Non-Small Cell Lung CancerNCT02271139
Expanded Access Study of Alectinib for Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC) After Disease Progression on or Intolerance to Prior ALK Tyrosine Kinase Inhibitor Therapy
A study testing Alectinib in people with Non-Small Cell Lung Cancer, run by Genentech, Inc. at 45 sites in United States.
Trial summary
This is an open-label, multicenter, single-arm, expanded access study designed to provide alectinib to participants with ALK-rearranged NSCLC after disease progression on or intolerance to prior ALK tyrosine kinase inhibitor (TKI) therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Alectinib
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 45 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with locally advanced (American Joint Committee on Cancer [AJCC] Stage IIIB) not amenable to curative therapy or metastatic (AJCC Stage IV) NSCLC
- Life expectancy of at least 12 weeks
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-3
- Histologically confirmed NSCLC
- Documented ALK rearrangement as assessed by approved fluorescence in situ hybridization (FISH) test, using the Vysis ALK Break Apart FISH Probe Kit or the Ventana immunohistochemistry (IHC) test
- After disease progression on or intolerance to prior ALK TKI therapy: 1) participants need to have a minimum washout period of at least 5 half-lives between the last dose of ALK TKI therapy or other targeted therapies and the first dose of study treatment; 2) participants must have recovered from treatment toxicities to less than or equal to (</=) Grade 1 or to their pretreatment levels (for participants who have developed interstitial lung disease [ILD], they must have fully recovered); 3) participants can either be chemotherapy-naïve or have received at least one line of platinum-based chemotherapy for locally advanced or metastatic disease
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- Recovery from effects of any major surgery or significant traumatic injury at least 28 days before the first dose of study treatment
- Adequate hematological and renal function
- Agreement to use highly effective methods of contraception per protocol definitions
Who cannot join
- Prior therapy with alectinib
- Participants with symptomatic central nervous system (CNS) metastases who are neurologically unstable or require increasing doses of steroids within 1 week prior to Day 1 to manage CNS symptoms
- Administration of strong/potent cytochrome P450 3A (CYP3A) inhibitors or inducers, or agents with potential QT prolonging effects within 14 days prior to first administration of study drug
- Participants with liver disease
- Any clinically significant concomitant disease or condition that could interfere with the conduct of the study
- Active or uncontrolled infectious diseases requiring treatment
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- History of organ transplant
- Participants with baseline QTc > 470 milliseconds (ms) or participants with symptomatic bradycardia
- Pregnant or lactating, or intending to become pregnant during the study
- History of hypersensitivity to any of the additives in alectinib formulation
- Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol requirements and/or follow-up procedures; those conditions should be discussed with the participants before trial entry
- Serious, uncontrolled infections or current known infection with human immunodeficiency virus (HIV)
Trial locations and contacts
45 sites in 1 country.
45 sites in 1 country
United States45 sites
University Cancer & Blood Center, LLC
Athens, Georgia, 30607
Billings Clinic Cancer Center; Billings Cancer Research
Billings, Montana, 59101
University of Alabama
Bimingham, Alabama, 35226
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana Farber Partners Can Ctr
Boston, Massachusetts, 02115-6084
Beth Israel Deaconess Med Ctr; Hem/Onc
Boston, Massachusetts, 02215
Medical University of South Carolina; Hollings Cancer Center
Charleston, South Carolina, 29425
Northwestern University
Chicago, Illinois, 60611
University of Chicago Hospital
Chicago, Illinois, 60637
Mark H. Zangmeister Center
Columbus, Ohio, 43219
UT Southwestern Medical Center
Dallas, Texas, 75390-8813
Southern Cancer Center
Daphne, Alabama, 36526
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031
San Juan Oncology Associates
Farmington, New Mexico, 87401
Karmanos Cancer Institute - Farmington Hills/Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334
Lalita Pandit Inc.
Fountain Valley, California, 92708
Investigative Clin Rsch of IN
Indianapolis, Indiana, 46260
University of California San Diego Medical Center; Moores Cancer Center
La Jolla, California, 92037
Loma Linda Cancer Center
Loma Linda, California, 92354
LAC USC Medical Center
Los Angeles, California, 90033
University of Southern California
Los Angeles, California, 90033
University of Wisconsin; Oncology
Madison, Wisconsin, 53792
Loyola University Med Center
Maywood, Illinois, 60153
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
University of Minnesota
Minneapolis, Minnesota, 55455
Southern Cancer Center
Mobile, Alabama, 36607
Southern Cancer Center - Mobile
Mobile, Alabama, 36608
Southern Cancer Center, PC
Mobile, Alabama, 36608
Forbes Hospital
Monroeville, Pennsylvania, 15146
Allegheny Valley Hospital
Natrona Heights, Pennsylvania, 15065
Columbia University Medical Center; Clinical Research Management Office
New York, New York, 10032
University of California Irvine Medical Center
Orange, California, 92868
Cancer Treatment Centers of America - Eastern Regional Medical Center
Philadelphia, Pennsylvania, 19124
Allegheny Cancer Center
Pittsburgh, Pennsylvania, 15212
West Penn Cancer Institute
Pittsburgh, Pennsylvania, 15224
Oregon Health & Science Uni
Portland, Oregon, 97239
W.G. Bill Hefner VA Medical Center
Salisbury, North Carolina
University of Washington Seattle Cancer Care Alliance
Seattle, Washington, 98195
St. Joseph Heritage Healthcare
Sebastopol, California, 95472
Comprehensive Cancer Care, P.C.
St Louis, Missouri, 63141
Northwest Medical Specialties
Tacoma, Washington, 98405
Tulsa Cancer Institute
Tulsa, Oklahoma, 74146
Henry Ford Health System
West Bloomfield, Michigan, 48322
Innovative Clinical Research Institute
Whittier, California, 90603
About this study
Official title: An Open Label, Multicenter, Single-Arm, Expanded Access Study of Alectinib for Patients With ALK-Rearranged Non-Small Cell Lung Cancer After Disease Progression on or Intolerance to Prior ALK Tyrosine Kinase Inhibitor Therapy
This is an open-label, multicenter, single-arm, expanded access study designed to provide alectinib to participants with ALK-rearranged NSCLC after disease progression on or intolerance to prior ALK tyrosine kinase inhibitor (TKI) therapy. Participants will receive alectinib until disease progression, unacceptable toxicity, withdrawal of consent, patient or physician decision to discontinue treatment, death, alectinib becomes commercially available in the United States following approval of alectinib by the FDA, or the Sponsor decides to close the trial, whichever occurs first (approximately 15 months).
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Alectinib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlectinibDrug
Alectinib 600 mg administered orally with food.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02271139
- Sponsor's protocol ID
- ML29453
- Status last verified
- Mar 2017
- First submitted
- 17 Oct 2014
- Last updated
- 9 Mar 2017
- Results posted
- No
Publications
Sikkema BJ, Baart SJ, Paats MS, Smit EF, Schols AMWJ, Mathijssen RHJ, van Rossum EFC, Dingemans AC. Body Weight Gain Associated With Alectinib in Patients With ALK+ Non-Small Cell Lung Cancer: Pooled Analysis of Individual Patient Data From Four Prospective Clinical Trials. J Clin Oncol. 2025 Feb 20;43(6):641-650. doi: 10.1200/JCO-24-01579. Epub 2024 Dec 11.
PubMed 39661917
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Multicenter, Single-Arm, Expanded Access Study of Alectinib for Patients With ALK-Rearranged Non-Small Cell Lung Cancer After Disease Progression on or Intolerance to Prior ALK Tyrosine Kinase Inhibitor Therapy
- ClinicalTrials.gov ID
- NCT02271139
- Acronym / sponsor ID
- ML29453
- Conditions
- Non-Small Cell Lung Cancer
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- First posted
- 22 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, multicenter, single-arm, expanded access study designed to provide alectinib to participants with ALK-rearranged NSCLC after disease progression on or intolerance to prior ALK tyrosine kinase inhibitor (TKI) therapy. Participants will receive alectinib until disease progression, unacceptable toxicity, withdrawal of consent, patient or physician decision to discontinue treatment, death, alectinib becomes commercially available in the United States following approval of alectinib by the FDA, or the Sponsor decides to close the trial, whichever occurs first (approximately 15 months).
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Participants with locally advanced (American Joint Committee on Cancer [AJCC] Stage IIIB) not amenable to curative therapy or metastatic (AJCC Stage IV) NSCLC
- Life expectancy of at least 12 weeks
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-3
- Histologically confirmed NSCLC
- Documented ALK rearrangement as assessed by approved fluorescence in situ hybridization (FISH) test, using the Vysis ALK Break Apart FISH Probe Kit or the Ventana immunohistochemistry (IHC) test
Key exclusion criteria (12 listed)
- Prior therapy with alectinib
- Participants with symptomatic central nervous system (CNS) metastases who are neurologically unstable or require increasing doses of steroids within 1 week prior to Day 1 to manage CNS symptoms
- Administration of strong/potent cytochrome P450 3A (CYP3A) inhibitors or inducers, or agents with potential QT prolonging effects within 14 days prior to first administration of study drug
- Participants with liver disease
- Any clinically significant concomitant disease or condition that could interfere with the conduct of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlectinibAlectinib 600 mg administered orally with food. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2017.
- Derived from this study: PubMed 39661917Sikkema BJ, Baart SJ, Paats MS, Smit EF, Schols AMWJ, Mathijssen RHJ, van Rossum EFC, Dingemans AC. Body Weight Gain Associated With Alectinib in Patients With ALK+ Non-Small Cell Lung Cancer: Pooled Analysis of Individual Patient Data From Four Prospective Clinical Trials. J Clin Oncol. 2025 Feb 20;43(6):641-650. doi: 10.1200/JCO-24-01579. Epub 2024 Dec 11.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
45 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alectinib in people with Non-Small Cell Lung Cancer, run by Genentech, Inc. at 45 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02271139, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2017.