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Multiple Therapies for Stage III Non-Small Cell Lung Cancer
Phase 3
Recruiting
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Documented ALK fusion positivity by an eligible result from: centralized multiplex molecular testing of tumor tissue at the Sponsor's designated central laboratory under Study BX43361 or available results from a Sponsor pre-approved local, appropriately validated ALK fusion test on tumor tissue performed in a Clinical Laboratory Improvement Amendments certified or equivalent laboratory
Histologically or cytologically documented locally advanced, unresectable Stage III NSCLC of either squamous or non-squamous histology
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization to the first deterioration of >/= 10 points that is either maintained for two consecutive assessments or followed by death from any cause within 3 weeks (up to 3 years)
Awards & highlights
Study Summary
This trial will test how well different therapies work in treating people with Stage III NSCLC that has spread and cannot be removed by surgery.
Who is the study for?
This trial is for adults with Stage III Non-Small Cell Lung Cancer (NSCLC) who can swallow pills, have had prior chemo and radiotherapy without disease progression, and are expected to live at least 12 weeks. They must not be pregnant or planning pregnancy, agree to use contraception, and have no history of certain bone disorders or severe allergies.Check my eligibility
What is being tested?
The study tests the effectiveness and safety of Entrectinib, Durvalumab, Alectinib in NSCLC patients with specific biomarkers. It requires a PET/CT scan for staging and uses electronic patient-reported outcomes for monitoring.See study design
What are the potential side effects?
Potential side effects may include liver issues, digestive disturbances that affect medication absorption, nerve damage symptoms like peripheral neuropathy, immune system reactions leading to inflammation in various organs including lungs (pneumonitis), fatigue from anemia or other blood disorders.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has a confirmed ALK fusion from an approved test.
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My lung cancer is at an advanced stage and cannot be removed by surgery.
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My cancer did not worsen during or after platinum-based chemo.
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My cancer has a ROS1 fusion confirmed by a specific test.
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I can take care of myself and am up and about more than half of my waking hours.
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I have had at least two rounds of platinum-based chemo with or before radiotherapy.
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My radiation therapy was between 54 Gy and 66 Gy, using advanced techniques.
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I can swallow pills whole without breaking them.
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I weigh at least 30 kg.
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My cancer's PD-L1 status is known, tested by a specific method.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from randomization to the first deterioration of >/= 10 points that is either maintained for two consecutive assessments or followed by death from any cause within 3 weeks (up to 3 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization to the first deterioration of >/= 10 points that is either maintained for two consecutive assessments or followed by death from any cause within 3 weeks (up to 3 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free survival (PFS)
Secondary outcome measures
DOR
Distant metastasis-free survival (DMFS)
Duration of response (DOR)
+10 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
4Treatment groups
Experimental Treatment
Active Control
Group I: Cohort A2: ROS 1-positive (entrectinib arm)Experimental Treatment1 Intervention
Participants will receive entrectinib 600 mg orally once daily until completion of treatment period (3 years), or until disease progression, unacceptable toxicity, patient or physician decision to discontinue, or death, whichever occurs first.
Cohort A2 has been closed to enrollment.
Group II: Cohort A1: ALK-Positive (alectinib arm)Experimental Treatment1 Intervention
Participants will receive alectinib 600 mg orally twice daily until completion of treatment period (3 years), or until disease progression, unacceptable toxicity, patient or physician decision to discontinue, or death, whichever occurs first
Group III: Cohort A2: ROS 1-positive (durvalumab arm)Active Control1 Intervention
Participants will receive 1500 mg of IV durvalumab every 4 weeks until completion of treatment period (1 year) or until disease progression, unacceptable toxicity, patient or physician decision to discontinue, or death, whichever occurs first
Cohort A2 has been closed to enrollment.
Group IV: Cohort A1: ALK-positive (durvalumab arm)Active Control1 Intervention
Participants will receive 1500 mg of intravenous (IV) durvalumab every 4 weeks until completion of treatment period (1 year) or until disease progression, unacceptable toxicity, patient or physician decision to discontinue, or death, whichever occurs first
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alectinib
2015
Completed Phase 3
~2400
Entrectinib
2014
Completed Phase 2
~360
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,430 Previous Clinical Trials
1,089,497 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
888,819 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have moderate to severe numbness, tingling, or pain in my hands or feet.My cancer has a confirmed ALK fusion from an approved test.My lung cancer is at an advanced stage and cannot be removed by surgery.I have severe side effects from previous treatments that haven't improved.I have a family or personal history of bone disorders.I haven't had a severe infection or been hospitalized for one in the last 4 weeks.I had hepatitis C but it's either treated or naturally resolved, shown by negative HCV RNA.I have no major side effects from previous cancer treatments.I am not currently on any cancer treatments like chemotherapy.My cancer did not worsen during or after platinum-based chemo.It is confirmed that there is a tumor sample preserved in a specific way for testing.I cannot swallow pills.I have a hereditary sugar digestion problem.My cancer has a ROS1 fusion confirmed by a specific test.Your heart's electrical activity has shown to be abnormal on ECG tests, with a prolonged QTc interval.I have only had NSCLC or low-risk cancers in the past 5 years.I haven't taken any strong immune system suppressing drugs in the last 2 weeks.I can take care of myself and am up and about more than half of my waking hours.I had a PET/CT scan from head to mid-thigh within the last 42 days for cancer staging.I do not have serious heart problems or recent heart attacks.I have severe liver problems, including issues with liver function or hepatitis.I have had at least two rounds of platinum-based chemo with or before radiotherapy.My lung cancer has a specific genetic change in the EGFR gene.I have risk factors for irregular heartbeats, like a family history of long QT syndrome.My radiation therapy was between 54 Gy and 66 Gy, using advanced techniques.I do not have an active autoimmune disease except for controlled thyroid issues or Type 1 diabetes.I can swallow pills whole without breaking them.I have been newly diagnosed with Stage III lung cancer that cannot be surgically removed.My blood and organs are functioning well.I have had severe lung inflammation from previous radiation therapy.You are expected to live for at least 12 more weeks.I have fully recovered from any past surgeries before starting the study treatment.I have a stomach or bowel condition that affects how I absorb pills.You have a positive test for hepatitis B surface antigen.I weigh at least 30 kg.I haven't had major surgery in the last 4 weeks and don't expect to need one during the study.I don't have any health issues that would make it unsafe for me to take a new drug.I haven't had a live vaccine in the last 4 weeks and don't plan to during or within 5 months after the study.I have been treated with ALK inhibitors before.I have previously been treated with specific immune therapies.I experience symptoms due to a very slow heartbeat.I have had severe side effects from past immunotherapy.I have not taken any strong antibiotics in the last 2 weeks.I have lung conditions that affect my daily activities or need treatment.You have had a bad reaction to alectinib or durvalumab in the past.My NSCLC has specific ALK mutations.Your heart's pumping ability is too low, as measured during the screening for the study.I have a hereditary condition that affects how my body processes certain sugars.My cancer's PD-L1 status is known, tested by a specific method.I agree to either not have sex or use birth control, and not donate sperm as per the study's rules.I have active tuberculosis.I haven't taken any immune-boosting drugs in the last 4 weeks or longer.I have a history of specific lung conditions or signs of lung inflammation on my recent chest scan.My cancer has spread to other parts of my body, such as the brain, bones, or lungs.If you have HIV, you can join the study only if your condition is well-controlled as defined by the study rules.I have had a previous transplant of stem cells or an organ.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort A2: ROS 1-positive (entrectinib arm)
- Group 2: Cohort A2: ROS 1-positive (durvalumab arm)
- Group 3: Cohort A1: ALK-positive (durvalumab arm)
- Group 4: Cohort A1: ALK-Positive (alectinib arm)
Awards:
This trial has 2 awards, including:- 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.
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.
What are the dangers that Alectinib poses to patients?
"Alectinib's safety is corroborated by its Phase 3 status, and it received a score of 3."
Answered by AI
What medical conditions does Alectinib usually treat?
"Alectinib is most commonly used to treat solid tumors. It can also be prescribed to patients with malignant neoplasms, for those who have had an unsuccessful surgical resection, or for medullary carcinoma of the thyroid."
Answered by AI
Are patients being actively recruited for this experiment as of now?
"That is correct, the clinical trial mentioned is recruiting patients as of right now. The original posting was on November 1st, 2022 and there has since been an update on recruitment numbers and sites. Currently, 11 centres are looking for 320 individuals to participate."
Answered by AI
What other scientific papers have been published that mention Alectinib?
"As of now, Alectinib is being trialed in 371 separate studies. Out of those active trials, 58 have reached Phase 3 status. The primary locations for these trial are Cordoba and Texas; though, there are 15733 sites running clinical trials for this medication globally."
Answered by AI
Is this trial also being conducted in other parts of Canada?
"There are 11 available for this trial such as Thompson Cancer Survival Center in Knoxville, Henry Ford Health System in Detroit, and UCLA Department of Medicine in Los Angeles."
Answered by AI
How many individuals are part of this experiment?
"320 participants that meet the study's requirements are necessary to conduct this research. Hoffmann-La Roche, the sponsor of the trial, will be running it from various locations including Thompson Cancer Survival Center in Knoxville, Tennessee and Henry Ford Health System in Detroit, Michigan."
Answered by AI
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