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

Dr Joanne CHIU1 site in 1 country46 target enrollmentOctober 5, 2021

ConditionsNsclc EGFR Activating Mutation EGF-R Positive Non-Small Cell Lung Cancer ALK Gene Rearrangement Positive ROS1 Gene Rearrangement ROS1 Positive NSCLC - Reactive Oxygen Species 1 Positive Non-Small Cell Lung Cancer

InterventionsPembrolizumab Lenvatinib Pemetrexed Carboplatin

Overview

Phase: Phase 2
Intervention: Pembrolizumab
Conditions: Nsclc
Sponsor: Dr Joanne CHIU
Enrollment: 46
Locations: 1
Primary Endpoint: Overall response rate
Status: Recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

October 5, 2021

End Date

December 2024

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Dr Joanne CHIU

Responsible Party

Sponsor Investigator

Principal Investigator

Dr Joanne CHIU

Assistant Professor

The University of Hong Kong

Eligibility Criteria

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

Arms & Interventions

Treatment

Intervention: Pembrolizumab

Treatment

Intervention: Lenvatinib

Treatment

Intervention: Pemetrexed

Treatment

Intervention: Carboplatin

Outcomes

Primary Outcomes

Overall response rate

Time Frame: 24 months

Proportion of patients who have a confirmed CR or PR per RECIST 1.1

Secondary Outcomes

The incidence, severity as graded by NCI CTCAE v5.0, seriousness and relationship to study medication of adverse events (AEs)(24 months)
Overall survival(36 months)
Progression-free survival(24 months)