A Study of Selpercatinib (LY3527723) in Participants With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer

PFS is defined as the time from randomization until the occurrence of documented disease progression by the BICR, per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, or death from any cause in the absence of BICR-documented progressive disease.

Time frame: Baseline to Progressive Disease or Death from Any Cause Up to 31 Months

Population: ITT Population: All randomized participants, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants were analyzed according to the treatment arm they were assigned to regardless of what actual treatment they received. Participants censored: TRT A: 98, TRT B:45.

PFS is defined as the time from randomization until the occurrence of documented disease progression by the BICR, per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, or death from any cause in the absence of BICR-documented progressive disease.

Time frame: Baseline to Progressive Disease or Death from Any Cause Up to 31 Months

Population: Intent to Treat (ITT) Pembrolizumab: Participants included in the ITT population who were stratified with the intent to receive pembrolizumab in the event of the control-arm assignment. Participants censored: TRT A: 80, TRT B: 34.

DoR was defined as the time from the date that measurement criteria for CR or PR (whichever is first recorded) were first met until the first date that disease was recurrent or documented disease progression was observed, or the date of death from any cause in the absence of documented disease progression or recurrence. The DOR according to both BICR and investigator-assessed BOR was evaluated per RECIST 1.1 criteria.

Time frame: Date of CR or PR to Date of Disease Progression or Death Due to Any Cause Up to 31 Months

Population: ITT Population: All randomized participants, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants were analyzed according to the treatment arm they were assigned to regardless of what actual treatment they received. Participants censored: TRT A: 90; TRT B: 33.

DoR was defined as the time from the date that measurement criteria for CR or PR (whichever is first recorded) were first met until the first date that disease was recurrent or documented disease progression was observed, or the date of death from any cause in the absence of documented disease progression or recurrence. The DOR according to both BICR and investigator-assessed BOR was evaluated per RECIST 1.1 criteria.

Time frame: Date of CR or PR to Date of Disease Progression or Death Due to Any Cause Up to 31 Months

Population: ITT Pembrolizumab: Participants included in the ITT population who were stratified with the intent to receive pembrolizumab in the event of the control-arm assignment. Participants censored: TRT A:74; TRT B: 25.

Intracranial DOR per RANO-BM by BICR (with or without Pembrolizumab)

Time frame: Date of Intracranial CR or PR to Date of CNS Progression or Death Due to Any Cause Up to 31 Months

Intracranial DOR per RANO-BM by BICR (with Pembrolizumab)

Time frame: Date of Intracranial CR or PR to Date of CNS Progression or Death Due to Any Cause Up to 31 Months

Intracranial ORR: Percentage of Participants with Intracranial CR or PR per RANO-BM by BICR (with or without Pembrolizumab)

Time frame: Baseline through CNS Progression or Death Up to 31 Months

Intracranial ORR: Percentage of Participants with Intracranial CR or PR per RECIST 1.1 by BICR (with or without Pembrolizumab)

Time frame: Baseline through CNS Progression or Death Up to 31 Months

Population: CNS Overall: All participants included in the ITT population who had baseline CNS assessment and who had CNS metastasis at baseline.

Intracranial ORR: Percentage of Participants with Intracranial CR or PR per RECIST 1.1 by BICR (with Pembrolizumab)

Time frame: Baseline through Central Nervous System (CNS) Progression or Death up to 31 Months

Population: CNS Pembrolizumab: Participants included in the ITT population who were stratified with the intent to receive pembrolizumab in the event of the control-arm assignment who had baseline CNS assessment and who had CNS metastasis at baseline.

Intracranial ORR: Percentage of Participants with Intracranial CR or PR per RANO-BM by BICR (with Pembrolizumab)

Time frame: Baseline through CNS Progression or Death Up to 31 Months

Median Intracranial DOR per RECIST 1.1 by BICR (with or without Pembrolizumab)

Time frame: Date of Intracranial CR or PR to Date of CNS Progression or Death Due to Any Cause Up to 31 Months

Population: CNS Overall: All participants included in the ITT population who had baseline CNS assessment and who had CNS metastasis at baseline. Participants censored: TRT A: 15; TRT B: 9.

Intracranial DOR per RECIST 1.1 by BICR (with Pembrolizumab)

Time frame: Date of Intracranial CR or PR to Date of CNS Progression or Death Due to Any Cause Up to 31 Months

Population: CNS Pembrolizumab: Participants included in the ITT population who were stratified with the intent to receive pembrolizumab in the event of the control-arm assignment who had baseline CNS assessment and who had CNS metastasis at baseline. Participants censored: TRT A: 13; TRT B: 9.

Time to CNS Progression per RECIST 1.1 by BICR (with or without Pembrolizumab)

Time frame: Baseline through CNS Progression or Death Up to 31 Months

Population: CNS Overall: All participants included in the ITT population who had baseline CNS assessment and who had CNS metastasis at baseline. Participants censored: TRT A: 137; TRT B: = 73.

Time to CNS Progression per RECIST 1.1 by BICR (with Pembrolizumab)

Time frame: Baseline through CNS Progression or Death Up to 31 Months

Population: CNS Pembrolizumab: Participants included in the ITT population who were stratified with the intent to receive pembrolizumab in the event of the control-arm assignment who had baseline CNS assessment and who had CNS metastasis at baseline. Number of participants censored: TRT A = 112; TRT B = 59.

ORR is defined as the number of participants who achieve a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the total number of participants randomized to each treatment arm.

Time frame: Baseline through Disease Progression or Death Up to 31 Months

Population: ITT Population: All randomized participants, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants were analyzed according to the treatment arm they were assigned to regardless of what actual treatment they received.

Overall survival was defined as the time from randomization until death from any cause. If the participant was alive or lost to follow-up at the time of data analysis, OS data will be censored on the last date the participant is known to be alive.

Time frame: Baseline to Date of Death from Any Cause Up to 38 Months

Population: ITT Population: All randomized participants, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants were analyzed according to the treatment arm they were assigned to regardless of what actual treatment they received. Participants censored: TRT A: 127; TRT B: 84.

ORR is defined as the number of participants who achieve a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the total number of participants randomized to each treatment arm.

Time frame: Baseline through Disease Progression or Death Up to 31 Months

Population: ITT Pembrolizumab: Participants included in the ITT population who were stratified with the intent to receive pembrolizumab in the event of the control-arm assignment.

Overall survival was defined as the time from randomization until death from any cause. If the participant was alive or lost to follow-up at the time of data analysis, OS data was censored on the last date the participant is known to be alive.

Time frame: Baseline to Date of Death from Any Cause Up to 38 Months

Population: ITT Pembrolizumab: Participants included in the ITT population who were stratified with the intent to receive pembrolizumab in the event of the control-arm assignment. Participants censored: TRT A: 104; TRT B: 68.

DCR by BICR (with or without Pembrolizumab) is defined as the number of participants who achieve a BOR of CR, PR, or SD lasting 16 or more weeks divided by the total number of participants randomized to each treatment arm.

Time frame: Baseline to Progressive Disease or Death from Any Cause Up to 31 Months

Population: ITT Population: All randomized participants, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants were analyzed according to the treatment arm they were assigned to regardless of what actual treatment they received.

DCR by BICR (with Pembrolizumab) is defined as the number of participants who achieve a BOR of complete response (CR), partial response (PR), or stable disease (SD) lasting 16 or more weeks divided by the total number of participants randomized to each treatment arm.

Time frame: Baseline to Progressive Disease or Death from Any Cause Up to 31 Months

Population: ITT Pembrolizumab: Participants included in the ITT population who were stratified with the intent to receive pembrolizumab in the event of the control-arm assignment.

PFS2 is defined as the time from randomization to disease progression on the next line of treatment or death from any cause in the absence of observed disease progression.

Time frame: Baseline to Second Disease Progression or Death from Any Cause Up to 38 Months

Population: ITT Population: All randomized participants, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants were analyzed according to the treatment arm they were assigned to regardless of what actual treatment they received. Participants censored: TRT A: 126; TRT B: 77

PFS2 is defined as the time from randomization to disease progression on the next line of treatment or death from any cause in the absence of observed disease progression.

Time frame: Baseline to Second Disease Progression or Death from Any Cause Up to 38 Months

Population: ITT Pembrolizumab: Participants included in the ITT population who were stratified with the intent to receive pembrolizumab in the event of the control-arm assignment. Participants censored: TRT A: 103; TRT B: 62

The Concordance of the Local Lab and the Central Lab RET Results: Percentage of Participants with RET-Positive Specimens as Called by the Central Lab, which is also RET-Positive as Called by a Local Lab (Positive Percent Agreement)

Time frame: Baseline

Time to Deterioration of Pulmonary Symptoms Measured by the NSCLC-SAQ (with or without Pembrolizumab)

Time frame: Baseline to Deterioration of Pulmonary Symptoms Up to 31 Months

Population: ITT Population: All randomized participants, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants were analyzed according to the treatment arm they were assigned to regardless of what actual treatment they received. Participants censored: TRT A: 121; TRT B: 58.

Time to Deterioration of Pulmonary Symptoms Measured by the NSCLC-Symptom Assessment Questionnaire (SAQ) (with Pembrolizumab)

Time frame: Baseline to Deterioration of Pulmonary Symptoms Up to 31 Months

Population: ITT Pembrolizumab: Participants included in the ITT population who were stratified with the intent to receive pembrolizumab in the event of the control-arm assignment. Participants censored: TRT A: 99; TRT B: 47.