This is a multicenter, two part (Part A and Part B) clinical study of CMP-001 administered intratumorally (IT) and subcutaneously (SC) in combination with atezolizumab with or without radiation therapy in participants with NSCLC.
Name: CMP-001
Name: Atezolizumab
Name: Radiation Therapy
Description: TEAEs will be evaluated and assigned a grade using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measure: Part A and B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Time: From first dose of CMP-001 (Week 1 Day 1) until 30 days after the last CMP-001 injection (up to approximately 2 years 9 months)Description: Oral temperature should be measured in supine or seated position, following at least 3 minutes of rest.
Measure: Part A and B: Oral Temperature Time: From screening up to end of treatment (EOT) (up to approximately 2 years 9 months)Description: Respiratory rate should be measured in supine or seated position, following at least 3 minutes of rest.
Measure: Part A and B: Respiratory Rate Time: From screening up to EOT (up to approximately 2 years 9 months)Description: Blood pressure should be measured in supine or seated position, following at least 3 minutes of rest.
Measure: Part A and B: Systolic and Diastolic Blood Pressure Time: From screening up to EOT (up to approximately 2 years 9 months)Description: Physical examination included body weight measurement.
Measure: Part A and B: Body Weight Time: From screening up to EOT (up to approximately 2 years 9 months)Description: Physical examination included BMI measurement.
Measure: Part A and B: Body Mass Index (BMI) Time: From screening up to EOT (up to approximately 2 years 9 months)Description: ECG parameters will include heart rate and PR, QRS, QT, and QT corrected for heart rate (QTc) intervals. QT will be corrected using Fridericia's (QTcF) formula. ECG will be performed after the participant has been resting in supine or semi-supine position for at least 5 minutes.
Measure: Part A and B: Number of Participants With Clinically Significant Abnormalities in 12-Lead Electrocardiogram (ECG) Parameters Time: From screening up to EOT (up to approximately 2 years 9 months)Description: Clinical laboratory parameters include serum chemistry, hematology, and urinalysis.
Measure: Part A and B: Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Parameters Time: From screening up to EOT (up to approximately 2 years 9 months)Description: ORR will be calculated as the number of participants with a confirmed complete response (CR) or partial response (PR) divided by the number of participants dosed.
Measure: Part A and B: Objective Response Rate (ORR) (Percentage of Participants With Objective Response) as per RECIST V1.1 or iRECIST Using CT/PET or MRI Scans Time: Baseline until confirmed disease progression (CR or PR) or death, whichever occur first (assessment at every 9 weeks throughout the study from Week 1 Day 1, up to approximately 2 years 9 monthsAllocation: Non-Randomized
Sequential Assignment
There is one SNP
- Participants with epidermal growth factor (EGFR) activating mutations, EGFR T790M or anaplastic lymphoma kinase (ALK) gene re-arrangement must have received prior standard of care and have evidence of disease progression. --- T790M ---