Non Small Cell Lung CancerPhase 1NCT04432207
A Study of IMU-201 (PD1-Vaxx), a B-Cell Immunotherapy, in Adults With Non-Small Cell Lung Cancer
A Phase 1 study testing IMU-201 (administered as PD1-Vaxx) - Regimen 1, IMU-201 (administered as PD1-Vaxx) - Regimen 2 and IMU-201 (administered as PD1-Vaxx) - Regimen 3 in people with Non Small Cell Lung Cancer and Non Small Cell Lung Cancer Stage IIIB, run by Imugene Limited at 6 sites in 2 countries.
Trial summary
An Open Label, Multi-Center, Dose Escalation/Expansion, Phase 1/1b Study of IMU 201 (PD1-Vaxx), a B-Cell Immunotherapy as monotherapy or in combination with atezolizumab with or without chemotherapy, in Adults with Non-Small Cell Lung Cancer (IMPrinter). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, Non Small Cell Lung Cancer Stage IIIB, Non-small Cell Lung Cancer Stage IV
- What is being tested?
- IMU-201 (administered as PD1-Vaxx) - Regimen 1, IMU-201 (administered as PD1-Vaxx) - Regimen 2 and IMU-201 (administered as PD1-Vaxx) - Regimen 3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 30 Nov 2020to 7 Nov 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years with histologically confirmed non-small-cell lung cancer (NSCLC) tumor stage IIIb not eligible for definitive treatment or stage IV
- Prior treatment criterion for Monotherapy dose escalation and expansion: progressed on/after prior PD-1/PD-L1 containing regimen
- Prior treatment criteria for Combination dose escalation arms:
- IMU-201 + atezolizumab, patients naïve to prior treatment or progressed on/after prior PD-1/PD-L1 containing regimen
- IMU-201 + atezolizumab + chemotherapy, patient naïve to prior treatment naive
- Prior treatment criteria for Combination dose expansion arms:
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- IMU-201 + atezolizumab, progressed on/after prior PD-1/PD-L1 containing regimen
- IMU-201 + atezolizumab, patients naïve to prior treatment
- IMU-201 + atezolizumab + chemotherapy, patients naïve to prior treatment
- PD-L1 expression criteria (testing by 22C3, SP142, or SP263) for Monotherapy dose escalation and expansion: TPS/TC ≥ 50% or IC ≥ 10%. Patients with PD-L1 TPS/TC<50% or IC<10% expression may be included with agreement of Sponsor
- PD-L1 expression criteria for Combination dose escalation arms:
- IMU-201 + atezolizumab, TPS/TC ≥ 50% or IC ≥ 10%
- IMU-201 + atezolizumab + chemotherapy, independent of PD-L1 expression
- PD-L1 expression criteria for Combination dose expansion arms:
- IMU-201 + atezolizumab, TPS/TC ≥ 50% or IC ≥ 10%
- IMU-201 + atezolizumab, TPS/TC ≥ 50% or IC ≥ 10%
- IMU-201 + atezolizumab + chemotherapy, independent of PD-L1 expression
- Life expectancy of at least 12 weeks in the opinion of the Investigator
- Zubrod/ECOG score performance status 0-1
- At least one measurable lesion as defined by RECIST 1.1 criteria.
- Adequate hematologic, liver, and renal function
Who cannot join
- Prior therapy for advanced NSCLC within 3 weeks prior to Day 1;
- Continuous systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 2 weeks prior to first dose of study treatment.;
- Any previous grade 3 or higher toxicity to a PD-1 inhibitor or PD-L1 inhibitor;
- Has a history of (non-infectious) pneumonitis/interstitial lung disease that required treatment with immunosuppressive agents or has current pneumonitis/interstitial lung disease;
- Known brain metastases requiring steroid treatment, or signs and symptoms indicating suspected brain metastases;
- Current or previous history of auto-immune disease;
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- NSCLC expressing epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), B-Raf proto-oncogene (BRAF) or ROS proto-oncogene 1 (ROS1) mutations who have not received appropriate therapies targeting these mutations and progress (if treatments are not available, patients who have NOT received appropriate therapies may be enrolled);
- Prior organ transplant;
- Concurrent active malignancy except for adequately controlled limited basal cell carcinoma of the skin;
- History of uncontrolled seizures, central nervous disorders, or psychiatric disability judged by the Investigator to be clinically significant and precluding informed consent, participation in the study, or adversely affecting compliance to study drugs;
- Active infection requiring intravenous antibiotics;
- Known history of human immunodeficiency virus (HIV) infection or Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV Ribonucleic acid (RNA) [qualitative] is detected) infection;
- Major surgery within 4 weeks prior to study entry. Minor surgery (excluding diagnostic biopsy) within 1 week prior to study entry;
- Any vaccination within 2 weeks prior to starting study treatment;
- Treatment with any investigational drug or participation in another investigational study within 3 weeks prior to first IMU-201 dose.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States3 sites
Ohio State University Medical Center
Columbus, Ohio, 43210
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Mayo Clinic
Phoenix, Arizona, 85054
Australia3 sites
Chris O'Brien Lifehouse
Camperdown, New South Wales, 2050
Macquarie University
Macquarie, New South Wales, 2109
Cabrini Malvern Hospital
Melbourne, Victoria, 3000
About this study
Official title: An Open Label, Multi-Center, Dose Escalation/Expansion, Phase 1/1b Study of IMU-201, a B-Cell Immunotherapy as Monotherapy or in Combination With Atezolizumab With or Without Chemotherapy, in Adults With Non- Small Cell Lung Cancer (IMPrinter)
An Open Label, Multi-Center, Dose Escalation/Expansion, Phase 1/1b Study of IMU 201 (PD1-Vaxx), a B-Cell Immunotherapy as monotherapy or in combination with atezolizumab with or without chemotherapy, in Adults with Non-Small Cell Lung Cancer (IMPrinter).
Read the detailed description
Investigational Medicinal Product, IMU-201, consists of drug substance, APi2568, which is a B-cell epitope (amino acids 92-110 from PD-1) linked to a promiscuous T-cell epitope (amino acid residues 288-302 from measles virus fusion protein) via a 4-amino acid linker (Gly-Pro-Ser-Leu), and combined with Water for Injection (WFI) forms the drug product, IMU-201, which becomes PD1-Vaxx when emulsified with excipient Montanide ISA 720 VG.
It is hypothesized that a polyclonal induced B-cell antibody response will be more effective or as effective with improved safety over current monoclonal antibody therapy.
This phase 1/1b study is an open-label dose escalation/dose expansion study designed to assess the safety, tolerability, immunogenicity and efficacy of IMU-201 (PD1-Vaxx). Phase 1 monotherapy dose-escalation of IMU-201 (PD1-Vaxx), will enroll approximately 9-18 patients and establish the optimal monotherapy biological dose (mBOD). Once established, the dose cohort will be expanded to enroll additional 10 patients at the mBOD dose level. Phase 1b, a combination dose-escalation of IMU-201 (PD1-Vaxx) with atezolizumab and with or without chemotherapy, will enroll approximately 18-36 patients and establish the optimal combotherapy biological dose (cBOD). Once established, the dose cohort will be expanded to enroll additional 30 patients at the cBOD dose level.
- Conditions
- Non Small Cell Lung Cancer, Non Small Cell Lung Cancer Stage IIIB, Non-small Cell Lung Cancer Stage IV, Squamous Non-small-cell Lung Cancer, Large Cell Carcinoma Lung, Adenocarcinoma Lung
- Being tested
- IMU-201 (administered as PD1-Vaxx) - Regimen 1, IMU-201 (administered as PD1-Vaxx) - Regimen 2, IMU-201 (administered as PD1-Vaxx) - Regimen 3, Atezolizumab, Standard of care chemotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMU-201 (administered as PD1-Vaxx) - Regimen 1Biological
Also called PD1-Vaxx, APi2568
IMU-201 consists of APi2568 (lyophilized IMU-201) dissolved in WFI and emulsified with the adjuvant (Montanide ISA 720 VG) to produce PD1-Vaxx. IMU-201 will be administered as PD1-Vaxx intramuscularly into the deltoid region of the upper arm on Days 1, 15, 29, 64 and thereafter every 63 days until discontinuation from study.
IMU-201 (administered as PD1-Vaxx) - Regimen 2Biological
Also called PD1-Vaxx, APi2568
IMU-201 consists of APi2568 (lyophilized IMU-201) dissolved in WFI and emulsified with the adjuvant (Montanide ISA 720 VG) to produce PD1-Vaxx. IMU-201 will be administered as PD1-Vaxx intramuscularly into the deltoid region of the upper arm on Days 1, 15, 29, 57 and thereafter every subsequent 63 days until discontinuation from study.
IMU-201 (administered as PD1-Vaxx) - Regimen 3Biological
Also called PD1-Vaxx, APi2568
IMU-201 consists of APi2568 (lyophilized IMU-201) dissolved in WFI and emulsified with the adjuvant (Montanide ISA 720 VG) to produce PD1-Vaxx. IMU-201 will be administered as PD1-Vaxx intramuscularly into the deltoid region of the upper arm on Days 1, 15, 29, 57 and thereafter every 56 or 63 days until discontinuation from study.
AtezolizumabDrug
Also called TECENTRIQ
Atezolizumab will be administered every 2 weeks (Q2W) starting Day 15 until discontinuation from study.
Standard of care chemotherapyDrug
Chemotherapy to be administered according to the prescribing information.
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation: Monotherapy Cohort 1 | Experimental | 10 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection Progressed on/after ICI, TPS/TC ≥50% or IC ≥10% Receives: Biological: IMU-201 (administered as PD1-Vaxx) - Regimen 1 |
| Dose Escalation: Monotherapy Cohort 2 | Experimental | 50 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection Progressed on/after ICI, TPS/TC ≥50% or IC ≥10% Receives: Biological: IMU-201 (administered as PD1-Vaxx) - Regimen 1 |
| Dose Escalation: Monotherapy Cohort 3 | Experimental | 100 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection Progressed on/after ICI, TPS/TC ≥50% or IC ≥10% Receives: Biological: IMU-201 (administered as PD1-Vaxx) - Regimen 1 |
| Dose Expansion Monotherapy | Experimental | mOBD (TBD) dose IMU-201 as a 0.5 mL PD1-Vaxx injection Progressed on/after ICI, TPS/TC ≥50% or IC ≥10% Receives: Biological: IMU-201 (administered as PD1-Vaxx) - Regimen 1 |
| Dose Escalation Arm 1: Combination with atezolizumab Cohort 1 | Experimental | 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% Receives: Biological: IMU-201 (administered as PD1-Vaxx) - Regimen 2; Drug: Atezolizumab |
| Dose Escalation Arm 1: Combination with atezolizumab Cohort 2 | Experimental | 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% Receives: Biological: IMU-201 (administered as PD1-Vaxx) - Regimen 2; Drug: Atezolizumab |
| Dose Escalation Arm 1: Combination with atezolizumab Cohort 3 | Experimental | 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% Receives: Biological: IMU-201 (administered as PD1-Vaxx) - Regimen 2; Drug: Atezolizumab |
| Dose Escalation Arm 2: Combination with atezolizumab and chemotherapy Cohort 1 | Experimental | 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 Receives: Biological: IMU-201 (administered as PD1-Vaxx) - Regimen 3; Drug: Atezolizumab; Drug: Standard of care chemotherapy |
| Dose Escalation Arm 2: Combination with atezolizumab and chemotherapy Cohort 2 | Experimental | 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 Receives: Biological: IMU-201 (administered as PD1-Vaxx) - Regimen 3; Drug: Atezolizumab; Drug: Standard of care chemotherapy |
| Dose Escalation Arm 2: Combination with atezolizumab and chemotherapy Cohort 3 | Experimental | 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 Receives: Biological: IMU-201 (administered as PD1-Vaxx) - Regimen 3; Drug: Atezolizumab; Drug: Standard of care chemotherapy |
| Dose Expansion Arm 1: Combination with atezolizumab | Experimental | 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% Receives: Biological: IMU-201 (administered as PD1-Vaxx) - Regimen 2; Drug: Atezolizumab |
| Dose Expansion Arm 2: Combination with atezolizumab | Experimental | 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% Receives: Biological: IMU-201 (administered as PD1-Vaxx) - Regimen 2; Drug: Atezolizumab |
| Dose Expansion Arm 3: Combination with atezolizumab and chemotherapy | Experimental | 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 Receives: Biological: IMU-201 (administered as PD1-Vaxx) - Regimen 3; Drug: Atezolizumab; Drug: Standard of care chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of IMU-201 graded per terminology criteria for adverse events (CTCAE) version 5.00 (Dose Escalation)
Safety and Tolerability Measures include: Frequency of adverse events (AEs) graded per terminology criteria for adverse events (CTCAE) version 5.00.
Measured: Baseline to Day 29
Identify Optimal Biological Dose (OBD) with safety/tolerability graded per terminology criteria for adverse events (CTCAE) version 5.00 and Immuogenicity (Dose Escalation).
Safety and Tolerability Measures: Adverse events (AEs); dose-limiting toxicities (DLTs) graded per terminology criteria for adverse events (CTCAE) version 5.00. Immunogenicity data for IMU-201 includes PD-1 specific antibody (IgG) titers.
Measured: Baseline to Day 43
Overall response rate (ORR) (Dose Expansion)
Efficacy of IMU-201 will be evaluated by overall response rate at OBD of IMU-201 measured as the proportion of participants with a best overall response of complete or partial response.
Measured: Baseline to documented progressive disease (Approximately 15 months)
Secondary outcomes (4)
Overall response rate (ORR) (Dose Escalation)
Efficacy of IMU-201 will be evaluated by overall response rate at OBD of IMU-201 measured as the proportion of participants with a best overall response of complete or partial response.
Measured: Baseline to documented progressive disease (Approximately 15 Months)
Progression free survival (PFS) (Dose Escalation/Expansion)
Efficacy of IMU-201 will be evaluated by progression free survival at OBD of IMU-201.
Measured: Baseline to documented progressive disease or death due to any cause (Approximately 15 Months)
Overall survival (OS) (Dose Escalation/Expansion)
Efficacy of IMU-201 will be evaluated by overall survival at OBD of IMU-201.
Measured: Baseline to death from any cause (Approximately 15 Months)
Duration of response (DOR) (Dose Escalation/Expansion)
Efficacy of IMU-201 will be evaluated by duration of response at OBD of IMU-201.
Measured: From date of earliest CR or PR until the date of first documented progression or death from any cause (Approximately 15 Months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start30 Nov 2020
- Primary completion8 Oct 2024
- Study completion7 Nov 2024
Why it stopped: Portfolio prioritization
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imugene Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04432207
- Sponsor's protocol ID
- IMU.201.101
- Status last verified
- Mar 2026
- First submitted
- 10 May 2020
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Multi-Center, Dose Escalation/Expansion, Phase 1/1b Study of IMU-201, a B-Cell Immunotherapy as Monotherapy or in Combination With Atezolizumab With or Without Chemotherapy, in Adults With Non- Small Cell Lung Cancer (IMPrinter)
- ClinicalTrials.gov ID
- NCT04432207
- Acronym / sponsor ID
- IMU.201.101
- Conditions
- Non Small Cell Lung Cancer, Non Small Cell Lung Cancer Stage IIIB, Non-small Cell Lung Cancer Stage IV, Squamous Non-small-cell Lung Cancer, Large Cell Carcinoma Lung, Adenocarcinoma Lung
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Portfolio prioritization
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Imugene LimitedIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- 8 Oct 2024 (actual)
- Study completion
- 7 Nov 2024 (actual)
- First posted
- 16 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An Open Label, Multi-Center, Dose Escalation/Expansion, Phase 1/1b Study of IMU 201 (PD1-Vaxx), a B-Cell Immunotherapy as monotherapy or in combination with atezolizumab with or without chemotherapy, in Adults with Non-Small Cell Lung Cancer (IMPrinter).
Detailed description
Investigational Medicinal Product, IMU-201, consists of drug substance, APi2568, which is a B-cell epitope (amino acids 92-110 from PD-1) linked to a promiscuous T-cell epitope (amino acid residues 288-302 from measles virus fusion protein) via a 4-amino acid linker (Gly-Pro-Ser-Leu), and combined with Water for Injection (WFI) forms the drug product, IMU-201, which becomes PD1-Vaxx when emulsified with excipient Montanide ISA 720 VG.
It is hypothesized that a polyclonal induced B-cell antibody response will be more effective or as effective with improved safety over current monoclonal antibody therapy.
This phase 1/1b study is an open-label dose escalation/dose expansion study designed to assess the safety, tolerability, immunogenicity and efficacy of IMU-201 (PD1-Vaxx). Phase 1 monotherapy dose-escalation of IMU-201 (PD1-Vaxx), will enroll approximately 9-18 patients and establish the optimal monotherapy biological dose (mBOD). Once established, the dose cohort will be expanded to enroll additional 10 patients at the mBOD dose level. Phase 1b, a combination dose-escalation of IMU-201 (PD1-Vaxx) with atezolizumab and with or without chemotherapy, will enroll approximately 18-36 patients and establish the optimal combotherapy biological dose (cBOD). Once established, the dose cohort will be expanded to enroll additional 30 patients at the cBOD dose level.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 13
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation: Monotherapy Cohort 1 | Experimental | Biological: IMU-201 (administered as PD1-Vaxx) - Regimen 110 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection Progressed on/after ICI, TPS/TC ≥50% or IC ≥10% |
| Dose Escalation: Monotherapy Cohort 2 | Experimental | Biological: IMU-201 (administered as PD1-Vaxx) - Regimen 150 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection Progressed on/after ICI, TPS/TC ≥50% or IC ≥10% |
| Dose Escalation: Monotherapy Cohort 3 | Experimental | Biological: IMU-201 (administered as PD1-Vaxx) - Regimen 1100 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection Progressed on/after ICI, TPS/TC ≥50% or IC ≥10% |
| Dose Expansion Monotherapy | Experimental | Biological: IMU-201 (administered as PD1-Vaxx) - Regimen 1mOBD (TBD) dose IMU-201 as a 0.5 mL PD1-Vaxx injection Progressed on/after ICI, TPS/TC ≥50% or IC ≥10% |
| Dose Escalation Arm 1: Combination with atezolizumab Cohort 1 | Experimental | Biological: IMU-201 (administered as PD1-Vaxx) - Regimen 2, Drug: Atezolizumab10 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% |
| Dose Escalation Arm 1: Combination with atezolizumab Cohort 2 | Experimental | Biological: IMU-201 (administered as PD1-Vaxx) - Regimen 2, Drug: Atezolizumab50 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% |
| Dose Escalation Arm 1: Combination with atezolizumab Cohort 3 | Experimental | Biological: IMU-201 (administered as PD1-Vaxx) - Regimen 2, Drug: AtezolizumabCohort 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% |
| Dose Escalation Arm 2: Combination with atezolizumab and chemotherapy Cohort 1 | Experimental | Biological: IMU-201 (administered as PD1-Vaxx) - Regimen 3, Drug: Atezolizumab, Drug: Standard of care chemotherapy10 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 |
| Dose Escalation Arm 2: Combination with atezolizumab and chemotherapy Cohort 2 | Experimental | Biological: IMU-201 (administered as PD1-Vaxx) - Regimen 3, Drug: Atezolizumab, Drug: Standard of care chemotherapy50 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 |
| Dose Escalation Arm 2: Combination with atezolizumab and chemotherapy Cohort 3 | Experimental | Biological: IMU-201 (administered as PD1-Vaxx) - Regimen 3, Drug: Atezolizumab, Drug: Standard of care chemotherapy100 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 |
| Dose Expansion Arm 1: Combination with atezolizumab | Experimental | Biological: IMU-201 (administered as PD1-Vaxx) - Regimen 2, Drug: AtezolizumabcOBD (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% |
| Dose Expansion Arm 2: Combination with atezolizumab | Experimental | Biological: IMU-201 (administered as PD1-Vaxx) - Regimen 2, Drug: AtezolizumabcOBD (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% |
| Dose Expansion Arm 3: Combination with atezolizumab and chemotherapy | Experimental | Biological: IMU-201 (administered as PD1-Vaxx) - Regimen 3, Drug: Atezolizumab, Drug: Standard of care chemotherapycOBD (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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Age ≥ 18 years with histologically confirmed non-small-cell lung cancer (NSCLC) tumor stage IIIb not eligible for definitive treatment or stage IV
- Prior treatment criterion for Monotherapy dose escalation and expansion: progressed on/after prior PD-1/PD-L1 containing regimen
- Prior treatment criteria for Combination dose escalation arms:
- Prior treatment criteria for Combination dose expansion arms:
- PD-L1 expression criteria (testing by 22C3, SP142, or SP263) for Monotherapy dose escalation and expansion: TPS/TC ≥ 50% or IC ≥ 10%. Patients with PD-L1 TPS/TC<50% or IC<10% expression may be included with agreement of Sponsor
Key exclusion criteria (15 listed)
- Prior therapy for advanced NSCLC within 3 weeks prior to Day 1;
- Continuous systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 2 weeks prior to first dose of study treatment.;
- Any previous grade 3 or higher toxicity to a PD-1 inhibitor or PD-L1 inhibitor;
- Has a history of (non-infectious) pneumonitis/interstitial lung disease that required treatment with immunosuppressive agents or has current pneumonitis/interstitial lung disease;
- Known brain metastases requiring steroid treatment, or signs and symptoms indicating suspected brain metastases;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMU-201 (administered as PD1-Vaxx) - Regimen 1Also: PD1-Vaxx, APi2568IMU-201 consists of APi2568 (lyophilized IMU-201) dissolved in WFI and emulsified with the adjuvant (Montanide ISA 720 VG) to produce PD1-Vaxx. IMU-201 will be administered as PD1-Vaxx intramuscularly into the deltoid region of the upper arm on Days 1, 15, 29, 64 and thereafter every 63 days until discontinuation from study. | Biological | Dose Escalation: Monotherapy Cohort 1, Dose Escalation: Monotherapy Cohort 2, Dose Escalation: Monotherapy Cohort 3, Dose Expansion Monotherapy |
| IMU-201 (administered as PD1-Vaxx) - Regimen 2Also: PD1-Vaxx, APi2568IMU-201 consists of APi2568 (lyophilized IMU-201) dissolved in WFI and emulsified with the adjuvant (Montanide ISA 720 VG) to produce PD1-Vaxx. IMU-201 will be administered as PD1-Vaxx intramuscularly into the deltoid region of the upper arm on Days 1, 15, 29, 57 and thereafter every subsequent 63 days until discontinuation from study. | Biological | Dose Escalation Arm 1: Combination with atezolizumab Cohort 1, Dose Escalation Arm 1: Combination with atezolizumab Cohort 2, Dose Escalation Arm 1: Combination with atezolizumab Cohort 3, Dose Expansion Arm 1: Combination with atezolizumab, Dose Expansion Arm 2: Combination with atezolizumab |
| IMU-201 (administered as PD1-Vaxx) - Regimen 3Also: PD1-Vaxx, APi2568IMU-201 consists of APi2568 (lyophilized IMU-201) dissolved in WFI and emulsified with the adjuvant (Montanide ISA 720 VG) to produce PD1-Vaxx. IMU-201 will be administered as PD1-Vaxx intramuscularly into the deltoid region of the upper arm on Days 1, 15, 29, 57 and thereafter every 56 or 63 days until discontinuation from study. | Biological | 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 2: Combination with atezolizumab and chemotherapy Cohort 3, Dose Expansion Arm 3: Combination with atezolizumab and chemotherapy |
| AtezolizumabAlso: TECENTRIQAtezolizumab will be administered every 2 weeks (Q2W) starting Day 15 until discontinuation from study. | Drug | Dose Escalation Arm 1: Combination with atezolizumab Cohort 1, Dose Escalation Arm 1: Combination with atezolizumab Cohort 2, Dose Escalation Arm 1: Combination with atezolizumab 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 2: Combination with atezolizumab and chemotherapy Cohort 3, Dose Expansion Arm 1: Combination with atezolizumab, Dose Expansion Arm 2: Combination with atezolizumab, Dose Expansion Arm 3: Combination with atezolizumab and chemotherapy |
| Standard of care chemotherapyChemotherapy to be administered according to the prescribing information. | Drug | 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 2: Combination with atezolizumab and chemotherapy Cohort 3, Dose Expansion Arm 3: Combination with atezolizumab and chemotherapy |
Primary outcome
Safety and tolerability of IMU-201 graded per terminology criteria for adverse events (CTCAE) version 5.00 (Dose Escalation)
Time frame: Baseline to Day 29
Safety and Tolerability Measures include: Frequency of adverse events (AEs) graded per terminology criteria for adverse events (CTCAE) version 5.00.
Identify Optimal Biological Dose (OBD) with safety/tolerability graded per terminology criteria for adverse events (CTCAE) version 5.00 and Immuogenicity (Dose Escalation).
Time frame: Baseline to Day 43
Safety and Tolerability Measures: Adverse events (AEs); dose-limiting toxicities (DLTs) graded per terminology criteria for adverse events (CTCAE) version 5.00. Immunogenicity data for IMU-201 includes PD-1 specific antibody (IgG) titers.
Overall response rate (ORR) (Dose Expansion)
Time frame: Baseline to documented progressive disease (Approximately 15 months)
Efficacy of IMU-201 will be evaluated by overall response rate at OBD of IMU-201 measured as the proportion of participants with a best overall response of complete or partial response.
4 secondary outcomes
Overall response rate (ORR) (Dose Escalation)
Time frame: Baseline to documented progressive disease (Approximately 15 Months)
Progression free survival (PFS) (Dose Escalation/Expansion)
Time frame: Baseline to documented progressive disease or death due to any cause (Approximately 15 Months)
Overall survival (OS) (Dose Escalation/Expansion)
Time frame: Baseline to death from any cause (Approximately 15 Months)
Duration of response (DOR) (Dose Escalation/Expansion)
Time frame: From date of earliest CR or PR until the date of first documented progression or death from any cause (Approximately 15 Months)
Results and safety
The study was stopped early (reason given: Portfolio prioritization). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Imugene LimitedLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IMU-201 (administered as PD1-Vaxx) - Regimen 1, IMU-201 (administered as PD1-Vaxx) - Regimen 2 and IMU-201 (administered as PD1-Vaxx) - Regimen 3 in people with Non Small Cell Lung Cancer and Non Small Cell Lung Cancer Stage IIIB, run by Imugene Limited at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Portfolio prioritization). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of IMU-201 graded per terminology criteria for adverse events (CTCAE) version 5.00 (Dose Escalation) (time frame: Baseline to Day 29). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.