Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Carcinoma

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

All subjects will receive carbozantinib 40mg PO once daily Days 1-21 Q3W and pembrolizumab 200mg IV infusion Q3W or 400mg IV infusion Q6W per the treating physician's discretion as maintenance therapy following 4 cycles of induction therapy with disease control

Note: Cabozantinib should be stopped at least 3 weeks prior to elective surgery. Do not administer cabozantinib for at least 2 weeks after major surgery and until complete wound healing.

Cabozantinib 40 MG

Pembrolizumab 200mg

Pembrolizumab 400mg

Ryan Nguyen, DO

Arielle Guzman, MPH

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

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.

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

PFS is defined as the time from initiation of induction treatment until the criteria for disease progression is met as defined by irRECIST1.1 or death as a result of any cause for patients with disease control (defined as complete response (CR), partial response (PR), or stable disease) following induction therapy who proceed to maintenance therapy with cabozantinib in combination with pembrolizumab

Number of subjects achieving ORR using RECIST v1.1 with disease control following standard first-line induction therapy who received cabozantinib in combination with pembrolizumab as maintenance thherapy

Number of subjects having a high score, which means a poorer quality of life

Number of subjects having a low score, which means a better quality of life

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Pilot Phase II Study of Maintenance Cabozantinib Plus Pembrolizumab for Patients With Metastatic Squamous Non-Small Cell Lung Cancer (sqNSCLC)	NCT05613413	Metastatic Squa...	Cabozantinib 40... Pembrolizumab 2... Pembrolizumab 4...	18 Years -	University of Illinois at Chicago
A Pilot Phase II Study of Maintenance Cabozantinib Plus Pembrolizumab for Patients With Metastatic Squamous Non-Small Cell Lung Cancer (sqNSCLC)	NCT05613413	Metastatic Squa...	Cabozantinib 40... Pembrolizumab 2... Pembrolizumab 4...	18 Years -	University of Illinois at Chicago

Spots Global Cancer Trial Database for pembrolizumab 400mg