A Study to See How Well and How Safely Different Treatments Work in a Group of Participants With Non-Small Cell Lung Cancer (NSCLC)

Phase 3

Recruiting

• Conditions: Non-Small Cell Lung Cancer
• Interventions: Drug: Alectinib; Drug: Cisplatin; Drug: Carboplatin; Drug: Pemetrexed

• 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

Study Timeline

• Study First Submitted: 2024-10-01
• Study First Submitted QC: 2024-10-01
• Study First Posted: 2024-10-02
• Study Start: 2024-11-18
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-19
• Last Update Posted: 2025-06-22
• Primary Completion: 2028-06-13
• Study Completion: 2033-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
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.
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.

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: 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: 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: 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 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: 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: 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)
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

Trial Locations

Locations (19)

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

Royal North Shore Hospital; 🇦🇺 St. Leonards, New South Wales, Australia

Peter Maccallum Cancer Centre; 🇦🇺 Melbourne, Victoria, 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

Sir Charles Gairdner Hospital; 🇦🇺 Nedlands, Western Australia, Australia

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