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Kinase Inhibitor
Alectinib + Cobimetinib for Lung Cancer
Phase 1 & 2
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
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I have leptomeningeal disease but no symptoms.
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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.
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I can swallow and keep down pills.
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My condition worsened while on alectinib treatment.
Select...
I agree to either not have sex or use barrier contraception and not donate sperm.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose as assessed by CTCAE v4.0
Secondary outcome measures
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 • NCT0260434224%
Fatigue
22%
Alopecia
16%
Asthenia
16%
Nausea
11%
Neutropenia
11%
Myalgia
11%
Decreased appetite
11%
Anaemia
11%
Constipation
11%
Cough
8%
Pruritus Generalised
8%
Pyrexia
8%
Paraesthesia
8%
Arthralgia
8%
Headache
5%
Pain in extremity
5%
Vomiting
5%
Tinnitus
5%
Febrile neutropenia
5%
Musculoskeletal Chest Pain
5%
Back pain
5%
Diarrhoea
5%
Dizziness
5%
Drug Hypersensitivity
5%
Oedema peripheral
5%
Neuropathy peripheral
3%
Gastroenteritis
3%
Abdominal pain
3%
Nasopharyngitis
3%
Stomatitis
3%
Upper Respiratory Tract Infection
3%
Lung infection
3%
Pneumonia bacterial
3%
Bronchitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Active Comparator: Premetrexed/Docetaxel
Experimental: Alectinib
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
Alectinib
FDA approved
Cobimetinib
FDA approved
Find a Location
Who is running the clinical trial?
Genentech, Inc.Industry Sponsor
1,540 Previous Clinical Trials
567,898 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
2,933 Previous Clinical Trials
13,198,470 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:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants is the trial recruiting?
"Affirmative. According to the information on clinicaltrials.gov, this medical test is currently enrolling participants - a process that began in September 2017 and was recently updated in March 2021. 31 patients are needed from one site for completion of the study."
Answered by AI
Is this a pioneering clinical trial?
"In the decade since 2013, 71 clinical trials related to Alectinib have been conducted in 693 cities and 59 countries. Bristol-Myers Squibb initiated the first trial of this drug with 1163 participants in 2013; 42 studies were concluded following initial Phase 1 & 2 Drug Approval stages."
Answered by AI
What investigations have been conducted to ascertain the efficacy of Alectinib?
"Currently, 71 clinical trials assessing Alectinib are in progress with 7 studies conducted at Phase 3. Portland Oregon has the most significant concentration of study sites but there are 2,769 total locations hosting these experiments."
Answered by AI
Is there still availability for individuals to join this experiment?
"Affirmative. Clinicaltrials.gov showcases that this clinical trial, initially posted on September 14th 2017 has launched a recruitment initiative for 31 patients across one location."
Answered by AI
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