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Alectinib for Non-Small Cell Lung Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
University Of Michigan, Ann Arbor, MINon-Small Cell Lung CancerAlectinib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Non-Small Cell Lung Cancer

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Similar Trials

1
Copanlisib
1
Atezolizumab
1
Selpercatinib

Study Objectives

1 Primary · 14 Secondary · Reporting Duration: 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)

Month 17
Proportion of participants who have maintained or improved baseline health as measured by the European Organisation for the Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30 physical functioning and role functioning scales
Proportion of participants who have maintained or improved from their baseline health in cough, chest pain, and dyspnea symptoms as measured using the EORTC QLQ-LC13
Year 5
Overall survival (OS)
Year 3
TTCD
Time-to-confirmed deterioration (TTCD)
Year 3
Progression-free survival (PFS)
Year 3
PFS
Year 3
Time to central nervous system (CNS) progression
Year 3
Time to CNS progression
Year 3
Distant metastasis-free survival (DMFS)
Year 3
DOR
Year 3
Duration of response (DOR)
Up to 3 years
ORR, defined as the percentage of participants with measurable disease who attain a CR or PR as determined by BICR per RECIST v1.1
Objective response rate (ORR), defined as the percentage of participants with measurable disease who attain a complete response (CR) or partial response (PR) as determined by the investigator per RECIST v1.1
Percentage of participants with adverse events (AEs)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
Copanlisib
2
Atezolizumab
2
Selpercatinib

Side Effects for

Experimental: Alectinib
21%Constipation
16%Anaemia
14%Oedema peripheral
14%Myalgia
13%Back pain
12%Dyspnoea
12%Asthenia
10%Cough
9%Upper Respiratory Tract Infection
9%Decreased appetite
8%Blood bilirubin increased
8%Pneumonia
6%Diarrhoea
6%Fatigue
6%Blood Creatinine Increased
6%Headache
6%Abdominal Pain
6%Bronchitis
5%Electrocardiogram QT Prolonged
5%Arthralgia
5%Nasopharyngitis
4%Vomiting
4%Dizziness
4%Nausea
4%Pyrexia
3%Acute kidney injury
3%Musculoskeletal Chest Pain
3%Pain in extremity
3%Tinnitus
1%Epilepsy
1%Skull fractured base
1%Haemoptysis
1%Erysipelas
1%H1N1 Influenza
1%Deep vein thrombosis
1%Hypertension
1%Death
1%Diverticulitis
1%Cerebellar ataxia
1%Wound Complication
1%Alopecia
1%Ankle fracture
1%Jaw fracture
1%Depression
1%Blood creatine phosphokinase increased
1%Invasive ductal breast carcinoma
1%Syncope
1%Pharyngitis
1%Neuropathy peripheral
1%Myocardial infarction
1%Abdominal pain
1%Cholelithiasis
1%Abscess jaw
1%Osteoporotic fracture
1%Paraesthesia
This histogram enumerates side effects from a completed 2018 Phase 3 trial (NCT02604342) in the Experimental: Alectinib ARM group. Side effects include: Constipation with 21%, Anaemia with 16%, Oedema peripheral with 14%, Myalgia with 14%, Back pain with 13%.

Trial Design

6 Treatment Groups

Cohort A1: ALK-positive (durvalumab arm)
1 of 6
Cohort A2: ROS 1-positive (durvalumab arm)
1 of 6
Cohort A3: RET fusion-positive (durvalumab arm)
1 of 6
Cohort A3: RET fusion-positive (pralsetinib arm)
1 of 6
Cohort A1: ALK-Positive (alectinib arm)
1 of 6
Cohort A2: ROS 1-positive (entrectinib arm)
1 of 6

Active Control

Experimental Treatment

320 Total Participants · 6 Treatment Groups

Primary Treatment: Alectinib · No Placebo Group · Phase 3

Cohort A3: RET fusion-positive (pralsetinib arm)
Drug
Experimental Group · 1 Intervention: Pralsetinib · Intervention Types: Drug
Cohort A1: ALK-Positive (alectinib arm)
Drug
Experimental Group · 1 Intervention: Alectinib · Intervention Types: Drug
Cohort A2: ROS 1-positive (entrectinib arm)
Drug
Experimental Group · 1 Intervention: Entrectinib · Intervention Types: Drug
Cohort A1: ALK-positive (durvalumab arm)
Drug
ActiveComparator Group · 1 Intervention: Durvalumab · Intervention Types: Drug
Cohort A2: ROS 1-positive (durvalumab arm)
Drug
ActiveComparator Group · 1 Intervention: Durvalumab · Intervention Types: Drug
Cohort A3: RET fusion-positive (durvalumab arm)
Drug
ActiveComparator Group · 1 Intervention: Durvalumab · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Entrectinib
FDA approved
Alectinib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 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)

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,373 Previous Clinical Trials
1,068,534 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,154 Previous Clinical Trials
876,410 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 18 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Your blood and organs are functioning properly.
You can swallow the entrectinib capsules whole, without breaking or crushing them.
You are expected to live for at least 12 more weeks.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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