CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 18 enrolled
Drug / intervention
Capmatinib +2 moredrug
Likely dose
Capmatinib 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03647488
NCT03647488Phase 2Completed

Phase II Multicenter Randomized Two-arm Study of Capmatinib and Spartalizumab Combination Therapy vs Docetaxel in Pretreated Adult Patients With EGFR Wild-type ALK Rearrangement Negative Advanced/Metastatic Non-small Cell Lung Cancer

Novartis Pharmaceuticals·interventional·Posted Aug 27, 2018·Updated Jan 24, 2022

In Brief

A Phase 2 clinical trial evaluating Capmatinib, Spartalizumab, and 1 other intervention for Carcinoma, Non-Small-Cell Lung. Completed, enrolled 18 participants across 8 sites in 6 countries.

Detailed Summary

The purpose of this trial was to evaluate the safety and efficacy of capmatinib in combination with spartalizumab in adult participants with epidermal growth factor receptor (EGFR) wild type (for exon 19 deletions and exon 21 L858R substitution mutations), anaplastic lymphoma kinase (ALK) rearrangement negative in locally advanced (stage IIIB, not eligible for definitive chemo-radiation) or metastatic (stage IV) Non-small cell lung cancer (NSCLC) after failure of platinum doublet and checkpoint inhibitor treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, France, Germany, Israel, Spain, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedAug 27, 2018
Enrollment StartDec 26, 2018
Primary CompletionSep 7, 2020
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 7.8 years ago

Interventions

Capmatinibdrug

Capmatinib 400 mg (tablets) orally taken twice daily

Spartalizumabdrug

Spartalizumab 400 mg via intravenous infusion once every 28 days

Docetaxeldrug

Docetaxel 75mg/m2 i.v. following local guidelines as per standard of care and product labels once every 21 days