is scored on a scale of 1-4, with higher scores indicating worse outcomes.

Posted

Median

Full Range

Scores on a scale

Baseline to week 12

ID	Title	Description
OG000	Pembro + Chemotherapy	Participants with squamous or non-squamous NSCLC received induction treatment with blinded pembro in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by maintenance therapy with blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.
OG001	Tobe + Chemotherapy	Participants with squamous or NSQ NSCLC received induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig with pemetrexed until disease progression or treatment discontinuation for a maximum of 24 months of treatment.

Secondary

Number of Participants With Adverse Events (AEs)

Posted

Number

Count of participants

From the start of treatment to 90 days after the final dose of treatment (up to 28 months)

ID	Title	Description
OG000	Pembro + Chemotherapy	Participants with squamous or non-squamous NSCLC received induction treatment with blinded pembro in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by maintenance therapy with blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.
OG001	Tobe + Chemotherapy	Participants with squamous or NSQ NSCLC received induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig with pemetrexed until disease progression or treatment discontinuation for a maximum of 24 months of treatment.

Units	Counts
Participants	OG000

Secondary

Maximum Serum Concentration (Cmax) of Tobemstomig

The pharmacokinetic (PK) population consisted of participants who received IV tobemstomig.

Posted

Geometric Mean

Geometric Coefficient of Variation

ug/mL

Up to approximately 15 months

ID	Title	Description
OG000	Pembro + Chemotherapy	Participants with squamous or non-squamous NSCLC received induction treatment with blinded pembro in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by maintenance therapy with blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.
OG001	Tobe + Chemotherapy	Participants with squamous or NSQ NSCLC received induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig with pemetrexed until disease progression or treatment discontinuation for a maximum of 24 months of treatment.

Units	Counts
Participants

Secondary

Time of Maximum Concentration (Tmax) of Tobemstomig

The pharmacokinetic (PK) population consisted of participants who received IV tobemstomig.

Posted

Median

Full Range

Day

Up to approximately 15 months

ID	Title	Description
OG000	Pembro + Chemotherapy	Participants with squamous or non-squamous NSCLC received induction treatment with blinded pembro in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by maintenance therapy with blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.
OG001	Tobe + Chemotherapy	Participants with squamous or NSQ NSCLC received induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig with pemetrexed until disease progression or treatment discontinuation for a maximum of 24 months of treatment.

Units	Counts
Participants

Secondary

Clearance (CL) of Tobemstomig

The pharmacokinetic (PK) population consisted of participants who received IV tobemstomig.

Posted

Geometric Mean

Geometric Coefficient of Variation

mL/day

Up to approximately 15 months

ID	Title	Description
OG000	Pembro + Chemotherapy	Participants with squamous or non-squamous NSCLC received induction treatment with blinded pembro in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by maintenance therapy with blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.
OG001	Tobe + Chemotherapy	Participants with squamous or NSQ NSCLC received induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig with pemetrexed until disease progression or treatment discontinuation for a maximum of 24 months of treatment.

Units	Counts
Participants

Secondary

Volume of Distribution at Steady State (Vss) of Tobemstomig

The pharmacokinetic (PK) population consisted of participants who received IV tobemstomig.

Posted

Geometric Mean

Geometric Coefficient of Variation

Liters

Up to approximately 15 months

ID	Title	Description
OG000	Pembro + Chemotherapy	Participants with squamous or non-squamous NSCLC received induction treatment with blinded pembro in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by maintenance therapy with blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.
OG001	Tobe + Chemotherapy	Participants with squamous or NSQ NSCLC received induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig with pemetrexed until disease progression or treatment discontinuation for a maximum of 24 months of treatment.

Units	Counts
Participants

Secondary

Area Under the Concentration-time Curve (AUC) of Tobemstomig

The pharmacokinetic (PK) population consisted of participants who received IV tobemstomig.

Posted

Geometric Mean

Geometric Coefficient of Variation

day*ug/mL

Up to approximately 15 months

ID	Title	Description
OG000	Pembro + Chemotherapy	Participants with squamous or non-squamous NSCLC received induction treatment with blinded pembro in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by maintenance therapy with blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.
OG001	Tobe + Chemotherapy	Participants with squamous or NSQ NSCLC received induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig with pemetrexed until disease progression or treatment discontinuation for a maximum of 24 months of treatment.

Units	Counts
Participants

Secondary

Half-life (T1/2) of Tobemstomig

The pharmacokinetic (PK) population consisted of participants who received IV tobemstomig.

Posted

Geometric Mean

Geometric Coefficient of Variation

Day

Up to approximately 15 months

ID	Title	Description
OG000	Pembro + Chemotherapy	Participants with squamous or non-squamous NSCLC received induction treatment with blinded pembro in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by maintenance therapy with blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.
OG001	Tobe + Chemotherapy	Participants with squamous or NSQ NSCLC received induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig with pemetrexed until disease progression or treatment discontinuation for a maximum of 24 months of treatment.

Units	Counts
Participants

Secondary

Percentage of Participants With Anti-drug Antibodies (ADAs)

The pharmacokinetic (PK) population consisted of participants who received IV tobemstomig.

Posted

Number

Percentage of participants

Baseline up to approximately 15 months

ID	Title	Description
OG000	Pembro + Chemotherapy	Participants with squamous or non-squamous NSCLC received induction treatment with blinded pembro in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by maintenance therapy with blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.
OG001	Tobe + Chemotherapy	Participants with squamous or NSQ NSCLC received induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig with pemetrexed until disease progression or treatment discontinuation for a maximum of 24 months of treatment.

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA v27.0	Systematic Assessment	EG0002 events1 affected25 at risk EG0010 events0 affected65 at risk EG0022 events2 affected24 at risk EG0033 events3 affected65 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0012 events2 affected65 at risk EG0020 events0 affected24 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected65 at risk EG0020 events0 affected24 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0012 events2 affected65 at risk EG0020 events0 affected24 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected65 at risk EG0020 events0 affected24 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected65 at risk EG0020 events0 affected24 at risk EG003
Atrial flutter	Cardiac disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected65 at risk EG0020 events0 affected24 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected65 at risk EG0020 events0 affected24 at risk EG003
Cardiovascular disorder	Cardiac disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected65 at risk EG0020 events0 affected24 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected65 at risk EG0020 events0 affected24 at risk EG003
Myocarditis	Cardiac disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected65 at risk EG0020 events0 affected24 at risk EG003
Adrenal insufficiency	Endocrine disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected65 at risk EG0021 events1 affected24 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected65 at risk EG0020 events0 affected24 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0012 events1 affected65 at risk EG0021 events1 affected24 at risk EG003
Duodenal ulcer	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected65 at risk EG0020 events0 affected24 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected65 at risk EG0020 events0 affected24 at risk EG003
Immune-mediated enterocolitis	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected65 at risk EG0020 events0 affected24 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected65 at risk EG0020 events0 affected24 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected65 at risk EG0020 events0 affected24 at risk EG003
Small intestinal haemorrhage	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected65 at risk EG0021 events1 affected24 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected65 at risk EG0020 events0 affected24 at risk EG003
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected65 at risk EG0020 events0 affected24 at risk EG003
Asthenia	General disorders	MedDRA v27.0	Systematic Assessment	EG0002 events2 affected25 at risk EG0010 events0 affected65 at risk EG0020 events0 affected24 at risk EG003
Death	General disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected65 at risk EG0020 events0 affected24 at risk EG003
Pain	General disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0012 events2 affected65 at risk EG0020 events0 affected24 at risk EG003
Pyrexia	General disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected65 at risk EG0021 events1 affected24 at risk EG003
Bacterial infection	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected65 at risk EG0020 events0 affected24 at risk EG003
Bronchitis	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected65 at risk EG0020 events0 affected24 at risk EG003
COVID-19	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected65 at risk EG0021 events1 affected24 at risk EG003
COVID-19 pneumonia	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected65 at risk EG0021 events1 affected24 at risk EG003
Diverticulitis	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected65 at risk EG0021 events1 affected24 at risk EG003
Infection	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected65 at risk EG0020 events0 affected24 at risk EG003
Influenza	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected65 at risk EG0020 events0 affected24 at risk EG003
Large intestine infection	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected65 at risk EG0020 events0 affected24 at risk EG003
Lymphangitis	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected65 at risk EG0020 events0 affected24 at risk EG003
Pneumonia	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0003 events2 affected25 at risk EG0018 events6 affected65 at risk EG0023 events3 affected24 at risk EG003
Pneumonia bacterial	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected65 at risk EG0020 events0 affected24 at risk EG003
Pneumonia influenzal	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected65 at risk EG0020 events0 affected24 at risk EG003
Pulmonary sepsis	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected65 at risk EG0020 events0 affected24 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0011 events1 affected65 at risk EG0020 events0 affected24 at risk EG003
Sepsis	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected65 at risk EG0021 events1 affected24 at risk EG003
Sinusitis	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected65 at risk EG0021 events1 affected24 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected65 at risk EG0021 events1 affected24 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected65 at risk EG0020 events0 affected24 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected65 at risk EG0021 events1 affected24 at risk EG003
C-reactive protein increased	Investigations	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected65 at risk EG0020 events0 affected24 at risk EG003
Troponin increased	Investigations	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected65 at risk EG0020 events0 affected24 at risk EG003
Weight decreased	Investigations	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected65 at risk EG0020 events0 affected24 at risk EG003
White blood cell count decreased	Investigations	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected65 at risk EG0020 events0 affected24 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected65 at risk EG0020 events0 affected24 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected65 at risk EG0021 events1 affected24 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected65 at risk EG0021 events1 affected24 at risk EG003
Hypophagia	Metabolism and nutrition disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected65 at risk EG0020 events0 affected24 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0012 events1 affected65 at risk EG0020 events0 affected24 at risk EG003
Myopathy	Musculoskeletal and connective tissue disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected65 at risk EG0020 events0 affected24 at risk EG003
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0011 events1 affected65 at risk EG0021 events1 affected24 at risk EG003
Cognitive disorder	Nervous system disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected65 at risk EG0020 events0 affected24 at risk EG003
Syncope	Nervous system disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0012 events2 affected65 at risk EG0021 events1 affected24 at risk EG003
Confusional state	Psychiatric disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected65 at risk EG0020 events0 affected24 at risk EG003
Delirium	Psychiatric disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected65 at risk EG0020 events0 affected24 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected65 at risk EG0021 events1 affected24 at risk EG003
Nephritis	Renal and urinary disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected65 at risk EG0020 events0 affected24 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected65 at risk EG0021 events1 affected24 at risk EG003
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected65 at risk EG0020 events0 affected24 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected65 at risk EG0020 events0 affected24 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA v27.0	Systematic Assessment	EG0003 events2 affected25 at risk EG0010 events0 affected65 at risk EG0020 events0 affected24 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected65 at risk EG0020 events0 affected24 at risk EG003
Immune-mediated lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected65 at risk EG0020 events0 affected24 at risk EG003
Laryngeal haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected65 at risk EG0021 events1 affected24 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected65 at risk EG0021 events1 affected24 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0013 events2 affected65 at risk EG0021 events1 affected24 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected65 at risk EG0020 events0 affected24 at risk EG003
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected65 at risk EG0020 events0 affected24 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected65 at risk EG0020 events0 affected24 at risk EG003
Embolism arterial	Vascular disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected65 at risk EG0020 events0 affected24 at risk EG003
Hypotension	Vascular disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected65 at risk EG0021 events1 affected24 at risk EG003
Orthostatic hypotension	Vascular disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected65 at risk EG0020 events0 affected24 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA v27.0	Systematic Assessment	EG00013 events11 affected25 at risk EG00152 events40 affected65 at risk EG0028 events6 affected24 at risk EG00348 events35 affected65 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0015 events3 affected65 at risk EG0020 events0 affected24 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected25 at risk EG00122 events16 affected65 at risk EG0025 events4 affected24 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected25 at risk EG00113 events8 affected65 at risk EG0023 events2 affected24 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA v27.0	Systematic Assessment	EG0002 events2 affected25 at risk EG0010 events0 affected65 at risk EG0022 events1 affected24 at risk EG003
Hyperthyroidism	Endocrine disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0014 events4 affected65 at risk EG0025 events5 affected24 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA v27.0	Systematic Assessment	EG0003 events3 affected25 at risk EG0014 events4 affected65 at risk EG0023 events3 affected24 at risk EG003
Lacrimation increased	Eye disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG00112 events10 affected65 at risk EG0020 events0 affected24 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0014 events4 affected65 at risk EG0020 events0 affected24 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0016 events4 affected65 at risk EG0020 events0 affected24 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0012 events2 affected65 at risk EG0023 events2 affected24 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG0006 events5 affected25 at risk EG00123 events18 affected65 at risk EG0026 events5 affected24 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG0007 events4 affected25 at risk EG00119 events16 affected65 at risk EG0027 events7 affected24 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0014 events3 affected65 at risk EG0022 events2 affected24 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG0007 events4 affected25 at risk EG00137 events24 affected65 at risk EG0028 events7 affected24 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0016 events6 affected65 at risk EG0021 events1 affected24 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA v27.0	Systematic Assessment	EG0002 events2 affected25 at risk EG0017 events7 affected65 at risk EG0021 events1 affected24 at risk EG003
Asthenia	General disorders	MedDRA v27.0	Systematic Assessment	EG0006 events5 affected25 at risk EG00131 events20 affected65 at risk EG0028 events7 affected24 at risk EG003
Chest pain	General disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0014 events4 affected65 at risk EG0020 events0 affected24 at risk EG003
Fatigue	General disorders	MedDRA v27.0	Systematic Assessment	EG0009 events4 affected25 at risk EG00117 events14 affected65 at risk EG0027 events5 affected24 at risk EG003
Mucosal inflammation	General disorders	MedDRA v27.0	Systematic Assessment	EG0003 events3 affected25 at risk EG0019 events6 affected65 at risk EG0022 events2 affected24 at risk EG003
Oedema peripheral	General disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0016 events5 affected65 at risk EG0022 events1 affected24 at risk EG003
Pain	General disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected65 at risk EG0021 events1 affected24 at risk EG003
Pyrexia	General disorders	MedDRA v27.0	Systematic Assessment	EG0004 events4 affected25 at risk EG0015 events5 affected65 at risk EG0021 events1 affected24 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0016 events5 affected65 at risk EG0020 events0 affected24 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0014 events2 affected65 at risk EG0024 events3 affected24 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0015 events5 affected65 at risk EG0020 events0 affected24 at risk EG003
Pneumonia	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0002 events2 affected25 at risk EG0014 events4 affected65 at risk EG0021 events1 affected24 at risk EG003
Rhinitis	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected65 at risk EG0020 events0 affected24 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0004 events3 affected25 at risk EG0010 events0 affected65 at risk EG0022 events2 affected24 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0014 events4 affected65 at risk EG0021 events1 affected24 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0014 events1 affected65 at risk EG00210 events6 affected24 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG00110 events6 affected65 at risk EG0022 events2 affected24 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA v27.0	Systematic Assessment	EG0002 events2 affected25 at risk EG00110 events6 affected65 at risk EG0024 events3 affected24 at risk EG003
Blood bicarbonate decreased	Investigations	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0013 events2 affected65 at risk EG0023 events2 affected24 at risk EG003
Blood creatinine increased	Investigations	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0015 events4 affected65 at risk EG0021 events1 affected24 at risk EG003
Blood lactate dehydrogenase increased	Investigations	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected65 at risk EG0022 events2 affected24 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected65 at risk EG0020 events0 affected24 at risk EG003
Lymphocyte count decreased	Investigations	MedDRA v27.0	Systematic Assessment	EG0002 events1 affected25 at risk EG0019 events3 affected65 at risk EG0027 events3 affected24 at risk EG003
Neutrophil count decreased	Investigations	MedDRA v27.0	Systematic Assessment	EG0002 events1 affected25 at risk EG00111 events5 affected65 at risk EG0021 events1 affected24 at risk EG003
Platelet count decreased	Investigations	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected25 at risk EG00110 events6 affected65 at risk EG0021 events1 affected24 at risk EG003
Weight decreased	Investigations	MedDRA v27.0	Systematic Assessment	EG0002 events2 affected25 at risk EG0016 events6 affected65 at risk EG0021 events1 affected24 at risk EG003
White blood cell count decreased	Investigations	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0015 events4 affected65 at risk EG0023 events3 affected24 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA v27.0	Systematic Assessment	EG0007 events7 affected25 at risk EG00122 events15 affected65 at risk EG0027 events5 affected24 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0018 events7 affected65 at risk EG0022 events2 affected24 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0011 events1 affected65 at risk EG0023 events2 affected24 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA v27.0	Systematic Assessment	EG0003 events2 affected25 at risk EG0019 events6 affected65 at risk EG0024 events4 affected24 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA v27.0	Systematic Assessment	EG0002 events2 affected25 at risk EG00110 events7 affected65 at risk EG0022 events2 affected24 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA v27.0	Systematic Assessment	EG0007 events5 affected25 at risk EG0017 events7 affected65 at risk EG0026 events5 affected24 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA v27.0	Systematic Assessment	EG0002 events2 affected25 at risk EG0015 events4 affected65 at risk EG0022 events2 affected24 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA v27.0	Systematic Assessment	EG0003 events2 affected25 at risk EG0010 events0 affected65 at risk EG0020 events0 affected24 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA v27.0	Systematic Assessment	EG0002 events2 affected25 at risk EG0015 events4 affected65 at risk EG0022 events2 affected24 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA v27.0	Systematic Assessment	EG0002 events2 affected25 at risk EG0015 events4 affected65 at risk EG0021 events1 affected24 at risk EG003
Dizziness	Nervous system disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0015 events5 affected65 at risk EG0021 events1 affected24 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0015 events5 affected65 at risk EG0021 events1 affected24 at risk EG003
Headache	Nervous system disorders	MedDRA v27.0	Systematic Assessment	EG0002 events2 affected25 at risk EG0013 events3 affected65 at risk EG0022 events1 affected24 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA v27.0	Systematic Assessment	EG0008 events8 affected25 at risk EG0012 events2 affected65 at risk EG0027 events7 affected24 at risk EG003
Neurotoxicity	Nervous system disorders	MedDRA v27.0	Systematic Assessment	EG0003 events3 affected25 at risk EG0010 events0 affected65 at risk EG0020 events0 affected24 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA v27.0	Systematic Assessment	EG0006 events5 affected25 at risk EG0012 events2 affected65 at risk EG0022 events2 affected24 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	MedDRA v27.0	Systematic Assessment	EG0003 events2 affected25 at risk EG0010 events0 affected65 at risk EG0021 events1 affected24 at risk EG003
Anxiety	Psychiatric disorders	MedDRA v27.0	Systematic Assessment	EG0002 events2 affected25 at risk EG0011 events1 affected65 at risk EG0021 events1 affected24 at risk EG003
Insomnia	Psychiatric disorders	MedDRA v27.0	Systematic Assessment	EG0002 events2 affected25 at risk EG0013 events3 affected65 at risk EG0021 events1 affected24 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA v27.0	Systematic Assessment	EG0001 events1 affected25 at risk EG0010 events0 affected65 at risk EG0020 events0 affected24 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA v27.0	Systematic Assessment	EG0004 events4 affected25 at risk EG0015 events5 affected65 at risk EG0025 events5 affected24 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA v27.0	Systematic Assessment	EG0004 events3 affected25 at risk EG00110 events10 affected65 at risk EG0024 events4 affected24 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA v27.0	Systematic Assessment	EG0002 events2 affected25 at risk EG0011 events1 affected65 at risk EG0020 events0 affected24 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA v27.0	Systematic Assessment	EG0002 events2 affected25 at risk EG0014 events4 affected65 at risk EG0021 events1 affected24 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA v27.0	Systematic Assessment	EG0005 events5 affected25 at risk EG0014 events4 affected65 at risk EG0024 events4 affected24 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA v27.0	Systematic Assessment	EG0000 events0 affected25 at risk EG0010 events0 affected65 at risk EG0022 events2 affected24 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA v27.0	Systematic Assessment	EG0007 events5 affected25 at risk EG00111 events9 affected65 at risk EG0025 events5 affected24 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA v27.0	Systematic Assessment	EG0009 events7 affected25 at risk EG00113 events11 affected65 at risk EG0026 events5 affected24 at risk EG003
Skin exfoliation	Skin and subcutaneous tissue disorders	MedDRA v27.0	Systematic Assessment	EG0003 events2 affected25 at risk EG0010 events0 affected65 at risk EG0020 events0 affected24 at risk EG003

ID	Title	Description
BG000	Pembro + Chemotherapy (Squamous)	Participants with squamous non small-cell lung cancer (NSCLC) received blinded pembrolizumab (pembro) in combination with paclitaxel and carboplatin on Day 1 every three weeks (Q3W) for four 21-day cycles, followed by blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.
BG001	Pembro + Chemotherapy (Non-squamous)	Participants with non-squamous NSCLC received induction treatment with blinded pembro in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by maintenance therapy with blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.
BG002	Tobe + Chemotherapy (Squamous)	Participants with SQ NSCLC received blinded tobemstomig in combination with paclitaxel and carboplatin on Day 1 Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.
BG003	Tobe + Chemotherapy (Non-squamous)	Participants with NSQ NSCLC received induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig with pemetrexed until disease progression or treatment discontinuation for a maximum of 24 months of treatment.
BG004	Total	Total of all reporting groups

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes
D006147	Guanine
D007042	Hypoxanthines
D011688	Purinones
D011687	Purines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D005971	Glutamates
D024342	Amino Acids, Acidic
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins
D000600	Amino Acids, Dicarboxylic
D056831	Coordination Complexes

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Pembro + Chemotherapy (Squamous)	Participants with squamous non small-cell lung cancer (NSCLC) received blinded pembrolizumab (pembro) in combination with paclitaxel and carboplatin on Day 1 every three weeks (Q3W) for four 21-day cycles, followed by blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.	4	25	10	25	25	25
EG001	Pembro + Chemotherapy (Non-squamous)	Participants with non-squamous NSCLC received induction treatment with blinded pembro in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by maintenance therapy with blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.	11	65	26	65	63	65
EG002	Tobe + Chemotherapy (Squamous)	Participants with SQ NSCLC received blinded tobemstomig in combination with paclitaxel and carboplatin on Day 1 Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.	8	24	14	24	24	24
EG003	Tobe + Chemotherapy (Non-squamous)	Participants with NSQ NSCLC received induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig with pemetrexed until disease progression or treatment discontinuation for a maximum of 24 months of treatment.	12	65	35	65	63	65

ID	Term
C582435	pembrolizumab
D017239	Paclitaxel
D000068437	Pemetrexed
D016190	Carboplatin