A Study to See How Well and How Safely Different Treatments Work in a Group of Participants With Non-Small Cell Lung Cancer (NSCLC)
NCT ID: NCT06624059
Last Updated: 2026-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
11 participants
INTERVENTIONAL
2024-11-18
2033-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort B1
Participants will receive alectinib in combination with platinum-based chemotherapy for up to 4 cycles (cycle length = 3 weeks), followed by alectinib monotherapy for up to 5 years.
Alectinib
Cohort B1: participants will receive oral alectinib twice daily (BID) for up to 5 years.
Cohort B2: Participants will receive oral alectinib BID for 3 cycles (cycle length = 3 weeks) prior to surgery, and for up to 5 years after surgery.
Cisplatin
Cohort B1: Participants will receive intravenous (IV) cisplatin on Day 1 of each cycle for up to 4 cycles (cycle length = 3 weeks).
Cohort B2: Participants will receive IV cisplatin on Day 1 of each cycle for up to 3 cycles (cycles length = 3 weeks) prior to surgery.
Carboplatin
Cohort B1: Participants will receive IV carboplatin on Day 1 of each cycle for up to 4 cycles (cycle length = 3 weeks).
Cohort B2: Participants will receive IV carboplatin on Day 1 of each cycle for up to 3 cycles (cycle length = 3 weeks) prior to surgery.
Pemetrexed
Cohort B1: Participants will receive IV pemetrexed on Day 1 of each cycle for up to 4 cycles (cycle length = 3 weeks).
Cohort B2: Participants will receive IV pemetrexed on Day 1 of each cycle for up to 3 cycles (cycle length = 3 weeks) prior to surgery.
Cohort B2
Participants will receive alectinib and platinum-based chemotherapy for up to 3 cycles (cycle length = 3 weeks) prior to surgery, and alectinib monotherapy after surgery for up to 5 years after surgery.
Alectinib
Cohort B1: participants will receive oral alectinib twice daily (BID) for up to 5 years.
Cohort B2: Participants will receive oral alectinib BID for 3 cycles (cycle length = 3 weeks) prior to surgery, and for up to 5 years after surgery.
Cisplatin
Cohort B1: Participants will receive intravenous (IV) cisplatin on Day 1 of each cycle for up to 4 cycles (cycle length = 3 weeks).
Cohort B2: Participants will receive IV cisplatin on Day 1 of each cycle for up to 3 cycles (cycles length = 3 weeks) prior to surgery.
Carboplatin
Cohort B1: Participants will receive IV carboplatin on Day 1 of each cycle for up to 4 cycles (cycle length = 3 weeks).
Cohort B2: Participants will receive IV carboplatin on Day 1 of each cycle for up to 3 cycles (cycle length = 3 weeks) prior to surgery.
Pemetrexed
Cohort B1: Participants will receive IV pemetrexed on Day 1 of each cycle for up to 4 cycles (cycle length = 3 weeks).
Cohort B2: Participants will receive IV pemetrexed on Day 1 of each cycle for up to 3 cycles (cycle length = 3 weeks) prior to surgery.
Interventions
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Alectinib
Cohort B1: participants will receive oral alectinib twice daily (BID) for up to 5 years.
Cohort B2: Participants will receive oral alectinib BID for 3 cycles (cycle length = 3 weeks) prior to surgery, and for up to 5 years after surgery.
Cisplatin
Cohort B1: Participants will receive intravenous (IV) cisplatin on Day 1 of each cycle for up to 4 cycles (cycle length = 3 weeks).
Cohort B2: Participants will receive IV cisplatin on Day 1 of each cycle for up to 3 cycles (cycles length = 3 weeks) prior to surgery.
Carboplatin
Cohort B1: Participants will receive IV carboplatin on Day 1 of each cycle for up to 4 cycles (cycle length = 3 weeks).
Cohort B2: Participants will receive IV carboplatin on Day 1 of each cycle for up to 3 cycles (cycle length = 3 weeks) prior to surgery.
Pemetrexed
Cohort B1: Participants will receive IV pemetrexed on Day 1 of each cycle for up to 4 cycles (cycle length = 3 weeks).
Cohort B2: Participants will receive IV pemetrexed on Day 1 of each cycle for up to 3 cycles (cycle length = 3 weeks) prior to surgery.
Eligibility Criteria
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Inclusion Criteria
* 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
* Evaluation by the operating attending surgeon and involved medical oncologist prior to study enrollment to verify study eligibility for complete surgical resection with curative intent
* Pathologically and/or histologically confirmed Stage II-IIIA and IIIB (T3N2 only) NSCLC of non-squamous (adenocarcinoma) histology
* Documented ALK fusion
Exclusion Criteria
* Prior exposure to any systemic anti-cancer therapy
* NSCLC of squamous or mixed histology regardless of the presence of an ALK mutation
* Known sensitivity to any component of alectinib, pemetrexed, cisplatin, or carboplatin
* Prior exposure to any systemic anti-cancer therapy
* Pregnancy or breastfeeding, or intention of becoming pregnant during the study
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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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
Institut Gustave Roussy
Villejuif, , France
Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia
Perugia, Umbria, Italy
Asan Medical Center
Seoul, , South Korea
Countries
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Other Identifiers
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BO43249
Identifier Type: -
Identifier Source: org_study_id
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