A Phase I-II, Multicenter Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Patients With Resectable Stage I-III Non-Small Cell Lung Cancer, Selected According to Biomarker Status
New lung cancer treatment study for early-stage non-squamous NSCLC with ALK fusion
Plain English Summary
A Study to See How Well and How Safely Different Treatments Work in a Group of Participants With Non-Small Cell Lung Cancer (NSCLC) is a Phase 2 clinical trial sponsored by Hoffmann-La Roche studying Non-Small Cell Lung Cancer. This study tests a combination of alectinib with chemotherapy (cisplatin or carboplatin and pemetrexed) after surgery for non-small cell lung cancer. It is for patients with early-stage (Stage I-III) non-squamous non-small cell lung cancer that has been surgically removed and has a specific genetic marker (ALK fusion). Participants will receive oral alectinib daily and chemotherapy for up to 4 cycles. The study will monitor for side effects and how well the treatment works. Alternative treatments after surgery may include observation or other chemotherapy regimens, depending on the specific cancer characteristics and patient health. The trial aims to enroll 11 participants.
Official Summary
The objective of this study is to explore the safety of alectinib in combination with chemotherapy in participants with resectable NSCLC. Cohort B1 is a phase II cohort that will assess the safety of alectinib in combination with up to four cycles of platinum-based chemotherapy in the adjuvant setting post complete surgical resection.
Who Can Participate
Here is what you need to know about eligibility for this trial. Patients with non-small cell lung cancer (adenocarcinoma) that has been completely removed by surgery. The cancer must be Stage II to select Stage IIIB and have a confirmed ALK fusion gene. Patients must have a good general health status (ECOG performance status of 0 or 1). Patients with squamous cell lung cancer or those who have had prior cancer treatment are not eligible. This trial is studying Non-Small Cell Lung Cancer, so participants generally need a confirmed diagnosis.
What They're Measuring
The study will primarily measure how safe the combination treatment is by tracking any side effects that occur. The specific primary outcome measures are: Incidence, Type, and Severity of Adverse Events (AEs) With Onset up to 28 Days After the Last Dose of Chemotherapy (Up to 28 days after the last dose of chemotherapy treatment (up to 4 cycles, cycle length = 3 weeks)). 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 trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.
Why This Trial Matters
This trial addresses a need for more effective treatments after surgery for specific types of early-stage lung cancer, aiming to reduce the chance of the cancer returning. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Non-Small Cell Lung Cancer, where improved treatment options are needed.
Investor Insight
This Phase II study, sponsored by Hoffmann-La Roche, investigates a targeted therapy (alectinib) in combination with chemotherapy for a specific lung cancer subtype, indicating a focus on personalized Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.
Is This Trial Right for Me?
Ask your doctor about the specific chemotherapy drugs used, the duration of treatment, and potential side effects. Participation involves taking daily medication and receiving chemotherapy infusions, with regular visits for monitoring and tests. Be prepared for potential side effects from both alectinib and chemotherapy, and discuss any concerns with your healthcare team. The trial is being conducted at 11 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: INTERVENTIONAL
- Allocation: NA
- Model: SINGLE_GROUP
- Masking: NONE
- Enrollment: 11 participants
Interventions
- DRUG: Alectinib — Participants will receive oral alectinib twice daily (BID) for up to 2 years.
- DRUG: Cisplatin — Participants will receive intravenous (IV) cisplatin on Day 1 of each cycle for up to 4 cycles (cycle length = 3 weeks).
- DRUG: Carboplatin — Participants will receive IV carboplatin on Day 1 of each cycle for up to 4 cycles (cycle length = 3 weeks).
- DRUG: Pemetrexed — Participants will receive IV pemetrexed on Day 1 of each cycle for up to 4 cycles (cycle length = 3 weeks).
Primary Outcomes
- Incidence, Type, and Severity of Adverse Events (AEs) With Onset up to 28 Days After the Last Dose of Chemotherapy (Up to 28 days after the last dose of chemotherapy treatment (up to 4 cycles, cycle length = 3 weeks))
Secondary Outcomes
- Incidence, Type, and Severity of AEs With Onset up to 28 Days After the Last Dose of Study Treatment or Until Last on Site/Discontinuation Visit, Whichever Comes First (From first dose to up to approximately 2 years)
Full Eligibility Criteria
Inclusion Criteria: * Complete resection of the primary NSCLC with negative margins * Confirmed stage II to select stage IIIB (T3N2) NSCLC of non-squamous (adenocarcinoma) histology * Eastern cooperative oncology group (ECOG) performance status of 0 or 1 * Documented ALK fusion Exclusion Criteria: * NSCLC of squamous or mixed histology regardless of the presence of an ALK mutation * Prior exposure to any systemic anti-cancer therapy * Pregnancy or breastfeeding, or intention of becoming pregnant during the study
Trial Locations
- Royal North Shore Hospital, St Leonards, New South Wales, Australia
- Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia
- Instituto do Cancer do Estado de Sao Paulo - ICESP, São Paulo, São Paulo, Brazil
- RedSalud Vitacura, Santiago, Chile
- Beijing Cancer Hospital, Beijing, China
- The third people's hospital of Chengdu, Chengdu, China
- Guangdong General Hospital, Guangzhou, China
- Jinhua municipal central hospital, Jinhua, China
- Yunnan Cancer Hospital, Kunming, China
- Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia, Perugia, Umbria, Italy
- ...and 1 more locations
Frequently Asked Questions
What is clinical trial NCT06624059?
NCT06624059 is a Phase 2 INTERVENTIONAL study titled "A Study to See How Well and How Safely Different Treatments Work in a Group of Participants With Non-Small Cell Lung Cancer (NSCLC)." It is currently active, not recruiting and is sponsored by Hoffmann-La Roche. The trial targets enrollment of 11 participants.
What conditions does NCT06624059 study?
This trial investigates treatments for Non-Small Cell Lung Cancer. The primary condition under study is Non-Small Cell Lung Cancer.
What treatments are being tested in NCT06624059?
The interventions being studied include: Alectinib (DRUG), Cisplatin (DRUG), Carboplatin (DRUG), Pemetrexed (DRUG). Participants will receive oral alectinib twice daily (BID) for up to 2 years.
What does Phase 2 mean for NCT06624059?
Phase 2 trials test whether the treatment works for the intended condition. They involve 100-300 patients and continue to evaluate safety while measuring effectiveness.
What is the current status of NCT06624059?
This trial is currently "Active, Not Recruiting." It started on 2024-11-18. The estimated completion date is 2026-08-28.
Who is sponsoring NCT06624059?
NCT06624059 is sponsored by Hoffmann-La Roche. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06624059?
The trial aims to enroll 11 participants. The trial status is active, not recruiting.
How is NCT06624059 designed?
This is a interventional study, uses na allocation, follows a single_group design, employs none masking.
What are the primary outcomes being measured in NCT06624059?
The primary outcome measures are: Incidence, Type, and Severity of Adverse Events (AEs) With Onset up to 28 Days After the Last Dose of Chemotherapy (Up to 28 days after the last dose of chemotherapy treatment (up to 4 cycles, cycle length = 3 weeks)). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06624059 being conducted?
This trial is being conducted at 11 sites, including St Leonards, New South Wales; Nedlands, Western Australia; São Paulo, São Paulo; Santiago and 7 more sites (Australia, Brazil, Chile).
Where can I find official information about NCT06624059?
The official record for NCT06624059 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06624059. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06624059 testing in simple terms?
This study tests a combination of alectinib with chemotherapy (cisplatin or carboplatin and pemetrexed) after surgery for non-small cell lung cancer. It is for patients with early-stage (Stage I-III) non-squamous non-small cell lung cancer that has been surgically removed and has a specific genetic marker (ALK fusion).
Why is this trial significant?
This trial addresses a need for more effective treatments after surgery for specific types of early-stage lung cancer, aiming to reduce the chance of the cancer returning.
What are the potential risks of participating in NCT06624059?
Common side effects may include fatigue, nausea, diarrhea, and skin rash. Chemotherapy can cause more significant side effects like low blood cell counts, hair loss, and mouth sores. There is a risk of allergic reactions to the medications and potential long-term effects that are still being studied. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06624059?
Ask your doctor about the specific chemotherapy drugs used, the duration of treatment, and potential side effects. Participation involves taking daily medication and receiving chemotherapy infusions, with regular visits for monitoring and tests. Be prepared for potential side effects from both alectinib and chemotherapy, and discuss any concerns with your healthcare team. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06624059 signal from an investment perspective?
This Phase II study, sponsored by Hoffmann-La Roche, investigates a targeted therapy (alectinib) in combination with chemotherapy for a specific lung cancer subtype, indicating a focus on personalized This is a Phase 2 trial, which is focused on confirming efficacy before larger pivotal studies.
What happens if the treatment in this trial doesn't work?
Participants will receive oral alectinib daily and chemotherapy for up to 4 cycles. The study will monitor for side effects and how well the treatment works. 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.
Related Conditions
More Non-Small Cell Lung Cancer Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.