Health TrialsbyHealthPanel

Real World Clinical Outcomes of Resected ALK-Positive Early Stage NSCLC Patients Treated With Alectinib as Adjuvant Therapy

ConditionCarcinoma, Non-Small-Cell Lung
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHoffmann-La Roche

About this trial

This study is a multicenter, prospective, cohort study designed to evaluate the clinical outcomes and characteristics of resected stage II-IIIB anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) adult patients treated with Alectinib as adjuvant therapy in China.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically-confirmed stage II-IIIA or selected IIIB (T3N2) NSCLC as per the American Joint Committee on Cancer and International Union Against Cancer (UICC/AJCC), 8th edition

ALK positive

Postoperative NSCLC patients who have undergone complete resection

Had taken Alectinib monotherapy without prior systemic therapy (including other ALK-TKIs or chemotherapy) as adjuvant† therapy for resected stage II-IIIB ALKpositive NSCLC and the time from the first dose to enrollment was no more than 28 days

Disqualifiers

Patients participating in interventional study of adjuvant treatment

Pregnant, lactating, or breastfeeding women

Trial population

Participants in China with resected stage II-IIIB ALK-positive NSCLC treated with adjuvant Alectinib according to standard of care.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Alectinib

    Drug

    Participants will have received alectinib adjuvant treatment for resected stage II-IIIB ALK-positive NSCLC in routine clinical practice. NOTE: No intervention will be provided in this study as the study is observational.

Treatment groups

800 Participants
are divided into 1 treatment group
Group A: Cohort 11 intervention

Trial outcomes

Primary outcomes

1

Real-world disease-free survival (rwDFS)

Time frame
From baseline to the date of the first documentation of cancer recurrence, as determined by the physician according to local clinical standard of care, or death due to any cause, whichever occurs first (up to approximately 2.5 years)

Secondary outcomes

1

Duration of alectinib therapy

Time frame
From start of treatment to the date of treatment discontinuation (up to approximately 2.5 years)
2

Participant demographics by disease stage and city tier

Time frame
Up to approximately 2.5 years
3

Participant clinical characteristics as determined by Eastern Cooperative Oncology Group performance status (ECOG PS) by disease stage and city tier

Time frame
Up to approximately 2.5 years
4

Participant clinical characteristics as determined by surgery history by disease stage and city tier

Time frame
Up to approximately 2.5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hoffmann-La Roche

Lead sponsor

Source ClinicalTrials.gov
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