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Tyrosine Kinase Inhibitor

Alectinib for Non-Small Cell Lung Cancer

Phase 1 & 2

Waitlist Available

Led By Justin Gainor, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

Summary

This trial is testing two drugs to see if they can treat advanced NSCLC.

Eligible Conditions

Non-Small Cell Lung Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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

Number of participants treated with the combination of alectinib and bevacizumab with adverse events

Recommended phase II dose of the combination of Alectinib and Bevacizumab

Secondary study objectives

Central nervous system disease control rate

Central Nervous System

Central nervous system progression-free survival

+6 more

Side effects data

From 2018 Phase 3 trial • 119 Patients • NCT02604342

21%

Constipation

16%

Anaemia

14%

Oedema peripheral

14%

Myalgia

13%

Back pain

12%

Asthenia

12%

Dyspnoea

10%

Cough

Decreased appetite

Upper Respiratory Tract Infection

Blood bilirubin increased

Pneumonia

Fatigue

Diarrhoea

Headache

Abdominal Pain

Blood Creatinine Increased

Bronchitis

Arthralgia

Electrocardiogram QT Prolonged

Nasopharyngitis

Pyrexia

Vomiting

Nausea

Dizziness

Acute kidney injury

Musculoskeletal Chest Pain

Pain in extremity

Tinnitus

Invasive ductal breast carcinoma

Deep vein thrombosis

Paraesthesia

Haemoptysis

Cholelithiasis

Myocardial infarction

Abscess jaw

Jaw fracture

Blood creatine phosphokinase increased

Ankle fracture

Skull fractured base

Depression

Cerebellar ataxia

Syncope

Osteoporotic fracture

Death

Diverticulitis

Erysipelas

H1N1 Influenza

Pharyngitis

Wound Complication

Neuropathy peripheral

Alopecia

Epilepsy

Abdominal pain

Hypertension

100%

80%

60%

40%

20%

Study treatment Arm

Experimental: Alectinib

Active Comparator: Premetrexed/Docetaxel

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Alectinib and Bevacizumab.Experimental Treatment2 Interventions

Phase 1 * Dose escalation will occur using a standard 3+3 dose escalation approach, beginning in dose level I with dose cohorts and rules for escalation and de-escalation. * Alectinib, orally, twice a day, per cycle * Bevacizumab, iv, once per cycle Phase II In the phase II portion of this study, the investigators will evaluate the combination of alectinib plus bevacizumab in ALK-positive patients with untreated or progressive, asymptomatic brain metastases. Eligible participants will receive alectinib plus bevacizumab at the recommended phase II doses determined in the phase I portion of the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bevacizumab

FDA approved

Alectinib

FDA approved

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