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PD1-Vaxx Immunotherapy for Non-Small Cell Lung Cancer
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have not received IMU-201, atezolizumab, or chemotherapy before.My cancer shows high PD-L1 levels suitable for specific treatment combinations.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 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.I have not received any previous treatments for my condition.I have not received previous treatments for my condition.I have not been treated or have progressed after treatment with PD-1/PD-L1 inhibitors.My cancer shows high PD-L1 levels based on specific tests.You have at least one spot that can be measured and monitored according to specific criteria.I have not had major surgery in the last 4 weeks or minor surgery in the last week.I have not received any vaccinations in the last 2 weeks.I am currently on IV antibiotics for an infection.My cancer progressed after treatment with a PD-1/PD-L1 inhibitor.I have no active cancer except for a controlled skin cancer.I have a history of HIV or active Hepatitis B or C.My cancer shows high PD-L1 levels suitable for specific treatment combinations.My cancer progressed after treatment with a PD-1/PD-L1 inhibitor.I have had an organ transplant.I haven't had treatment for advanced lung cancer in the last 3 weeks.I haven't taken high-dose steroids or immunosuppressants in the last 2 weeks.I have or had lung inflammation that needed treatment with immune-suppressing drugs.You have had an autoimmune disease in the past or currently have one.I am over 18 and have advanced stage lung cancer.My cancer's PD-L1 status does not affect my eligibility for a specific treatment combination.I need steroids for my brain metastases.My cancer shows high PD-L1 levels suitable for specific treatment combinations.I have experienced severe side effects from PD-1 or PD-L1 inhibitors.My cancer's PD-L1 status does not affect my eligibility for a specific treatment combination.
- Group 1: Dose Escalation Arm 1: Combination with atezolizumab Cohort 1
- Group 2: Dose Expansion Arm 2: Combination with atezolizumab
- Group 3: Dose Expansion Monotherapy
- Group 4: Dose Expansion Arm 1: Combination with atezolizumab
- Group 5: Dose Escalation Arm 1: Combination with atezolizumab Cohort 2
- Group 6: Dose Escalation: Monotherapy Cohort 3
- Group 7: Dose Escalation Arm 2: Combination with atezolizumab and chemotherapy Cohort 3
- Group 8: Dose Escalation Arm 2: Combination with atezolizumab and chemotherapy Cohort 1
- Group 9: Dose Escalation Arm 2: Combination with atezolizumab and chemotherapy Cohort 2
- Group 10: Dose Escalation Arm 1: Combination with atezolizumab Cohort 3
- Group 11: Dose Expansion Arm 3: Combination with atezolizumab and chemotherapy
- Group 12: Dose Escalation: Monotherapy Cohort 1
- Group 13: Dose Escalation: Monotherapy Cohort 2
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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