Description:
The objective of this study is to investigate the safety, tolerability and antitumor activity
of novel combination therapies administered in subjects with advanced EGFRm NSCLC
Title
- Brief Title: Oleclumab (MEDI9447) EGFRm NSCLC Novel Combination Study
- Official Title: A Multiarm, Open-label, Multicenter, Phase 1b/2 Study to Evaluate Novel Combination Therapies in Subjects With Previously Treated Advanced EGFRm NSCLC
Clinical Trial IDs
- ORG STUDY ID:
D6070C00004
- NCT ID:
NCT03381274
Conditions
- Carcinoma, Non-Small-Cell Lung
Interventions
Drug | Synonyms | Arms |
---|
MEDI9447 | | Arm A |
Osimertinib | | Arm A |
AZD4635 | | Arm B |
Purpose
The objective of this study is to investigate the safety, tolerability and antitumor activity
of novel combination therapies administered in subjects with advanced EGFRm NSCLC
Trial Arms
Name | Type | Description | Interventions |
---|
Arm A | Experimental | MEDI9447 and osimertinib | |
Arm B | Experimental | MEDI9447 and AZD4635 | |
Eligibility Criteria
Inclusion Criteria:
1. Age ≥ 18
2. ECOG Performance Status of 0 or 1
3. Weight ≥ 35 kg
4. Diagnosed with histologically or cytologically confirmed locally advanced/metastatic
NSCLC with EGFR mutation
- For Arm A: must have received 1 prior line of therapy with an EGFR TKI and
confirmed T790M negative
- For Arm B: must have received at least 2 but not more than 4 prior lines of
therapy.
Exclusion Criteria:
1. Receipt of an EGFR TKI within 14 days of the first dose of study treatment.
2. Receipt of any conventional or investigational anticancer therapy not otherwise
specified within 21 days of the planned first dose.
3. Prior receipt of any investigational immunotherapy. Subjects may have received agents
that have local health authority approval for the disease indication
4. Concurrent enrollment in another therapeutic clinical study. Enrollment in
observational studies will be allowed
5. Subjects with a history of venous thrombosis within the past 3 months
6. Subjects with prior history of myocardial infarction, transient ischemic attack, or
stroke in the last 6 months
7. Active or prior documented autoimmune or inflammatory disorders within the past 3
years prior to the start of treatment
8. Other invasive malignancy within 2 years.
9. Untreated CNS metastatic disease, leptomeningeal disease, or cord compression
10. Current or prior use of immunosuppressive medication within 14 days prior to the first
dose
Additional Exclusion Criteria for Arm A
1. Concurrent treatment (or inability to stop therapy) with medications or herbal
supplements known to be potent inducers of CYP3A4
2. Subject has a history of ILD, drug-induced ILD, radiation pneumonitis that required
steroid treatment, or any evidence of clinically active ILD.
3. Subject requires continuous supplemental oxygen for any reason.
Additional Exclusion Criteria for Arm B
1. Herbal preparations/medications are not allowed throughout the study
2. History of seizures excluding those that occurred due to previously untreated CNS
metastasis
Maximum Eligible Age: | 101 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Incidence of Adverse Events as a measure of safety |
Time Frame: | Screening through 90 days after last dose of investigational product |
Safety Issue: | |
Description: | The primary endpoint is safety as assessed by the presence of adverse events and serious adverse events |
Secondary Outcome Measures
Measure: | Duration of Response (DoR) |
Time Frame: | During treatment through study completion, about 2 years after the last subject dosed |
Safety Issue: | |
Description: | The duration from the first documentation of objective response (OR) to the first documented disease progression or death due to any cause, whichever occurs first |
Measure: | Disease Control (DC) |
Time Frame: | During treatment through study completion, about 2 years after the last subject dosed |
Safety Issue: | |
Description: | Defined as complete response (CR), partial response (PR) or stable disease (SD) |
Measure: | Progression Free Survival (PFS) |
Time Frame: | During treatment through study completion, about 2 years after the last subject dosed |
Safety Issue: | |
Description: | From the start of treatment with investigational product until the first documentation of disease progression or death due to any cause, whichever occurs first. |
Measure: | Overall Survival (OS) |
Time Frame: | During treatment through study completion, about 2 years after the last subject dosed |
Safety Issue: | |
Description: | From the start of treatment with investigational product until death due to any cause |
Measure: | Objective Response by T790M status |
Time Frame: | During treatment through study completion, about 2 years after the last subject dosed |
Safety Issue: | |
Description: | Defined as best overall response of confirmed CR or confirmed PR according to RECIST version 1.1 |
Measure: | Disease Control by T790M status |
Time Frame: | During treatment through study completion, about 2 years after the last subject dosed |
Safety Issue: | |
Description: | Defined as CR, PR or SD |
Measure: | Serum MEDI9447 concentration levels |
Time Frame: | During treatment through 90 days after last dose of investigational product |
Safety Issue: | |
Description: | Pharmacokinetic |
Measure: | Serum Osimertinib concentration levels |
Time Frame: | During treatment through 90 days after last dose of investigational product |
Safety Issue: | |
Description: | Pharmacokinetic |
Measure: | Serum AZD4635 concentration levels |
Time Frame: | During treatment through 90 days after last dose of investigational product |
Safety Issue: | |
Description: | Pharmacokinetic |
Measure: | Development of detectable anti-drug antibody(ADA) to MEDI9447 |
Time Frame: | During treatment through 90 days after last dose of investigational product |
Safety Issue: | |
Description: | Immunogenicity |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | MedImmune LLC |
Trial Keywords
- EGFR mutated, CD73, A2AR, oleclumab, MEDI9447, AZD4635, osimertinib, NSCLC, immunotherapy
Last Updated
August 2, 2021