A Study to See How Well and How Safely Different Treatments Work in a Group of Participants With Non-Small Cell Lung Cancer (NSCLC)
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT06624059
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
The objective of this study is to evaluate the efficacy and/or safety of multiple therapies in patients with early-stage resectable NSCLC. Cohort B1 is a phase II cohort that will evaluate the safety, and efficacy of alectinib in combination with up to four cycles of platinum-based chemotherapy in the adjuvant setting post complete surgical resection. Cohort B2 is a phase II cohort that will evaluate the efficacy and safety of perioperative alectinib in combination with chemotherapy in the neoadjuvant setting.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort B2 Carboplatin 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. Cohort B2 Pemetrexed 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. Cohort B1 Alectinib 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. Cohort B1 Cisplatin 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. Cohort B1 Carboplatin 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. Cohort B1 Pemetrexed 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. Cohort B2 Alectinib 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. Cohort B2 Cisplatin 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.
- Primary Outcome Measures
Name Time Method Cohort B1: 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) Cohort B2: Investigator-assessed pathologic complete response (inv-pCR) At the time of surgical resection (approximately weeks 14-17)
- Secondary Outcome Measures
Name Time Method Cohort B1: Incidence, type, and severity of AEs with onset up to 28 days after the last dose of study treatment From first dose to up to approximately 5 years Cohort B1: Time to first onset of selected AEs From first dose to up to approximately 5 years Cohort B2: Pathologic complete response (pCR) by independent review At the time of surgical resection (approximately weeks 14-17) Cohort B2: Major pathologic response (MPR) by independent review At the time of surgical resection (approximately weeks 14-17) Cohort B2: Investigator-assessed overall response rate (ORR) Up to approximately Week 17 Cohort B2: Length of treatment-related surgical delays, incidence of operative and post-operative complications, and/or reasons for surgical cancellations Approximately weeks 14-24 Cohort B1: Investigator-assessed disease-free survival (DFS) From initiation of study treatment to the first documented recurrence of disease or new primary NSCLC or death from any cause, whichever occurs first (up to approximately 5 years) Cohort B1: Overall survival (OS) From initiation of study treatment to death from any cause (up to approximately 8 years) Cohort B1: Change from baseline in target safety parameters From first dose to up to approximately 5 years Cohort B2: Investigator-assessed major pathological response (inv-MPR) At the time of surgical resection (approximately weeks 14-17) Cohort B2: Investigator-assessed event-free survival (EFS) From first treatment to the first documented disease progression that prevents surgery, local or distant disease recurrence, or death from any cause (up to approximately 5 years) Cohort B2: Overall Survival (OS) From initiation of study treatment to death from any cause (up to approximately 8 years) Cohort B2: Incidence, severity, and type of AEs From first dose up to approximately 5 years Cohort B2: Change from baseline in target safety parameters From first dose to up to approximately 5 years Cohort B2: Frequency of surgery completion, defined as participants who have successfully completed surgery without treatment-related delays (> 60 days) from the last dose of neoadjuvant treatment At the time of surgical resection (approximately weeks 14-17)
Trial Locations
- Locations (17)
Royal North Shore Hospital
🇦🇺St. Leonards, New South Wales, Australia
Calvary Mater Newcastle
🇦🇺Waratah, New South Wales, Australia
Xiangya Hospital of Centre-South University
🇨🇳Changsha, China
The third people's hospital of Chengdu
🇨🇳Chengdu, China
Centro de Estudios Clínicos SAGA
🇨🇱Santiago, Chile
OrlandiOncología
🇨🇱Santiago, Chile
Inst. Nacional Del Cancer; Servicio de Oncologia Medica
🇨🇱Santiago, Chile
James Lind Centro de Investigación Del Cáncer
🇨🇱Temuco, Chile
Peter Maccallum Cancer Centre
🇦🇺Melbourne, Victoria, Australia
Sir Charles Gairdner Hospital
🇦🇺Nedlands, Western Australia, Australia
Beijing Cancer Hospital
🇨🇳Beijing, China
RedSalud Vitacura
🇨🇱Santiago, Chile
K2 Oncology
🇨🇱Providencia, Chile
Clinical Research Alliance
🇺🇸Westbury, New York, United States
Hospital de Cancer de Barretos
🇧🇷Barretos, São Paulo, Brazil
Hospital de Base de Sao Jose do Rio Preto
🇧🇷Sao Jose do Rio Preto, São Paulo, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
🇧🇷Sao Paulo, São Paulo, Brazil