Pembrolizumab, Lenvatinib and Chemotherapy After TKIs in NSCLC

Dr Joanne CHIU

Status and phase

Enrolling

Phase 2

Conditions

EGFR Activating Mutation

ALK Gene Rearrangement Positive

Nsclc

ROS1 Positive NSCLC - Reactive Oxygen Species 1 Positive Non-Small Cell Lung Cancer

ROS1 Gene Rearrangement

EGF-R Positive Non-Small Cell Lung Cancer

Treatments

Drug: Lenvatinib

Drug: Carboplatin

Drug: Pemetrexed

Drug: Pembrolizumab

Study type

Interventional

Funder types

Other

Identifiers

NCT04989322

MK-3475-C50 (Other Identifier)

475-0708-MT-Lung

Details and patient eligibility

About

Adding chemotherapy or anti-VEGF to immunotherapy is an emerging strategy to enhance the efficacy of immunotherapy in many cancers. This phase 2 study aims to explore the preliminary efficacy of combination pembrolizumab with lenvatinib and chemotherapy in NSCLC patients with sensitizing EGFR, ALK, or ROS1 genetic aberration refractory to standard targeted therapy.

Enrollment

46 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

Histologically proven NSCLC
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

Main Exclusion Criteria:

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