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NCT04951115

A Trial With Chemotherapy, Immunotherapy, and Radiotherapy for Patients With Newly Diagnosed Stage IV Small Cell Lung Cancer

Terminated Phase 2 Results posted Last updated 26 November 2024
What this trial tests

Phase 2 trial testing Carboplatin in Small-cell Lung Cancer in 6 participants. Terminated before completion.

Timeline
12 July 2021
Primary endpoint
17 January 2024
17 January 2024

Quick facts

Lead sponsorWeill Medical College of Cornell University
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment6
Start date12 July 2021
Primary completion17 January 2024
Estimated completion17 January 2024
Sites3 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Weill Medical College of Cornell University

Who can join

18 and older, any sex, with Small-cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Toxicities Grade 3 or Above Related to Therapy Primary · Up to 29 months

Measured by the number of adverse of events that are deemed definitely or probably related to the treatments given while receiving study treatment

GroupValue95% CI
Radiation + Chemo-Immunotherapy3
Efficacy of Multi-site, Non-ablative Radiation to Standard Systemic Therapy for Patients With Extensive-stage Small Cell Lung, as Measured by a Change in Disease Response Primary · Up to 12 months

Progression free survival at 12 months

GroupValue95% CI
Radiation + Chemo-Immunotherapy2
Objective Response Rate, Determined by Disease Response Rate Defined by the RECIST 1.1 Criteria Secondary · Through study completion (an average of 2 years)
GroupValue95% CI
Radiation + Chemo-Immunotherapy5
Overall Survival, Defined as the Time From First Study Treatment to the Time of Death From Any Cause Secondary · Up to 12 months

To determine the percentage of subjects that have achieved survival at the 12 month timepoint

GroupValue95% CI
Radiation + Chemo-Immunotherapy4
Pattern of Disease Progression, Defined by the Progression in Radiated Lesions vs. Non-radiated Lesions and the Rates of New Lesions as Determined by RECIST 1.1 Secondary · From baseline through progression of disease (approximately 12 months)

Determined by the number of subjects that experienced disease progression in radiated vs. non-radiated lesions and if there were any new lesions

GroupValue95% CI
Radiation + Chemo-Immunotherapy1
Radiation + Chemo-Immunotherapy2
Radiation + Chemo-Immunotherapy2

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 29 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Radiation + Chemo-Immunotherapy
Serious: 5/6 (83%)
Deaths: 1/6

Serious adverse events (17 terms)

ReactionSystemRadiation + Chemo-Immunoth…
Pleural EffusionRespiratory, thoracic and mediastinal disorders
Atrial FibrillationCardiac disorders
AnemiaBlood and lymphatic system disorders
Anuric Renal FailureRenal and urinary disorders
Colonic PerforationGastrointestinal disorders
DyspepsiaGastrointestinal disorders
Alanine Aminotransferase IncreasedInvestigations
FeverGeneral disorders
Respiratory FailureRespiratory, thoracic and mediastinal disorders
Periorbital EdemaEye disorders
Neutrophil Count DecreasedInvestigations
TachycardiaCardiac disorders
TransaminitisRenal and urinary disorders
OdynophagiaRespiratory, thoracic and mediastinal disorders
Febrile NeutropeniaBlood and lymphatic system disorders
EsophagitisGastrointestinal disorders
PneumonitisRespiratory, thoracic and mediastinal disorders
Other adverse events (49 terms — click to expand)

ReactionSystemRadiation + Chemo-Immunoth…
FatigueGeneral disorders
CoughRespiratory, thoracic and mediastinal disorders
NeuropathyNervous system disorders
Rash Maculo-papularSkin and subcutaneous tissue disorders
Back PainMusculoskeletal and connective tissue disorders
ConstipationGastrointestinal disorders
DiarrheaGastrointestinal disorders
Dry MouthGastrointestinal disorders
DyspneaRespiratory, thoracic and mediastinal disorders
VomitingGastrointestinal disorders
FeverGeneral disorders
InsomniaPsychiatric disorders
NauseaGastrointestinal disorders
Sore ThroatRespiratory, thoracic and mediastinal disorders
TachycardiaCardiac disorders
Abdominal PainGastrointestinal disorders
AgeusiaNervous system disorders
AnorexiaMetabolism and nutrition disorders
AnxietyPsychiatric disorders
Pain in ExtremityMusculoskeletal and connective tissue disorders
PainGeneral disorders
Bulging EyesEye disorders
Concentration ImpairmentNervous system disorders
CongestionRespiratory, thoracic and mediastinal disorders
Productive CoughRespiratory, thoracic and mediastinal disorders
DizzinessNervous system disorders
DyspepsiaGastrointestinal disorders
Alkaline Phosphatase IncreasedInvestigations
Alanine Aminotransferase IncreasedBlood and lymphatic system disorders
Aspartate Aminotransferase IncreasedBlood and lymphatic system disorders
MalaiseGeneral disorders
Gastroesophageal Reflux DiseaseGastrointestinal disorders
HeadacheNervous system disorders
HoarsenessRespiratory, thoracic and mediastinal disorders
HyperthyroidismEndocrine disorders
Periorbital EdemaEye disorders
Hearing ImpairedEar and labyrinth disorders
AmnesiaNervous system disorders
Muscle CrampMusculoskeletal and connective tissue disorders
Neck PainMusculoskeletal and connective tissue disorders

Most-reported serious reactions: Pleural Effusion, Atrial Fibrillation, Anemia, Anuric Renal Failure, Colonic Perforation, Dyspepsia, Alanine Aminotransferase Increased, Fever.

Data from ClinicalTrials.gov NCT04951115 adverse events section.

Sponsor's own description

This study is for subjects with untreated Stage IV small cell lung cancer. Subjects will be given radiation therapy for five days, followed by standard of care chemo-immunotherapy (etoposide + carboplatin or cisplatin + durvalumab) for 4 cycles. Subjects may continue to receive durvalumab after 4 cycles have been completed until disease progression.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

  1. The application of patient-derived organoid in the research of lung cancer.
    Li Y, Gao X, Ni C, Zhao B, et al · · 2023 · cited 29× · PMID 36696006 · DOI 10.1007/s13402-023-00771-3
  2. Immunotherapy for extensive-stage small-cell lung cancer: current landscape and future perspectives.
    Zhang S, Cheng Y. · · 2023 · cited 26× · PMID 37188176 · DOI 10.3389/fonc.2023.1142081
  3. Immunotherapy and Radiotherapy as an Antitumoral Long-Range Weapon-A Partnership with Unsolved Challenges: Dose, Fractionation, Volumes, Therapeutic Sequence.
    Mireștean CC, Iancu RI, Iancu DT. · · 2022 · cited 12× · PMID 36290857 · DOI 10.3390/curroncol29100580
  4. Application of organoids in precision immunotherapy of lung cancer (Review).
    Tian H, Ren J, Mou R, Jia Y. · · 2023 · cited 4× · PMID 37818130 · DOI 10.3892/ol.2023.14071
  5. The dynamic duo: A narrative review on the synergy between stereotactic body radiotherapy and immunotherapy in lung cancer treatment (Review).
    Cheng SH, Tu KY, Lee HH. · · 2024 · cited 3× · PMID 38874014 · DOI 10.3892/or.2024.8755
  6. Patient-Derived Ex Vivo Cultures and Endpoint Assays with Surrogate Biomarkers in Functional Testing for Prediction of Therapeutic Response.
    Tsukamoto Y, Hirashita Y, Shibata T, Fumoto S, et al · · 2023 · cited 3× · PMID 37627132 · DOI 10.3390/cancers15164104
  7. Immune organoid for cancer immunotherapy.
    Wang XH, Wang WY, Sun ZJ. · · 2025 · cited 2× · PMID 40698131 · DOI 10.1016/j.apsb.2025.04.031

Verify or expand the search:

Other trials of Carboplatin

Trials testing the same drug.

Other recruiting trials for Small-cell Lung Cancer

Currently open trials in the same condition.

Other Weill Medical College of Cornell University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04951115.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing