Status:
TERMINATED
Study Evaluating Efficacy and Safety of Capmatinib in Combination With Osimertinib in Adult Subjects With Non-small Cell Lung Cancers as Second Line Therapy
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study aimed to evaluate the anticancer activity of capmatinib in combination with osimertinib compared to platinum-pemetrexed based doublet chemotherapy as second line treatment in patients with ...
Detailed Description
This was a multicenter, open-label, randomized, active-controlled, global phase III study that enrolled adult participants with locally advanced or metastatic NSCLC with epidermal growth factor recept...
Eligibility Criteria
Inclusion
- Key
- Histologically or cytologically confirmed diagnosis of NSCLC with EGFR mutations known to be associated with EGFR TKI sensitivity, EGFR T790M negative and MET gene amplification
- Stage IIIB/IIIC or IV NSCLC
- Participants must have progressed on one prior line of therapy (1st/2nd generation EGFR TKIs, osimertinib or other third generation EGFR TKIs) for advanced/metastatic disease (stage IIIB/IIIC and must be candidates for platinum (cisplatin or carboplatin) - pemetrexed doublet based chemotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
- Participants must have recovered from all toxicities related to prior systemic therapy to grade ≤ 1 Common Terminology Criteria Adverse Event 5.0 (CTCAE v 5.0)
- At least one measurable lesion as defined by RECIST 1.1
- Participants must have adequate organ function
- Key
Exclusion
- Prior treatment with any MET inhibitor or HGF-targeting therapy
- Participants with symptomatic central nervous system (CNS) metastases who were neurologically unstable or had required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms
- Carcinomatous meningitis
- Presence or history of a malignant disease other than NSCLC that had been diagnosed and/or required therapy within the past 3 years
- Presence or history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis
- Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome
- Clinically significant, uncontrolled heart diseases
- known druggable molecular alterations that may render participants eligible for alternative targeted therapies
Key Trial Info
Start Date :
September 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 27 2022
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04816214
Start Date
September 22 2021
End Date
December 27 2022
Last Update
March 5 2024
Active Locations (4)
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1
Novartis Investigative Site
Kashiwa, Chiba, Japan, 277 8577
2
Novartis Investigative Site
Sunto Gun, Shizuoka, Japan, 411 8777
3
Novartis Investigative Site
Singapore, Singapore, 168583
4
Novartis Investigative Site
Seoul, South Korea, 05505