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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

Must not have

Prior radiotherapy within 2 weeks of start of study treatment

Known active CNS metastasis or carcinomatous meningitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had radiotherapy in the last 2 weeks.

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I have active brain metastases or cancer in the lining of my brain.

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My NSCLC has a specific gene change treatable with targeted therapy.

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I have received treatment that affects my whole body to fight cancer.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response Rate (ORR)

Secondary study objectives

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%

Stomatitis

11%

Vomiting

11%

Neuropathy peripheral

10%

Arthralgia

Neutrophil count decreased

Rash

Headache

Dysgeusia

Paraesthesia

Pain in extremity

Mucosal inflammation

Back pain

Peripheral sensory neuropathy

Insomnia

Febrile neutropenia

Pneumonia

Lacrimation increased

Abdominal pain

Dry skin

Dizziness

Malaise

Urinary tract infection

Weight decreased

Haemoptysis

Nail disorder

Chest pain

Nasopharyngitis

Musculoskeletal pain

Bronchitis

Productive cough

Upper respiratory tract infection

Pruritus

Influenza like illness

Alanine aminotransferase increased

Aspartate aminotransferase increased

Syncope

Dehydration

Atrial fibrillation

Lower respiratory tract infection

Lung infection

Respiratory tract infection

Acute kidney injury

Chronic obstructive pulmonary disease

Pleural effusion

Depression

Musculoskeletal chest pain

100%

80%

60%

40%

20%

Study treatment Arm

Docetaxel

Atezolizumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

2016

Completed Phase 3

~5860

0 / 8Eligibility criteria met