Small Cell Lung Cancer Community Engagement to Eliminate Research Discepancies (SUCCEED)

August 1, 2026 updated by: Addario Lung Cancer Medical Institute

A Study to Evaluate a Remote, Decentralized, Direct-to-Patient Strategy for Clinical Research Engagement of Patients With Small Cell Lung Cancer (SCLC).

This study will evaluate if a direct-to-patient, de-centralized, remote approach will improve clinical research outreach and engagement for patients with SCLC, in the context of a bio-specimen collection study. The study will also assess self-reported preferences and needs of patients with SCLC, regarding choosing and accessing novel therapies in research or standard clinical care settings and supportive gaps in this area, through an initial and 3 month follow up survey.

Study Overview

Status

Active, not recruiting

Conditions

Small-cell Lung Cancer

Detailed Description

This is a non-interventional, non-treatment, non-randomized, single coordinating center, study to determine the feasibility of decentralized bio-specimen collection in USA-based adult subjects with SCLC, to be conducted in conformance with Good Clinical Practices. Potential study subjects will be referred to contact staff through a dedicated study webpage form or dedicated study phone hotline at the coordinating center (ALCMI) who will handle informed consent, coordinate remote blood sample collection with study subjects, and collect medical records to confirm diagnosis and treatment history. Subjects will also be asked to complete a baseline and follow up questionnaire/survey documenting their self-report diagnosis, treatment history, factors impacting care and quality of life, and needs/preferences regarding supportive resources.

Patients who have been diagnosed with either extensive stage primary SCLC or patients diagnosed with primary NSCLC who experienced histological "transformation" with a SCLC component after initial diagnosis and subsequent treatment (transformed SCLC; tSCLC) will be invited to volunteer for this study.

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Alabama
  - Multiple Locations, Alabama, United States, 37232
    - Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html
- Alaska
  - Multiple Locations, Alaska, United States, 37232
    - Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html
- Arizona
  - Multiple Locations, Arizona, United States, 37232
    - Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html
- Arkansas
  - Multiple Locations, Arkansas, United States, 37232
    - Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html
- California
  - Multiple Locations, California, United States, 37232
    - Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html
- Colorado
  - Multiple Locations, Colorado, United States, 37232
    - Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html
- Connecticut
  - Multiple Locations, Connecticut, United States, 37232
    - Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html
- Delaware
  - Multiple Locations, Delaware, United States, 37232
    - Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html
- District of Columbia
  - Multiple Locations, District of Columbia, United States, 37232
    - Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html
- Florida
  - Multiple Locations, Florida, United States, 37232
    - Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html
- Georgia
  - Multiple Locations, Georgia, United States, 37232
    - Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html
- Hawaii
  - Multiple Locations, Hawaii, United States, 37232
    - Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html
- Idaho
  - Multiple Locations, Idaho, United States, 37232
    - Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html
- Illinois
  - Multiple Locations, Illinois, United States, 37232
    - Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html
- Indiana
  - Multiple Locations, Indiana, United States, 37232
    - Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html
- Iowa
  - Multiple Locations, Iowa, United States, 37232
    - Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html
- Kansas
  - Multiple Locations, Kansas, United States, 37232
    - Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html
- Kentucky
  - Multiple Locations, Kentucky, United States, 37232
    - Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html
- Louisiana
  - Multiple Locations, Louisiana, United States, 37232
    - Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html
- Maine
  - Multiple Locations, Maine, United States, 37232
    - Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html
- Maryland
  - Multiple Locations, Maryland, United States, 37232
    - Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html
- Massachusetts
  - Multiple Locations, Massachusetts, United States, 37232
    - Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html
- Michigan
  - Multiple Locations, Michigan, United States, 37232
    - Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html
- Minnesota
  - Multiple Locations, Minnesota, United States, 37232
    - Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html
- Mississippi
  - Multiple Locations, Mississippi, United States, 37232
    - Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html
- Missouri
  - Multiple Locations, Missouri, United States, 37232
    - Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html
- Montana
  - Multiple Locations, Montana, United States, 37232
    - Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html
- Nebraska
  - Multiple Locations, Nebraska, United States, 37232
    - Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html
- Nevada
  - Multiple Locations, Nevada, United States, 37232
    - Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html
- New Hampshire
  - Multiple Locations, New Hampshire, United States, 37232
    - Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html
- New Jersey
  - Multiple Locations, New Jersey, United States, 37232
    - Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html
- New Mexico
  - Multiple Locations, New Mexico, United States, 37232
    - Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html
- New York
  - Multiple Locations, New York, United States, 37232
    - Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html
- North Carolina
  - Multiple Locations, North Carolina, United States, 37232
    - Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html
- North Dakota
  - Multiple Locations, North Dakota, United States, 37232
    - Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html
- Ohio
  - Multiple Locations, Ohio, United States, 37232
    - Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html
- Oklahoma
  - Multiple Locations, Oklahoma, United States, 37232
    - Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html
- Oregon
  - Multiple Locations, Oregon, United States, 37232
    - Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html
- Pennsylvania
  - Multiple Locations, Pennsylvania, United States, 37232
    - Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html
- Rhode Island
  - Multiple Locations, Rhode Island, United States, 37232
    - Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html
- South Carolina
  - Multiple Locations, South Carolina, United States, 37232
    - Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html
- South Dakota
  - Multiple Locations, South Dakota, United States, 37232
    - Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html
- Tennessee
  - Multiple Locations, Tennessee, United States, 37232
    - Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html
  - Nashville, Tennessee, United States, 37232
    - Vanderbilt-Ingram Cancer Center
- Texas
  - Multiple Locations, Texas, United States, 37232
    - Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html
- Utah
  - Multiple Locations, Utah, United States, 37232
    - Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html
- Vermont
  - Multiple Locations, Vermont, United States, 37232
    - Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html
- Virginia
  - Multiple Locations, Virginia, United States, 37232
    - Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html
- Washington
  - Multiple Locations, Washington, United States, 37232
    - Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html
- West Virginia
  - Multiple Locations, West Virginia, United States, 37232
    - Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html
- Wisconsin
  - Multiple Locations, Wisconsin, United States, 37232
    - Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html
- Wyoming
  - Multiple Locations, Wyoming, United States, 37232
    - Https://Alcmi.Org/Clinical-Trials/Current-Studies/Succeed-Study.Html

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Adults (USA-based) with a diagnosis of extensive stage primary SCLC or tSCLC

Description

Inclusion Criteria:

Men or women greater than or equal to 18 years of age at the time of consent
Ability to read, write and communicate in English
Provide voluntary consent to participate in this study, documented via a signed informed Consent Form (ICF)
Willing to provide clinical and medical information related to his/her cancer diagnoses to the study team as required
Willing to comply with the requirements of the study
Diagnosis of extensive stage primary SCLC or tSCLC

Exclusion Criteria:

Known existence of an uncontrolled intercurrent illness including, but not limited to, psychiatric illness or social situations that would impair compliance with study requirements
Subjects who previously enrolled to this study

Note: Concurrent enrollment in other clinical trials is NOT exclusionary

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
SCLC (primary de novo) Blood collection, survey (baseline and Month 3)
SCLC (transformed) Blood collection, survey (baseline and Month 3)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of conducting trial in SCLC population Time Frame: 12 months	Percentage of overall eligible subjects enrolled. Percentage of primary SCLC eligible subjects enrolled. Percentage of tSCLC eligible subjects enrolled. Percentage of SCLC eligible subjects enrolled compared to percentage of tSCLC eligible subjects enrolled. Percentage of primary SCLC enrolled subjects completed. Percentage of tSCLC enrolled subjects completed. Percentage of SCLC enrolled subjects completed compared to percentage of tSCLC enrolled subjects completed. Overall reasons for early termination. Reasons for early termination from trial in primary SCLC enrolled. Reasons for early termination from trial in tSCLC enrolled.	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject Surveys (baseline and at 3 months) Time Frame: 3 months	Percentage of successful Survey completions; at baseline; at Month 3. Reasons for failure to complete Survey(s).	3 months
Bio-specimen collection Time Frame: 12 months	Percentage of blood collections during trial in overall enrolled and in SCLC enrolled compared to in tSCLC enrolled. Reasons for failure to obtain blood collections. Percentage of successful blood collections during trial (Overall and in SCLC compared to tSCLC). Reasons for failure to obtain blood collections. Percentage of successful blood collections during trial (Overall and in SCLC compared to tSCLC). Reasons for failure to obtain blood collections.	12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Addario Lung Cancer Medical Institute

Investigators

Principal Investigator: Christine Lovly, MD PhD, Vanderbilt-Ingram Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2025

Primary Completion (Actual)

July 15, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

December 15, 2023

First Submitted That Met QC Criteria

July 1, 2024

First Posted (Actual)

July 3, 2024

Study Record Updates

Last Update Posted (Actual)

August 4, 2026

Last Update Submitted That Met QC Criteria

August 1, 2026

Last Verified