Phase I/II Evaluation of a Cancer Lysate Vaccine and Montanide(R) ISA-51 VG With or Without the IL-15 Super-Agonist N-803 as Adjuvant Therapy for PD-L1 Negative Non-Small Cell Lung Cancer

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Record identity and dates

Source

ClinicalTrials.gov

Source record ID

NCT05642195

Title field or adapter rule

{'original_value': 'Phase I/II Evaluation of a Cancer Lysate Vaccine and Montanide(R) ISA-51 VG With or Without the IL-15 Super-Agonist N-803 as Adjuvant Therapy for PD-L1 Negative Non-Small Cell Lung Cancer', 'source_field': 'protocolSection.identificationModule.officialTitle'}

Ingested At

2026-10-31T23:27:28.160161+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", "Non-Small Cell Lung Carcinoma", "Carcinoma, Non-Small-Cell Lung", "Carcinomas"]

protocolSection.statusModule.lastUpdatePostDateStruct

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

protocolSection.identificationModule.nctId

"NCT05642195"

protocolSection.identificationModule.officialTitle

"Phase I/II Evaluation of a Cancer Lysate Vaccine and Montanide(R) ISA-51 VG With or Without the IL-15 Super-Agonist N-803 as Adjuvant Therapy for PD-L1 Negative Non-Small Cell Lung Cancer"

protocolSection.statusModule.overallStatus

"SUSPENDED"

protocolSection.designModule.phases

["PHASE1", "PHASE2"]

protocolSection.statusModule.resultsFirstPostDateStruct

null

Study condition terms

• Non-Small Cell Lung Cancer (protocolSection.conditionsModule.conditions)
• Non-Small Cell Lung Carcinoma (protocolSection.conditionsModule.conditions)
• Carcinoma, Non-Small-Cell Lung (protocolSection.conditionsModule.conditions)
• Carcinomas (protocolSection.conditionsModule.conditions)

Interventions recorded in this study

• {'armGroupLabels': ['1/ Vaccine with Montanide Adjuvant', '2/ Vaccine with Montanide Adjuvant and N-803'], 'description': 'H1299 cell lysate with Montanide (Registered Trademark) ISA-51 VG adjuvant vaccine via subcutaneous injections once every cycle (1 cycle=28 days) for 6 cycles (i.e., 6 vaccinations). Dose Level 1 (DL1) starting dose is 20 mcg lysate protein in 2-2.5 mL Montanide (Registered) ISA-51 VG adjuvant; lysate concentration will be 8-10 mcg/mL. Additional 2 vaccine injections for subjects with immunologic response and NED.', 'name': 'Montanide (Registered Trademark) ISA-51 VG Adjuvant', 'type': 'BIOLOGICAL'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['1/ Vaccine with Montanide Adjuvant', '2/ Vaccine with Montanide Adjuvant and N-803'], 'description': 'H1299 cell lysate with Montanide (Registered) ISA-51 VG adjuvant vaccine via subcutaneous injections once every cycle (1 cycle=28 days) for 6 cycles (i.e., 6 vaccinations). Dose Level 1 (DL1) starting dose is 20 mcg lysate protein in 2-2.5 mL Montanide (Registered Trademark) ISA-51 VG adjuvant; lysate concentration will be 8-10 mcg/mL. Additional 2 vaccine injections for subjects with immunologic response and NED.', 'name': 'H1299 Cell Lysates', 'type': 'BIOLOGICAL'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['1/ Vaccine with Montanide Adjuvant', '2/ Vaccine with Montanide Adjuvant and N-803'], 'description': 'N-803 via subcutaneous injection in the abdomen at dose of 15 ug/kg every 4 weeks, on Day 1 of each cycle. N-803 dosing will be calculated using a weight obtained within 5 days prior to the first dose. Dose re-calculated at the beginning of each subsequent cycle in the event of a 10% or greater weight change.', 'name': 'N-803', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['1/ Vaccine with Montanide Adjuvant', '2/ Vaccine with Montanide Adjuvant and N-803'], 'description': 'FDA-approved assays used off-label for study as treatment determining in-vitro diagnostic devices to assess subject PD-L1 quantitation. Testing will be performed on provided archival samples or on fresh sample that is collected at screening for confirmation of diagnosis; no additional sample collection for purposes of PD-L1 testing.', 'name': 'Ventana PD-L1 (SP263 or SP142) assay', 'type': 'DEVICE'} (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

• N-803 (protocolSection.armsInterventionsModule.interventions[].name)

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

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