Measured by the number of adverse of events that are deemed definitely or probably related to the treatments given while receiving study treatment
| Group | Value | 95% CI |
|---|---|---|
| Radiation + Chemo-Immunotherapy | 3 |
Last reviewed · How we verify
A Trial With Chemotherapy, Immunotherapy, and Radiotherapy for Patients With Newly Diagnosed Stage IV Small Cell Lung Cancer
Phase 2 trial testing Carboplatin in Small-cell Lung Cancer in 6 participants. Terminated before completion.
| Lead sponsor | Weill Medical College of Cornell University |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 6 |
| Start date | 12 July 2021 |
| Primary completion | 17 January 2024 |
| Estimated completion | 17 January 2024 |
| Sites | 3 locations across United States |
Weill Medical College of Cornell University
18 and older, any sex, with Small-cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Measured by the number of adverse of events that are deemed definitely or probably related to the treatments given while receiving study treatment
| Group | Value | 95% CI |
|---|---|---|
| Radiation + Chemo-Immunotherapy | 3 |
Progression free survival at 12 months
| Group | Value | 95% CI |
|---|---|---|
| Radiation + Chemo-Immunotherapy | 2 |
| Group | Value | 95% CI |
|---|---|---|
| Radiation + Chemo-Immunotherapy | 5 |
To determine the percentage of subjects that have achieved survival at the 12 month timepoint
| Group | Value | 95% CI |
|---|---|---|
| Radiation + Chemo-Immunotherapy | 4 |
Determined by the number of subjects that experienced disease progression in radiated vs. non-radiated lesions and if there were any new lesions
| Group | Value | 95% CI |
|---|---|---|
| Radiation + Chemo-Immunotherapy | 1 | |
| Radiation + Chemo-Immunotherapy | 2 | |
| Radiation + Chemo-Immunotherapy | 2 |
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.
| Reaction | System | Radiation + Chemo-Immunoth… |
|---|---|---|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | — |
| Atrial Fibrillation | Cardiac disorders | — |
| Anemia | Blood and lymphatic system disorders | — |
| Anuric Renal Failure | Renal and urinary disorders | — |
| Colonic Perforation | Gastrointestinal disorders | — |
| Dyspepsia | Gastrointestinal disorders | — |
| Alanine Aminotransferase Increased | Investigations | — |
| Fever | General disorders | — |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | — |
| Periorbital Edema | Eye disorders | — |
| Neutrophil Count Decreased | Investigations | — |
| Tachycardia | Cardiac disorders | — |
| Transaminitis | Renal and urinary disorders | — |
| Odynophagia | Respiratory, thoracic and mediastinal disorders | — |
| Febrile Neutropenia | Blood and lymphatic system disorders | — |
| Esophagitis | Gastrointestinal disorders | — |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | — |
| Reaction | System | Radiation + Chemo-Immunoth… |
|---|---|---|
| Fatigue | General disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Neuropathy | Nervous system disorders | — |
| Rash Maculo-papular | Skin and subcutaneous tissue disorders | — |
| Back Pain | Musculoskeletal and connective tissue disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Dry Mouth | Gastrointestinal disorders | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Fever | General disorders | — |
| Insomnia | Psychiatric disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Sore Throat | Respiratory, thoracic and mediastinal disorders | — |
| Tachycardia | Cardiac disorders | — |
| Abdominal Pain | Gastrointestinal disorders | — |
| Ageusia | Nervous system disorders | — |
| Anorexia | Metabolism and nutrition disorders | — |
| Anxiety | Psychiatric disorders | — |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | — |
| Pain | General disorders | — |
| Bulging Eyes | Eye disorders | — |
| Concentration Impairment | Nervous system disorders | — |
| Congestion | Respiratory, thoracic and mediastinal disorders | — |
| Productive Cough | Respiratory, thoracic and mediastinal disorders | — |
| Dizziness | Nervous system disorders | — |
| Dyspepsia | Gastrointestinal disorders | — |
| Alkaline Phosphatase Increased | Investigations | — |
| Alanine Aminotransferase Increased | Blood and lymphatic system disorders | — |
| Aspartate Aminotransferase Increased | Blood and lymphatic system disorders | — |
| Malaise | General disorders | — |
| Gastroesophageal Reflux Disease | Gastrointestinal disorders | — |
| Headache | Nervous system disorders | — |
| Hoarseness | Respiratory, thoracic and mediastinal disorders | — |
| Hyperthyroidism | Endocrine disorders | — |
| Periorbital Edema | Eye disorders | — |
| Hearing Impaired | Ear and labyrinth disorders | — |
| Amnesia | Nervous system disorders | — |
| Muscle Cramp | Musculoskeletal and connective tissue disorders | — |
| Neck Pain | Musculoskeletal 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.
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.
7 peer-reviewed publications reference this trial (live from Europe PMC):
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