NCT05613413

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: University of Illinois at Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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 sqNSCLC who have received 4 cycles of induction therapy with pembrolizumab, carboplatin, and nab-paclitaxel or paclitaxel and achieved disease control following induction therapy defined as complete response, partial response, or stable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1 criteria. Subjects with disease control would proceed to maintenance therapy with pembrolizumab and cabozantinib.

Conditions

• Metastatic Squamous Non-Small Cell Lung Carcinoma

Interventions

Type	Name	Description
DRUG	Pacliltaxel 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)
DRUG	Carboplatin 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).
DRUG	Pembrolizumab	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).
DRUG	Cabozantinib	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)

Timeline

• Start date: 2022-12-28
• Primary completion: 2028-09-01
• Completion: 2028-09-01
• First posted: 2022-11-14
• Last updated: 2026-01-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study