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Checkpoint Inhibitor

NT-I7 + Atezolizumab for Lung Cancer

Phase 2

Waitlist Available

Research Sponsored by NeoImmuneTech

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have histologically or cytologically confirmed metastatic or locally advanced NSCLC, and have not received prior systemic therapy. Subjects with locally advanced disease must have Stage III NSCLC and are not candidates for surgical resection or definitive chemoradiation

Tumor PD-L1 expression (TPS≥1%) as determined by PD-L1 22C3 immunohistochemistry local or central assay

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 2 years

Awards & highlights

Study Summary

This trial will test the effectiveness of a new cancer treatment in people with squamous or non-squamous non-small cell lung cancer who haven't received prior systemic therapy. Up to 83 people will be enrolled in the study.

Who is the study for?

This trial is for adults with a type of lung cancer called NSCLC that shows PD-L1 expression and hasn't spread too far. They should be fairly fit (ECOG 0-1), have not had previous systemic treatments, and can't be candidates for surgery or definitive chemoradiation if their disease is locally advanced.Check my eligibility

What is being tested?

The study tests NT-I7 combined with Atezolizumab in patients to see how well it works against this lung cancer. It's an open-label Phase II trial, meaning both researchers and participants know what treatment is being given.See study design

What are the potential side effects?

Possible side effects include immune-related reactions since both drugs work on the immune system, infusion reactions from receiving medication through a vein, fatigue, potential blood disorders, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lung cancer is advanced but hasn't been treated with systemic therapy yet.

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My tumor shows PD-L1 expression of 1% or more.

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I agree to give a tissue sample to test for PD-L1.

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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective Response Rate (ORR)

Secondary outcome measures

Disease Control Rate (DCR)

Duration of response (DoR)

Overall survival (OS)

+1 more

Side effects data

From 2019 Phase 3 trial • 1225 Patients • NCT02008227

36%

Fatigue

35%

Alopecia

24%

Diarrhoea

23%

Nausea

23%

Decreased appetite

22%

Anaemia

20%

Asthenia

19%

Cough

19%

Dyspnoea

16%

Myalgia

15%

Neutropenia

14%

Constipation

14%

Oedema peripheral

12%

Pyrexia

11%

Neuropathy peripheral

11%

Vomiting

11%

Stomatitis

10%

Arthralgia

Rash

Neutrophil count decreased

Dysgeusia

Paraesthesia

Headache

Pain in extremity

Peripheral sensory neuropathy

Insomnia

Mucosal inflammation

Back pain

Pneumonia

Febrile neutropenia

Abdominal pain

Dry skin

Lacrimation increased

Dizziness

Haemoptysis

Weight decreased

Malaise

Urinary tract infection

Nail disorder

Productive cough

Chest pain

Nasopharyngitis

Musculoskeletal pain

Bronchitis

Pruritus

Upper respiratory tract infection

Alanine aminotransferase increased

Aspartate aminotransferase increased

Influenza like illness

Respiratory tract infection

Musculoskeletal chest pain

Lower respiratory tract infection

Acute kidney injury

Depression

Lung infection

Dehydration

Chronic obstructive pulmonary disease

Atrial fibrillation

Syncope

Pleural effusion

100%

80%

60%

40%

20%

Study treatment Arm

Docetaxel

Atezolizumab

Trial Design

1Treatment groups

Experimental Treatment

Group I: NT-I7 and atezolizumabExperimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

2017

Completed Phase 3

~5860

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

NeoImmuneTechLead Sponsor

10 Previous Clinical Trials

424 Total Patients Enrolled

Roche Pharma AGIndustry Sponsor

408 Previous Clinical Trials

395,713 Total Patients Enrolled

Media Library

Atezolizumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04984811 — Phase 2

Non-Small Cell Lung Cancer Research Study Groups: NT-I7 and atezolizumab

Non-Small Cell Lung Cancer Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT04984811 — Phase 2

Atezolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04984811 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any new participants being taken into this experiment?

"Affirmative. Data hosted on clinicaltrials.gov confirms that this medical study, which was first posted on November 3rd 2021, is actively recruiting. Roughly 83 patients need to be recruiter from 14 different medical centres."

Answered by AI

Has Atezolizumab been granted regulatory approval by the FDA?

"The safety of Atezolizumab has been rated 2 on our internal scale, as this Phase 2 trial suggests some level of security with no clinical evidence for its effectiveness."

Answered by AI

How many sites are participating in the execution of this clinical research?

"Patients interested in participating can find the trial at Norton Cancer Institute (Louisville, KY), BRCR Medical Center (Plantation, FL) and Innovative Clinical Research Institute (Whittier, CA) as well as 14 other locations."

Answered by AI

In what illnesses is Atezolizumab commonly employed?

"Atezolizumab is a popular treatment for small cell lung cancer, but it can also be utilized to combat postoperative malignancies and non-small cell lung carcinoma."

Answered by AI

What other explorations of Atezolizumab have been conducted?

"Atezolizumab was initially studied in 2008 by SCRI Tennessee Oncology Chattanooga. Since then, a total of 80 trials have concluded and there are currently 360 active studies being conducted mostly out of Louisville, Kentucky."

Answered by AI

How many volunteers are participating in this research endeavor?

"NeoImmuneTech requires a total of 83 eligible individuals to successfully run this trial. Those interested can be seen at the Norton Cancer Institute in Louisville, Kentucky or BRCR Medical Center located in Plantation, Florida."

Answered by AI

Is this the inaugural implementation of this medical experiment?

"Atezolizumab has been under scrutiny since 2008, when Hoffmann-La Roche sponsored its first clinical trial. This Phase 2 drug was approved after the original study of 720 patients and is now being investigated in 360 trials across 74 countries and 1646 cities."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

NT-I7 in Combination With Atezolizumab in Previously Untreated, PD-L1-expressing, Locally Advanced or Metastatic NSCLC

2021. "NT-I7 in Combination With Atezolizumab in Previously Untreated, PD-L1-expressing, Locally Advanced or Metastatic NSCLC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04984811.

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