Metastatic Lung Small Cell CarcinomaPhase 1NCT04514497

Testing the Addition of an Anti-cancer Drug, BAY 1895344, to Usual Chemotherapy for Advanced Stage Solid Tumors, With a Specific Focus on Patients With Small Cell Lung Cancer, Poorly Differentiated Neuroendocrine Cancer, and Pancreatic Cancer

A Phase 1 study testing Biopsy Procedure, Biospecimen Collection and Computed Tomography in people with Metastatic Lung Small Cell Carcinoma and Metastatic Malignant Solid Neoplasm, run by National Cancer Institute (NCI) at 23 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Metastatic Lung Small Cell Carcinoma, Metastatic Malignant Solid Neoplasm, Metastatic Neuroendocrine Carcinoma
What is being tested?: Biopsy Procedure, Biospecimen Collection and Computed Tomography
Type of treatment: Pill or oral medicine, Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 29 participants
Where: 23 sitesUnited States
Study dates: 20 Oct 2021to 4 Mar 2027
Phase: Phase 1

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

Who may be able to join

DOSE ESCALATION COHORTS: Patients must have a biopsy-proven solid tumor that is metastatic or unresectable and has progressed on at least one line of standard therapy
DOSE ESCALATION COHORTS: Patients must have a solid tumor for which irinotecan or topotecan is considered standard of care
DOSE EXPANSION COHORTS: Patients must have biopsy proven metastatic or unresectable small cell lung cancer (SCLC), poorly differentiated neuroendocrine carcinoma (PD-NEC) (any extrapulmonary neuroendocrine carcinoma with small cell or large cell histology) or pancreatic adenocarcinoma (PDA) and have progressed on at least one line of standard therapy
DOSE EXPANSION COHORTS: Patients must have at least one measurable lesion outside of the lesion to be biopsied
Patients must be able to swallow pills
Age >= 18 years. Because no dosing or adverse event data are currently available on the use of BAY 1895344 in combination with irinotecan or topotecan in patients < 18 years of age, children are excluded from this study

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Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
Hemoglobin > 9 g/dL
Absolute neutrophil count >= 1,500/mcL
Platelets >= 100,000/mcL
Total bilirubin =< 2 x institutional upper limit of normal (ULN)
Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional ULN (=< 5 x institutional ULN if liver metastases present)
Glomerular filtration rate (GFR) >= 60 mL/min/1.73 m^2
Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression. Furthermore, these patients must be asymptomatic from previously treated brain metastases (e.g. not on steroids for neurologic symptoms within 30 days of study enrollment)
Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
The effects of BAY 1895344 on the developing human fetus are unknown. For this reason and because DNA-damage response inhibitors as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and for 6 months after completion of BAY 1895344 administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of BAY 1895344 administration
Patient must have the ability to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity (IDMC) who have a legally-authorized representative (LAR) and/or family member available will also be eligible

Who cannot join

Patients who have previously been treated with irinotecan will not be eligible to participate in the irinotecan arm and patients who have previously been treated with topotecan will not be eligible to participate in the topotecan arm. However, patients who previously received irinotecan may be treated with topotecan (and vice versa) should the other agent be considered a possible standard of care for their disease. Patients who have previously been treated with BAY 1895344 will be excluded from the study
Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study
Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > grade 1) with the exception of alopecia and endocrinopathies from prior immunotherapy
Patients who are receiving any other investigational agents
The investigator(s) must state a medical or scientific reason if patients who have brain metastases will be excluded from the study
History of allergic reactions attributed to compounds of similar chemical or biologic composition to BAY 1895344 or other agents used in study

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Patients receiving any medications or substances that are substrates of CYP3A4 with a narrow therapeutic window, or strong inhibitors/inducers of CYP3A4 are ineligible, if they cannot be transferred to alternative medication. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product
Patients with uncontrolled intercurrent illness
Patients with psychiatric illness/social situations that would limit compliance with study requirements
Pregnant women are excluded from this study because BAY 1895344 is agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with BAY 1895344, breastfeeding should be discontinued if the mother is treated with BAY 1895344. These potential risks may also apply to other agents used in this study
Patients with an uncontrolled infection requiring IV antibiotics will not be eligible to participate in the study
Patients on strong CYP3A4 inhibitors must discontinue them at least 1 week prior to starting irinotecan therapy

Trial locations and contacts

23 sites in 1 country.

City, postcode or hospital

23 sites in 1 country

United States23 sites

Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141
University of Kansas Clinical Research Center
Fairway, Kansas, 66205
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
University of Kansas Cancer Center
Kansas City, Kansas, 66160
University of Kansas Cancer Center - North
Kansas City, Missouri, 64154
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, 64064
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232
Yale University
New Haven, Connecticut, 06520
University of Kansas Cancer Center at North Kansas City Hospital
North Kansas City, Missouri, 64116
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, 66210
University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas, 66211
Mayo Clinic Hospital in Arizona
Phoenix, Arizona, 85054
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Washington University School of Medicine
St Louis, Missouri, 63110
Siteman Cancer Center-South County
St Louis, Missouri, 63129
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, 63136
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, 06611
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, 66205

Other trials in United States

About this study

Official title: BAY 1895344 Plus Topoisomerase-1 (Top1) Inhibitors in Patients With Advanced Solid Tumors, Phase I Studies With Expansion Cohorts in Small Cell Lung Carcinoma (SCLC), Poorly Differentiated Neuroendocrine Carcinoma (PD-NEC) and Pancreatic Adenocarcinoma (PDA)

This phase I trial tests the safety, side effects and best dose of BAY 1895344 when given together with usual chemotherapy (irinotecan or topotecan) in treating patients with solid tumors that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced), with a specific focus on small cell lung cancer, poorly differentiated neuroendocrine cancer, and pancreatic cancer. BAY 1895344 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as irinotecan and topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Adding BAY 1895344 to irinotecan or topotecan may be safe and tolerable in treating patients with advanced solid tumors.

Read the detailed description

PRIMARY OBJECTIVES:

To assess safety and tolerability of each of the elimusertib (BAY 1895344) plus topoisomerase 1 (top1) inhibitor (irinotecan hydrochloride [irinotecan] or topotecan hydrochloride [topotecan]) combinations.

II. To estimate maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of each of the combinations.

SECONDARY OBJECTIVES:

To observe and record anti-tumor activity. II. To estimate objective response rate (ORR), progression free survival (PFS), overall survival (OS) and duration of response (DOR) in patients treated with each combination.

III. To estimate plasma pharmacokinetic (PK) characteristics of BAY 1895344 plus each top1 inhibitor (irinotecan or topotecan) when used in combination.

IV. To estimate changes in pharmacodynamic (PD) markers of deoxyribonucleic acid (DNA) damage (gamma-H2AX, phosphorylated [p]S343-NBS1) elicited by each combination from on-treatment tumor biopsies (in dose expansion cohorts only).

EXPLORATORY OBJECTIVES:

To estimate response outcomes (ORR, PFS, OS, DOR) in study patients by tumor ataxia telangiectasia mutated (ATM) expression loss (assessed by immunohistochemistry [IHC]).

II. To estimate response outcomes (ORR, PFS, OS, DOR) in study patients with tumor DNA damage response (DDR) mutations (assessed by whole exome sequencing [WES], ribonucleic acid [RNA] sequencing [RNA Seq], and circulating tumor DNA [ctDNA] analysis).

OUTLINE: This is a dose-escalation study. Patients are assigned to 1 of 3 cohorts.

COHORT I: Patients receive elimusertib orally (PO) twice daily (BID) on days 1 and 2 and irinotecan intravenously (IV) over 90 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) and/or magnetic resonance imaging (MRI) throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening.

COHORT II: Patients receive elimusertib PO once daily (QD) on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening.

COHORT III: Patients receive elimusertib PO QD on days 2 and 5 and topotecan IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening.

After completion of study treatment, patients are followed every 2 months for up to 6 months.

Conditions: Metastatic Lung Small Cell Carcinoma, Metastatic Malignant Solid Neoplasm, Metastatic Neuroendocrine Carcinoma, Metastatic Pancreatic Adenocarcinoma, Stage III Lung Cancer AJCC v8, Stage III Pancreatic Cancer AJCC v8
Being tested: Biopsy Procedure, Biospecimen Collection, Computed Tomography, Elimusertib, Irinotecan Hydrochloride
Medical subject headings: Small Cell Lung Carcinoma, Neoplasm Metastasis, Carcinoma, Neuroendocrine, Lung Neoplasms, Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Biopsy ProcedureProcedure or surgery
Also called Biopsy, BIOPSY_TYPE, Bx
Undergo tumor biopsy
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo collection of blood samples
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT
ElimusertibDrug
Also called ATR Inhibitor BAY1895344, ATR Kinase Inhibitor BAY1895344, BAY 1895344, BAY-1895344
Given PO
Irinotecan HydrochlorideDrug
Also called Campto, Camptosar, Camptothecin 11, Camptothecin-11
Given IV
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan
Undergo MRI
Topotecan HydrochlorideDrug
Also called Evotopin, Hycamptamine, Hycamtin, Nogitecan Hydrochloride
Given IV

Study groups in NCT04514497
Study group	Role	What they receive
Cohort I (elimusertib, irinotecan)	Experimental	Patients receive elimusertib PO BID on days 1 and 2 and irinotecan IV over 90 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Drug: Elimusertib; Drug: Irinotecan Hydrochloride; Procedure: Magnetic Resonance Imaging
Cohort II (elimusertib, irinotecan)	Experimental	Patients receive elimusertib PO QD on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Drug: Elimusertib; Drug: Irinotecan Hydrochloride; Procedure: Magnetic Resonance Imaging
Cohort III (elimusertib, topotecan)	Experimental	Patients receive elimusertib PO QD on days 2 and 5 and topotecan IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Drug: Elimusertib; Procedure: Magnetic Resonance Imaging; Drug: Topotecan Hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Tolerated Dose (MTD) (Dose Escalation Phase) of Elimursertib
Defined by occurrence of >= 2 dose limiting toxicities (DLTs) defined as grade 4 neutropenia lasting >= 7 days, grade 4 thrombocytopenia, grade 4 anemia, grade 3 neutropenia with fever, grade 3 thrombocytopenia with bleeding, any grade 3 hematologic toxicity lasting >= 7 days (counting from first day of toxicity grade recognition) or any non-hematologic grade >= 2 adverse events (AEs) lasting >= 7 days (with the exception of grade 2 [G2] fatigue, G2 nausea or G2 diarrhea) (counting from first day of toxicity grade recognition) in any dose level during cycle 1 of treatment. DLTs will be graded by Common Terminology Criteria for Adverse Events version 5.0.
Measured: Up to 21 days (first treatment cycle)
Maximum Tolerated Dose (MTD) (Dose Escalation Phase) of Irinotecan
Defined by occurrence of >= 2 dose limiting toxicities (DLTs) defined as grade 4 neutropenia lasting >= 7 days, grade 4 thrombocytopenia, grade 4 anemia, grade 3 neutropenia with fever, grade 3 thrombocytopenia with bleeding, any grade 3 hematologic toxicity lasting >= 7 days (counting from first day of toxicity grade recognition) or any non-hematologic grade >= 2 adverse events (AEs) lasting >= 7 days (with the exception of grade 2 [G2] fatigue, G2 nausea or G2 diarrhea) (counting from first day of toxicity grade recognition) in any dose level during cycle 1 of treatment. DLTs will be graded by Common Terminology Criteria for Adverse Events version 5.0.
Measured: Up to 21 days (first treatment cycle)
Maximum Tolerated Dose (MTD) (Dose Escalation Phase) of Topotecan
Defined by occurrence of >= 2 dose limiting toxicities (DLTs) defined as grade 4 neutropenia lasting >= 7 days, grade 4 thrombocytopenia, grade 4 anemia, grade 3 neutropenia with fever, grade 3 thrombocytopenia with bleeding, any grade 3 hematologic toxicity lasting >= 7 days (counting from first day of toxicity grade recognition) or any non-hematologic grade >= 2 adverse events (AEs) lasting >= 7 days (with the exception of grade 2 [G2] fatigue, G2 nausea or G2 diarrhea) (counting from first day of toxicity grade recognition) in any dose level during cycle 1 of treatment. DLTs will be graded by Common Terminology Criteria for Adverse Events version 5.0.
Measured: Up to 21 days (first treatment cycle)
Occurrence of Grade 4 Hematologic AEs (Dose Expansion Phase)
Grade 4 hematologic toxicity will be monitored using the Bayesian approach of Thall, Simon, Estey as extended by Thall and Sung. Clinical safety data (e.g. AEs) will be tabulated and summarized using descriptive statistics as requested by the sponsor investigator, executive committee, medical monitor or Data Safety Monitoring Board using methods described in the Data Safety Monitoring Plan.
Measured: Up to 6 months post-treatment

Secondary outcomes (12)

Objective Response Rate (ORR)
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT and/or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response Rate (ORR) = CR + PR.
Measured: Tumor response was performed every 6 weeks during treatment and up to 6 months after completing treatment
Duration of Response (DOR)
DOR will be estimated by the Kaplan-Meier method. Duration of response was calculated among patients with complete response, partial response, or stable disease.
Measured: Response was assessed every 6 weeks while the patient was on treatment, and up to 6 months post-treatment.
Progression-free Survival (PFS)
PFS will be estimated by the Kaplan-Meier method.
Measured: Disease Progression was assessed every 6 weeks while the patient was on treatment, and up to 6 months post-treatment.
Overall Survival (OS)
OS will be estimated by the Kaplan-Meier method.
Measured: From date the participant starts treatment until the date of death from any cause, assessed up to 6 months following completion of treatment
Maximum Concentration (Cmax) of Elimusertib
Estimated for elimusertib based upon plasma collections from cycle 1 in all study patients.
TACs 1,2: Before treatment, 30 min, 1h, 1.3h, 2h, 4h, 6h, 8h, 24h, and 48 h after first elimusertib dose; TACs 4,5: on Cycle 1 Day 1 Before treatment, 30 min, 1h, and 1.3h into infusion and 0.5h, 2.5h, 4.5h and 22h post end of infusion and Day 2 30 min, 1h, 1.3, 2h, 4h, 6h, 8h, 24h after the first elimursertib dose; TACs 7,14: cycle 1 day 1 and 2 before infusion, 5, 15, and 25 min into infusion, and 5, 15, 30 min, 1, 2, 4, 6, and 24 h post end of infusion
Measured: See above as time frames were different fore each dose cohort
Area Under the Concentration-time Curve (AUC) for Elimusertib
Will be estimated for elimusertib based upon plasma collections from cycle 1 in all study patients.
TACs 1,2: Before treatment, 30 min, 1h, 1.3h, 2h, 4h, 6h, 8h, 24h, and 48 h after first elimusertib dose; TACs 4,5: on Cycle 1 Day 1 Before treatment, 30 min, 1h, and 1.3h into infusion and 0.5h, 2.5h, 4.5h and 22h post end of infusion and Day 2 30 min, 1h, 1.3, 2h, 4h, 6h, 8h, 24h after the first elimursertib dose; TACs 7,14: cycle 1 day 1 and 2 before infusion, 5, 15, and 25 min into infusion, and 5, 15, 30 min, 1, 2, 4, 6, and 24 h post end of infusion
Measured: See above as time frames are different for each dose cohort
Maximum Concentration (Cmax) of Irinotecan (Cohorts I and II)
Estimated for irinotecan based upon plasma collections from cycle 1 in all study patients.
TACs 1,2: Before treatment, 30 min, 1h, 1.3h, 2h, 4h, 6h, 8h, 24h, and 48 h after first elimusertib dose; TACs 4,5: on Cycle 1 Day 1 Before treatment, 30 min, 1h, and 1.3h into infusion and 0.5h, 2.5h, 4.5h and 22h post end of infusion and Day 2 30 min, 1h, 1.3, 2h, 4h, 6h, 8h, 24h after the first elimursertib dose
Measured: See above as time frames were different for each cohort
Area Under the Concentration-time Curve (AUC) for Irinotecan
Will be estimated for irinotecan based upon plasma collections from cycle 1 in all study patients.
TACs 1,2: Before treatment, 30 min, 1h, 1.3h, 2h, 4h, 6h, 8h, 24h, and 48 h after first elimusertib dose; TACs 4,5: on Cycle 1 Day 1 Before treatment, 30 min, 1h, and 1.3h into infusion and 0.5h, 2.5h, 4.5h and 22h post end of infusion and Day 2 30 min, 1h, 1.3, 2h, 4h, 6h, 8h, 24h after the first elimursertib dose
Measured: See above as time frames were different for each cohort
Maximum Concentration (Cmax) of Topotecan (Cohort III, TACs 7 and 14)
Estimated for topotecan based upon plasma collections from cycle 1 in all study patients.
Measured: Cycle 1 day 1 and 2 before infusion, 5, 15, and 25 min into infusion, and 5, 15, 30 min, 1, 2, 4, 6, and 24 h post end of infusion
Area Under the Concentration-time Curve (AUC) for Topotecan
Will be estimated for topotecan based upon plasma collections from cycle 1 in all study patients.
Measured: Cycle 1
Changes in Tumor Expression Patterns of Gamma-H2AX
Will be estimated for expansion cohort only study patients.
Measured: Baseline up to cycle 1, day 6
Changes in Tumor Expression Patterns of pS343-NBS1
Will be estimated for expansion cohort only study patients.
Measured: Baseline up to cycle 1, day 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Oct 20214 Mar 2027

First posted17 Aug 2020
Study start20 Oct 2021
Primary completion15 Feb 2025
Study completion4 Mar 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Metastatic Lung Small Cell CarcinomaStudies of the same condition, open and under way.
More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
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: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04514497
Sponsor's protocol ID: NCI-2020-05958
Other IDs: NCI-2020-05958, 10402, 10402, UM1CA186689
Status last verified: Sep 2026
First submitted: 14 Aug 2020
Last updated: 10 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.