An Open-label, Multicenter Phase Ib/II Clinical Study to Evaluate the Safety, Efficacy, and Pharmacokinetic of PLB1004 Capsules Combined With Platinum-based Doublet Chemotherapy in Patients With EGFR Mutation-positive NSCLC

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Record identity and dates

Source

ClinicalTrials.gov

Source record ID

NCT07063329

Title field or adapter rule

{'original_value': 'An Open-label, Multicenter Phase Ib/II Clinical Study to Evaluate the Safety, Efficacy, and Pharmacokinetic of PLB1004 Capsules Combined With Platinum-based Doublet Chemotherapy in Patients With EGFR Mutation-positive NSCLC', 'source_field': 'protocolSection.identificationModule.officialTitle'}

Ingested At

2026-11-01T01:03:03.867261+00:00

Published At

2026-10-28T00:00:00+00:00

Record Updated At

2026-10-28

Source Retrieved At

2026-11-01T01:03:02.902675+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

["NSCLC (Non-small Cell Lung Cancer)"]

protocolSection.statusModule.lastUpdatePostDateStruct

{"date": "2026-10-28", "type": "ACTUAL"}

protocolSection.identificationModule.nctId

"NCT07063329"

protocolSection.identificationModule.officialTitle

"An Open-label, Multicenter Phase Ib/II Clinical Study to Evaluate the Safety, Efficacy, and Pharmacokinetic of PLB1004 Capsules Combined With Platinum-based Doublet Chemotherapy in Patients With EGFR Mutation-positive NSCLC"

protocolSection.statusModule.overallStatus

"RECRUITING"

protocolSection.designModule.phases

["PHASE1", "PHASE2"]

protocolSection.statusModule.resultsFirstPostDateStruct

null

Study condition terms

• NSCLC (Non-small Cell Lung Cancer) (protocolSection.conditionsModule.conditions)

Interventions recorded in this study

• {'armGroupLabels': ['phase Ib Dose Escalation'], 'description': 'For non-squamous NSCLC patients：Pemetrexed (500 mg/m2) plus carboplatin (AUC5) or cisplatin（75 mg/m²）on Day 1 of 21day cycles (every 3 weeks) , followed by PLB1004 80mg/160mg/240mg oral once daily。 For squamous NSCLC subjects: Docetaxel（75 mg/m² ）or paclitaxel（175 mg/mg） plus carboplatin (AUC5) or cisplatin（75 mg/m²）on Day 1 of 21day cycles (every 3 weeks) , followed by PLB1004 80mg/160mg/240mg oral once daily.', 'name': 'PLB1004 80mg/160mg/240mg oral once daily Combined with Platinum-Based Chemotherapy', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['phase Ib Dose Expansion'], 'description': 'Multiple doses of PLB1004 for oral administration. Platinum-based chemotherapy is combined and administered on Day 1 of 21days（every 3 weeks).', 'name': 'PLB1004 80mg/160mg/240mg oral once daily Combined with Platinum-Based Chemotherapy', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['phase II Cohort1'], 'description': 'RP2D of PLB1004 as determined during Phase Ib . Platinum-based chemotherapy is combined and administered on Day 1 of 21days（every 3 weeks）.', 'name': 'RP2D of PLB1004 oral once daily Combined with Platinum-Based Chemotherapy', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['phase II Cohort2'], 'description': 'RP2D of PLB1004 as determined during Phase Ib，patients will undergo surgical treatment after 3 cycles of combination therapy with platinum-based chemotherapy. Post-surgery, they will receive an additional cycle of platinum-based chemotherapy followed by 13 cycles of maintenance therapy with PLB1004.', 'name': 'RP2D of PLB1004 oral once daily Combined 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

• PLB1004 80mg/160mg/240mg oral once daily Combined with Platinum-Based Chemotherapy (protocolSection.armsInterventionsModule.interventions[].name)
• PLB1004 80mg/160mg/240mg oral once daily Combined with Platinum-Based Chemotherapy (protocolSection.armsInterventionsModule.interventions[].name)
• RP2D of PLB1004 oral once daily Combined with Platinum-Based Chemotherapy (protocolSection.armsInterventionsModule.interventions[].name)
• RP2D of PLB1004 oral once daily Combined 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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