Your session is about to expire
← Back to Search
Kinase Inhibitor
Alectinib + Cobimetinib for Lung Cancer
Phase 1 & 2
Waitlist Available
Led By Ibiayi T Dagogo-Jack, 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
Chemotherapy-naive or received platinum-based chemotherapy for locally advanced or metastatic disease
Patients with asymptomatic leptomeningeal disease are eligible
Must not have
Prior allogeneic stem cell or solid organ transplantation
Current diagnosis of symptomatic congestive heart failure or history of symptomatic congestive heart failure in the preceding 3 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Summary
This trial is testing if the two drugs work better together than either drug alone in treating ALK+ non-small cell lung cancer.
Who is the study for?
This trial is for adults with advanced ALK-positive non-small cell lung cancer who have seen their disease progress on alectinib. They should be able to perform daily activities (ECOG ≤ 2), swallow pills, and have a life expectancy over 12 weeks. Pregnant women, those unable or unwilling to use contraception, and individuals with certain health conditions or treatments are excluded.
What is being tested?
The study tests combining Alectinib with Cobimetinib as a treatment for ALK+ NSCLC. Participants must have previously experienced disease progression while on Alectinib alone and meet specific health criteria to join the study.
What are the potential side effects?
Potential side effects of Alectinib include liver problems, muscle pain, constipation, fatigue, and swelling. Cobimetinib may cause rash, diarrhea, sun sensitivity, abnormal liver tests results among others. Side effects can vary from person to person.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have not had chemotherapy or only had platinum-based chemo for advanced cancer.
Select...
I have leptomeningeal disease but no symptoms.
Select...
My lung cancer is at stage IV and has ALK changes.
Select...
I have waited the required time after my last TKI therapy before starting the study treatment.
Select...
I can swallow and keep down pills.
Select...
My condition worsened while on alectinib treatment.
Select...
I agree to either not have sex or use barrier contraception and not donate sperm.
Select...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had a previous transplant of stem cells or an organ.
Select...
I have had symptoms of heart failure recently or currently.
Select...
I have pain from my cancer that isn't managed well.
Select...
I am taking denosumab and cannot or will not switch to a bisphosphonate during the study.
Select...
My liver isn't working properly according to tests.
Select...
I have had active cancer in the last 3 years.
Select...
My brain cancer progressed after alectinib treatment without any local brain therapies.
Select...
I have not had radiation therapy (except for bone pain relief) in the last 7 days.
Select...
I have severe lung scarring or disease affecting both lungs.
Select...
I have tested positive for HIV or have had active tuberculosis.
Select...
I am using or might need drugs that strongly affect liver enzyme levels.
Select...
I am not taking any other tyrosine kinase inhibitors.
Select...
I have been treated with a MAPK inhibitor before.
Select...
I have not had major surgery in the last 28 days.
Select...
I have an active stomach or bowel inflammation, or I've had stomach surgery.
Select...
I am using or might need drugs that strongly affect how my body processes some medications.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Maximum tolerated dose as assessed by CTCAE v4.0
Secondary study objectives
Duration of Response as assessed by RECIST v1.1.
Overall Survival as assessed by the Kaplan-Meier method
Progression Free Survival as assessed by RECIST v1.1 and the Kaplan-Meier method
+2 moreSide effects data
From 2018 Phase 3 trial • 119 Patients • NCT0260434221%
Constipation
16%
Anaemia
14%
Oedema peripheral
14%
Myalgia
13%
Back pain
12%
Asthenia
12%
Dyspnoea
10%
Cough
9%
Decreased appetite
9%
Upper Respiratory Tract Infection
8%
Blood bilirubin increased
8%
Pneumonia
6%
Diarrhoea
6%
Fatigue
6%
Headache
6%
Abdominal Pain
6%
Blood Creatinine Increased
6%
Bronchitis
5%
Arthralgia
5%
Electrocardiogram QT Prolonged
5%
Nasopharyngitis
4%
Nausea
4%
Pyrexia
4%
Vomiting
4%
Dizziness
3%
Acute kidney injury
3%
Musculoskeletal Chest Pain
3%
Pain in extremity
3%
Tinnitus
1%
Jaw fracture
1%
Ankle fracture
1%
Depression
1%
Blood creatine phosphokinase increased
1%
Deep vein thrombosis
1%
Cholelithiasis
1%
Haemoptysis
1%
Syncope
1%
Abscess jaw
1%
Skull fractured base
1%
Paraesthesia
1%
Death
1%
Myocardial infarction
1%
Cerebellar ataxia
1%
Osteoporotic fracture
1%
Invasive ductal breast carcinoma
1%
Diverticulitis
1%
Erysipelas
1%
H1N1 Influenza
1%
Pharyngitis
1%
Wound Complication
1%
Neuropathy peripheral
1%
Alopecia
1%
Epilepsy
1%
Abdominal pain
1%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Experimental: Alectinib
Active Comparator: Premetrexed/Docetaxel
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Cobimetinib + AlectinibExperimental Treatment2 Interventions
Alectinib administered twice daily at pre-determined dosage orally Cobimetinib administered daily at pre-determined dosage orally
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cobimetinib
FDA approved
Alectinib
FDA approved
Find a Location
Who is running the clinical trial?
Genentech, Inc.Industry Sponsor
1,565 Previous Clinical Trials
570,040 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
3,026 Previous Clinical Trials
13,413,783 Total Patients Enrolled
Ibiayi T Dagogo-Jack, MDPrincipal InvestigatorMassachusetts General Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had chemotherapy or only had platinum-based chemo for advanced cancer.I have had a previous transplant of stem cells or an organ.I have had symptoms of heart failure recently or currently.I have pain from my cancer that isn't managed well.I am taking denosumab and cannot or will not switch to a bisphosphonate during the study.My liver isn't working properly according to tests.I have had active cancer in the last 3 years.You have allergies or strong reactions to the ingredients in cobimetinib.I do not have any other diseases or conditions that my doctor is concerned about.My brain cancer progressed after alectinib treatment without any local brain therapies.I have not had radiation therapy (except for bone pain relief) in the last 7 days.I have severe lung scarring or disease affecting both lungs.I have tested positive for HIV or have had active tuberculosis.I am using or might need drugs that strongly affect liver enzyme levels.I am taking seizure medication that does not induce enzymes.I have leptomeningeal disease but no symptoms.My lung cancer is at stage IV and has ALK changes.I can take care of myself but might not be able to do heavy physical work.I am willing to undergo multiple biopsies for my treatment.I have waited the required time after my last TKI therapy before starting the study treatment.I am not taking any other tyrosine kinase inhibitors.I have been treated with a MAPK inhibitor before.I can swallow and keep down pills.You have at least one specific, measurable area of disease as defined by RECIST version 1.1.You can't or don't want to swallow pills.I have not had chemotherapy in the last 3 weeks.Your blood albumin level is less than 2.5 g/dL.My condition worsened while on alectinib treatment.You have a history of eye problems or signs of eye issues during an eye exam.I have not had major surgery in the last 28 days.You are expected to live for at least 12 more weeks.My blood tests show abnormal results.I have an active stomach or bowel inflammation, or I've had stomach surgery.I have untreated brain lesions that do not cause symptoms.I agree to either not have sex or use barrier contraception and not donate sperm.I have recovered from any major surgery or serious injury for at least 28 days.I am using or might need drugs that strongly affect how my body processes some medications.I have recovered from previous treatment side effects to mild or my normal health.I have been on a stable or decreasing dose of steroids for at least a week.I am 18 years old or older.You have had a bad reaction to alectinib or any of its ingredients in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Cobimetinib + Alectinib
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.