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Report for Clinical Trial NCT03438318

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Multicenter, Two-Part, Phase 1B Clinical Study of CMP-001 in Combination With Atezolizumab With and Without Radiation Therapy in Subjects With Advanced Non Small Cell Lung Cancer (NSCLC)

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.

NCT03438318 Non Small Cell Lung Cancer
MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Neoplasm of the lung Non-small cell lung carcinoma

3 Interventions

Name: CMP-001

Description: CMP-001 will be administered as per the dose and schedule specified in the respective arms.
Type: Drug
Group Labels: 2

Part A (CMP-001, Atezolizumab and Optional Radiation Therapy) Part B (Radiation Therapy, CMP-001 and Atezolizumab)

Name: Atezolizumab

Description: Atezolizumab will be administered as per the approved label and according to the schedule specified in the respective arms.
Type: Drug
Group Labels: 2

Part A (CMP-001, Atezolizumab and Optional Radiation Therapy) Part B (Radiation Therapy, CMP-001 and Atezolizumab)

Name: Radiation Therapy

Description: Radiation therapy will be administered using either 3-dimensional (3D) conformal radiotherapy or intensity-modulated radiation therapy (IMRT) to non-target node or metastatic lesion as per the dose and schedule specified in the respective arms.
Type: Radiation
Group Labels: 2

Part A (CMP-001, Atezolizumab and Optional Radiation Therapy) Part B (Radiation Therapy, CMP-001 and Atezolizumab)


Primary Outcomes

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)

Measure: Part A and B: DLT

Time: First 30 days of therapy starting from Week 1 Day 1

Secondary Outcomes

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)

Measure: Part A and B: Concentration of Chemokine IP-10

Time: Day 1 of Weeks 1, 3, 8, and Day 2 of Weeks 3, 8

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 months

Measure: Part A and B: Time to Response (TTR) as per RECIST V1.1 or iRECIST Using CT/PET or MRI Scans

Time: From first dose of CMP-001 until disease progression or death, whichever occur first (assessment at every 9 weeks throughout the study from Week 1 Day 1, up to approximately 2 years 9 months)

Measure: Part A and B: Duration of Response (DOR) as per RECIST V1.1 or iRECIST Using CT/PET or MRI Scans

Time: From the date of first confirmed CR or PR until the first date of recurrent or progressive disease (assessment at every 9 weeks throughout the study from Week 1 Day 1, up to approximately 2 years 9 months)

Purpose: Treatment

Allocation: Non-Randomized

Sequential Assignment


There is one SNP

SNPs


1 T790M

- 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 ---



HPO Nodes


HPO: