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NCT03529084WITHDRAWNanonymous

A Randomized, Open-label, Phase III Study of Single Agent Nazartinib Versus Investigator's Choice (Erlotinib or Gefitinib) as First-Line Treatment in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Activating Mutations

Sponsor

Source record

Novartis Pharmaceuticals

Phase

Source record

PHASE3

Modality

AI-normalized

small molecule

Target

AI-normalized

EFG816, erlotinib or gefitinib

Indication / condition

AI-normalized

Carcinoma, Non-small Cell Lung

Intervention

Source record

EFG816, erlotinib or gefitinib

Source & freshness

Source record

NCT ID

NCT03529084

Original source

ClinicalTrials.gov

Source last updated

Nov 22, 2019

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

NCT03529084

Title

A Randomized, Open-label, Phase III Study of Single Agent Nazartinib Versus Investigator's Choice (Erlotinib or Gefitinib) as First-Line Treatment in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Activating Mutations

Sponsor

Novartis Pharmaceuticals

Status

WITHDRAWN

Phase

PHASE3

Condition raw

Carcinoma, Non-small Cell Lung

Condition normalized

Carcinoma, Non-small Cell Lung

Modality raw

small molecule

Modality normalized

small molecule

Target raw

EFG816, erlotinib or gefitinib

Target normalized

EFG816, erlotinib or gefitinib

Interventions

EFG816, erlotinib or gefitinib

Public preview

Source record

This is a phase III, open label, randomized controlled multi-center global study designed to evaluate the safety and efficacy of single agent nazartinib (EGF816) compared with investigator's choice (erlotinib or gefitinib) in patients with locally advanced or metastatic NSCLC who are treatment naïve and whose tumors harbor EGFR activating mutations (L858R or ex19del).

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

A Randomized, Open-label, Phase III Study of Single Agent Nazartinib Versus Investigator's Choice (Erlotinib or Gefitinib) as First-Line Treatment in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Activating Mutations

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

Generated

Jun 13, 2026

NCT ID

NCT03529084

Status

WITHDRAWN

Phase

PHASE3

Sponsor

Novartis Pharmaceuticals

Executive brief

Investment-Ready Snapshot

This is a phase III, open label, randomized controlled multi-center global study designed to evaluate the safety and efficacy of single agent nazartinib (EGF816) compared with investigator's choice (erlotinib or gefitinib) in patients with locally advanced or metastatic NSCLC who are treatment naïve and whose tumors harbor EGFR activating mutations (L858R or ex19del).

Source & freshness

Provenance

SourceClinicalTrials.gov
Source updatedNov 22, 2019
Internal syncJun 09, 2026
Model versiontrialsignal-ai-v1

https://clinicaltrials.gov/study/NCT03529084

Indication

Carcinoma, Non-small Cell Lung

Modality

small molecule

Target

EFG816, erlotinib or gefitinib

Intervention

EFG816, erlotinib or gefitinib

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.