Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC

  • STATUS
    Recruiting
  • End date
    Nov 4, 2022
  • participants needed
    157
  • sponsor
    Novartis Pharmaceuticals
Updated on 14 May 2021
Investigator
Novartis Pharmaceuticals
Primary Contact
Novartis Investigative Site (0.0 mi away) Contact
+9 other location

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.

Description

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.

Details
Condition EGFR-mutant Non-small Cell Lung Cancer, EGFR-mutant Non-small Cell Lung Cancer, EGFR-mutant Non-small Cell Lung Cancer, EGFR-mutant Non-small Cell Lung Cancer, EGFR-mutant Non-small Cell Lung Cancer, EGFR-mutant Non-small Cell Lung Cancer, EGFR-mutant Non-small Cell Lung Cancer, EGFR-mutant Non-small Cell Lung Cancer, EGFR-mutant Non-small Cell Lung Cancer, EGFR-mutant Non-small Cell Lung Cancer, EGFR-mutant Non-small Cell Lung Cancer, EGFR-mutant Non-small Cell Lung Cancer
Treatment INC280, Ribociclib, Gefitinib, Trametinib, EGF816, LXH254
Clinical Study IdentifierNCT03333343
SponsorNovartis Pharmaceuticals
Last Modified on14 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
weeks for fluoropyrimidine monotherapy
weeks for nitrosoureas and mitomycin
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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