Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for all trials

Timeline

13mo left

Started May 2025

Typical duration for all trials

Geographic Reach

1 country

52 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2 years study duration

Study Progress47%

May 2025Jun 2027

First Submitted

Initial submission to the registry

December 15, 2023

Completed

7 months until next milestone

First Posted

Study publicly available on registry

July 3, 2024

Completed

11 months until next milestone

Study Start

First participant enrolled

May 23, 2025

Completed

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

August 1, 2025

Status Verified

July 1, 2025

Enrollment Period

1.5 years

First QC Date

December 15, 2023

Last Update Submit

July 30, 2025

Conditions

Small-cell Lung Cancer

Keywords

SCLCLung Cancer

Outcome Measures

Primary Outcomes (1)

Feasibility of conducting trial in SCLC population
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 Outcomes (2)

Bio-specimen collection
12 months
Subject Surveys (baseline and at 3 months)
3 months

Study Arms (2)

SCLC (primary de novo)

Blood collection, survey (baseline and Month 3)

SCLC (transformed)

Blood collection, survey (baseline and Month 3)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.