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

NCT06624059 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: BO43249
• Study Type: interventional
• Target: 11
• Locations: 6 countries
• Sites: 11

Brief Summary

The objective of this study is to explore the safety of alectinib in combination with chemotherapy in participants with resectable NSCLC. Cohort B1 is a phase II cohort that will assess the safety of alectinib in combination with up to four cycles of platinum-based chemotherapy in the adjuvant setting post complete surgical resection.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• Incidence, Type, and Severity of AEs With Onset up to 28 Days After the Last Dose of Study Treatment or Until Last on Site/Discontinuation Visit, Whichever Comes First

  From first dose to up to approximately 2 years

Study Arms (1)

Cohort B1

EXPERIMENTAL

Participants will receive alectinib in combination with a platinum-based chemotherapy for up to 4 cycles (cycle length = 3 weeks), followed by alectinib monotherapy for up to 2 years.

Drug: Alectinib; Drug: Cisplatin; Drug: Carboplatin; Drug: Pemetrexed

Interventions

Cisplatin DRUG

Participants will receive intravenous (IV) cisplatin on Day 1 of each cycle for up to 4 cycles (cycle length = 3 weeks).

Cohort B1

Carboplatin DRUG

Participants will receive IV carboplatin on Day 1 of each cycle for up to 4 cycles (cycle length = 3 weeks).

Cohort B1

Pemetrexed DRUG

Participants will receive IV pemetrexed on Day 1 of each cycle for up to 4 cycles (cycle length = 3 weeks).

Cohort B1

Alectinib DRUG

Participants will receive oral alectinib twice daily (BID) for up to 2 years.

Cohort B1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Documented ALK fusion

You may not qualify if:

• NSCLC of squamous or mixed histology regardless of the presence of an ALK mutation
• Prior exposure to any systemic anti-cancer therapy
• Pregnancy or breastfeeding, or intention of becoming pregnant during the study

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (11)

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

Location

Sir Charles Gairdner Hospital

Nedlands, Western Australia, 6009, Australia

Location

Instituto do Cancer do Estado de Sao Paulo - ICESP

São Paulo, São Paulo, 01246-000, Brazil

Location

RedSalud Vitacura

Santiago, Chile

Location

Beijing Cancer Hospital

Beijing, 100142, China

Location

The third people's hospital of Chengdu

Chengdu, China

Location

Guangdong General Hospital

Guangzhou, 510000, China

Location

Jinhua municipal central hospital

Jinhua, China

Location

Yunnan Cancer Hospital

Kunming, 650118, China

Location

Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia

Perugia, Umbria, 06156, Italy

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

alectinib; Cisplatin; Carboplatin; Pemetrexed

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 2, 2024
• Study Start: November 18, 2024
• Primary Completion (Estimated): August 28, 2026
• Study Completion (Estimated): August 28, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

IT (1); AU (2); CL (1); KR (1); BR (1); CN (5)