Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as EGF816, EFG816
Nazartinib · 2 trials · 2 indications
Assess safety and tolerability including incidence of dose limiting toxicities, adverse events, and serious adverse events.
A Dose-Limiting Toxicity (DLT) is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 assessed as unrelated to disease, disease progression, inter-current illness or concomitant medications that occurs within the first 28 days of combination treatment during the dose escalation part of the study. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher.
Assessment of tolerability. For patients who do not tolerate the protocol-specified dosing schedule, dose adjustments may be permitted in order to allow patients to continue the study treatment.
Dose intensity is computed as the ratio of actual cumulative dose received to actual duration of exposure.
Modified objective response rate (ORR2) per RECIST v1.1 (taking as baseline the most recent assessment prior to initiating combination)
Number of participants with DLTs during the first 28 days of therapy. A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle of treatment with EGF816 and meets any of the criteria described in the protocol. A participant with multiple occurrences of DLTs under one treatment is counted only once.
ORR is defined as the percentage of patients with a best overall response of complete response (CR) or partial response (PR) determined by BIRC assessment in accordance to Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | EGF816+ trametinib in escalation phase |
| Arm 2 | EXPERIMENTAL | EGF816 + ribociclib in escalation phase |
| Arm 3 | EXPERIMENTAL | EGF816 + LXH254 in escalation phase |
| Arm A | EXPERIMENTAL | EGF816 + INC280 in expansion phase (patients with no known resistance mechanism) |
| Arm B | EXPERIMENTAL | EGF816 + trametinib in expansion phase |
| Arm C | EXPERIMENTAL | EGF816 + ribociclib in expansion phase |
| Arm D | EXPERIMENTAL | EGF816 + LXH254 in expansion phase (patients with no known resistance mechanism) |
| Arm E | EXPERIMENTAL | EGF816 + LXH254 in expansion phase (patients with known resistance mechanism) |
| Arm F | EXPERIMENTAL | EGF816 + gefitinib in expansion phase |
| Arm G | EXPERIMENTAL | EGF816 + INC280 in expansion phase (patients with known resistance mechanism) |
| Phase I part | EXPERIMENTAL | Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations will be administered escalated doses of EGF816 orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study. The starting dose for the Phase I part first cohort of patients will be 75 mg once per day capsule. |
| Phase II part | EXPERIMENTAL | Treatment naïve participants with locally advanced or metastatic NSCLC harboring EGFR mutations will be administered with EGF816 at RP2D during Phase II part of the study. |
| Name | Type | Description |
|---|---|---|
| EGF816 | DRUG | Study Drug |
| trametinib | DRUG | Study Drug |
| ribociclib | DRUG | Study Drug |
| LXH254 | DRUG | Study Drug |
| INC280 | DRUG | Study Drug |
| gefitinib | DRUG | Study Drug |
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...
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Nazartinib is an investigational oral therapy being studied for advanced non-small cell lung cancer, including EGFR-mutant non-small cell lung cancer. It is being evaluated in adults with these EGFR-mutant solid tumors, and it is not yet an approved treatment. It is a small molecule developed in oncology.
Nazartinib targets EGFR, the epidermal growth factor receptor. It is an EGFR inhibitor, meaning it is designed to block EGFR signaling in tumors that carry EGFR mutations. Its clinical development is biomarker-selected, focusing on patients whose cancers are EGFR-mutant, including EGFR-mutant non-small cell lung cancer.
Nazartinib is being developed by Novartis AG, which trades under the ticker NVS. Novartis is the sponsor of the clinical program evaluating the drug in EGFR-mutant non-small cell lung cancer and advanced non-small cell lung cancer.
Nazartinib is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The program includes Phase 1 studies in EGFR-mutant non-small cell lung cancer and advanced non-small cell lung cancer, with one trial active and not recruiting and one completed.
Nazartinib has been studied in NCT03333343, a Phase 1 trial of EGF816 combined with selected targeted agents in EGFR-mutant NSCLC, and NCT02108964, a Phase 1/2 study of EGF816 in EGFR-mutant solid malignancies. NCT03333343 is active but not recruiting, while NCT02108964 is completed.
Yes, nazartinib is also known as EGF816. EGF816 is the code name used in the trial titles for the same Novartis compound, so searches for either name refer to the same EGFR inhibitor being studied in EGFR-mutant non-small cell lung cancer.