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

Study summary

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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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedSpartalizumab and Capmatinib

Plus 1 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · MET · Locally advanced

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 9, 2024 · 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?15 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: Spartalizumab; Drug: Capmatinib; Drug: spartalizumab placebo

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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)→

Disease setting

Locally advanced→Metastatic or stage IV→

Biomarkers

MET→

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

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

Reasons someone may not be able to joinExclusion criteria

Prior treatment with a PD-1/PD-L1 inhibitor, MET inhibitor or HGF inhibitor
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
Impaired cardiac function or clinically significant cardiac disease
Presence or history of interstitial lung disease, non-infectious pneumonitis or interstitial pneumonitis, including clinically significant radiation pneumonitis
History of allogenic bone marrow or solid organ transplant
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)

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

Massachusetts General Hospital Liver and Kidney TXBoston, Massachusetts
Novartis Investigative SiteLeuven
Novartis Investigative SiteMontreal, Quebec
Novartis Investigative SiteLille
Novartis Investigative SiteParis
Novartis Investigative SitePierre-Bénite
Novartis Investigative SiteBerlin
Novartis Investigative SiteCologne
Novartis Investigative SiteGerlingen
Novartis Investigative SiteTübingen
Novartis Investigative SiteBologna, BO
Novartis Investigative SiteŌsaka-sayama, Osaka

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 9, 2024. Always confirm current availability with the study team.

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