Study of Capmatinib and Spartalizumab Combination Therapy vs Docetaxel in Non-small Cell Lung Cancer

NCT03647488 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2022-01-24

Study results available
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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.

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

DRUG

Capmatinib

Capmatinib 400 mg (tablets) orally taken twice daily

DRUG

Spartalizumab

Spartalizumab 400 mg via intravenous infusion once every 28 days

DRUG

Docetaxel

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

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-26
Primary Completion
2020-09-07
Completion
2020-09-07
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • France
  • Germany
  • Israel
  • Spain

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03647488 on ClinicalTrials.gov