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
You may not be if
Prior exposure to immunotherapy or chemotherapy
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
Clareo Health | Pembrolizumab, Lenvatinib and Chemotherapy After TKIs in NSCLC
