A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC)
Running, not enrolling · Phase 2/Phase 3
Conditions studied: Non-Small Cell Lung Cancer
In brief
This is a phase 2/3, global, multicenter, open-label, multi-cohort study designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or in combination in participants with unresectable, advanced or metastatic NSCLC determined to harbor oncogenic somatic mutations or positive by tumor mutational burden (TMB) assay as identified by a blood-based next-generation sequencing (NGS) circulating tumor DNA (ctDNA) assay.
Key facts
- Study ID
- NCT03178552
- Run by
- Hoffmann-La Roche
- People needed
- 1000
- Starts
- 2017-09-22
- Expected to finish
- 2026-10-31
- Last updated by the study team
- 2026-06-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically or cytologically confirmed diagnosis of unresectable Stage IIIb not amenable to treatment with combined modality chemoradiation (advanced) or Stage IV (metastatic) NSCLC
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- Measurable disease
- Adequate recovery from most recent systemic or local treatment for cancer
- Adequate organ function
- Life expectancy greater than or equal to (>/=) 12 weeks
- For female participants of childbearing potential and male participants, willingness to use acceptable methods of contraception
You may not qualify if…
- Inability to swallow oral medication
- Women who are pregnant or lactating
- Symptomatic, untreated CNS metastases
- History of malignancy other than NSCLC within 5 years prior to screening with the exception of malignancies with negligible risk of metastasis or death
- Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction, or cerebrovascular accident within 3 months prior to randomization, unstable arrhythmias, or unstable angina
- Known active or uncontrolled human immunodeficiency virus (HIV) infection
- Either a concurrent condition or history of a prior condition that places the patient at unacceptable risk if he/she were treated with the study drug or confounds the ability to interpret data from the study
- Inability to comply with other requirements of the protocol
Where it is running
- Rocky Mountain Cancer Center — Denver, Colorado, United States
- SCRI Florida Cancer Specialists South — Fort Myers, Florida, United States
- Florida Cancer Specialist, North Region — St. Petersburg, Florida, United States
- University of Kentucky — Lexington, Kentucky, United States
- Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
- Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
- Weill Cornell Medical College-New York Presbyterian Hospital — New York, New York, United States
- Montefiore Medical Center — The Bronx, New York, United States
- Oregon HSU — Portland, Oregon, United States
- St. Luke's University Health network — Bethlehem, Pennsylvania, United States
- Sarah Cannon Research Institute / Tennessee Oncology — Chattanooga, Tennessee, United States
- Fundación CENIT para la Investigación en Neurociencias — Buenos Aires, Argentina
- Hospital Italiano — Buenos Aires, Argentina
- Hospital Britanico de Buenos Aires — Ciudad Autonoma Buenos Aires, Argentina
- Royal North Shore Hospital — St Leonards, New South Wales, Australia
- The Prince Charles Hospital — Chermside, Queensland, Australia
- Ashford Cancer Center Research — Kurralta Park, South Australia, Australia
- UZ Brussel — Brussels, Belgium
- Cliniques Universitaires St-Luc — Brussels, Belgium
- UZ Leuven Gasthuisberg — Leuven, Belgium
- Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda — Ijuí, Rio Grande do Sul, Brazil
- Hospital Sao Lucas - PUCRS — Porto Alegre, Rio Grande do Sul, Brazil
- Instituto do Cancer do Estado de Sao Paulo - ICESP — São Paulo, São Paulo, Brazil
- Instituto Nacional de Cancer - INCa — Rio de Janeiro, Brazil
- UC Davis — Sacramento, California, United States
Full record on ClinicalTrials.gov
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