RecruitingPhase 2NCT05613413

A Pilot Phase II Study of Maintenance Cabozantinib Plus Pembrolizumab for Patients With Metastatic Squamous Non-Small Cell Lung Cancer (sqNSCLC)

LUNG-IST-127: A Pilot Phase II Study of Maintenance Cabozantinib Plus Pembrolizumab (CP) for Patients With Metastatic sqNSCLC With Disease Control Following Induction Therapy

Sponsor

University of Illinois at Chicago

Enrollment

36 participants

Start Date

Dec 28, 2022

Study Type

INTERVENTIONAL

Conditions

Metastatic Squamous Non-Small Cell Lung Carcinoma

Summary

This is a phase II study to assess the efficacy, safety, and Health Related Quality of Life (HRQoL) of combination cabozantinib and pembrolizumab as maintenance therapy for patients with metastatic squamous Non Small Cell Lung Cancer(sqNSCLC) who have received 4 cycles of induction therapy with pembrolizumab, carboplatin, and nab-paclitaxel or paclitaxel.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two cancer drugs — cabozantinib and pembrolizumab — as a maintenance treatment for people with advanced squamous non-small cell lung cancer (a type of lung cancer) after their initial chemotherapy keeps the disease stable or shrinking. **You may be eligible if...** - You are 18 or older with stage IV squamous non-small cell lung cancer - Your cancer has been confirmed by a biopsy or lab test - Your cancer did not get worse during initial (induction) chemotherapy - Your tumor has been tested for a protein called PD-L1 - Your blood counts, liver, and kidney function are within acceptable ranges - You have not previously been treated with cabozantinib **You may NOT be eligible if...** - You are pregnant, breastfeeding, or currently have an active serious infection - Your cancer has specific genetic mutations that have approved targeted therapies (such as EGFR, ALK, ROS1, or others) - You have had a stroke, heart attack, or blood clot in the last 6 months - You have uncontrolled high blood pressure or serious heart problems - You have an active autoimmune disease or immune deficiency (such as HIV) - You cannot swallow tablets - You have brain metastases that are not stable Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPacliltaxel or Nab-paclitaxel

Individuals will receive either paclitaxel or nab-paclitaxel as part of their induction treatment. Paclitaxel will be administered as a 200 mg/m2 IV infusion on Day 1 of Cycles 1-4 (1 cycle = 21 days). Nab-paclitaxel will be administered as a 100 mg/m2 IV infusion on Days 1, 8, and 15 of Cycles 1-4 (1 cycles = 21 days)

DRUGCarboplatin or Cisplatin

Individuals will receive either paclitaxel or nab-paclitaxel as part of their induction treatment. Carboplatin will be administered as an AUC6 IV infusion on Day 1 of Cycles 1-4 (1 cycle = 21 days). Cisplatin will be administered as a 75 mg/m2 IV infusion on Day 1 of Cycles 1-4 (1 cycle = 21 days).

DRUGPembrolizumab

For the induction phase, pembrolizumab will be given as a 200 mg IV infusion on Day 1 of Cycles 1-4 of Induction (1 cycle = 21 days). For the maintenance phase, pembrolizumab will be given as a 200 mg IV infusion on Day 1 of each cycle (1 cycle = 21 days).

DRUGCabozantinib

For the maintenance phase, cabozantinib will be given at 40 mg orally each day for Days 1-21 of each cycle of maintenance (1 cycle = 21 days)

Locations(1)

Ryan Nguyen

Chicago, Illinois, United States

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NCT05613413

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