Pembrolizumab, Lenvatinib and Chemotherapy After TKIs in NSCLC
NCT ID: NCT04989322
Last Updated: 2021-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
46 participants
INTERVENTIONAL
2021-10-05
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment
Pembrolizumab
200 mg Q3W
Lenvatinib
8 mg daily
Pemetrexed
500 mg/m2 Q3W
Carboplatin
AUC5 Q3W
Interventions
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Pembrolizumab
200 mg Q3W
Lenvatinib
8 mg daily
Pemetrexed
500 mg/m2 Q3W
Carboplatin
AUC5 Q3W
Eligibility Criteria
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Inclusion Criteria
* Unresectable or metastatic NSCLC, including squamous cell carcinoma, harboring sensitizing EGFR, ALK, or ROS1 genetic aberrations who have received standard of care targeted therapy and have progressed on treatment. Patients with known T790M mutation should have received osimertinib and failed.
* Measurable disease per RECIST 1.1
* ECOG performance status ≤ 1
* Adequate organ function
* Adequately controlled blood pressure
Exclusion Criteria
* Active untreated brain metastasis and/or carcinomatous meningitis
* Active, known or suspected autoimmune disease
* History of (noninfectious) pneumonitis that required systemic steroids or current pneumonitis/interstitial lung disease
* Condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications
* Baseline proteinuria ≥ 1 g/24 hrs
* Electrolyte abnormalities that have not been corrected
* Significant cardiovascular impairment
* Gastrointestinal pathology that might affect the absorption of lenvatinib
* Preexisting grade ≥ 3 gastrointestinal or non gastrointestinal fistula
* Bleeding or thrombotic disorders or subjects at risk for severe hemorrhage
* Radiographic evidence of intratumoral caviations, encasement, or invasion of a major blood vessel
* Known history of tuberculosis
* Active, acute, or chronic clinically significant infections requiring therapy, including hepatitis B, hepatitis C, and HIV
* ECG with long QTc interval ≥ 470 ms
18 Years
ALL
No
Sponsors
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Dr Joanne CHIU
OTHER
Responsible Party
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Dr Joanne CHIU
Assistant Professor
Locations
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Queen Mary Hospital
Hong Kong, , Hong Kong
Countries
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Central Contacts
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Other Identifiers
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MK-3475-C50
Identifier Type: OTHER
Identifier Source: secondary_id
475-0708-MT-Lung
Identifier Type: -
Identifier Source: org_study_id