Small Cell Cancer Of The LungNCT07795411
Prospective Multiomic Analysis in Small-Cell Lung Cancer
An observational study of Small Cell Cancer Of The Lung and Small Cell Lung Cancer ( SCLC ), run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This is an observational study to collects blood samples and tumor tissue from adults with relapsed small-cell lung cancer (SCLC) receiving standard of care commercial DLL3 T cell engager. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Cancer Of The Lung, Small Cell Lung Cancer ( SCLC ), Lung Cancer
- What is being tested?
- Biospecimen collection
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Nov 2026to 31 Dec 2028
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The sample population will include adult patients with relapsed small cell lung cancer (SCLC) receiving care at The Ohio State University Comprehensive Cancer Center - James Cancer Hospital (OSUCCC - The James).
Who may be able to join
- 18 years of age or older
- Confirmed pathologic diagnosis of active SCLC or neuroendocrine cancer.
- Relapsed small cell lung cancer (SCLC) planning to receive commercial DLL3 bispecific T cell engager.
- Willing to provide informed consent.
- Willing to provide blood samples and undergo tissue biopsy at various time points throughout the study, collected in concurrence with treatment cycles and/or imaging visits
- Patients with multiple primary malignancies, recurrent lung cancer, or mixed histology are not excluded.
- Patients who have contraindications or are unable to receive immunotherapy will be eligible for the study, and their samples will be used for comparison and control.
Who cannot join
- Prisoners or incarcerated patients
- Those with cognitive impairments lacking decision-making capacity are excluded.
- There will be no specific restrictions with respect to performance status, organ function, or prior/concurrent modes of therapy other than that the patient must be able to tolerate venipuncture and any planned interventional radiology or surgical procedures deemed necessary by their treating physicians.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
The Ohio State University Comprehensive Cancer Center contact
United States1 site, 1 recruiting
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Asrar Alahamadi, MBBS, 614-293-6786, Asrar.Alahmadi@osumc.edu
Asrar Alahmadi, MBBS, MAS-CR
About this study
Official title: Prospective Multiomic Analysis in Small-Cell Lung Cancer to Inform Therapeutic Vulnerabilities and Predict Clinical Outcomes: Deep Phenotyping of Relapsed SCLC Cohort
This is an observational study to collects blood samples and tumor tissue from adults with relapsed small-cell lung cancer (SCLC) receiving standard of care commercial DLL3 T cell engager. The goal of the study is to understand the changes in tumor markers over time and examine whether these changes are associated with clinical outcomes. Participants will provide blood samples and, when clinically feasible, tumor tissue during routine care visits, treatment, and imaging assessments. The study does not assign cancer treatment.
Read the detailed description
The goal of this study is to prospectively and longitudinally collect blood and tumor tissue from patients with relapsed small cell lung cancer (SCLC) receiving standard of care commercial DLL3 T cell engager. The investigators will do a comprehensive multi-omic analysis integrating genomic, transcriptomic, proteomic, and clinical data to investigate mechanisms of resistance, and identify potential therapeutic vulnerabilities.
Primary objective is to assess the feasibility of obtaining paired tumor samples and serial blood collection in relapsed ES-SCLC patients
Secondary objectives are to characterize longitudinal SCLC tumor-associated markers, including DLL3; evaluate concordance between plasma and tissue, Circulating-Tumor DNA (ctDNA), protomics and explore associations between molecular findings and clinical outcomes.
- Conditions
- Small Cell Cancer Of The Lung, Small Cell Lung Cancer ( SCLC ), Lung Cancer, Small-Cell Lung Cancer (SCLC)
- Being tested
- Biospecimen collection
- Keywords
- relapsed small-cell lung cancer, multiomic analysis
- Medical subject headings
- Small Cell Lung Carcinoma, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen collectionProcedure or surgery
Undergo blood and tissue sample collection
| Study group | Role | What they receive |
|---|---|---|
| Relapsed SCLC Patients | Blood and tissue samples will be collected at baseline, during treatment, and at disease progression, in concordance with routine clinical visits and imaging assessments. Receives: Procedure: Biospecimen collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of obtaining paired tumor samples and serial blood collection
The feasibility rate is defined as the proportion of enrolled patients who obtained paired pre- and post-treatment biopsies with good quality (≥30% cellularity) and were compliant with serial blood samples collection
Measured: Up to 3 years
Secondary outcomes (3)
Investigator-assessed objective response rate (ORR)
The proportion of patients achieving a confirmed complete response (CR) or partial response (PR) according to RECIST v1.1
Measured: Up to 3 years
Progression-free survival (PFS
The time from treatment initiation until disease progression or death from any cause
Measured: Up to 3 years
Overall survival (OS)
The time from treatment initiation until death from any cause
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start25 Nov 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Cancer Of The LungStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Ohio State University Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Principal investigator, Asrar Alahmadi, Ohio State University Comprehensive Cancer Center
- Investigators
- Asrar Alahmadi, MBBS, MAS-CR, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07795411
- Sponsor's protocol ID
- OSU-25319
- Status last verified
- Sep 2026
- First submitted
- 26 Aug 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multiomic Analysis in Small-Cell Lung Cancer to Inform Therapeutic Vulnerabilities and Predict Clinical Outcomes: Deep Phenotyping of Relapsed SCLC Cohort
- ClinicalTrials.gov ID
- NCT07795411
- Acronym / sponsor ID
- OSU-25319
- Conditions
- Small Cell Cancer Of The Lung, Small Cell Lung Cancer ( SCLC ), Lung Cancer, Small-Cell Lung Cancer (SCLC)
- Keywords
- relapsed small-cell lung cancer, multiomic analysis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- 25 Nov 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 31 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an observational study to collects blood samples and tumor tissue from adults with relapsed small-cell lung cancer (SCLC) receiving standard of care commercial DLL3 T cell engager. The goal of the study is to understand the changes in tumor markers over time and examine whether these changes are associated with clinical outcomes. Participants will provide blood samples and, when clinically feasible, tumor tissue during routine care visits, treatment, and imaging assessments. The study does not assign cancer treatment.
Detailed description
The goal of this study is to prospectively and longitudinally collect blood and tumor tissue from patients with relapsed small cell lung cancer (SCLC) receiving standard of care commercial DLL3 T cell engager. The investigators will do a comprehensive multi-omic analysis integrating genomic, transcriptomic, proteomic, and clinical data to investigate mechanisms of resistance, and identify potential therapeutic vulnerabilities.
Primary objective is to assess the feasibility of obtaining paired tumor samples and serial blood collection in relapsed ES-SCLC patients
Secondary objectives are to characterize longitudinal SCLC tumor-associated markers, including DLL3; evaluate concordance between plasma and tissue, Circulating-Tumor DNA (ctDNA), protomics and explore associations between molecular findings and clinical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Relapsed SCLC Patients | – | Procedure: Biospecimen collectionBlood and tissue samples will be collected at baseline, during treatment, and at disease progression, in concordance with routine clinical visits and imaging assessments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The sample population will include adult patients with relapsed small cell lung cancer (SCLC) receiving care at The Ohio State University Comprehensive Cancer Center - James Cancer Hospital (OSUCCC - The James).
Key inclusion criteria (7 listed)
- 18 years of age or older
- Confirmed pathologic diagnosis of active SCLC or neuroendocrine cancer.
- Relapsed small cell lung cancer (SCLC) planning to receive commercial DLL3 bispecific T cell engager.
- Willing to provide informed consent.
- Willing to provide blood samples and undergo tissue biopsy at various time points throughout the study, collected in concurrence with treatment cycles and/or imaging visits
Key exclusion criteria (3 listed)
- Prisoners or incarcerated patients
- Those with cognitive impairments lacking decision-making capacity are excluded.
- There will be no specific restrictions with respect to performance status, organ function, or prior/concurrent modes of therapy other than that the patient must be able to tolerate venipuncture and any planned interventional radiology or surgical procedures deemed necessary by their treating physicians.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen collectionUndergo blood and tissue sample collection | Procedure or surgery | Relapsed SCLC Patients |
Primary outcome
Feasibility of obtaining paired tumor samples and serial blood collection
Time frame: Up to 3 years
The feasibility rate is defined as the proportion of enrolled patients who obtained paired pre- and post-treatment biopsies with good quality (≥30% cellularity) and were compliant with serial blood samples collection
3 secondary outcomes
Investigator-assessed objective response rate (ORR)
Time frame: Up to 3 years
Progression-free survival (PFS
Time frame: Up to 3 years
Overall survival (OS)
Time frame: Up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The Ohio State University Comprehensive Cancer Center contact
Asrar Alahmadi, MBBS, MAS-CR principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Small Cell Cancer Of The Lung and Small Cell Lung Cancer ( SCLC ), run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact The Ohio State University Comprehensive Cancer Center (800-293-5066, OSUCCCClinicaltrials@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of obtaining paired tumor samples and serial blood collection (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.