For Healthcare Professionals

Clinical Study of Oral cMET Inhibitor INC280 in Adult Patients With EGFR Wild-type Advanced Non-small Cell Lung Cancer (Geometry Mono-1)

clipboard-pencil

About the study

A phase II study to evaluate antitumor activity of oral cMET inhibitor INC280 in adult patients with EGFR wild-type, advanced non-small cell lung cancer (NSCLC) as measured by overall response rate (ORR). The study will also evaluate safety and pharmacokinetics of INC280.
user-3

Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. Stage IIIB or IV NSCLC (any histology) at the time of study entry
  2. Histologically or cytologically confirmed diagnosis of NSCLC that is:
  3. EGFR wt as per patient standard of care by a validated test
  4. AND ALK-negative rearrangement as part of the patient standard of care by a validated test
  5. AND (by central assessment) either:
  6. Cohort 1: Pre-treated patients with cMET GCN ≥ 6 or
  7. Cohort 2: Pre-treated patients with cMET GCN ≥4 and < 6, or
  8. Cohort 3: Pre-treated patients with cMET GCN < 4, or
  9. Cohort 4: Pre-treated patients with cMET mutations regardless of cMET GCN, or
  10. Cohort 5: Treatment-naïve patients with cMET dysregulation, or
  11. Cohort 6: Pre-treated patients with either cMET GCN ≥ 10 without cMET mutations or cMET mutations regardless of cMET GCN, or
  12. Cohort 7: Treatment-naïve patients with cMET mutations regardless of cMET GCN
  13. To be eligible for Cohorts 1-4, patients must have failed one or two prior lines of systemic therapy for advanced/metastatic disease
  14. To be eligible for Cohort 6, patients must have failed one prior line of systemic therapy for advanced/metastatic disease
  15. To be eligible for Cohort 5 and Cohort 7, patients must not have received any systemic therapy for advanced/metastatic disease
  16. At least one measurable lesion as defined by RECIST 1.1
  17. Patients must have recovered from all toxicities related to prior anticancer therapies to grade ≤ 1 (CTCAE v 4.03). Patients with any grade of alopecia are allowed to enter the study.
  18. Patients must have adequate organ function
  19. ECOG performance status (PS) of 0 or 1 Details and other protocol-defined inclusion criteria may apply

EXCLUSION CRITERIA

  1. Prior treatment with crizotinib, or any other cMET or HGF inhibitor
  2. Patients with characterized EGFR mutations that predict sensitivity to EGFR therapy, including, but not limited to exon 19 deletions and exon 21 mutations
  3. Patients with characterized ALK-positive rearrangement
  4. Clinically significant, uncontrolled heart diseases.
  5. Patients receiving treatment with medications that cannot be discontinued at least 1 week prior to first INC280 treatment and for the duration of the study:
  6. Strong inducers of CYP3A4
  7. Impairment of GI function or GI disease that may significantly alter the absorption of INC280
  8. Patients receiving treatment with any enzyme-inducing anticonvulsant
  9. Applicable to Cohorts 1-4 and Cohort 6 only: Previous anti-cancer and investigational agents within 4 weeks or ≤ 5 x half-life of the agent (whichever is longer) before first dose
  10. Pregnant or nursing women
  11. Women of child-bearing potential, unless they are using highly effective methods of contraception
  12. Sexually active males unless they use a condom during intercourse
  13. Presence or history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis Other protocol-defined exclusion criteria may apply
pin location

Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 1-888-669-6682Email iconEmail Study Center

Study’s details


Contition

Carcinoma, Non-Small-Cell Lung

Age (in years)

18 - 200

Phase

Phase 2

Participants needed

373

Est. Completion Date

May 2023

Treatment type

Interventional


Sponsor

Novartis

ClinicalTrials.gov identifier

NCT02414139

Study number

CINC280A2201

Understanding Clinical Trials


Get answers to your questions about clinical trials.What is a clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?
Vector

Interested?

Sign up to save your favorites, 
receive newsletters, resources, and alerts 
about clinical trials related to your conditions of interest.