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

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...

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
150
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Cohort B1CarboplatinParticipants 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 B1PemetrexedParticipants 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 B1AlectinibParticipants 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 B1CisplatinParticipants 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 B2AlectinibParticipants 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 B2CisplatinParticipants 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 B2CarboplatinParticipants 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 B2PemetrexedParticipants 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
NameTimeMethod
Cohort B1: Incidence, type, and severity of adverse events (AEs) with onset up to 28 days after the last dose of chemotherapyUp 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
NameTimeMethod
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 treatmentFrom first dose to up to approximately 5 years
Cohort B1: Time to first onset of selected AEsFrom 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 reviewAt the time of surgical resection (approximately weeks 14-17)
Cohort B2: Major pathologic response (MPR) by independent reviewAt 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 B1: Change from baseline in target safety parametersFrom first dose to up to approximately 5 years
Cohort B2: Incidence, severity, and type of AEsFrom first dose up to approximately 5 years
Cohort B2: Change from baseline in target safety parametersFrom 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 treatmentAt 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 cancellationsApproximately weeks 14-24

Trial Locations

Locations (6)

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

🇦🇺

Saint Leornards, New South Wales, Australia

Peter Maccallum Cancer Centre

🇦🇺

Melbourne, Victoria, Australia

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