First-In-Human Study of STX-721/PFL-721 in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR or HER2 Exon 20 Insertion Mutations

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Record identity and dates

Source

ClinicalTrials.gov

Source record ID

NCT06043817

Title field or adapter rule

{'original_value': 'First-In-Human Study of STX-721/PFL-721 in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR or HER2 Exon 20 Insertion Mutations', 'source_field': 'protocolSection.identificationModule.officialTitle'}

Ingested At

2026-10-31T23:27:28.143431+00:00

Published At

2026-10-30T00:00:00+00:00

Record Updated At

2026-10-30

Source Retrieved At

2026-10-31T22:18:03.495925+00:00

Timestamp Basis

ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter

Date limitation

ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter

Fields recorded by this source

protocolSection.conditionsModule.conditions

["Non-Small Cell Lung Cancer", "NSCLC", "EGFR/HER2 Exon 20 Insertion Mutation"]

protocolSection.statusModule.lastUpdatePostDateStruct

{"date": "2026-10-30", "type": "ACTUAL"}

protocolSection.identificationModule.nctId

"NCT06043817"

protocolSection.identificationModule.officialTitle

"First-In-Human Study of STX-721/PFL-721 in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR or HER2 Exon 20 Insertion Mutations"

protocolSection.statusModule.overallStatus

"RECRUITING"

protocolSection.designModule.phases

["PHASE1", "PHASE2"]

protocolSection.statusModule.resultsFirstPostDateStruct

null

Study condition terms

• Non-Small Cell Lung Cancer (protocolSection.conditionsModule.conditions)
• NSCLC (protocolSection.conditionsModule.conditions)
• EGFR/HER2 Exon 20 Insertion Mutation (protocolSection.conditionsModule.conditions)

Interventions recorded in this study

• {'armGroupLabels': ['Part 1a: Dose Escalation'], 'description': 'STX-721/PFL-721 dose will be escalated per cBLRM-design.', 'name': 'STX-721/PFL-721 (Escalated)', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['Part 2a: RP2D Selection'], 'description': 'Participants will receive STX-721/PFL-721 at one of three dose levels.', 'name': 'STX-721/PFL-721 (3 dose levels)', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['Part 3: Dose Expansion'], 'description': 'Participants will receive the RP2D of STX-721/PFL-721.', 'name': 'STX-721/PFL-721 (RP2D)', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['Part 1b: Dose Escalation'], 'description': 'STX-721/PFL-721 in combination with platinum-based chemotherapy dose will be escalated per iBOIN-design.', 'name': 'STX-721/PFL-721 (Escalated) with platinum-based chemotherapy', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['Part 2b: RP2D Selection'], 'description': 'Participants will receive STX-721/PFL-721 at dose selected in Part 1b in combination with platinum-based chemotherapy.', 'name': 'STX-721/PFL-721 with platinum-based chemotherapy', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])

An intervention appearing in a study record does not establish an effect or an approved use.

Drug names recorded in this source

• STX-721/PFL-721 (Escalated) (protocolSection.armsInterventionsModule.interventions[].name)
• STX-721/PFL-721 (3 dose levels) (protocolSection.armsInterventionsModule.interventions[].name)
• STX-721/PFL-721 (RP2D) (protocolSection.armsInterventionsModule.interventions[].name)
• STX-721/PFL-721 (Escalated) with platinum-based chemotherapy (protocolSection.armsInterventionsModule.interventions[].name)
• STX-721/PFL-721 with platinum-based chemotherapy (protocolSection.armsInterventionsModule.interventions[].name)

A recorded drug name is not by itself an indication or a condition-specific relationship.

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