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Cancer Vaccine

PD1-Vaxx Immunotherapy for Non-Small Cell Lung Cancer

Phase 1
Waitlist Available
Research Sponsored by Imugene Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Prior treatment criteria for Combination dose expansion arms: IMU-201 + atezolizumab + chemotherapy, patients naïve to prior treatment
PD-L1 expression criteria for Combination dose expansion arms: IMU-201 + atezolizumab, TPS/TC ≥ 50% or IC ≥ 10%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to death from any cause (approximately 15 months)
Awards & highlights

Study Summary

This trial is testing a new cancer immunotherapy drug, IMU-201, to see if it is safe and effective in patients with non-small cell lung cancer.

Who is the study for?
Adults over 18 with advanced non-small cell lung cancer (NSCLC) who have either not been treated or have progressed after treatment with PD-1/PD-L1 inhibitors. They should be in relatively good health, with a life expectancy of at least 12 weeks and able to perform daily activities with little assistance (Zubrod/ECOG score 0-1). Patients must not have received certain treatments recently, have active infections requiring IV antibiotics, known HIV/Hepatitis B/C infection, uncontrolled other cancers or brain metastases needing steroids.Check my eligibility
What is being tested?
The trial is testing IMU-201 (PD1-Vaxx), an immunotherapy for NSCLC. It's given alone or combined with the drug Atezolizumab and/or standard chemotherapy. The study has different parts: dose escalation to find safe amounts and expansion where more patients receive these doses. Participants are grouped based on previous treatments and their tumor's PD-L1 protein levels.See study design
What are the potential side effects?
IMU-201 could cause immune-related side effects like inflammation in various organs, potential allergic reactions during infusion into the body, fatigue, blood disorders that affect how your blood clots or fights infection, liver issues indicated by abnormal tests results, and possibly increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have not received IMU-201, atezolizumab, or chemotherapy before.
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My cancer shows high PD-L1 levels suitable for specific treatment combinations.
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I have not received any previous treatments for my condition.
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I am fully active and can carry on all my pre-disease activities without restriction.
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My blood, liver, and kidney functions are all within normal ranges.
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I have not received previous treatments for my condition.
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I have not been treated or have progressed after treatment with PD-1/PD-L1 inhibitors.
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My cancer shows high PD-L1 levels based on specific tests.
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My cancer progressed after treatment with a PD-1/PD-L1 inhibitor.
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My cancer shows high PD-L1 levels suitable for specific treatment combinations.
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My cancer progressed after treatment with a PD-1/PD-L1 inhibitor.
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I am over 18 and have advanced stage lung cancer.
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My cancer's PD-L1 status does not affect my eligibility for a specific treatment combination.
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My cancer shows high PD-L1 levels suitable for specific treatment combinations.
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My cancer's PD-L1 status does not affect my eligibility for a specific treatment combination.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to death from any cause (approximately 15 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to death from any cause (approximately 15 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Identify Optimal Biological Dose (OBD) with safety/tolerability graded per terminology criteria for adverse events (CTCAE) version 5.00 and Immuogenicity (Dose Escalation).
Overall response rate (ORR) (Dose Expansion)
Safety and tolerability of IMU-201 graded per terminology criteria for adverse events (CTCAE) version 5.00 (Dose Escalation)
Secondary outcome measures
Duration of response (DOR) (Dose Escalation/Expansion)
Overall response rate (ORR) (Dose Escalation)
Overall survival (OS) (Dose Escalation/Expansion)
+1 more
Other outcome measures
Exploratory Outcome: Cellular immunogenicity of IMU-201 (Dose Escalation/Expansion)
Exploratory Outcome: Humoral immunogenicity of IMU-201 (Dose Escalation/Expansion)

Trial Design

13Treatment groups
Experimental Treatment
Group I: Dose Expansion MonotherapyExperimental Treatment1 Intervention
mOBD (TBD) dose IMU-201 as a 0.5 mL PD1-Vaxx injection Progressed on/after ICI, TPS/TC ≥50% or IC ≥10%
Group II: Dose Expansion Arm 3: Combination with atezolizumab and chemotherapyExperimental Treatment3 Interventions
cOBD (TBD) dose IMU-201 as a 05 mL PD1-Vaxx injection with atezolizumab 840 mg and SOC chemotherapy Naïve to ICI, Any PD-L1 Level
Group III: Dose Expansion Arm 2: Combination with atezolizumabExperimental Treatment2 Interventions
cOBD (TBD) dose IMU-201 as a 0.5 mL PD1-Vaxx injection with atezolizumab 840 mg Naïve to ICI, TPS/TC ≥50% or IC ≥10%
Group IV: Dose Expansion Arm 1: Combination with atezolizumabExperimental Treatment2 Interventions
cOBD (TBD) dose IMU-201 as a 0.5 mL PD1-Vaxx injection with atezolizumab 840 mg Progressed on/after ICI, TPS/TC ≥50% or IC ≥10%
Group V: Dose Escalation: Monotherapy Cohort 3Experimental Treatment1 Intervention
100 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection Progressed on/after ICI, TPS/TC ≥50% or IC ≥10%
Group VI: Dose Escalation: Monotherapy Cohort 2Experimental Treatment1 Intervention
50 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection Progressed on/after ICI, TPS/TC ≥50% or IC ≥10%
Group VII: Dose Escalation: Monotherapy Cohort 1Experimental Treatment1 Intervention
10 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection Progressed on/after ICI, TPS/TC ≥50% or IC ≥10%
Group VIII: Dose Escalation Arm 2: Combination with atezolizumab and chemotherapy Cohort 3Experimental Treatment3 Interventions
100 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection with atezolizumab 840 mg and SOC chemotherapy Naïve to ICI, Any PD-L1 Level
Group IX: Dose Escalation Arm 2: Combination with atezolizumab and chemotherapy Cohort 2Experimental Treatment3 Interventions
50 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection with atezolizumab 840 mg and SOC chemotherapy Naïve to ICI, Any PD-L1 Level
Group X: Dose Escalation Arm 2: Combination with atezolizumab and chemotherapy Cohort 1Experimental Treatment3 Interventions
10 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection with atezolizumab 840 mg and SOC chemotherapy Naïve to ICI, Any PD-L1 Level
Group XI: Dose Escalation Arm 1: Combination with atezolizumab Cohort 3Experimental Treatment2 Interventions
Cohort 3: 100 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection with atezolizumab 840 mg Naïve to ICI or Progressed on/after ICI, TPS/TC ≥50% or IC ≥10%
Group XII: Dose Escalation Arm 1: Combination with atezolizumab Cohort 2Experimental Treatment2 Interventions
50 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection with atezolizumab 840 mg Naïve to ICI or Progressed on/after ICI, TPS/TC ≥50% or IC ≥10%
Group XIII: Dose Escalation Arm 1: Combination with atezolizumab Cohort 1Experimental Treatment2 Interventions
10 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection with atezolizumab 840 mg Naïve to ICI or Progressed on/after ICI, TPS/TC ≥50% or IC ≥10%
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Standard of care chemotherapy
2020
Completed Phase 1
~30
Atezolizumab
2016
Completed Phase 3
~6040

Find a Location

Who is running the clinical trial?

Imugene LimitedLead Sponsor
6 Previous Clinical Trials
324 Total Patients Enrolled

Media Library

IMU-201 (PD1-Vaxx) (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT04432207 — Phase 1
Non-Small Cell Lung Cancer Research Study Groups: Dose Escalation Arm 1: Combination with atezolizumab Cohort 1, Dose Expansion Arm 2: Combination with atezolizumab, Dose Expansion Monotherapy, Dose Expansion Arm 1: Combination with atezolizumab, Dose Escalation Arm 1: Combination with atezolizumab Cohort 2, Dose Escalation: Monotherapy Cohort 3, Dose Escalation Arm 2: Combination with atezolizumab and chemotherapy Cohort 3, Dose Escalation Arm 2: Combination with atezolizumab and chemotherapy Cohort 1, Dose Escalation Arm 2: Combination with atezolizumab and chemotherapy Cohort 2, Dose Escalation Arm 1: Combination with atezolizumab Cohort 3, Dose Expansion Arm 3: Combination with atezolizumab and chemotherapy, Dose Escalation: Monotherapy Cohort 1, Dose Escalation: Monotherapy Cohort 2
Non-Small Cell Lung Cancer Clinical Trial 2023: IMU-201 (PD1-Vaxx) Highlights & Side Effects. Trial Name: NCT04432207 — Phase 1
IMU-201 (PD1-Vaxx) (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04432207 — Phase 1

Frequently Asked Questions

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

Is IMU-201 (as PD1-Vaxx) considered a riskless approach for individuals?

"Since this is a Stage 1 trial, with limited evidence of effectiveness and safety, the team at Power rated IMU-201 (administered as PD1-Vaxx) with a score of 1."

Answered by AI

Is this research program seeking additional participants at the moment?

"Details published on clinicaltrials.gov demonstrate that this medical trial is currently recruiting patients, with an initial posting date of November 30th 2020 and a recent update occurring January 19th 2022."

Answered by AI

How many individuals are actively participating in this research?

"Indeed, the data on clinicaltrials.gov confirms that this trial is currently recruiting participants. Initially posted in November 2020, it was last modified on January 19th 2022 and requires 22 people to be enrolled at 3 distinct sites."

Answered by AI
~9 spots leftby Feb 2026