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Checkpoint Inhibitor

Nivolumab + Vorolanib for Lung Cancer

Phase 1 & 2

Waitlist Available

Led By Leora Horn, MD

Research Sponsored by Vanderbilt-Ingram Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Having progressed on at least one prior line of therapy, or refused chemotherapy, histologically or cytologically confirmed diagnosis of specific cancer types

Men not azoospermic who are sexually active with women of childbearing potential must agree to follow instructions for acceptable contraception

Must not have

Significant cardiovascular disease or condition

Infection requiring parenteral antibiotics

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new combination treatment for lung cancer patients who have not responded to other treatments.

Who is the study for?

Adults with certain thoracic tumors, including various types of lung cancer and thymic carcinoma, who have previously undergone treatment or refused chemotherapy. Participants must not be pregnant or breastfeeding, agree to use contraception if applicable, have at least one measurable lesion, good organ function, and a performance status indicating they are fully active or restricted in physically strenuous activity but ambulatory.

What is being tested?

The trial is testing the combination of oral Vorolanib and infusional Nivolumab in patients with different stages of lung cancer and thymic carcinoma. It's an open-label study where everyone knows what treatment they're getting; it includes dose escalation to find the right amount followed by expansion to see how well it works.

What are the potential side effects?

Potential side effects may include immune-related reactions due to Nivolumab affecting organs like lungs (pneumonitis), liver (hepatitis), intestines (colitis), hormone glands (endocrinopathies) as well as skin rash and infusion-related reactions. Vorolanib could cause high blood pressure, diarrhea, fatigue among other symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has worsened after treatment or I refused chemotherapy.

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I am a man who can father children and will use birth control.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a serious heart condition.

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I am currently on IV antibiotics for an infection.

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I have wounds that are not healing.

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I am not taking any strong CYP3A4 inhibitors or inducers.

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I am allergic to certain cancer treatments I've had before.

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My brain metastasis is stable and doesn't cause symptoms.

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I do not have an active Hepatitis B or C infection.

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I have not had another type of cancer in the last 2 years.

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I do not have any serious or uncontrolled infections.

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I have active lung inflammation or scarring.

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I have had a fever over 38.0 ºC without a known cause.

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I cannot swallow pills or have a severe gut problem.

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I have had a condition where my lymphocytes grow abnormally.

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I am currently experiencing or at risk of significant bleeding.

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I have an autoimmune disease.

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I have had a solid tumor transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Disease Control Rate in Phase II. Best Response Per Response Evaluation Criteria in Solid Tumors (RECIST)

Duration of Response in Phase II.

Objective Response Rate in Phase II.

+3 more

Secondary study objectives

Disease control rate

Objective response rate as related to PD-L1 status measured as < 1%, 1-49%, and > 50%.

Progression-free survival

Other study objectives

Correlation Between Biomarkers and Response for Phase II Patients

Side effects data

From 2024 Phase 3 trial • 529 Patients • NCT02017717

80%

Fatigue

70%

Diarrhoea

70%

Headache

40%

Vomiting

40%

Aspartate aminotransferase increased

40%

Rash maculo-papular

40%

Alanine aminotransferase increased

40%

Lipase increased

30%

Partial seizures

30%

Hemiparesis

30%

Gait disturbance

30%

Fall

30%

Cough

30%

Dry skin

30%

Amylase increased

30%

Nausea

30%

Confusional state

20%

Malignant neoplasm progression

20%

Pyrexia

20%

Candida infection

20%

Mucosal infection

20%

Decreased appetite

20%

Back pain

20%

Dysphonia

20%

Hypotension

20%

Colitis

20%

Hyperthyroidism

20%

Oedema peripheral

20%

Muscular weakness

20%

Hypothyroidism

10%

Tinnitus

10%

Cushingoid

10%

Diabetic ketoacidosis

10%

Procedural haemorrhage

10%

Blood bilirubin increased

10%

Bradycardia

10%

Sinus tachycardia

10%

Hyperglycaemia

10%

Hypocalcaemia

10%

Neck pain

10%

Brain oedema

10%

Hydrocephalus

10%

Lethargy

10%

Seizure

10%

Hypertension

10%

Palpitations

10%

Cheilitis

10%

Presyncope

10%

Face oedema

10%

Oedema

10%

Conjunctivitis

10%

Enterocolitis infectious

10%

Oral candidiasis

10%

Pneumonia

10%

Sinusitis

10%

Staphylococcal infection

10%

Blood alkaline phosphatase increased

10%

Spinal pain

10%

Tremor

10%

Dizziness

10%

Dysarthria

10%

Urinary retention

10%

Dyspnoea exertional

10%

Nasal congestion

10%

Pneumonitis

10%

Dermatitis

10%

Erythema

10%

Rash

10%

Klebsiella infection

10%

Hypomagnesaemia

10%

Syncope

10%

Haemorrhage intracranial

10%

Pancreatitis

10%

Cholecystitis

10%

Upper respiratory tract infection

10%

Acute kidney injury

10%

Dermatitis bullous

10%

Lymphopenia

10%

Optic nerve disorder

10%

Visual impairment

10%

Dehydration

10%

Hypokalaemia

10%

Scoliosis

10%

Cognitive disorder

10%

Memory impairment

10%

Hallucination

10%

Insomnia

10%

Irritability

10%

Urinary incontinence

10%

Dyspnoea

10%

Dermatitis acneiform

10%

Pelvic venous thrombosis

10%

Sepsis

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 1: Arm N1+I3

Cohort 2: Arm B

Part A Cohort 1c: Arm N3+RT+TMZ

Part A Cohort 1d: Arm N3+RT

Part B Cohort 1c: Arm N3+RT+TMZ

Part B Cohort 1d: Arm N3+RT

Cohort 1: Arm N3

Cohort 1b: Arm N3+I1

Cohort 2: Arm N3

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups

Experimental Treatment

Group I: EscalationExperimental Treatment2 Interventions

Participants receive vorolanib PO QD on days 1-56 and nivolumab IV over 30 minutes every two weeks (i.e. on Days 1, 15, 29, and 43 of each 56-day cycle) for the first two treatment cycles. After which, the treatment schedule can change to every four weeks (i.e., on Days 1 and 29 of each 56-day cycle) if the patient is not exhibiting disease progression.

Group II: Dose Expansion - Thymic CarcinomaExperimental Treatment2 Interventions

Group III: Dose Expansion - Small Cell Lung Cancer - Progressed on Platinum-based ChemotherapyExperimental Treatment2 Interventions

Group IV: Dose Expansion - Non Small-Cell-Lung Cancer Primary RefractoryExperimental Treatment2 Interventions

Group V: Dose Expansion - Non Small-Cell-Lung Cancer NaiveExperimental Treatment2 Interventions

Group VI: Dose Expansion - Non Small-Cell-Lung Cancer Acquired ResistanceExperimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vorolanib

2018

Completed Phase 2