Summary

Eligibility
for people ages 18-101 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

Summary

The objective of this study is to investigate the safety, tolerability, and antitumor activity of novel combination therapies administered in participants with advanced EGFRm NSCLC.

Official Title

A Multiarm, Open-label, Multicenter, Phase 1b/2 Study to Evaluate Novel Combination Therapies in Subjects With Previously Treated Advanced EGFRm NSCLC

Keywords

Carcinoma, Non-Small-Cell Lung, EGFR mutated, CD73, A2AR, Oleclumab, MEDI9447, AZD4635, Osimertinib, NSCLC, Immunotherapy, Non-Small-Cell Lung Carcinoma

Eligibility

You can join if…

Open to people ages 18-101

  1. Age ≥ 18
  2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  3. Weight ≥ 35 kg
  4. Diagnosed with histologically or cytologically confirmed locally advanced/metastatic NSCLC with EGFRm
    • For Arm A (Oleclumab + Osimertinib arms): must have received 1 prior line of therapy with an EGFR tyrosine kinase inhibitor (TKI) and confirmed T790M negative
    • For Arm B (Oleclumab + AZD4635 arms): must have received at least 2 but not more than 4 prior lines of therapy.

You CAN'T join if...

  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. Participants 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. Participants with a history of venous thrombosis within the past 3 months
  6. Participants 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 central nervous system (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 cytochrome P (CYP) 3A4
  2. Participants has a history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD
  3. Participants 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

Locations

  • Research Site
    San Francisco California 94143 United States
  • Research Site
    La Jolla California 92093 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
MedImmune LLC
Links
D6070C00004 redacted protocol D6070C00004 SAP redacted D6070C00004 CSR Synopsis redacted
ID
NCT03381274
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
About 43 people participating
Last Updated