Clinical trial · Interventional
Study of Capmatinib and Spartalizumab/Placebo in Advanced NSCLC Patients With MET Exon 14 Skipping Mutations
A Double-blind, Placebo Controlled, Randomized, Phase II Study Evaluating the Efficacy and Safety of Capmatinib and Spartalizumab vs Capmatinib and Placebo as 1st Line Treatment for Advanced NSCLC Patients With MET exon14 Skipping Mutations
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study termination based on sponsor decision due to lack of tolerability observed with capmatinib and spartalizumab combination treatment when compared to data from capmatinib single agent studies
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capmatinib | Drug | Capmatinib | ALIAS |
| Spartalizumab | Drug | — | UNRESOLVED |
| spartalizumab placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Run-in part
- description
- capmatinib in combination with spartalizumab
- interventionNames
- Drug: Spartalizumab
- Drug: Capmatinib
- type
- EXPERIMENTAL
- label
- Randomized part - Arm 1 spartalizumab
- description
- capmatinib in combination with spartalizumab
- interventionNames
- Drug: Spartalizumab
- Drug: Capmatinib
- type
- EXPERIMENTAL
- label
- Randomized part - Arm 2 placebo
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * 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 Exclusion 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)
References
Publications (0)
Data not yet available