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NCT04194944ACTIVE_NOT_RECRUITINGanonymous

LIBRETTO-431: A Multicenter, Randomized, Open-Label, Phase 3 Trial Comparing Selpercatinib to Platinum-Based and Pemetrexed Therapy With or Without Pembrolizumab as Initial Treatment of Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer

Sponsor

Source record

Eli Lilly and Company

Phase

Source record

PHASE3

Modality

AI-normalized

small molecule

Target

AI-normalized

Selpercatinib, Carboplatin, Cisplatin, Pemetrexed, Pembrolizumab

Indication / condition

AI-normalized

Non-Small Cell Lung Cancer

Intervention

Source record

Selpercatinib, Carboplatin, Cisplatin, Pemetrexed, Pembrolizumab

Source & freshness

Source record

NCT ID

NCT04194944

Original source

ClinicalTrials.gov

Source last updated

Oct 21, 2025

Ingested at

Jun 09, 2026

Internal sync

Jun 09, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

Open original registry record
View original source fields

NCT ID

NCT04194944

Title

LIBRETTO-431: A Multicenter, Randomized, Open-Label, Phase 3 Trial Comparing Selpercatinib to Platinum-Based and Pemetrexed Therapy With or Without Pembrolizumab as Initial Treatment of Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer

Sponsor

Eli Lilly and Company

Status

ACTIVE_NOT_RECRUITING

Phase

PHASE3

Condition raw

Non-Small Cell Lung Cancer

Condition normalized

Non-Small Cell Lung Cancer

Modality raw

small molecule

Modality normalized

small molecule

Target raw

Selpercatinib, Carboplatin, Cisplatin, Pemetrexed, Pembrolizumab

Target normalized

Selpercatinib, Carboplatin, Cisplatin, Pemetrexed, Pembrolizumab

Interventions

Selpercatinib, Carboplatin, Cisplatin, Pemetrexed, Pembrolizumab

Public preview

Source record

The reason for this study is to see if the study drug selpercatinib compared to a standard treatment is effective and safe in participants with rearranged during transfection (RET) fusion-positive non-squamous non-small cell lung cancer (NSCLC) that has spread to other parts of the body. Participants who are assigned to the standard treatment and discontinue due to progressive disease have the option to potentially crossover to selpercatinib.

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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TrialSignal

Clinical trial intelligence report

LIBRETTO-431: A Multicenter, Randomized, Open-Label, Phase 3 Trial Comparing Selpercatinib to Platinum-Based and Pemetrexed Therapy With or Without Pembrolizumab as Initial Treatment of Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer

Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.

Generated

Jun 13, 2026

NCT ID

NCT04194944

Status

ACTIVE_NOT_RECRUITING

Phase

PHASE3

Sponsor

Eli Lilly and Company

Executive brief

Investment-Ready Snapshot

The reason for this study is to see if the study drug selpercatinib compared to a standard treatment is effective and safe in participants with rearranged during transfection (RET) fusion-positive non-squamous non-small cell lung cancer (NSCLC) that has spread to other parts of the body. Participants who are assigned to the standard treatment and discontinue due to progressive disease have the option to potentially crossover to selpercatinib.

Source & freshness

Provenance

SourceClinicalTrials.gov
Source updatedOct 21, 2025
Internal syncJun 09, 2026
Model versiontrialsignal-ai-v1

https://clinicaltrials.gov/study/NCT04194944

Indication

Non-Small Cell Lung Cancer

Modality

small molecule

Target

Selpercatinib, Carboplatin, Cisplatin, Pemetrexed, Pembrolizumab

Intervention

Selpercatinib, Carboplatin, Cisplatin, Pemetrexed, Pembrolizumab

Source record

Protocol Description

Detailed source ingestion pending.

Source record

Outcome Measures

Detailed source ingestion pending.

Source record

Eligibility

Detailed source ingestion pending.

AI analysis

Known Results And Readout Context

Detailed source ingestion pending.

IP intelligence

Patent And IP Landscape

Detailed source ingestion pending.

Source record

Contacts

Detailed source ingestion pending.