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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Illinois at Chicago
Study ID
NCT05613413
Phase
PHASE2
Status
Recruiting
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Conditions

  • Metastatic Squamous Non-Small Cell Lung Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pacliltaxel or Nab-paclitaxel — DRUG
    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)
  • Carboplatin or Cisplatin — DRUG
    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).
  • Pembrolizumab — DRUG
    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).
  • Cabozantinib — DRUG
    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)

Study Details

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.

Key Dates

Start date
Dec 28, 2022
Status verified
Jan 2026
Primary completion
Sep 30, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single
    All individuals will receive four cycles of induction therapy consisting of a combination of either carboplatin or cisplatin, nab-paclitaxel or paclitaxel, and pembrolizumab. Individuals' whose disease is stable or has decreased in size will proceed with maintenance therapy which will consist of pembrolizumab and cabozantinib.

Primary Outcome Measure

To estimate the median progression-free survival (PFS) of individuals with metastatic squamous non-small cell lung cancer (sqNSCLC) [ Time Frame: Up to 24 months post-Cycle 1 Day 1 of induction (1 cycle = 21 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ryan NguyenChicagoIllinois60612
Ryan Nguyen, DO
[email protected]
312-996-1581
Ruihong Yin, BSN
[email protected]
(312) 355-2545

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By research site
Ryan Nguyen· Chicago, IL

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