Clinical Trials

Inclusion Criteria:

1. Age ≥ 18 years with histologically confirmed non-small-cell lung cancer (NSCLC) tumor
stage IIIb not eligible for definitive treatment or stage IV

2. Prior treatment criterion for Monotherapy dose escalation and expansion: progressed
on/after prior PD-1/PD-L1 containing regimen

3. Prior treatment criteria for Combination dose escalation arms:

1. IMU-201 + atezolizumab, patients naïve to prior treatment or progressed on/after
prior PD-1/PD-L1 containing regimen

2. IMU-201 + atezolizumab + chemotherapy, patient naïve to prior treatment naive

4. Prior treatment criteria for Combination dose expansion arms:

1. IMU-201 + atezolizumab, progressed on/after prior PD-1/PD-L1 containing regimen

2. IMU-201 + atezolizumab, patients naïve to prior treatment

3. IMU-201 + atezolizumab + chemotherapy, patients naïve to prior treatment

5. 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

6. PD-L1 expression criteria for Combination dose escalation arms:

1. IMU-201 + atezolizumab, TPS/TC ≥ 50% or IC ≥ 10%

2. IMU-201 + atezolizumab + chemotherapy, independent of PD-L1 expression

7. PD-L1 expression criteria for Combination dose expansion arms:

1. IMU-201 + atezolizumab, TPS/TC ≥ 50% or IC ≥ 10%

2. IMU-201 + atezolizumab, TPS/TC ≥ 50% or IC ≥ 10%

3. IMU-201 + atezolizumab + chemotherapy, independent of PD-L1 expression

8. Life expectancy of at least 12 weeks in the opinion of the Investigator

9. Zubrod/ECOG score performance status 0-1

10. At least one measurable lesion as defined by RECIST 1.1 criteria.

11. Adequate hematologic, liver, and renal function

Exclusion Criteria:

1. Prior therapy for advanced NSCLC within 3 weeks prior to Day 1;

2. 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.;

3. Any previous grade 3 or higher toxicity to a PD-1 inhibitor or PD-L1 inhibitor;

4. Has a history of (non-infectious) pneumonitis/interstitial lung disease that required
treatment with immunosuppressive agents or has current pneumonitis/interstitial lung
disease;

5. Known brain metastases requiring steroid treatment, or signs and symptoms indicating
suspected brain metastases;

6. Current or previous history of auto-immune disease;

7. 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);

8. Prior organ transplant;

9. Concurrent active malignancy except for adequately controlled limited basal cell
carcinoma of the skin;

10. 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;

11. Active infection requiring intravenous antibiotics;

12. 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;

13. Major surgery within 4 weeks prior to study entry. Minor surgery (excluding diagnostic
biopsy) within 1 week prior to study entry;

14. Any vaccination within 2 weeks prior to starting study treatment;

15. Treatment with any investigational drug or participation in another investigational
study within 3 weeks prior to first IMU-201 dose.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 6/6/23. Questions regarding updates should be directed to the study team contact.