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Summary

for people ages 18–130 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

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

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 Osimertinib

Eligibility

You can join if…

Open to people ages 18–130

  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
  5. For Arm A: must have received 1 prior line of therapy with an EGFR TKI and confirmed T790M negative
  6. For Arm B: must have received at least 2 but not more than 3 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. 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 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, prior traumatic brain injury, prior stroke, or other predisposing risk of seizure (excluding CNS metastasis)

Locations

  • Research Site not yet accepting patients
    San Francisco, California, 94143, United States
  • Research Site withdrawn
    Santa Monica, California, 90404, United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
MedImmune LLC
ID
NCT03381274
Phase
Phase 1/2
Study Type
Interventional
Last Updated
April 24, 2018
I’m interested in this study!