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

Trial Title: 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

Condition: Non-Small Cell Lung Cancer

Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Carboplatin
Pemetrexed
Alectinib

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Alectinib
Description: 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.
Arm group label: Cohort B1
Arm group label: Cohort B2

Intervention type: Drug
Intervention name: Cisplatin
Description: 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.
Arm group label: Cohort B1
Arm group label: Cohort B2

Intervention type: Drug
Intervention name: Carboplatin
Description: 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.
Arm group label: Cohort B1
Arm group label: Cohort B2

Intervention type: Drug
Intervention name: Pemetrexed
Description: 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.
Arm group label: Cohort B1
Arm group label: Cohort B2

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Centro de Estudios Clínicos SAGA

Address:
City: Santiago
Zip: 7500653
Country: Chile

Facility:
Name: OrlandiOncología

Address:
City: Santiago
Zip: 7500713
Country: Chile

Facility:
Name: Inst. Nacional Del Cancer; Servicio de Oncologia Medica

Address:
City: Santiago
Country: Chile

Facility:
Name: James Lind Centro de Investigación Del Cáncer

Address:
City: Temuco
Zip: 4800827
Country: Chile

Start date: December 20, 2024

Completion date: March 31, 2033

Lead sponsor:
Agency: Hoffmann-La Roche
Agency class: Industry

Source: Hoffmann-La Roche

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06624059