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

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

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

NCT06624059•Hoffmann-La Roche

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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
•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
•Documented ALK fusion

Exclusion Criteria

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

Locations (12)

Royal North Shore Hospital

St Leonards, New South Wales, Australia

Sir Charles Gairdner Hospital

Nedlands, Western Australia, Australia

Instituto do Cancer do Estado de Sao Paulo - ICESP

São Paulo, São Paulo, Brazil

RedSalud Vitacura

Santiago, Chile

Beijing Cancer Hospital

Beijing, China

The third people's hospital of Chengdu

Chengdu, China

Guangdong General Hospital

Guangzhou, China

Jinhua municipal central hospital

Jinhua, China

Yunnan Cancer Hospital

Kunming, China

Institut Gustave Roussy

Villejuif, France

Key Dates

Start Date

November 18, 2024

Primary Completion Date

June 13, 2028

Completion Date

March 31, 2033

Last Updated

January 21, 2026

Enrollment

ACTUAL participants

Conditions

Non-Small Cell Lung Cancer

Interventions

Alectinib

DRUG

Cisplatin

DRUG

Carboplatin

DRUG

Pemetrexed

DRUG

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

NCT07190248

Non-small Cell Lung Cancer

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RECRUITINGPHASE3

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

NCT06305754

Non-small Cell Lung Cancer (NSCLC)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 21, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)

Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment

Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations

Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)