Trial Outcomes & Findings for A Trial With Chemotherapy, Immunotherapy, and Radiotherapy for Patients With Newly Diagnosed Stage IV Small Cell Lung Cancer (NCT NCT04951115)
NCT ID: NCT04951115
Last Updated: 2024-11-26
Results Overview
Measured by the number of adverse of events that are deemed definitely or probably related to the treatments given while receiving study treatment
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
Up to 29 months
Results posted on
2024-11-26
Participant Flow
Participant milestones
| Measure |
Radiation + Chemo-Immunotherapy
Carboplatin: AUC = 5-6 mg/mL per min on Day 1 of each 21-day cycle, for 4 cycles
Cisplatin: 75-80 mg/m2 on Day 1 of each 21-day cycle, for 4 cycles
Etoposide: 80-100 mg/m2 on Day 1, Day 2, and Day 3 of each 21-day cycle, for 4 cycles
Durvalumab: 1500 mg on Day 1 of each 21-day cycle, for 4 cycles. Following this, 1500 mg once every 4 weeks until disease progression
Stereotactic Body Radiotherapy: 6 Gy of radiotherapy targeting multiple sites of intrathoracic disease on Days 1-5 of cycle 1.
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Trial With Chemotherapy, Immunotherapy, and Radiotherapy for Patients With Newly Diagnosed Stage IV Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Radiation + Chemo-Immunotherapy
n=6 Participants
Carboplatin: AUC = 5-6 mg/mL per min on Day 1 of each 21-day cycle, for 4 cycles
Cisplatin: 75-80 mg/m2 on Day 1 of each 21-day cycle, for 4 cycles
Etoposide: 80-100 mg/m2 on Day 1, Day 2, and Day 3 of each 21-day cycle, for 4 cycles
Durvalumab: 1500 mg on Day 1 of each 21-day cycle, for 4 cycles. Following this, 1500 mg once every 4 weeks until disease progression
Stereotactic Body Radiotherapy: 6 Gy of radiotherapy targeting multiple sites of intrathoracic disease on Days 1-5 of cycle 1.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 29 monthsMeasured by the number of adverse of events that are deemed definitely or probably related to the treatments given while receiving study treatment
Outcome measures
| Measure |
Radiation + Chemo-Immunotherapy
n=6 Participants
Carboplatin: AUC = 5-6 mg/mL per min on Day 1 of each 21-day cycle, for 4 cycles
Cisplatin: 75-80 mg/m2 on Day 1 of each 21-day cycle, for 4 cycles
Etoposide: 80-100 mg/m2 on Day 1, Day 2, and Day 3 of each 21-day cycle, for 4 cycles
Durvalumab: 1500 mg on Day 1 of each 21-day cycle, for 4 cycles. Following this, 1500 mg once every 4 weeks until disease progression
Stereotactic Body Radiotherapy: 6 Gy of radiotherapy targeting multiple sites of intrathoracic disease on Days 1-5 of cycle 1.
|
|---|---|
|
Number of Toxicities Grade 3 or Above Related to Therapy
|
3 serious adverse events
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: 1 subject was not analyzed as they were not on trial long enough to receive radiation therapy.
Progression free survival at 12 months
Outcome measures
| Measure |
Radiation + Chemo-Immunotherapy
n=5 Participants
Carboplatin: AUC = 5-6 mg/mL per min on Day 1 of each 21-day cycle, for 4 cycles
Cisplatin: 75-80 mg/m2 on Day 1 of each 21-day cycle, for 4 cycles
Etoposide: 80-100 mg/m2 on Day 1, Day 2, and Day 3 of each 21-day cycle, for 4 cycles
Durvalumab: 1500 mg on Day 1 of each 21-day cycle, for 4 cycles. Following this, 1500 mg once every 4 weeks until disease progression
Stereotactic Body Radiotherapy: 6 Gy of radiotherapy targeting multiple sites of intrathoracic disease on Days 1-5 of cycle 1.
|
|---|---|
|
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
|
2 Participants
|
SECONDARY outcome
Timeframe: Through study completion (an average of 2 years)Population: 1 subject was not analyzed as they were not on trial long enough to receive radiation therapy.
Outcome measures
| Measure |
Radiation + Chemo-Immunotherapy
n=5 Participants
Carboplatin: AUC = 5-6 mg/mL per min on Day 1 of each 21-day cycle, for 4 cycles
Cisplatin: 75-80 mg/m2 on Day 1 of each 21-day cycle, for 4 cycles
Etoposide: 80-100 mg/m2 on Day 1, Day 2, and Day 3 of each 21-day cycle, for 4 cycles
Durvalumab: 1500 mg on Day 1 of each 21-day cycle, for 4 cycles. Following this, 1500 mg once every 4 weeks until disease progression
Stereotactic Body Radiotherapy: 6 Gy of radiotherapy targeting multiple sites of intrathoracic disease on Days 1-5 of cycle 1.
|
|---|---|
|
Objective Response Rate, Determined by Disease Response Rate Defined by the RECIST 1.1 Criteria
|
5 participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: 1 subject was not analyzed as they were not on trial long enough to receive radiation therapy.
To determine the percentage of subjects that have achieved survival at the 12 month timepoint
Outcome measures
| Measure |
Radiation + Chemo-Immunotherapy
n=5 Participants
Carboplatin: AUC = 5-6 mg/mL per min on Day 1 of each 21-day cycle, for 4 cycles
Cisplatin: 75-80 mg/m2 on Day 1 of each 21-day cycle, for 4 cycles
Etoposide: 80-100 mg/m2 on Day 1, Day 2, and Day 3 of each 21-day cycle, for 4 cycles
Durvalumab: 1500 mg on Day 1 of each 21-day cycle, for 4 cycles. Following this, 1500 mg once every 4 weeks until disease progression
Stereotactic Body Radiotherapy: 6 Gy of radiotherapy targeting multiple sites of intrathoracic disease on Days 1-5 of cycle 1.
|
|---|---|
|
Overall Survival, Defined as the Time From First Study Treatment to the Time of Death From Any Cause
|
4 Participants
|
SECONDARY outcome
Timeframe: From baseline through progression of disease (approximately 12 months)Population: 1 subject was not analyzed as they were not on trial long enough to receive radiation therapy.
Determined by the number of subjects that experienced disease progression in radiated vs. non-radiated lesions and if there were any new lesions
Outcome measures
| Measure |
Radiation + Chemo-Immunotherapy
n=5 Participants
Carboplatin: AUC = 5-6 mg/mL per min on Day 1 of each 21-day cycle, for 4 cycles
Cisplatin: 75-80 mg/m2 on Day 1 of each 21-day cycle, for 4 cycles
Etoposide: 80-100 mg/m2 on Day 1, Day 2, and Day 3 of each 21-day cycle, for 4 cycles
Durvalumab: 1500 mg on Day 1 of each 21-day cycle, for 4 cycles. Following this, 1500 mg once every 4 weeks until disease progression
Stereotactic Body Radiotherapy: 6 Gy of radiotherapy targeting multiple sites of intrathoracic disease on Days 1-5 of cycle 1.
|
|---|---|
|
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
Experienced Progression in Non-Radiated Lesions Only
|
1 Participants
|
|
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
Experienced Progression in Both Irradiated and Non-Radiated Lesions
|
2 Participants
|
|
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
Experienced New Lesions
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Through study completion (an average of 2 years)Using tumor organoids grown from tissue samples and circulating tumor cells from peripheral blood collected, the tumor cells will be characterized
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Through study completion (an average of 2 years)Using circulating tumor cells from peripheral blood collected, the tumor cells will be characterized
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Through study completion (an average of 2 years)Using circulating tumor cells from peripheral blood collected, the tumor cells will be characterized
Outcome measures
Outcome data not reported
Adverse Events
Radiation + Chemo-Immunotherapy
Serious events: 5 serious events
Other events: 6 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Radiation + Chemo-Immunotherapy
n=6 participants at risk
Carboplatin: AUC = 5-6 mg/mL per min on Day 1 of each 21-day cycle, for 4 cycles
Cisplatin: 75-80 mg/m2 on Day 1 of each 21-day cycle, for 4 cycles
Etoposide: 80-100 mg/m2 on Day 1, Day 2, and Day 3 of each 21-day cycle, for 4 cycles
Durvalumab: 1500 mg on Day 1 of each 21-day cycle, for 4 cycles. Following this, 1500 mg once every 4 weeks until disease progression
Stereotactic Body Radiotherapy: 6 Gy of radiotherapy targeting multiple sites of intrathoracic disease on Days 1-5 of cycle 1.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
16.7%
1/6 • Number of events 2 • Up to 29 months
|
|
Renal and urinary disorders
Anuric Renal Failure
|
16.7%
1/6 • Number of events 1 • Up to 29 months
|
|
Gastrointestinal disorders
Colonic Perforation
|
16.7%
1/6 • Number of events 1 • Up to 29 months
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
1/6 • Number of events 1 • Up to 29 months
|
|
Investigations
Alanine Aminotransferase Increased
|
16.7%
1/6 • Number of events 1 • Up to 29 months
|
|
General disorders
Fever
|
16.7%
1/6 • Number of events 1 • Up to 29 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
16.7%
1/6 • Number of events 1 • Up to 29 months
|
|
Eye disorders
Periorbital Edema
|
16.7%
1/6 • Number of events 1 • Up to 29 months
|
|
Investigations
Neutrophil Count Decreased
|
16.7%
1/6 • Number of events 1 • Up to 29 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
33.3%
2/6 • Number of events 2 • Up to 29 months
|
|
Cardiac disorders
Tachycardia
|
16.7%
1/6 • Number of events 1 • Up to 29 months
|
|
Renal and urinary disorders
Transaminitis
|
16.7%
1/6 • Number of events 1 • Up to 29 months
|
|
Respiratory, thoracic and mediastinal disorders
Odynophagia
|
16.7%
1/6 • Number of events 1 • Up to 29 months
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
16.7%
1/6 • Number of events 1 • Up to 29 months
|
|
Gastrointestinal disorders
Esophagitis
|
16.7%
1/6 • Number of events 1 • Up to 29 months
|
|
Cardiac disorders
Atrial Fibrillation
|
33.3%
2/6 • Number of events 2 • Up to 29 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
16.7%
1/6 • Number of events 1 • Up to 29 months
|
Other adverse events
| Measure |
Radiation + Chemo-Immunotherapy
n=6 participants at risk
Carboplatin: AUC = 5-6 mg/mL per min on Day 1 of each 21-day cycle, for 4 cycles
Cisplatin: 75-80 mg/m2 on Day 1 of each 21-day cycle, for 4 cycles
Etoposide: 80-100 mg/m2 on Day 1, Day 2, and Day 3 of each 21-day cycle, for 4 cycles
Durvalumab: 1500 mg on Day 1 of each 21-day cycle, for 4 cycles. Following this, 1500 mg once every 4 weeks until disease progression
Stereotactic Body Radiotherapy: 6 Gy of radiotherapy targeting multiple sites of intrathoracic disease on Days 1-5 of cycle 1.
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
16.7%
1/6 • Number of events 1 • Up to 29 months
|
|
Nervous system disorders
Ageusia
|
16.7%
1/6 • Number of events 1 • Up to 29 months
|
|
Metabolism and nutrition disorders
Anorexia
|
16.7%
1/6 • Number of events 2 • Up to 29 months
|
|
Psychiatric disorders
Anxiety
|
16.7%
1/6 • Number of events 1 • Up to 29 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
33.3%
2/6 • Number of events 2 • Up to 29 months
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
16.7%
1/6 • Number of events 2 • Up to 29 months
|
|
General disorders
Pain
|
16.7%
1/6 • Number of events 2 • Up to 29 months
|
|
Eye disorders
Bulging Eyes
|
16.7%
1/6 • Number of events 1 • Up to 29 months
|
|
Nervous system disorders
Concentration Impairment
|
16.7%
1/6 • Number of events 1 • Up to 29 months
|
|
Respiratory, thoracic and mediastinal disorders
Congestion
|
16.7%
1/6 • Number of events 1 • Up to 29 months
|
|
Gastrointestinal disorders
Constipation
|
33.3%
2/6 • Number of events 3 • Up to 29 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
3/6 • Number of events 8 • Up to 29 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
16.7%
1/6 • Number of events 1 • Up to 29 months
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
2/6 • Number of events 2 • Up to 29 months
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Number of events 3 • Up to 29 months
|
|
Gastrointestinal disorders
Dry Mouth
|
33.3%
2/6 • Number of events 3 • Up to 29 months
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
1/6 • Number of events 2 • Up to 29 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
2/6 • Number of events 3 • Up to 29 months
|
|
Investigations
Alkaline Phosphatase Increased
|
16.7%
1/6 • Number of events 2 • Up to 29 months
|
|
Blood and lymphatic system disorders
Alanine Aminotransferase Increased
|
16.7%
1/6 • Number of events 2 • Up to 29 months
|
|
Blood and lymphatic system disorders
Aspartate Aminotransferase Increased
|
16.7%
1/6 • Number of events 3 • Up to 29 months
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
2/6 • Number of events 3 • Up to 29 months
|
|
General disorders
Fatigue
|
66.7%
4/6 • Number of events 4 • Up to 29 months
|
|
General disorders
Fever
|
33.3%
2/6 • Number of events 5 • Up to 29 months
|
|
General disorders
Malaise
|
16.7%
1/6 • Number of events 2 • Up to 29 months
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
16.7%
1/6 • Number of events 1 • Up to 29 months
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Number of events 1 • Up to 29 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
16.7%
1/6 • Number of events 1 • Up to 29 months
|
|
Endocrine disorders
Hyperthyroidism
|
16.7%
1/6 • Number of events 1 • Up to 29 months
|
|
Psychiatric disorders
Insomnia
|
33.3%
2/6 • Number of events 3 • Up to 29 months
|
|
Eye disorders
Periorbital Edema
|
16.7%
1/6 • Number of events 1 • Up to 29 months
|
|
Ear and labyrinth disorders
Hearing Impaired
|
16.7%
1/6 • Number of events 1 • Up to 29 months
|
|
Nervous system disorders
Amnesia
|
16.7%
1/6 • Number of events 1 • Up to 29 months
|
|
Musculoskeletal and connective tissue disorders
Muscle Cramp
|
16.7%
1/6 • Number of events 1 • Up to 29 months
|
|
Gastrointestinal disorders
Nausea
|
33.3%
2/6 • Number of events 5 • Up to 29 months
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
16.7%
1/6 • Number of events 1 • Up to 29 months
|
|
Nervous system disorders
Neuropathy
|
50.0%
3/6 • Number of events 4 • Up to 29 months
|
|
General disorders
Edema Face
|
16.7%
1/6 • Number of events 1 • Up to 29 months
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-papular
|
50.0%
3/6 • Number of events 5 • Up to 29 months
|
|
Nervous system disorders
Extrapyramidal Disorder
|
16.7%
1/6 • Number of events 1 • Up to 29 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
33.3%
2/6 • Number of events 3 • Up to 29 months
|
|
Eye disorders
Stye
|
16.7%
1/6 • Number of events 2 • Up to 29 months
|
|
Cardiac disorders
Tachycardia
|
33.3%
2/6 • Number of events 2 • Up to 29 months
|
|
Ear and labyrinth disorders
Tinnitus
|
16.7%
1/6 • Number of events 1 • Up to 29 months
|
|
Investigations
Weight Gain
|
16.7%
1/6 • Number of events 1 • Up to 29 months
|
|
General disorders
Generalized Edema
|
16.7%
1/6 • Number of events 1 • Up to 29 months
|
|
Endocrine disorders
Hypothyroidism
|
16.7%
1/6 • Number of events 1 • Up to 29 months
|
|
Cardiac disorders
Hypertension
|
16.7%
1/6 • Number of events 1 • Up to 29 months
|
|
Gastrointestinal disorders
Toothache
|
16.7%
1/6 • Number of events 1 • Up to 29 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place