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

A Phase II, Multicenter, Open-label Study of EGF816 in Combination With Nivolumab in Adult Patients With EGFR Mutated Non-small Cell Lung Cancer and of INC280 in Combination With Nivolumab in Adult Patients With cMet Positive Non-small Cell Lung Cancer

ClinicalTrials.gov Identifier: NCT02323126

Novartis Reference Number: CEGF816X2201C

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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

Condition 
Non Small Cell Lung Cancer
Phase 
Phase 2
Overall status 
Active, not recruiting
Enrollment count 
64 participants
Start date 
Feb 09, 2015
Completion date 
Dec 31, 2021
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
EGF816
Drug
INC280
Drug
Nivolumab

Eligibility Criteria

Inclusion 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).

Exclusion 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 must have no 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 with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity

Prior therapy:

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.

Other protocol-related inclusion/exclusion criteria may apply.

Study Locations

United States
University of Texas MD Anderson Cancer Center Thoractic Head/Neck Med.Onc(2)
-
Houston, 77030
Texas
United States
Australia
Novartis Investigative Site
-
Camperdown, 2050
New South Wales
Australia
Novartis Investigative Site
-
Chermside, 4032
Queensland
Australia
France
Novartis Investigative Site
-
La Tronche, 38700
-
France
Germany
Novartis Investigative Site
-
Koeln, 50937
Nordrhein-Westfalen
Germany
Italy
Novartis Investigative Site
-
Perugia, 06129
PG
Italy
Novartis Investigative Site
-
Aviano, 33081
PN
Italy
Netherlands
NKI-AVL, Department of Thoracic-Oncology
-
Amsterdam, 1066 CX
-
Netherlands
Singapore
Novartis Investigative Site
-
Singapore, 169610
-
Singapore
Spain
Novartis Investigative Site
-
Malaga, 29010
Andalucia
Spain
Novartis Investigative Site
-
Barcelona, 08035
Catalunya
Spain
Novartis Investigative Site
-
Alicante, 03010
Comunidad Valenciana
Spain
Novartis Investigative Site
-
Madrid, 28040
-
Spain
Switzerland
Novartis Investigative Site
-
Chur, 7000
-
Switzerland

Have a question?

Call 1-999-669-6682 or email [email protected]