24 Participants Needed

PD1-Vaxx Immunotherapy for Non-Small Cell Lung Cancer

Recruiting at 5 trial locations
AJ
BN
AG
YK
Overseen ByYuni Kim
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests IMU-201 (PD1-Vaxx), a new treatment for adults with Non-Small Cell Lung Cancer. It aims to help the immune system create antibodies to fight cancer cells more effectively and safely than current treatments.

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have not received IMU-201, atezolizumab, or chemotherapy before.
I am fully active and can carry on all my pre-disease activities without restriction.
My blood, liver, and kidney functions are all within normal ranges.
See 13 more

Exclusion Criteria

My NSCLC has specific mutations (EGFR, ALK, BRAF, or ROS1) and I haven't had targeted treatments for these.
I haven't taken part in any drug trials or received experimental treatments in the last 3 weeks.
I have not had major surgery in the last 4 weeks or minor surgery in the last week.
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Phase 1 monotherapy dose-escalation of IMU-201 (PD1-Vaxx) to establish the optimal monotherapy biological dose (mBOD).

6-8 weeks
Multiple visits for dose administration and monitoring

Dose Expansion

Expansion of the dose cohort to enroll additional patients at the mBOD dose level.

8-12 weeks
Regular visits for treatment and monitoring

Combination Dose Escalation

Phase 1b combination dose-escalation of IMU-201 (PD1-Vaxx) with atezolizumab and with or without chemotherapy to establish the optimal combotherapy biological dose (cBOD).

6-8 weeks
Multiple visits for combination treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

15 months
Periodic visits for monitoring response and survival

What Are the Treatments Tested in This Trial?

Interventions

  • IMU-201 (PD1-Vaxx)
Trial Overview 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.
How Is the Trial Designed?
13Treatment groups
Experimental Treatment
Group I: Dose Expansion MonotherapyExperimental Treatment1 Intervention
Group II: Dose Expansion Arm 3: Combination with atezolizumab and chemotherapyExperimental Treatment3 Interventions
Group III: Dose Expansion Arm 2: Combination with atezolizumabExperimental Treatment2 Interventions
Group IV: Dose Expansion Arm 1: Combination with atezolizumabExperimental Treatment2 Interventions
Group V: Dose Escalation: Monotherapy Cohort 3Experimental Treatment1 Intervention
Group VI: Dose Escalation: Monotherapy Cohort 2Experimental Treatment1 Intervention
Group VII: Dose Escalation: Monotherapy Cohort 1Experimental Treatment1 Intervention
Group VIII: Dose Escalation Arm 2: Combination with atezolizumab and chemotherapy Cohort 3Experimental Treatment3 Interventions
Group IX: Dose Escalation Arm 2: Combination with atezolizumab and chemotherapy Cohort 2Experimental Treatment3 Interventions
Group X: Dose Escalation Arm 2: Combination with atezolizumab and chemotherapy Cohort 1Experimental Treatment3 Interventions
Group XI: Dose Escalation Arm 1: Combination with atezolizumab Cohort 3Experimental Treatment2 Interventions
Group XII: Dose Escalation Arm 1: Combination with atezolizumab Cohort 2Experimental Treatment2 Interventions
Group XIII: Dose Escalation Arm 1: Combination with atezolizumab Cohort 1Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Imugene Limited

Lead Sponsor

Trials
7
Recruited
340+
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