Real World Clinical Outcomes of Resected ALK-Positive Early Stage NSCLC Patients Treated With Alectinib as Adjuvant Therapy in China: A Multicenter, Prospective Cohort Study
Real-world lung cancer outcomes with Alectinib in China
Plain English Summary
Real World Clinical Outcomes of Resected ALK-Positive Early Stage NSCLC Patients Treated With Alectinib as Adjuvant Therapy is a Not Applicable clinical trial sponsored by Hoffmann-La Roche studying Carcinoma, Non-Small-Cell Lung. This study observes how well Alectinib works for patients with early-stage, ALK-positive lung cancer in China after surgery. It is for adults diagnosed with a specific type of non-small cell lung cancer (NSCLC) that is ALK-positive and has been surgically removed. Participation involves being monitored as you receive Alectinib as part of your standard medical care; no new treatments are given in this study. The main alternative is standard chemotherapy or other targeted therapies if Alectinib is not used. The trial aims to enroll 800 participants.
Official Summary
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.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you are an adult with ALK-positive NSCLC, stages II-IIIB, have had surgery to remove the tumor, and started Alectinib within 28 days of surgery without prior systemic treatment. You cannot join if you are pregnant, breastfeeding, or currently in another interventional treatment study. Age is not specified, but it is for adults. Good general health is implied, as it follows standard post-surgical treatment. This trial is studying Carcinoma, Non-Small-Cell Lung, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
Disease-free survival means the study will track how long patients live without their cancer returning after treatment. The specific primary outcome measures are: Real-world disease-free survival (rwDFS) (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)). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial matters because it will provide real-world data on how effective Alectinib is for early-stage ALK-positive lung cancer in China, filling a gap in understanding its use outside of controlled This research targets Carcinoma, Non-Small-Cell Lung, where improved treatment options are needed.
Investor Insight
This observational study in China, sponsored by a major pharmaceutical company, signals confidence in Alectinib's market potential for early-stage lung cancer, suggesting a favorable outlook for its c The large enrollment target of 800 participants suggests significant investment in this program.
Is This Trial Right for Me?
Ask your doctor if this study is right for you and what the potential benefits and risks of Alectinib are. Participation means your medical information and treatment progress will be collected and reviewed by researchers. Day-to-day involvement is minimal, as it follows your regular medical care and appointments. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: OBSERVATIONAL
- Enrollment: 800 participants
Interventions
- DRUG: Alectinib — 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.
Primary Outcomes
- Real-world disease-free survival (rwDFS) (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
- Duration of alectinib therapy (From start of treatment to the date of treatment discontinuation (up to approximately 2.5 years))
- Participant demographics by disease stage and city tier (Up to approximately 2.5 years)
- Participant clinical characteristics as determined by Eastern Cooperative Oncology Group performance status (ECOG PS) by disease stage and city tier (Up to approximately 2.5 years)
- Participant clinical characteristics as determined by surgery history by disease stage and city tier (Up to approximately 2.5 years)
- Emotional and physical functioning as determined by the 36-item short form survey (SF-36) v2 questionnaires (At enrollment, then every approximately 3 months thereafter (up to approximately 2.5 years))
Full Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Patients participating in interventional study of adjuvant treatment * Pregnant, lactating, or breastfeeding women
Trial Locations
- Affiliated Hospital of Guangdong Medical University, Zhanjiang, Guangdong, China
- Affiliated Cancer Hospital and Institute of Guangzhou Medical University, Guangzhou, Guangzhou, China
- Huai He Hospital of Henan University, Kaifeng, Henan, China
- Henan Provincial Chest Hospital, Zhengzhou, Henan, China
- The First Affiliated Hospital of Xinjiang Medical University, Ürümqi, Xinjiang, China
- Peking University First Hospital, Beijing, China
- Xuanwu Hospital, Capital Medical University, Beijing, China
- Changzhou First People's Hospital, Changzhou, China
- Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital, Chengdu, China
- The First Affiliated Hospital, Chongqing Medical University, Chongqing, China
- ...and 10 more locations
Frequently Asked Questions
What is clinical trial NCT06862869?
NCT06862869 is a Not Applicable OBSERVATIONAL study titled "Real World Clinical Outcomes of Resected ALK-Positive Early Stage NSCLC Patients Treated With Alectinib as Adjuvant Therapy." It is currently recruiting and is sponsored by Hoffmann-La Roche. The trial targets enrollment of 800 participants.
What conditions does NCT06862869 study?
This trial investigates treatments for Carcinoma, Non-Small-Cell Lung. The primary condition under study is Carcinoma, Non-Small-Cell Lung.
What treatments are being tested in NCT06862869?
The interventions being studied include: 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.
What does Not Applicable mean for NCT06862869?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT06862869?
This trial is currently "Recruiting." It started on 2025-04-30. The estimated completion date is 2029-04-30.
Who is sponsoring NCT06862869?
NCT06862869 is sponsored by Hoffmann-La Roche. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06862869?
The trial aims to enroll 800 participants. The trial is currently recruiting and accepting new participants.
How is NCT06862869 designed?
This is a observational study.
What are the primary outcomes being measured in NCT06862869?
The primary outcome measures are: Real-world disease-free survival (rwDFS) (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)). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06862869 being conducted?
This trial is being conducted at 20 sites, including Zhanjiang, Guangdong; Guangzhou, Guangzhou; Kaifeng, Henan; Zhengzhou, Henan and 16 more sites (China).
Where can I find official information about NCT06862869?
The official record for NCT06862869 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06862869. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06862869 testing in simple terms?
This study observes how well Alectinib works for patients with early-stage, ALK-positive lung cancer in China after surgery. It is for adults diagnosed with a specific type of non-small cell lung cancer (NSCLC) that is ALK-positive and has been surgically removed.
Why is this trial significant?
This trial matters because it will provide real-world data on how effective Alectinib is for early-stage ALK-positive lung cancer in China, filling a gap in understanding its use outside of controlled
What are the potential risks of participating in NCT06862869?
The main risk is that Alectinib may not prevent the cancer from returning. Common side effects of Alectinib can include fatigue, nausea, swelling, and muscle pain, which should be discussed with your doctor. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06862869?
Ask your doctor if this study is right for you and what the potential benefits and risks of Alectinib are. Participation means your medical information and treatment progress will be collected and reviewed by researchers. Day-to-day involvement is minimal, as it follows your regular medical care and appointments. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06862869 signal from an investment perspective?
This observational study in China, sponsored by a major pharmaceutical company, signals confidence in Alectinib's market potential for early-stage lung cancer, suggesting a favorable outlook for its c This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves being monitored as you receive Alectinib as part of your standard medical care; no new treatments are given in this study. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.