Clinical trial NCT06624059: A Study to See How Well and How Safely Different Treatments Work in a Group of Participants With Non-Small Cell Lung Cancer (NSCLC)
Official title: A Phase I-III, 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2024-10-02
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria Cohort B1:

* 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

Inclusion Criteria Cohort B2:

* 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

Inclusion Criteria Cohorts B1 and B2:

* Documented ALK fusion

Exclusion Criteria Cohort B1:

* NSCLC of squamous or mixed histology regardless of the presence of an ALK mutation
* Prior exposure to any systemic anti-cancer therapy

Exclusion Criteria Cohort B2:

* 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

Exclusion Criteria Cohorts B1 and B2:

* Pregnancy or breastfeeding, or intention of becoming pregnant during the study

Primary outcomes:
measure: Cohort B1: Incidence, type, and severity of adverse events (AEs) with onset up to 28 days after the last dose of chemotherapy
timeFrame: Up to 28 days after the last dose of chemotherapy treatment (up to 4 cycles, cycle length = 3 weeks)
measure: Cohort B2: Investigator-assessed pathologic complete response (inv-pCR)
timeFrame: At the time of surgical resection (approximately weeks 14-17)
Secondary outcomes:
measure: Cohort B1: Investigator-assessed disease-free survival (DFS)
timeFrame: 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)
measure: Cohort B1: Overall survival (OS)
timeFrame: From initiation of study treatment to death from any cause (up to approximately 8 years)
measure: Cohort B1: Incidence, type, and severity of AEs with onset up to 28 days after the last dose of study treatment
timeFrame: From first dose to up to approximately 5 years
measure: Cohort B1: Time to first onset of selected AEs
timeFrame: From first dose to up to approximately 5 years
measure: Cohort B1: Change from baseline in target safety parameters
timeFrame: From first dose to up to approximately 5 years
measure: Cohort B2: Investigator-assessed major pathological response (inv-MPR)
timeFrame: At the time of surgical resection (approximately weeks 14-17)
measure: Cohort B2: Pathologic complete response (pCR) by independent review
timeFrame: At the time of surgical resection (approximately weeks 14-17)
measure: Cohort B2: Major pathologic response (MPR) by independent review
timeFrame: At the time of surgical resection (approximately weeks 14-17)
measure: Cohort B2: Investigator-assessed overall response rate (ORR)
timeFrame: Up to approximately Week 17
measure: Cohort B2: Investigator-assessed event-free survival (EFS)
timeFrame: 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)
measure: Cohort B2: Overall Survival (OS)
timeFrame: From initiation of study treatment to death from any cause (up to approximately 8 years)
measure: Cohort B2: Incidence, severity, and type of AEs
timeFrame: From first dose up to approximately 5 years
measure: Cohort B2: Change from baseline in target safety parameters
timeFrame: From first dose to up to approximately 5 years
measure: 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
timeFrame: At the time of surgical resection (approximately weeks 14-17)
measure: Cohort B2: Length of treatment-related surgical delays, incidence of operative and post-operative complications, and/or reasons for surgical cancellations
timeFrame: Approximately weeks 14-24
Other outcomes:
Locations:
city: Westbury
country: United States
facility: Clinical Research Alliance
state: New York
city: St. Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Waratah
country: Australia
facility: Calvary Mater Newcastle
state: New South Wales
city: Melbourne
country: Australia
facility: Peter Maccallum Cancer Centre
state: Victoria
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas - PUCRS
state: Rio Grande Do Sul
city: Barretos
country: Brazil
facility: Hospital de Cancer de Barretos
state: São Paulo
city: Sao Jose do Rio Preto
country: Brazil
facility: Hospital de Base de Sao Jose do Rio Preto
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Instituto do Cancer do Estado de Sao Paulo - ICESP
state: São Paulo
city: Providencia
country: Chile
facility: K2 Oncology
city: Santiago
country: Chile
facility: RedSalud Vitacura
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Changsha
country: China
facility: Xiangya Hospital of Centre-South University
city: Chengdu
country: China
facility: The third people's hospital of Chengdu
city: Guangzhou
country: China
facility: Guangdong General Hospital
city: Jinhua
country: China
facility: Jinhua municipal central hospital
city: Kunming
country: China
facility: Yunnan Cancer Hospital
city: Wuhan City
country: China
facility: Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
city: Zhejiang
country: China
facility: Zhejiang Cancer Hospital
city: Perugia
country: Italy
facility: Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia
state: Umbria
city: Gyeonggi-do
country: Korea, Republic of
facility: St. Vincent's Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Malaga
country: Spain
facility: Hospital Regional Universitario Carlos Haya
city: Dusit
country: Thailand
facility: Oncology Unit, Faculty of Medicine, Vajira Hospital
city: Khon Kaen
country: Thailand
facility: Srinagarind Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: