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Carcinoma, Non-Small-Cell LungPhase 2ATALKNCT03155009

A Study of the Efficacy and Safety of Alectinib in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer

A Phase 2 study testing Alectinib in people with Carcinoma, Non-Small-Cell Lung, run by Hoffmann-La Roche at 16 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will evaluate the efficacy and safety of alectinib, in selected participants, with anaplastic lymphoma kinase-rearranged (ALK-rearranged) non-small cell lung cancer (NSCLC), after disease progression on prior treatment strategy with crizotinib, as only ALK inhibitor, and eventually chemotherapy treatment(s). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
Alectinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
16 sitesFrance
Study dates
10 Jul 2017to 26 Sep 2019
Phase
Phase 2
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 histologically or cytologically confirmed locally advanced or metastatic NSCLC (Stage IIIB or IV accordingly to American Joint Committee on Cancer [AJCC] classification)
  • Life expectancy of at least 12 weeks, in the opinion of the Investigator
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 2
  • Having contributive biopsy performed on fresh tissue (FFPE blocks required) taken after progression on previous therapy showing presence of anaplastic lymphoma kinase (ALK) rearrangement, assessed by immunohistochemistry (IHC) and confirmed by fluorescence in situ hybridization (FISH)
  • Absence of resistance mechanism to alectinib assessed by the Biomarkers Board
  • Disease progression, limited to central nervous system (CNS) without possibility of tissue biopsy
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  • Non-contributive molecular analyses (not enough tumor cells or deoxyribonucleic acid, [DNA] amount or failure of analyses for technical reasons): inclusion is at investigator discretion (decision made upon Biomarker Board recommendation)
  • History of crizotinib exposure
  • Washout period: if previous progression on crizotinib: 7 days from last intake of the drug
  • If previous progression on chemotherapy: 28 days
  • If previous radiation therapy: 15 days
  • Participants must have recovered from treatment toxicities to ≤ Grade 1 or to their pretreatment levels (for participants who have developed interstitial lung disease [ILD], they must have fully recovered)
  • Recovery from effects of any major surgery, or significant traumatic injury, at least 35 days before the first dose of alectinib
  • Adequate hematologic function
  • Adequate renal function
  • For all females of childbearing potential, a negative pregnancy test must be obtained within three days before starting study drug
  • For women who are not postmenopausal (≥ 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use two adequate methods of contraception, including at least one method with a failure rate of < 1% per year, during the treatment period and for at least 90 days after the last dose of study drug
  • For men: agreement to remain abstinent or use a barrier method of contraception (e.g., condom) during the treatment period and for at least 90 days after the last dose of study drug and agreement to refrain from donating sperm during this same period
  • Participant has national health insurance coverage

Who cannot join

  • Prior therapy with other ALK inhibitors than crizotinib (including alectinib)
  • Participants with symptomatic CNS metastases who are neurologically unstable or require increasing doses of steroids within one week prior to Day 0 to manage CNS symptoms
  • Participants with progression limited to CNS and eligible to a focal treatment (surgery or stereotaxic radiotherapy)
  • 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
  • Liver disease
  • Any clinically significant concomitant disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study or the absorption of oral medications or that would, in the opinion of the investigator, pose an unacceptable risk to the participant in this study
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  • Active or uncontrolled infectious diseases requiring treatment
  • History of organ transplant
  • Participants with baseline QTc > 470 ms or participants with symptomatic bradycardia
  • Pregnant or lactating women
  • History of hypersensitivity to any of the additives in the alectinib drug
  • 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 participant before trial entry
  • Serious, uncontrolled infections or current known infection with human immunodeficiency virus (HIV).

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

France16 sites

  • CHU Angers

    Angers, 49933

  • Hopital Jean Minjoz; Pneumologie

    Besançon, 25030

  • Hopital Augustin Morvan; Oncologie Thoracique

    Brest, 29609

  • Centre Francois Baclesse; Comite 3

    Caen, 14076

  • Centre Hospitalier Intercommunal; Service de Pneumologie

    Créteil, 94010

  • Hôpital Nord Michallon; Pneumologie

    La Tronche, 38700

  • CHRU Lille Service de Pneumologie et Oncologie Thoracique

    Lille, 59000

  • Hôpital Nord - AP-HM Marseille#

    Marseille, 13915

  • Hopital Emile Muller;Pneumologie

    Mulhouse, 68070

  • Institut Curie

    Paris, 75005

  • Hopital Tenon;Pneumologie

    Paris, 75970

  • CHU de Bordeaux

    Pessac, 33600

  • Hopital de Pontchaillou; Service de Pneumologie

    Rennes, 35033

  • CHU de Rouen - Hôpital Charles Nicolle

    Rouen, 76031

  • CHU de Toulouse - Hôpital Larrey; Service de pneumologie et oncologie pneumologique

    Toulouse, 31100

  • Hopital Robert Schuman; Pneumologie

    Vantoux, 57070

Other trials in France

About this study

Official title: An Open-Label, Multicenter, Single-Arm, Phase II Study to Assess the Efficacy and Safety of Alectinib in Patients With ALK-Rearranged Non-Small Cell Lung Cancer After Disease Progression on Prior ALK Inhibitor Therapy

This study will evaluate the efficacy and safety of alectinib, in selected participants, with anaplastic lymphoma kinase-rearranged (ALK-rearranged) non-small cell lung cancer (NSCLC), after disease progression on prior treatment strategy with crizotinib, as only ALK inhibitor, and eventually chemotherapy treatment(s).

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

    600 mg orally BID with food

Study groups in NCT03155009
Study groupRoleWhat they receive
AlectinibExperimental600 mg orally twice daily (BID) for up to 2 years
Receives: Drug: Alectinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

    ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) assessed by the investigator using the Response Evaluation Criteria in Solid Tumors (RECIST), v.1.1. CR is defined as disappearance of all target and non-target lesions and no new lesions, and all pathological lymph nodes must have decreased to <10 mm in short axis. PR is defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions.

    Measured: Up to 2 years

Secondary outcomes (12)

  1. Central Nervous System Objective Response Rate (C-ORR)

    C-ORR is defined as the percentage of participants who attain a CR or PR of the baseline CNS metastases based on RECIST v.1.1. CR is defined as disappearance of all target and non-target lesions and no new lesions, and all pathological lymph nodes must have decreased to <10 mm in short axis. PR is defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions.

    Measured: Up to 2 years

  2. Progression-Free Survival (PFS)

    PFS is defined as the time between first intake of alectinib and the first occurrence of disease progression, or death from any cause during the study, whichever occurs first. Progressive disease (PD) based on RECIST v.1.1. is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.

    Measured: Up to 2 years

  3. Time to Progression (TTP)

    TTP is defined as the time between first intake of alectinib and the first occurrence of disease progression. PD based on RECIST v.1.1. is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.

    Measured: Up to 2 years

  4. Disease Control Rate (DCR)

    DCR is defined as the percentage of participants who attain CR, PR, or stable disease (SD) for at least five weeks, based on RECIST v.1.1. CR is defined as disappearance of all target and non-target lesions and no new lesions, and all pathological lymph nodes must have decreased to <10 mm in short axis. PR is defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression, taking as reference the smallest sum on study.

    Measured: Up to 2 years

  5. Duration of Response (DOR)

    DOR is defined as the time from when response (CR or PR), based on RECIST v.1.1, will be first documented to first documented disease progression or death (whichever occurs first). CR is defined as disappearance of all target and non-target lesions and no new lesions, and all pathological lymph nodes must have decreased to <10 mm in short axis. PR is defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.

    Measured: Up to 2 years

  6. Central Nervous System DOR (C-DOR)

    C-DOR is defined as the time from the first observation of a CNS response of CR or PR based on RECIST V1.1 until first observation of CNS progression or death from any cause (whichever occurs first). CR is defined as disappearance of all target and non-target lesions and no new lesions, and all pathological lymph nodes must have decreased to <10 mm in short axis. PR is defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.

    Measured: Up to 2 years

  7. Overall Survival (OS)

    OS is defined as the percentage of participants alive two years after the start of treatment.

    Measured: Up to 2 years

  8. Time to Central Nervous System (CNS) Progression

    Time to central nervous system (CNS) progression is defined as the time from first drug intake to first documented occurrence of disease progression in the CNS. PD based on RECIST v.1.1. is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.

    Measured: Up to 2 years

  9. Percentage of Participants with Adverse Events (AEs)

    An adverse event is considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsen during the study are reported as adverse events.

    Measured: Up to 2 years

  10. Health-Related Quality of Life (QoL), as Assessed by the QLQ-C30 Questionnaire

    The QLQ-C30 Questionnaire is used to assess the quality of life of participants with cancer. It includes five functional scales, three symptom scales, a global health status / QoL scale, and six single items. These components range in score from 0 (low response level) to 100 (high response level).

    Measured: Up to 2 years

  11. Health-Related QoL, as Assessed by the LC13 Questionnaire

    The LC13 Questionnaire includes 13 questions assessing lung cancer-associated symptoms (cough, hemoptysis, dyspnea and site-specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia), and pain medication. This scale ranges in score from 0 (low response level) to 100 (high response level).

    Measured: Up to 2 years

  12. Health-Related QoL, as Assessed by the BN20 Questionnaire

    The BN20 Questionnaire includes 20 items assessing future uncertainty, visual disorder, motor dysfunction, communication deficit and other disease symptoms, and treatment toxicities. This scale ranges in score from 0 (low response level) to 100 (high response level).

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2017
  2. Study start10 Jul 2017
  3. Primary completion26 Sep 2019
  4. Study completion26 Sep 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03155009
Sponsor's protocol ID
ML39349
Other IDs
2016-003924-22, 2016
Acronym
ATALK
Status last verified
Feb 2020
First submitted
11 May 2017
Last updated
10 Feb 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Alectinib in people with Carcinoma, Non-Small-Cell Lung, run by Hoffmann-La Roche at 16 sites in France.

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 19 inclusion and 13 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: finished, as of the sponsor's last update on 10 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in France. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03155009.

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 10 Feb 2020.

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