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Cytotoxic agent

Sitravatinib + Nivolumab for Advanced Non-Small Cell Lung Cancer (SAPPHIRE Trial)

Phase 3

Waitlist Available

Research Sponsored by Mirati Therapeutics Inc.

Eligibility Criteria Checklist

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

Must have

Prior treatment with PD-1/PD-L1 checkpoint inhibitor therapy and platinum-based chemotherapy in combination or in sequence (i.e., platinum-based chemotheraphy followed by checkpoint inhibitor therapy)

Most recent treatment regimen must have included a checkpoint inhibitor therapy with radiographic disease progression on or after treatment

Must not have

Receipt of systemic anti-cancer therapy post checkpoint inhibitor therapy, other than maintenance chemotherapy

Tumors that have tested positive for EGFR, ROS1, ALK mutations, or ALK fusions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization date to date of death due to any cause (up to approximately 44 months)

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial will compare the effectiveness of sitravatinib when given with nivolumab versus docetaxel in patients with advanced non-squamous NSCLC who have previously experienced disease progression after platinum-based chemotherapy and checkpoint inhibitor therapy.

Who is the study for?

This trial is for adults with advanced non-squamous NSCLC who've had disease progression after platinum-based chemo and checkpoint inhibitor therapy. They should have tried one or two treatments before, but not more, and can't have uncontrolled brain metastases or certain genetic mutations.

What is being tested?

The study tests sitravatinib combined with nivolumab against docetaxel in patients whose lung cancer worsened despite previous therapies. It aims to see if the new combination is more effective than the standard treatment of docetaxel alone.

What are the potential side effects?

Sitravatinib may cause high blood pressure, fatigue, nausea, while Nivolumab can lead to immune-related issues like inflammation of organs. Docetaxel commonly causes hair loss, low white blood cell count increasing infection risk, and mouth sores.

Eligibility Criteria

Inclusion Criteria

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

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I have been treated with both PD-1/PD-L1 inhibitors and platinum-based chemotherapy.

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My cancer progressed after treatment with a checkpoint inhibitor.

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I've had 1 or 2 treatments for my advanced illness.

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I've had treatments with PD-1/PD-L1 inhibitors and platinum-based chemotherapy.

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I am eligible for docetaxel as my second or third treatment option.

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I have been diagnosed with non-squamous non-small cell lung cancer.

Exclusion Criteria

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

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I've had cancer treatment after immunotherapy, not including maintenance chemo.

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My tumor is positive for EGFR, ROS1, ALK mutations, or ALK fusions.

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I have brain metastases that are not currently under control.

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I had severe side effects from previous immunotherapy.

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My heart doesn't work as well as it should.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization date to date of death due to any cause (up to approximately 44 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization date to date of death due to any cause (up to approximately 44 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization date to date of death due to any cause (up to approximately 44 months) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Overall Survival (OS)

Secondary study objectives

1-Year Survival Rate

Change From Baseline in the European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L) - Health Utility Index (HUI)

Change From Baseline in the European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L) - Visual Analogue Score (VAS)

+9 more

Side effects data

From 2022 Phase 1 & 2 trial • 42 Patients • NCT03015740

87%

Anemia

87%

Hyperglycemia

87%

Hypertriglyceridemia

80%

Investigations - Other, specify

80%

Creatinine increased

80%

Weight loss

80%

Fatigue

73%

Diarrhea

73%

Anorexia

73%

Lipase increased

67%

Lymphocyte count decreased

67%

Serum amylase increased

67%

Proteinuria

67%

Cough

60%

Hypertension

53%

Abdominal pain

53%

Constipation

53%

Nausea

47%

Cholesterol high

47%

Vomiting

47%

Alanine aminotransferase increased

47%

Hyperkalemia

47%

Hoarseness

47%

Rash acneiform

47%

Back pain

40%

Pain

40%

Aspartate aminotransferase increased

40%

Hypoalbuminemia

40%

Dyspnea

40%

Mucositis oral

40%

Arthralgia

40%

Myalgia

33%

Metabolism and nutrition disorders - Other, specify

33%

Hyponatremia

33%

Hypophosphatemia

33%

INR increased

33%

Dizziness

33%

Headache

33%

Edema Limbs

33%

Activated partial thromboplastin time prolonged

33%

Alkaline phosphatase increased

33%

Hypomagnesemia

33%

Insomnia

33%

Postnasal drip

33%

Endocrine disorders - Other, specify

27%

Sinusitis

27%

Hypothyroidism

27%

Rash maculo-papular

27%

Skin and subcutaneous tissue disorders - Other, specify

27%

Hypocalcemia

20%

Allergic rhinitis

20%

Urinary frequency

20%

Anxiety

20%

Nasal congestion

20%

Wheezing

20%

Fever

20%

Bruising

20%

Dry skin

13%

Hypoglycemia

13%

Pruritus

13%

Non-cardiac chest pain

13%

Productive cough

13%

Flu like symptoms

13%

White blood cell decreased

13%

Ear pain

13%

Surgical and medical procedures - Other, specify

13%

Generalized muscle weakness

13%

Hypernatremia

13%

Vertigo

13%

Gastrointestinal disorders - Other, specify

13%

Pancreatitis

13%

Chills

13%

Cardiac disorders - Other, specify

13%

Blood bilirubin increased

13%

Hypokalemia

13%

Paresthesia

13%

Thromboembolic event

13%

Arthritis

13%

Urinary tract infection

13%

Atrial fibrillation

13%

Gait disturbance

13%

Platelet count decreased

13%

Renal and urinary disorders - Other, specify

13%

Sore throat

13%

Palmar-plantar erythrodysesthesia syndrome

Dry mouth

anemia

Gastroesophageal reflux disease

Erectile dysfunction

Hypersomnia

Watering eyes

Blurred vision

Irritability

Conjunctivitis

Fall

Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify

appendicitus

Hyperthyroidism

Oral dysesthesia

Urinary urgency

Respiratory, thoracic and mediastinal disorders - Other, specify

abodominal pain

Laryngeal hemorrhage

Upper gastrointestinal hemorrhage

Sinus tachycardia

Tinnitus

Hepatobiliary disorders - Other, specify

Infections and infestations - Other, specify

Seroma

Cardiac troponin I increased

Hemoglobin increased

Hypercalcemia

Concentration impairment

Nervous system disorders - Other, specify

Depression

Chronic kidney disease

Urinary retention

Epistaxis

Hyperhidrosis

Photosensitivity

Lymphocele

Bone pain

Muscle weakness lower limb

Neck pain

Pain in extremity

bronchial obsturction

Localized edema

Blood and lymphatic system disorders - Other, specify

Abdominal distension

Hematuria

Sneezing

Pain of skin

Phlebitis

Oral pain

Malaise

Dehydration

Hot flashes

100%

80%

60%

40%

20%

Study treatment Arm

Received Sitravatinib 80 mg in Combination With Nivolumab

Received Sitravatinib 120 mg in Combination With Nivolumab

Received Sitravatinib 150 mg in Combination With Nivolumab

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Nivolumab and SitravatinibExperimental Treatment2 Interventions

Nivolumab will be administered by intravenous infusion over 30 minutes at 240 mg every 2 weeks or at 480 mg every 4 weeks. Sitravatinib capsules will be administered orally, once daily.

Group II: DocetaxelActive Control1 Intervention

Docetaxel will be administered by intravenous infusion at 75 mg/m2 over 1 hour every 3 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sitravatinib

2017

Completed Phase 2

~510

Nivolumab

2015