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UNKNOWNPHASE2

Pembrolizumab, Lenvatinib and Chemotherapy After TKIs in NSCLC

A Phase 2 Open-label Single-arm Study to Evaluate the Combination of Pembrolizumab, Lenvatinib and Chemotherapy in Non-small Cell Lung Cancer (NSCLC) Harbouring Targetable Mutation and Failed Standard Tyrosine Kinase Inhibitors

NCT04989322•Dr Joanne CHIU

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

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
+5 more criteria

Locations (1)

Queen Mary Hospital

Hong Kong, Hong Kong

Key Dates

Start Date

October 5, 2021

Primary Completion Date

August 1, 2024

Completion Date

December 1, 2024

Last Updated

December 8, 2021

Enrollment

ESTIMATED participants

Conditions

NsclcEGFR Activating MutationEGF-R Positive Non-Small Cell Lung CancerALK Gene Rearrangement PositiveROS1 Gene RearrangementROS1 Positive NSCLC - Reactive Oxygen Species 1 Positive Non-Small Cell Lung Cancer

Interventions

Pembrolizumab

DRUG

Lenvatinib

DRUG

Pemetrexed

DRUG

Carboplatin

DRUG

Contacts

Dr Joanne Chiu, MBBS

CONTACT

+852-22553111 jwychiu@hku.hk

Dr James Ho, MBBS

CONTACT

+852-22553111 jhocm@hku.hk

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RECRUITING

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RECRUITINGPHASE1/PHASE2

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 8, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Pembrolizumab, Lenvatinib and Chemotherapy After TKIs in NSCLC

Inclusion Criteria

Exclusion Criteria

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

Magnetic Resonance Imaging of the Lung: Oncological Applications

Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers

Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

Delayed or Upfront Brain RAdiotherapy in Treatment naïve Lung Cancer Patients With Asymptomatic or Minimally Symptomatic Brain Metastases and ALK rEarrangements