Non-Small Cell Lung CancerPhase 3HORIZON 2NCT06624059
A Study to See How Well and How Safely Different Treatments Work in a Group of Participants With Non-Small Cell Lung Cancer (NSCLC)
A Phase 3 study testing Alectinib, Cisplatin and Carboplatin in people with Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 11 sites in 6 countries.
Trial 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… 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, Cisplatin and Carboplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 11 sitesin 6 countries
- Study dates
- 18 Nov 2024to 31 Jul 2026
- Phase
- Phase 3
- 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
- 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
Who cannot join
- 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 and contacts
11 sites in 6 countries.
11 sites in 6 countries
China5 sites
Beijing Cancer Hospital
Beijing, 100142
The third people's hospital of Chengdu
Chengdu
Guangdong General Hospital
Guangzhou, 510000
Jinhua municipal central hospital
Jinhua
Yunnan Cancer Hospital
Kunming, 650118
Australia2 sites
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009
Royal North Shore Hospital
St Leonards, New South Wales, 2065
Brazil1 site
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo, São Paulo, 01246-000
Italy1 site
Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia
Perugia, Umbria, 06156
About this study
Official title: 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
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.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Alectinib, Cisplatin, Carboplatin, Pemetrexed
- 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
Participants will receive oral alectinib twice daily (BID) for up to 2 years.
CisplatinDrug
Participants will receive intravenous (IV) cisplatin on Day 1 of each cycle for up to 4 cycles (cycle length = 3 weeks).
CarboplatinDrug
Participants will receive IV carboplatin on Day 1 of each cycle for up to 4 cycles (cycle length = 3 weeks).
PemetrexedDrug
Participants will receive IV pemetrexed on Day 1 of each cycle for up to 4 cycles (cycle length = 3 weeks).
| Study group | Role | What they receive |
|---|---|---|
| Cohort B1 | Experimental | Participants will receive alectinib in combination with a platinum-based chemotherapy for up to 4 cycles (cycle length = 3 weeks), followed by alectinib monotherapy for up to 2 years. Receives: Drug: Alectinib; Drug: Cisplatin; Drug: Carboplatin; Drug: Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, Type, and Severity of Adverse Events (AEs) With Onset up to 28 Days After the Last Dose of Chemotherapy
Measured: Up to 28 days after the last dose of chemotherapy treatment (up to 4 cycles, cycle length = 3 weeks)
Secondary outcomes (1)
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
Measured: From first dose to up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start18 Nov 2024
- Primary completion31 Jul 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06624059
- Sponsor's protocol ID
- BO43249
- Acronym
- HORIZON 2
- Status last verified
- Aug 2026
- First submitted
- 1 Oct 2024
- Last updated
- 19 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06624059
- Acronym / sponsor ID
- HORIZON 2 / BO43249
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 2 Oct 2024 (actual)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort B1 | Experimental | Drug: Alectinib, Drug: Cisplatin, Drug: Carboplatin, Drug: PemetrexedParticipants will receive alectinib in combination with a platinum-based chemotherapy for up to 4 cycles (cycle length = 3 weeks), followed by alectinib monotherapy for up to 2 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| AlectinibParticipants will receive oral alectinib twice daily (BID) for up to 2 years. | Drug | Cohort B1 |
| CisplatinParticipants will receive intravenous (IV) cisplatin on Day 1 of each cycle for up to 4 cycles (cycle length = 3 weeks). | Drug | Cohort B1 |
| CarboplatinParticipants will receive IV carboplatin on Day 1 of each cycle for up to 4 cycles (cycle length = 3 weeks). | Drug | Cohort B1 |
| PemetrexedParticipants will receive IV pemetrexed on Day 1 of each cycle for up to 4 cycles (cycle length = 3 weeks). | Drug | Cohort B1 |
Primary outcome
Incidence, Type, and Severity of Adverse Events (AEs) With Onset up to 28 Days After the Last Dose of Chemotherapy
Time frame: Up to 28 days after the last dose of chemotherapy treatment (up to 4 cycles, cycle length = 3 weeks)
1 secondary outcome
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
Time frame: From first dose to up to approximately 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: Yes. For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
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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
11 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Alectinib, Cisplatin and Carboplatin in people with Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 11 sites in 6 countries.
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 4 inclusion and 3 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 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in China, Australia, Brazil, Chile, Italy and 1 more country. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Incidence, Type, and Severity of Adverse Events (AEs) With Onset up to 28 Days After the Last Dose of Chemotherapy (time frame: Up to 28 days after the last dose of chemotherapy treatment (up to 4 cycles, cycle length = 3 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2026.