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sponsor decision (not for safety)
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| Name | Class |
|---|---|
| Roche Pharma AG | INDUSTRY |
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This is a multicenter, open-label, single-arm Phase II study to evaluate anti-tumor efficacy and safety of NT-I7 in combination with atezolizumab in subjects with PD-L1-expressing (TPS ≥ 1%), metastatic (Stage IV) or locally advanced squamous or non-squamous NSCLC who have not received prior systemic therapy in the metastatic or locally advanced setting. Eligible subjects must have measurable disease according to RECIST 1.1. This Phase II study will enroll up to 83 subjects.
The main purpose of this study is to assess the preliminary anti-tumor activity of NT-I7 in combination with atezolizumab in subjects with programmed cell death ligand 1 (PD-L1)-expressing (tumor proportion score [TPS] ≥ 1%), locally advanced or metastatic squamous or non-squamous non-small cell lung cancer (NSCLC) who have not received prior systemic therapy for locally advanced or metastatic disease. The primary objective is evaluated based on the objective response rate (ORR) as assessed by investigators using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) and immune RECIST (iRECIST).
Secondary objectives include further evaluation of the anti-tumor activity and efficacy of the combination therapy based on the duration of response (DoR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS) per RECIST 1.1 and iRECIST. In addition, the safety and tolerability of NT-I7 will be evaluated.
One treatment cycle is defined as 21 days (3 weeks). Atezolizumab is administered at a dose of 1200 mg via intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle. NT-I7 is administered at a dose of 1200 μg/kg via intramuscular (IM) injection once every 6 weeks (Q6W) on Day 1 of alternating cycles, starting on Cycle 1 Day 1. On days when both study drugs are administered, atezolizumab is given prior to NT-I7.
Each subject may participate for a maximum of 35 cycles (approximately 2 years) of study treatment. The last safety follow-up visit will occur 90 days after the last dose, meaning the total participant duration could be up to 27 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NT-I7 and atezolizumab | Experimental | Participants with no prior systemic therapy for advanced NSCLC will receive 1200 μg/kg NT-I7 IM on Day 1 and every 6 weeks and atezolizumab IV 1200 mg every 3 weeks until disease progression. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| efineptakin alfa | Drug | 1200 μg/kg NT-I7 administered intramuscularly (IM) once every 6 weeks (Q6W) starting on Cycle 1. The treatment will be continued up to a maximum of 35 cycles (approximately 2 years). |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | The percentage of subjects with a best overall response (BOR) of a complete response (CR) or partial response (PR), per RECIST 1.1 and iRECIST as determined by the investigator. Per RECIST v1.1, Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition, the sum must also demonstrate an absolute increase of at least 5 mm. Furthermore, the appearance of one or more new lesions is also considered progression). Under iRECIST, tumor response is classified as immune Complete Response (iCR) or immune Partial Response (iPR) using the same size thresholds as RECIST 1.1. | The first on-study imaging assessment were performed every 6 weeks for the first 6 months and every 9 weeks, or more frequently if clinically indicated, until disease progression or treatment discontinuation (up to 2 years). |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DoR) | Time from the first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs first, per RECIST 1.1 and iRECIST as determined by the investigator. Per RECIST v1.1, Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition, the sum must also demonstrate an absolute increase of at least 5 mm. Furthermore, the appearance of one or more new lesions is also considered progression). Under iRECIST, tumor response is classified as immune Complete Response (iCR) or immune Partial Response (iPR) using the same size thresholds as RECIST 1.1. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Donghoon Choi, PhD | NeoImmuneTech | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Alabama | Mobile | Alabama | 36604 | United States | ||
| TOI Clinical Research |
This was a multicenter, open-label, single-arm Phase 2 study.
A total of 33 participants were enrolled in the United States from November 2021 to March 2024 due to early termination decision.
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| ID | Title | Description |
|---|---|---|
| FG000 | NT-I7 and Atezoliaumab (Phase 2, Single Arm) | Participants received NT-I7 in combination with atezolizumab. 1200 μg/kg NT-I7 administered intramuscularly (IM) once every 6 weeks (Q6W) starting on Cycle 1, and 1200 mg atezolizumab administered intravenously (IV) once every 3 weeks (Q3W) starting on Cycle 1. On days where both drugs are given, atezolizumab was given prior to NT-I7. The treatment continued up to a maximum of 35 cycles (approximately 2 years). One treatment cycle is defined as 21 days (3 weeks). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 15, 2022 | Jan 9, 2026 |
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|
| Atezolizumab | Drug | 1200 mg atezolizumab administered intravenously (IV) once every 3 weeks (Q3W) starting on Cycle 1. The treatment will be continued up to a maximum of 35 cycles (approximately 2 years). |
|
|
| The first on-study imaging assessment were performed every 6 weeks for the first 6 months and every 9 weeks, or more frequently if clinically indicated, until disease progression or treatment discontinuation (up to 2 years). |
| Disease Control Rate (DCR) | The proportion of subjects with a best overall response of CR, PR or SD, per RECIST 1.1 and iRECIST as determined by the investigator. | The first on-study imaging assessment were performed every 6 weeks for the first 6 months and every 9 weeks, or more frequently if clinically indicated, until disease progression or treatment discontinuation (up to 2 years). |
| Progression Free Survival (PFS) | The time from the first study treatment (Cycle 1, Day 1) to the first occurrence of progression or death from any cause, whichever occurs first, per RECIST 1.1 and iRECIST as determined by the investigator. Progression is defined using RECIST 1.1 as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition, the sum must also demonstrate an absolute increase of at least 5 mm. Furthermore, the appearance of one or more new lesions is also considered progression. Under iRECIST, initial progression is classified as immune unconfirmed progressive disease (iUPD). Progression is confirmed as immune confirmed progressive disease (iCPD) if a subsequent assessment (proportionately 4-8 weeks later) shows a further increase in tumor burden (an additional 5 mm increase in the sum of diameters of target or new lesions, or further progression of non-target lesions) or the appearance of additional new lesions. | The first on-study imaging assessment were performed every 6 weeks for the first 6 months and every 9 weeks, or more frequently if clinically indicated, until disease progression or treatment discontinuation (up to 2 years). |
| Overall Survival (OS) | The time from first study treatment (Cycle 1, Day 1) to death from any cause. | Up to 2 years |
| Cerritos |
| California |
| 90703 |
| United States |
| Eastern CT Hematology & Oncology Associates | Norwich | Connecticut | 06360 | United States |
| Florida Cancer Specialists - South Research Office | Fort Myers | Florida | 33916 | United States |
| BRCR Medical Center | Plantation | Florida | 33322 | United States |
| Florida Cancer Specialists - North Research Office | St. Petersburg | Florida | 33705 | United States |
| Florida Cancer Specialists - East Research Office | West Palm Beach | Florida | 33401 | United States |
| University Cancer and Blood Center | Athens | Georgia | 30607 | United States |
| Goshen Center for Cancer Care | Goshen | Indiana | 46526 | United States |
| Norton Cancer Institute | Louisville | Kentucky | 40217 | United States |
| Pikeville Medical Center, Inc. | Pikeville | Kentucky | 41501 | United States |
| MaineHealth Cancer Care | South Portland | Maine | 04106 | United States |
| TidalHealth Peninsula Regional, Inc. | Salisbury | Maryland | 21801 | United States |
| Summit Health Medical Center | Florham Park | New Jersey | 07932 | United States |
| East Carolina University | Greenville | North Carolina | 27834 | United States |
| Zangmeister Cancer Center | Columbus | Ohio | 43219 | United States |
| OHSU Knight Cancer Institute | Portland | Oregon | 97239 | United States |
| Tennessee Oncology - Chattanooga | Chattanooga | Tennessee | 37404 | United States |
| Thompson Cancer Survival Center | Knoxville | Tennessee | 37916 | United States |
| Tennessee Oncology - Nashville | Nashville | Tennessee | 37203 | United States |
| Renovatio Clinical - El Paso | El Paso | Texas | 79915 | United States |
| Renovatio Clinical - The Woodlands | The Woodlands | Texas | 77380 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | NT-I7 and Atezoliaumab (Phase 2, Single Arm) | Participants received NT-I7 in combination with atezolizumab. 1200 μg/kg NT-I7 administered intramuscularly (IM) once every 6 weeks (Q6W) starting on Cycle 1, and 1200 mg atezolizumab administered intravenously (IV) once every 3 weeks (Q3W) starting on Cycle 1. On days where both drugs are given, atezolizumab was given prior to NT-I7. The treatment continued up to a maximum of 35 cycles (approximately 2 years). One treatment cycle is defined as 21 days (3 weeks). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Weight | Median | Full Range | killograms |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Objective Response Rate (ORR) | The percentage of subjects with a best overall response (BOR) of a complete response (CR) or partial response (PR), per RECIST 1.1 and iRECIST as determined by the investigator. Per RECIST v1.1, Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition, the sum must also demonstrate an absolute increase of at least 5 mm. Furthermore, the appearance of one or more new lesions is also considered progression). Under iRECIST, tumor response is classified as immune Complete Response (iCR) or immune Partial Response (iPR) using the same size thresholds as RECIST 1.1. | Efficacy Evaluable Population: Subjects were required to complete at least Cycle 1 treatment and at least one post-baseline tumor scan to be considered evaluable. | Posted | Count of Participants | Participants | The first on-study imaging assessment were performed every 6 weeks for the first 6 months and every 9 weeks, or more frequently if clinically indicated, until disease progression or treatment discontinuation (up to 2 years). |
|
|
| |||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DoR) | Time from the first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs first, per RECIST 1.1 and iRECIST as determined by the investigator. Per RECIST v1.1, Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition, the sum must also demonstrate an absolute increase of at least 5 mm. Furthermore, the appearance of one or more new lesions is also considered progression). Under iRECIST, tumor response is classified as immune Complete Response (iCR) or immune Partial Response (iPR) using the same size thresholds as RECIST 1.1. | Efficacy Evaluable Population: Subjects were required to complete at least Cycle 1 treatment and at least one post-baseline tumor scan to be considered evaluable. | Posted | Median | 95% Confidence Interval | months | The first on-study imaging assessment were performed every 6 weeks for the first 6 months and every 9 weeks, or more frequently if clinically indicated, until disease progression or treatment discontinuation (up to 2 years). |
| ||||||||||||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR) | The proportion of subjects with a best overall response of CR, PR or SD, per RECIST 1.1 and iRECIST as determined by the investigator. | Efficacy Evaluable Population: Subjects were required to complete at least Cycle 1 treatment and at least one post-baseline tumor scan to be considered evaluable. | Posted | Count of Participants | Participants | The first on-study imaging assessment were performed every 6 weeks for the first 6 months and every 9 weeks, or more frequently if clinically indicated, until disease progression or treatment discontinuation (up to 2 years). |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) | The time from the first study treatment (Cycle 1, Day 1) to the first occurrence of progression or death from any cause, whichever occurs first, per RECIST 1.1 and iRECIST as determined by the investigator. Progression is defined using RECIST 1.1 as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition, the sum must also demonstrate an absolute increase of at least 5 mm. Furthermore, the appearance of one or more new lesions is also considered progression. Under iRECIST, initial progression is classified as immune unconfirmed progressive disease (iUPD). Progression is confirmed as immune confirmed progressive disease (iCPD) if a subsequent assessment (proportionately 4-8 weeks later) shows a further increase in tumor burden (an additional 5 mm increase in the sum of diameters of target or new lesions, or further progression of non-target lesions) or the appearance of additional new lesions. | Efficacy Evaluable Population: Subjects were required to complete at least Cycle 1 treatment and at least one post-baseline tumor scan to be considered evaluable. | Posted | Median | 95% Confidence Interval | months | The first on-study imaging assessment were performed every 6 weeks for the first 6 months and every 9 weeks, or more frequently if clinically indicated, until disease progression or treatment discontinuation (up to 2 years). |
| ||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | The time from first study treatment (Cycle 1, Day 1) to death from any cause. | Efficacy Evaluable Population: Subjects were required to complete at least Cycle 1 treatment and at least one post-baseline tumor scan to be considered evaluable. | Posted | Median | 95% Confidence Interval | months | Up to 2 years |
|
|
Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment.
Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NT-I7 and Atezoliaumab (Phase 2, Single Arm) | Participants received NT-I7 in combination with atezolizumab. 1200 μg/kg NT-I7 administered intramuscularly (IM) once every 6 weeks (Q6W) starting on Cycle 1, and 1200 mg atezolizumab administered intravenously (IV) once every 3 weeks (Q3W) starting on Cycle 1. On days where both drugs are given, atezolizumab was given prior to NT-I7. The treatment continued up to a maximum of 35 cycles (approximately 2 years). One treatment cycle is defined as 21 days (3 weeks). Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available. | 6 | 33 | 24 | 33 | 32 | 33 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MeDRA (24.0) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MeDRA (24.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MeDRA (24.0) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MeDRA (24.0) | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MeDRA (24.0) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MeDRA (24.0) | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MeDRA (24.0) | Systematic Assessment |
| |
| Death | General disorders | MeDRA (24.0) | Systematic Assessment |
| |
| Injection site erythema | General disorders | MeDRA (24.0) | Systematic Assessment |
| |
| Injection site pain | General disorders | MeDRA (24.0) | Systematic Assessment |
| |
| Injection site pruritus | General disorders | MeDRA (24.0) | Systematic Assessment |
| |
| Injection site swelling | General disorders | MeDRA (24.0) | Systematic Assessment |
| |
| Injection site warmth | General disorders | MeDRA (24.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MeDRA (24.0) | Systematic Assessment |
| |
| Sudden death | General disorders | MeDRA (24.0) | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MeDRA (24.0) | Systematic Assessment |
| |
| Intervertebral discitis | Infections and infestations | MeDRA (24.0) | Systematic Assessment |
| |
| pneumonia | Infections and infestations | MeDRA (24.0) | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MeDRA (24.0) | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MeDRA (24.0) | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MeDRA (24.0) | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MeDRA (24.0) | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MeDRA (24.0) | Systematic Assessment |
| |
| Neurotoxicity | Nervous system disorders | MeDRA (24.0) | Systematic Assessment |
| |
| Toxic encephalopathy | Nervous system disorders | MeDRA (24.0) | Systematic Assessment |
| |
| Oliguria | Nervous system disorders | MeDRA (24.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MeDRA (24.0) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MeDRA (24.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MeDRA (24.0) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MeDRA (24.0) | Systematic Assessment |
| |
| Peripheral artery occlusion | Vascular disorders | MeDRA (24.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MeDRA (24.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MeDRA (24.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MeDRA (24.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MeDRA (24.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MeDRA (24.0) | Systematic Assessment |
| |
| Chills | General disorders | MeDRA (24.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MeDRA (24.0) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MeDRA (24.0) | Systematic Assessment |
| |
| Injection site pruritus | General disorders | MeDRA (24.0) | Systematic Assessment |
| |
| Injection site rash | General disorders | MeDRA (24.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MeDRA (24.0) | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MeDRA (24.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MeDRA (24.0) | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MeDRA (24.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MeDRA (24.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MeDRA (24.0) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MeDRA (24.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MeDRA (24.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MeDRA (24.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MeDRA (24.0) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MeDRA (24.0) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MeDRA (24.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MeDRA (24.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MeDRA (24.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MeDRA (24.0) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MeDRA (24.0) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MeDRA (24.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MeDRA (24.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MeDRA (24.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MeDRA (24.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MeDRA (24.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MeDRA (24.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MeDRA (24.0) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MeDRA (24.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MeDRA (24.0) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MeDRA (24.0) | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MeDRA (24.0) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MeDRA (24.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MeDRA (24.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MeDRA (24.0) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MeDRA (24.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Young Joo (Paul) Kim | NeoImmuneTech, Inc. | +82 70-8847-9485 | yjkim@neoimmunetech.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 30, 2024 | Jan 9, 2026 | SAP_003.pdf |
Not provided
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000712767 | efineptakin alfa |
| C000594389 | atezolizumab |
Not provided
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
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