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Clinical Trials 101

Clinical trials can offer people with lung cancer an opportunity to be treated with therapies before they are approved and available publicly. Finding relevant clinical trials and understanding if you may be an appropriate candidate to participate can be confusing. Here we explain key elements of a clinical trial listing as they appear on clinicaltrials.gov. You can also ask your doctor if there is a clinical trial that may be right for you.

To learn more about clinical trials and drug development, visit:
http://www.fda.gov/downloads/Drugs/ResourcesForYou/Consumers/UCM284393.pdf

Find a trial

Use LUNGevity’s Clinical Trial Finder to browse lung cancer clinical trials for which participants are being sought.

A Study of Treatment X in Advanced Non-Small Cell Lung Cancer

Recruitment Status

If a trial is currently seeking participants, it will be noted in green. Trials that are ongoing but have enough participants, or are not recruiting for a variety of other reasons, are noted in red.

Sponsor: The pharmaceutical company or research institution responsible for the trial.

ClinicalTrials.gov Identifier

The unique National Clinical Trial (NCT) number assigned to a particular trial. The format is NCT followed by 8 numbers. This number can help you locate the trial online or find results when they are published.

Click on History of Changes to view changes that have been made to the written description of how the trial will be conducted.

Purpose: the overall goal of the study and what it will evaluate.

Condition

The specific type of lung cancer will be described (e.g., stage or necessary biomarkers).

Intervention

Lists the medications to be compared. Only generic drug names are used, even if a drug is already approved.

Phase

The stage of clinical research the drug is in (from 1 to 4). Learn more about the different phases of clinical trials and the drug approval process, here.

Study design:
describes the methods the trial will use to answer the research questions. Details may include whether patients or researchers will know what treatment they are receiving, and whether treatments will be randomly assigned. In an open-label trial, the researchers know which medication participants receive; in a blinded study, the researchers and/or patients do not know. A blinded study is considered to be more scientifically rigorous because the researchers are not potentially influenced by knowing what medication is given.

Primary outcome measures: the main question the study seeks to answer and how it will be measured.

Secondary outcome measures: other questions the trial seeks to answer and how they will be measured.

Estimated Enrollment: The total number of participants needed.

Arms

The different treatment groups to which participants can be assigned.

Interventions

Specific information about the treatment program in each arm, such as drug dose, how the treatment is given, how many days of therapy make up each cycle and how many cycles are required.

Eligibility/Inclusion and Exclusion Criteria: medical or health characteristics about potential participants and their disease that would allow them to participate in the clinical trial or not.

Contacts and Locations: medical centers where the study is being conducted. Often there are multiple study centers throughout the U.S. The principal investigator is the researcher in charge of the study.