For Healthcare Professionals

Study of Capmatinib and Spartalizumab/Placebo in Advanced NSCLC Patients With MET Exon 14 Skipping Mutations

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About the study

A double-blind, placebo controlled, randomized, phase II study evaluating the efficacy and safety of capmatinib (INC280) and spartalizumab (PDR001) combination therapy versus capmatinib and placebo as first line treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with MET exon 14 skipping (METΔex14) mutations
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Who can take part

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

INCLUSION CRITERIA

  1. Histologically confirmed locally advanced or metastatic NSCLC which is EGFR wild-type, ALK rearrangement negative and METΔex14 mutated
  2. No prior systemic therapy for advanced/metastatic disease (neo-adjuvant/adjuvant treatment completed > 12 months before relapse are permitted)
  3. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
  4. Measurable disease as per RECIST 1.1
  5. Known PD-L1 tumor expression status (applicable to Randomized part 2 only) Key

EXCLUSION CRITERIA

  1. Prior treatment with a PD-1/PD-L1 inhibitor, MET inhibitor or HGF inhibitor
  2. Presence of symptomatic CNS metastases or requiring local CNS-directed therapy (radiotherapy or surgery), or increasing doses of corticosteroids 2 weeks prior to study entry
  3. Impaired cardiac function or clinically significant cardiac disease
  4. Presence or history of interstitial lung disease, non-infectious pneumonitis or interstitial pneumonitis, including clinically significant radiation pneumonitis
  5. History of allogenic bone marrow or solid organ transplant
  6. Radiotherapy to lung fields ≤ 4 weeks or to any other anatomic site ≤ 2 weeks prior to start of study treatment (palliative radiotherapy for bone lesions is allowed) Other inclusion and exclusion criteras may apply
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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

18+

Phase

Phase 2

Participants needed

31

Est. Completion Date

Jan 2023

Treatment type

Interventional


Sponsor

Novartis

ClinicalTrials.gov identifier

NCT04323436

Study number

CINC280J12201

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