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Summary

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

Description

Summary

The study purpose is to evaluate the safety, tolerability, and preliminary efficacy of the addition of INC280, trametinib, ribociclib, gefitinib, or LXH254 to EGF816 in adult patients with advanced EGFR-mutant NSCLC.

Official Title

A Phase Ib, Open Label, Multi-center Study to Characterize the Safety, Tolerability and Preliminary Efficacy of EGF816 in Combination With Selected Targeted Agents in EGFR Mutant NSCLC

Details

This is a Phase Ib, open label, non-randomized dose escalation study of EGF816 in combination with ribociclib, trametinib, or LXH254, followed by dose expansion of EGF816 in combination with ribociclib, trametinib, LXH254, INC280, or gefitinib in adult patients with advanced EGFR-mutant NSCLC.

During the dose escalation part, patients will be assigned to the addition of trametinib, ribociclib, or LXH254 to EGF816.

Following determination of the recommended dose for the combination of EGF816 + trametinib, EGF816 + ribociclib, and EGF816 + LXH254, patients may be enrolled to the dose expansion arms of each of these combinations. Patients may also be assigned to EGF816 + INC280 or EGF816 + gefitinib in dose expansion.

Efficacy assessments will be performed at baseline and every 2 cycles during treatment.

Keywords

EGFR-mutant Non-small Cell Lung Cancer EGFR-mutant NSCLC EGF816 LXH254 INC280 ribociclib trametinib gefitinib EGFR T790M BRAF mutation BRAF fusion BRAF rearrangement MET amplification Carcinoma, Non-Small-Cell Lung

Eligibility

You can join if…

Open to people ages 18 years and up

  • Patients must have histologically or cytologically confirmed locally advanced (stage IIIB) or metastatic (stage IV) EGFR mutant (ex19del, L858R) NSCLC.
  • Requirements of EGFR mutation status and prior lines of treatment:
  • Treatment naive patients, who have locally advanced or metastatic NSCLC with EGFR sensitizing mutation (e.g., L858R and/or ex19del), have not received any systemic antineoplastic therapy for advanced NSCLC and are eligible to receive EGFR TKI treatment. Patients with EGFR exon 20 insertion/duplication are not eligible. Note:patients who have received only one cycle of chemotherapy in the advanced setting are allowed.
  • Patients who have locally advanced or metastatic NSCLC with EGFR sensitizing mutation AND an acquired T790M mutation (e.g., L858R and/or ex19del, T790M+) following progression on prior treatment with a 1st-generation EGFR TKI or 2nd-generation EGFR TKI. These patients may not have received more than 4 prior lines of antineoplastic therapy in the advanced setting, including EGFR TKI, and may not have received any agent targeting EGFR T790M mutation (i.e., 3rd-generation EGFR TKI).
  • Patients who have locally advanced or metastatic NSCLC with EGFR sensitizing mutation and a "de novo" T790M mutation (i.e., no prior treatment with any agent known to inhibit EGFR including EGFR TKI). These patients may not have received more than 3 prior lines of antineoplastic therapy in the advanced setting, and may not have received any prior 3rd generation EGFR TKI.
  • Patients must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy according to the treating institution's guidelines. Patients must be willing to undergo a new tumor biopsy during therapy on this study, and at screening if an archival tumor sample obtained since the diagnosis of advanced disease (1L patients)or since last treatment failure (2L+ patients) is not available.

You CAN'T join if...

  • Patients with a history or presence of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis.
  • Patients with unstable brain metastases.
  • Patients with a history of another malignancy.
  • Patients with a known history of human immunodeficiency virus (HIV) seropositivity.
  • Patients with clinically significant, uncontrolled heart disease.
  • Patients participating in additional parallel investigational drug or medical device studies.
  • Prior therapies:
  • Patients who have been treated with EGFR TKI in the adjuvant setting within 6 months,unless acquired EGFR T790M is present in a tumor or blood sample obtained since the discontinuation of the EGFR TKI.
  • Patients who have been treated with prior EGFR TKI targeting T790M (3rd generation).
  • Patients who have been treated with systemic anti-neoplastic therapy within:
  • 2 weeks for fluoropyrimidine monotherapy
  • 6 weeks for nitrosoureas and mitomycin
  • 4 weeks or ≤ 5 half-lives (whichever is shorter) for biological therapy(including monoclonal antibodies) and continuous or intermittent small molecule therapeutics or any other investigational agent

Locations

  • University of California San Francisco (UCSF) not yet accepting patients
    San Francisco, California, 94143, United States
  • MD Anderson Ceancer Center (MDACC) not yet accepting patients
    Houston, Texas, 77030, United States
  • Memorial Sloan Kettering Cancer Center (MSKCC) not yet accepting patients
    New York, New York, 10065, United States
  • Massachusetts General Hospital (MGH) not yet accepting patients
    Boston, Massachusetts, 02114, United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT03333343
Phase
Phase 1
Study Type
Interventional
Last Updated
November 2, 2017
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