NCT05613413 A Pilot Phase II Study of Maintenance Cabozantinib Plus Pembrolizumab for Patients With Metastatic Squamous Non-Small Cell Lung Cancer (sqNSCLC)
| NCT ID | NCT05613413 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Illinois at Chicago |
| Condition | Metastatic Squamous Non-Small Cell Lung Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2022-12-28 |
| Primary Completion | 2028-09 |
Trial Parameters
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Brief 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 Criteria
Inclusion Criteria: 1. Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately. 2. Age ≥ 18 years at the time of consent. 3. ECOG Performance Status of 0, 1, or 2 within 28 days prior to registration 4. Life expectancy of 6 months or greater as determined by the site investigator. 5. Subjects with histologically or cytologically confirmed squamous non-small cell lung cancer (sqNSCLC). 6. Subjects with stage IV NSCLC as defined by American Joint Committee on Cancer (AJCC) 8th Edition who have not received prior therapy for stage IV NSCLC. Patients with locally advanced or recurrent disease who are candidates for first-line induction systemic therapies for stage IV NSCLC are also allowed. • Only patients with disease control, defined as complete response (CR), partial response (PR), or stable disease (SD) to induction therapy will be allowed