NCT02949843

Targeted Therapy in Treating Patients With Incurable Non-Small Cell Lung Cancer With Genetic Mutations

Phase II Pilot Study Evaluating Strategies to Overcome Resistance at the Time of Progression for Patients With Non-small Cell Lung Cancers Harboring Major Oncogenic Drivers

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well targeted therapy works in treating patients with incurable non-small cell lung cancer with a genetic mutation. Giving drugs that target other genetic mutations or other specific proteins may work better when a patient has cancer caused by a driver mutation and the treatment that targets that mutation stops working.

Detailed description

PRIMARY OBJECTIVES: I. To estimate the objective response rate among patients with high PD-L1 expressing cancers after failure of targeted therapy. SECONDARY OBJECTIVES: I. To compare the overall survival for patients receiving treatment targeting primary mutations, secondary mutations, or immunotherapy at the time of progression on tyrosine kinase inhibitor therapy. II. To assess the incidence of secondary mutations in this population according to smoking status. III. To evaluate the response rates of patients treated using these different approaches. IV. To correlate outcomes with specific secondary genetic changes. OUTLINE: Patients are assigned to 1 of 3 treatment arms. ARM I (PD-L1 \>= 50%): Patients receive nivolumab intravenously (IV) over 60 minutes every 2 weeks or pembrolizumab IV every 3 weeks in the absence of disease progression or unacceptable toxicity. ARM II (PD-L1 \< 50% without secondary oncogenic driver): Patients receive tyrosine kinase inhibitor therapy orally (PO) targeting the initial oncogenic driver or other treatment for about 3 weeks. ARM III (PD-L1 \< 50% with secondary oncogenic driver): Patients receive tyrosine kinase inhibitor therapy PO targeting initial oncogenic driver, a drug targeting the secondary mutation, or other treatment for about 3 weeks. After completion of study treatment, patients are followed up for a minimum of 30 days.

Conditions

• EGFR Activating Mutation
• Recurrent Non-Small Cell Lung Carcinoma
• Stage IV Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Chemotherapy	Receive other treatment
BIOLOGICAL	Immunotherapy	Receive other treatment
OTHER	Laboratory Biomarker Analysis	Correlative studies
BIOLOGICAL	Nivolumab	Given IV
BIOLOGICAL	Pembrolizumab	Given IV
DRUG	Targeted Molecular Therapy	Receive drug targeting secondary mutation
DRUG	Tyrosine Kinase Inhibitor	Given PO

Timeline

• Start date: 2017-03-10
• Primary completion: 2018-01-08
• Completion: 2021-01-12
• First posted: 2016-10-31
• Last updated: 2024-06-28
• Results posted: 2024-06-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study