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Phase II Study of Cabozantinib Plus Pembrolizumab for Metastatic Squamous Non-Small Cell Lung Cancer

This study is looking at a new treatment approach for metastatic squamous non-small cell lung cancer (sqNSCLC). It combines two drugs, cabozantinib and pembrolizumab, as a maintenance therapy after initial chemotherapy. You might be able to join if you are 18 or older, have metastatic sqNSCLC, and have responded well to initial chemotherapy (paclitaxel or nab-paclitaxel, plus carboplatin or cisplatin, and pembrolizumab). The main goal is to see how long people live without their cancer getting worse (progression-free survival), measured for up to 24 months. The study also looks at safety and quality of life. The current status of the study is unclear.

Study design
This is a Phase II interventional study planning to enroll 36 participants. It is testing a combination of cabozantinib and pembrolizumab as maintenance therapy.
What's involved
Participants will receive initial chemotherapy for 4 cycles, followed by daily oral cabozantinib and intravenous pembrolizumab every 21 days during the maintenance phase.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for progression-free survival for up to 24 months after starting treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05613413

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Illinois at Chicago
~36 participants
Updated 2026-01-08 on ClinicalTrials.gov
What's tested:Pacliltaxel or Nab-paclitaxelCarboplatin or CisplatinPembrolizumabCabozantinib

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To estimate the median progression-free survival (PFS) of individuals with metastatic squamous non-small cell lung cancer (sqNSCLC)
Measured over Up to 24 months post-Cycle 1 Day 1 of induction (1 cycle = 21 days)

Conditions

Metastatic Squamous Non-Small Cell Lung Carcinoma

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NCT05613413

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Ryan Nguyen

    Chicago, Illinoisstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Ryan Nguyen, DO
[email protected]
312-996-1581
Email the study team

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Eligibility criteria

Inclusion

Absolute Neutrophil Count (ANC): ≥ 1,500/uL without the support of Filgrastim or ≥ 1,000/L in subjects with constitutional neutropenia
Hemoglobin (Hgb): ≥ 9 g/dL
Platelets (Plt): ≥ 100,000/µL without transfusion.
Serum creatinine: ≤ 1.5 mg/dL
Calculated creatine clearance: ≥ 40 mL/min; for subjects with serum creatinine \> 1.5 mg/dL
Urine protein/creatinine ratio (UPCR): ≤ 1 mg/mg (≤ 113.2 mg/mmol), or 24-h urine protein ≤ 1 g
Total Bilirubin or Direct Bilirubin: ≤ 1.5 × upper limit of normal (ULN) or ≤ 3 × ULN for subjects with Gilbert's disease, ≤ ULN for subjects with total bilirubin levels \> 1.5 x ULN
Aspartate aminotransferase (AST): ≤ 3 × ULN or ≤ 5 x ULN for subjects with known hepatic metastasis
Alanine aminotransferase (ALT): ≤ 3 × ULN or ≤ 5 x ULN for subjects with known hepatic metastasis
Alkaline phosphatase (ALP): ≤ 3 × ULN or ≤ 5 x ULN with documented bone metastases.
Serum albumin: ≥ 2.8 g/dl
International Normalized Ratio (INR) : ≤ 1.3 × ULN; For subjects receiving warfarin or LMWH, the subjects must, in the site investigator's opinion, be clinically stable with no evidence of active bleeding while receiving anticoagulant therapy. The INR for these subjects may exceed 1.3 × ULN if that is the goal of anticoagulant therapy. 9. Recovery to baseline or ≤ Grade 1 CTCAE v5.0 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy. 10. Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception (e.g., barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 4 months after the last dose of cabozantinib and 4 months after the last dose of pembrolizumab. 11. Females of childbearing potential must have a negative serum pregnancy test within 3 days prior to registration. Female subjects of childbearing potential must not be pregnant at screening. Female subjects are considered to be of childbearing potential unless one of the following criteria is met: documented permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman \> 45 years-of-age in the absence of other biological or physiological causes. In addition, females \< 55 years-of-age must have a serum follicle stimulating (FSH) level \> 40 mIU/mL to confirm menopause). Note: Documentation may include review of medical records, medical examinations, or medical history interview by study site. 12. As determined by the enrolling physician or protocol designee, subjects should be capable of understanding and complying with the protocol requirements and must have signed the informed consent document. 13. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Exclusion

iv. Subjects with a diagnosis of incidental, subsegmental PE or DVT within 6 months are allowed if stable, asymptomatic, and treated with a stable dose of permitted anticoagulation for at least 1 week before first dose of study treatment. 2. Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation:
vi. Any condition requiring systemic treatment with either steroid therapy (\>10 mg daily prednisone equivalent) or any other form of immunosuppressive therapy within 2 weeks prior to first dose of study treatment. Note: Inhaled, intranasal, intra-articular, or topical steroids are permitted. Adrenal replacement steroid doses \> 10 mg daily prednisone equivalent are permitted. Transient short-term use of systemic corticosteroids for allergic conditions (e.g., contrast allergy) is also allowed.
a. Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH).
b. Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban in subjects without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor.

What this trial measures

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

    To estimate the median progression-free survival (PFS) of metastatic squamous non-small cell lung cancer (sqNSCLC) treated with maintenance cabozantinib in combination with pembrolizumab with disease control (defined as complete response, partial response, or stable disease) following standard first-line induction therapy with chemotherapy with pembrolizumab.