Study of Efficacy and Safety of Nivolumab in Combination With EGF816 and of Nivolumab in Combination With INC280 in Patients With Previously Treated Non-small Cell Lung Cancer

Study summary

To determine the efficacy and safety of nivolumab in combination with EGF816 and of nivolumab in combination with INC280 in previously treated NSCLC patients

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedEGF816 and INC280

Plus 1 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Feb 28, 2022 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?13 U.S. locations

Locations may change over time.

Who runs it?Novartis Pharmaceuticals

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 2
Sponsor: Novartis Pharmaceuticals
Interventions being studied: Drug: EGF816; Drug: INC280; Drug: Nivolumab

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Treatment approach

Immunotherapy→

Study topics

After prior treatment→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Written informed consent must be obtained prior to any screening procedures
Presence of at least one measurable lesion according to RECIST v.1.1
ECOG performance status ≤ 2
Patients with histologically documented locally advanced, recurrent and/or metastatic NSCLC
Tumor tissue for determination and/or confirmation of genetic pre-requisites (i.e. EGFR T790M positivity post progression on EGFR TKI for Group 1; cMet status for Group 2) must be provided for analysis Group 1 patients:
Patients with EGFR T790M NSCLC (adenocarcinoma)
Documented progression of disease according to RECIST v1.1 following primary standard of care (e.g. erlotinib, gefitinib) Group 2 patients:
Patients with EGFR wild-type NSCLC
Documented progression of disease according to RECIST v1.1 following standard of care (e.g. platinum doublet).

Reasons someone may not be able to joinExclusion criteria

Patients who have received more than one prior line of EGFR TKI therapy1 (applies only to Group 1)
Previous treatment with a c-MET inhibitor or HGF-targeting therapy (applies only to Group 2)
Patients with brain metastases. However, if radiation therapy and/or surgery has been completed and serial evaluation by CT (with contrast enhancement) or MRI over a minimum of one month demonstrates the disease to be stable and if the patient remains asymptomatic without the need for treatment with steroids
Patients who require emergent use of systemic steroids, chronic use of prednisone (greater than 10mg or an equivalent steroid dose daily) or emergent surgery and/or radiotherapy.
History of allergy or hypersensitivity to nivolumab components
Patients with any known or suspected, current or past history of, autoimmune disease. Patients with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
Patients with a condition requiring chronic systemic treatment with either corticosteroids(\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of treatment start. Inhaled or topical steroids, and adrenal replacement steroid doses\> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease
Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection
Patients with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity
Patients who have been treated with prior PD-1 and PD-L1 agents
Patients who previously received agents targeting c-MET and/or EGFR T790M Note: Previous treatment with afatinib may be allowable after discussions between Novartis and Investigator.
Patients with the following laboratory abnormalities:
Absolute Neutrophil Count (ANC) \<1.5 x 109/L
Hemoglobin (Hgb) \<9 g/dL
Platelets \<100 x 109/L
Total bilirubin \>1.5 x upper limit of normal (ULN). For patients with Gilbert's syndrome total bilirubin \>2.5 x upper limit of normal (ULN)
Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \>3 x ULN
Serum creatinine \>1.5 x ULN and/or measured or calculated creatinine clearance \<75% LLN
For patients being screened for Group 2, asymptomatic serum amylase \> CTCAE Grade 2 (1.5-2.0 x ULN). Patients with Grade 1 or Grade 2 serum amylase at the beginning of the study must be confirmed to have no signs or symptoms suggesting pancreatitis or pancreatic injury (e.g., elevated P-amylase, abnormal imaging findings of pancreas, etc.)
For patients being screened for Group 2: Serum lipase \> ULN
Female patients who are either pregnant or nursing.
Women of child bearing potential who refuse or are not able to use a highly effective method of contraception as defined in the study protocol.
Sexually active males unless they use a condom during intercourse while taking drug and for 31 weeks after the last dose of study treatment.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

University of Texas MD Anderson Cancer Center Thoractic Head/Neck Med.Onc(2)Houston, Texas
Novartis Investigative SiteCamperdown, New South Wales
Novartis Investigative SiteChermside, Queensland
Novartis Investigative SiteLa Tronche
Novartis Investigative SiteCologne, North Rhine-Westphalia
Novartis Investigative SitePerugia, PG
Novartis Investigative SiteAviano, PN
Novartis Investigative SiteSingapore
Novartis Investigative SiteMálaga, Andalusia
Novartis Investigative SiteBarcelona, Catalonia
Novartis Investigative SiteAlicante, Valencia
Novartis Investigative SiteMadrid

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 28, 2022. Always confirm current availability with the study team.

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