Trial Outcomes & Findings for Chemoradiation Plus Durvalumab Followed by Surgery Followed by Adjuvant Durvalumab in Patients With Surgically Resectable Stage III (N2) Non-Small Cell Lung Cancer (NCT NCT03871153)
NCT ID: NCT03871153
Last Updated: 2023-11-01
Results Overview
Pathologic Complete Response Rate is defined as lack of evidence of viable cancer in the surgical specimen at the time of surgery.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
3 months
Results posted on
2023-11-01
Participant Flow
Participant milestones
| Measure |
Treatment
Neoadjuvant chemotherapy(Durvalumab, Paclitaxel, Carboplatin), radiation and immunotherapy (durvalumab) followed by surgical resection followed by adjuvant immunotherapy (durvalumab)
Durvalumab: Neoadjuvant Durvalumab 750 mg IV on Days 1, 15 and 29
Adjuvant Durvalumab 12 weeks after undergoing surgical resection 1,500 mg IV on Day 1
Paclitaxel: Paclitaxel 45 mg/m2 IV Days 1, 8, 15, 22, 29 and +/- 36
Carboplatin: Carboplatin AUC of 2 IV Days 1, 8, 15, 22, 29 +/- 36
Radiation: 1.8-2.0 Gy per day (5 days/week) for a total of 45-61.2 Gy over 5-6 weeks. Treatment will be delivered using IMRT or 3DCRT using typically 6-10MV photons. Proton therapy is also allowed. 4D simulation and appropriate IGRT are encouraged. Radiation therapy must begin within one week of the first day of chemotherapy (or vice versa).
Surgical Resection: Patients will undergo repeat imaging between 4 and 12 weeks after completing neoadjuvant therapy. Those without evidence of progressive disease and found to be a surgical candidate by a thoracic surgeon will undergo surgical resection between 4 and 12 weeks after neoadjuvant therapy.
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Overall Study
STARTED
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6
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Overall Study
COMPLETED
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6
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Chemoradiation Plus Durvalumab Followed by Surgery Followed by Adjuvant Durvalumab in Patients With Surgically Resectable Stage III (N2) Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Treatment
n=6 Participants
Neoadjuvant chemotherapy(Durvalumab, Paclitaxel, Carboplatin), radiation and immunotherapy (durvalumab) followed by surgical resection followed by adjuvant immunotherapy (durvalumab)
Durvalumab: Neoadjuvant Durvalumab 750 mg IV on Days 1, 15 and 29
Adjuvant Durvalumab 12 weeks after undergoing surgical resection 1,500 mg IV on Day 1
Paclitaxel: Paclitaxel 45 mg/m2 IV Days 1, 8, 15, 22, 29 and +/- 36
Carboplatin: Carboplatin AUC of 2 IV Days 1, 8, 15, 22, 29 +/- 36
Radiation: 1.8-2.0 Gy per day (5 days/week) for a total of 45-61.2 Gy over 5-6 weeks. Treatment will be delivered using IMRT or 3DCRT using typically 6-10MV photons. Proton therapy is also allowed. 4D simulation and appropriate IGRT are encouraged. Radiation therapy must begin within one week of the first day of chemotherapy (or vice versa).
Surgical Resection: Patients will undergo repeat imaging between 4 and 12 weeks after completing neoadjuvant therapy. Those without evidence of progressive disease and found to be a surgical candidate by a thoracic surgeon will undergo surgical resection between 4 and 12 weeks after neoadjuvant therapy.
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Age, Continuous
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66 years
n=5 Participants
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Sex: Female, Male
Female
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3 Participants
n=5 Participants
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Sex: Female, Male
Male
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3 Participants
n=5 Participants
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|
Ethnicity (NIH/OMB)
Hispanic or Latino
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1 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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5 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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1 Participants
n=5 Participants
|
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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1 Participants
n=5 Participants
|
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Race (NIH/OMB)
White
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3 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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1 Participants
n=5 Participants
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Region of Enrollment
United States
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6 participants
n=5 Participants
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Baseline ECOG
ECOG = 0
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3 Participants
n=5 Participants
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Baseline ECOG
ECOG = 1
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3 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: 3 monthsPopulation: 4 Subjects completed the surgical procedure and were evaluable for Pathologic Complete Response
Pathologic Complete Response Rate is defined as lack of evidence of viable cancer in the surgical specimen at the time of surgery.
Outcome measures
| Measure |
Treatment
n=4 Participants
Neoadjuvant chemotherapy(Durvalumab, Paclitaxel, Carboplatin), radiation and immunotherapy (durvalumab) followed by surgical resection followed by adjuvant immunotherapy (durvalumab)
Durvalumab: Neoadjuvant Durvalumab 750 mg IV on Days 1, 15 and 29
Adjuvant Durvalumab 12 weeks after undergoing surgical resection 1,500 mg IV on Day 1
Paclitaxel: Paclitaxel 45 mg/m2 IV Days 1, 8, 15, 22, 29 and +/- 36
Carboplatin: Carboplatin AUC of 2 IV Days 1, 8, 15, 22, 29 +/- 36
Radiation: 1.8-2.0 Gy per day (5 days/week) for a total of 45-61.2 Gy over 5-6 weeks. Treatment will be delivered using IMRT or 3DCRT using typically 6-10MV photons. Proton therapy is also allowed. 4D simulation and appropriate IGRT are encouraged. Radiation therapy must begin within one week of the first day of chemotherapy (or vice versa).
Surgical Resection: Patients will undergo repeat imaging between 4 and 12 weeks after completing neoadjuvant therapy. Those without evidence of progressive disease and found to be a surgical candidate by a thoracic surgeon will undergo surgical resection between 4 and 12 weeks after neoadjuvant therapy.
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Pathologic Complete Response Rate
Pathological Complete Response Achieved
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0 Participants
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Pathologic Complete Response Rate
Pathological Complete Response Not Achieved
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4 Participants
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SECONDARY outcome
Timeframe: 3 monthsPopulation: 4 subjects completed the surgical procedure and were evaluable for Pathologic N0 status
Pathologic N0 rate is defined as a lack of evidence of viable cancer in the removed lymph nodes at the time of surgery.
Outcome measures
| Measure |
Treatment
n=4 Participants
Neoadjuvant chemotherapy(Durvalumab, Paclitaxel, Carboplatin), radiation and immunotherapy (durvalumab) followed by surgical resection followed by adjuvant immunotherapy (durvalumab)
Durvalumab: Neoadjuvant Durvalumab 750 mg IV on Days 1, 15 and 29
Adjuvant Durvalumab 12 weeks after undergoing surgical resection 1,500 mg IV on Day 1
Paclitaxel: Paclitaxel 45 mg/m2 IV Days 1, 8, 15, 22, 29 and +/- 36
Carboplatin: Carboplatin AUC of 2 IV Days 1, 8, 15, 22, 29 +/- 36
Radiation: 1.8-2.0 Gy per day (5 days/week) for a total of 45-61.2 Gy over 5-6 weeks. Treatment will be delivered using IMRT or 3DCRT using typically 6-10MV photons. Proton therapy is also allowed. 4D simulation and appropriate IGRT are encouraged. Radiation therapy must begin within one week of the first day of chemotherapy (or vice versa).
Surgical Resection: Patients will undergo repeat imaging between 4 and 12 weeks after completing neoadjuvant therapy. Those without evidence of progressive disease and found to be a surgical candidate by a thoracic surgeon will undergo surgical resection between 4 and 12 weeks after neoadjuvant therapy.
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Pathologic N0 Rate
Pathologic N0 Status Achieved
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3 Participants
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Pathologic N0 Rate
Pathologic N0 Status Not Achieved
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1 Participants
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SECONDARY outcome
Timeframe: AEs had been recorded from time of signed informed consent until 90 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 13 months.Adverse events, \>= grade 3 and related to treatment will be summarized by frequency and severity according to the NCI Common Terminology Criteria for (NCI CTCAE) v5
Outcome measures
| Measure |
Treatment
n=6 Participants
Neoadjuvant chemotherapy(Durvalumab, Paclitaxel, Carboplatin), radiation and immunotherapy (durvalumab) followed by surgical resection followed by adjuvant immunotherapy (durvalumab)
Durvalumab: Neoadjuvant Durvalumab 750 mg IV on Days 1, 15 and 29
Adjuvant Durvalumab 12 weeks after undergoing surgical resection 1,500 mg IV on Day 1
Paclitaxel: Paclitaxel 45 mg/m2 IV Days 1, 8, 15, 22, 29 and +/- 36
Carboplatin: Carboplatin AUC of 2 IV Days 1, 8, 15, 22, 29 +/- 36
Radiation: 1.8-2.0 Gy per day (5 days/week) for a total of 45-61.2 Gy over 5-6 weeks. Treatment will be delivered using IMRT or 3DCRT using typically 6-10MV photons. Proton therapy is also allowed. 4D simulation and appropriate IGRT are encouraged. Radiation therapy must begin within one week of the first day of chemotherapy (or vice versa).
Surgical Resection: Patients will undergo repeat imaging between 4 and 12 weeks after completing neoadjuvant therapy. Those without evidence of progressive disease and found to be a surgical candidate by a thoracic surgeon will undergo surgical resection between 4 and 12 weeks after neoadjuvant therapy.
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Assess Adverse Events (AE)
LUNG INFECTION Grade 5
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1 Participants
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Assess Adverse Events (AE)
HYPOKALEMIA Grade 4
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1 Participants
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Assess Adverse Events (AE)
ACIDOSIS Grade 3
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1 Participants
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Assess Adverse Events (AE)
APPENDICITIS Grade 3
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1 Participants
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Assess Adverse Events (AE)
PAIN Grade 3
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1 Participants
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SECONDARY outcome
Timeframe: Time from surgical resection until disease recurrence or death, up to a maximum of 8 monthsPopulation: 4 patients out of 6 are evaluable for DFS. 2 patients did not go through the surgery and no response was recorded.
Disease free survival will be defined as the time from surgical resection until the criteria for disease recurrence is met or death as a result of any cause. Disease recurrence is return of the cancer to where it started (local) or in another part of the body (distant).
Outcome measures
| Measure |
Treatment
n=4 Participants
Neoadjuvant chemotherapy(Durvalumab, Paclitaxel, Carboplatin), radiation and immunotherapy (durvalumab) followed by surgical resection followed by adjuvant immunotherapy (durvalumab)
Durvalumab: Neoadjuvant Durvalumab 750 mg IV on Days 1, 15 and 29
Adjuvant Durvalumab 12 weeks after undergoing surgical resection 1,500 mg IV on Day 1
Paclitaxel: Paclitaxel 45 mg/m2 IV Days 1, 8, 15, 22, 29 and +/- 36
Carboplatin: Carboplatin AUC of 2 IV Days 1, 8, 15, 22, 29 +/- 36
Radiation: 1.8-2.0 Gy per day (5 days/week) for a total of 45-61.2 Gy over 5-6 weeks. Treatment will be delivered using IMRT or 3DCRT using typically 6-10MV photons. Proton therapy is also allowed. 4D simulation and appropriate IGRT are encouraged. Radiation therapy must begin within one week of the first day of chemotherapy (or vice versa).
Surgical Resection: Patients will undergo repeat imaging between 4 and 12 weeks after completing neoadjuvant therapy. Those without evidence of progressive disease and found to be a surgical candidate by a thoracic surgeon will undergo surgical resection between 4 and 12 weeks after neoadjuvant therapy.
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Disease Free Survival (DFS)
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6.7 Months
Interval 0.8 to
Not enough participants achieved response to calculate upper 95% CI.
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Adverse Events
Treatment
Serious events: 2 serious events
Other events: 6 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Treatment
n=6 participants at risk
Neoadjuvant chemotherapy(Durvalumab, Paclitaxel, Carboplatin), radiation and immunotherapy (durvalumab) followed by surgical resection followed by adjuvant immunotherapy (durvalumab)
Durvalumab: Neoadjuvant Durvalumab 750 mg IV on Days 1, 15 and 29
Adjuvant Durvalumab 12 weeks after undergoing surgical resection 1,500 mg IV on Day 1
Paclitaxel: Paclitaxel 45 mg/m2 IV Days 1, 8, 15, 22, 29 and +/- 36
Carboplatin: Carboplatin AUC of 2 IV Days 1, 8, 15, 22, 29 +/- 36
Radiation: 1.8-2.0 Gy per day (5 days/week) for a total of 45-61.2 Gy over 5-6 weeks. Treatment will be delivered using IMRT or 3DCRT using typically 6-10MV photons. Proton therapy is also allowed. 4D simulation and appropriate IGRT are encouraged. Radiation therapy must begin within one week of the first day of chemotherapy (or vice versa).
Surgical Resection: Patients will undergo repeat imaging between 4 and 12 weeks after completing neoadjuvant therapy. Those without evidence of progressive disease and found to be a surgical candidate by a thoracic surgeon will undergo surgical resection between 4 and 12 weeks after neoadjuvant therapy.
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Infections and infestations
APPENDICITIS
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16.7%
1/6 • Number of events 1 • Adverse events had been recorded from time of signed informed consent until 90 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 13 months.
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Metabolism and nutrition disorders
HYPOKALEMIA
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16.7%
1/6 • Number of events 1 • Adverse events had been recorded from time of signed informed consent until 90 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 13 months.
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Infections and infestations
LUNG INFECTION
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16.7%
1/6 • Number of events 1 • Adverse events had been recorded from time of signed informed consent until 90 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 13 months.
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Other adverse events
| Measure |
Treatment
n=6 participants at risk
Neoadjuvant chemotherapy(Durvalumab, Paclitaxel, Carboplatin), radiation and immunotherapy (durvalumab) followed by surgical resection followed by adjuvant immunotherapy (durvalumab)
Durvalumab: Neoadjuvant Durvalumab 750 mg IV on Days 1, 15 and 29
Adjuvant Durvalumab 12 weeks after undergoing surgical resection 1,500 mg IV on Day 1
Paclitaxel: Paclitaxel 45 mg/m2 IV Days 1, 8, 15, 22, 29 and +/- 36
Carboplatin: Carboplatin AUC of 2 IV Days 1, 8, 15, 22, 29 +/- 36
Radiation: 1.8-2.0 Gy per day (5 days/week) for a total of 45-61.2 Gy over 5-6 weeks. Treatment will be delivered using IMRT or 3DCRT using typically 6-10MV photons. Proton therapy is also allowed. 4D simulation and appropriate IGRT are encouraged. Radiation therapy must begin within one week of the first day of chemotherapy (or vice versa).
Surgical Resection: Patients will undergo repeat imaging between 4 and 12 weeks after completing neoadjuvant therapy. Those without evidence of progressive disease and found to be a surgical candidate by a thoracic surgeon will undergo surgical resection between 4 and 12 weeks after neoadjuvant therapy.
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Metabolism and nutrition disorders
ACIDOSIS
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16.7%
1/6 • Number of events 1 • Adverse events had been recorded from time of signed informed consent until 90 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 13 months.
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Blood and lymphatic system disorders
ANEMIA
|
33.3%
2/6 • Number of events 2 • Adverse events had been recorded from time of signed informed consent until 90 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 13 months.
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Metabolism and nutrition disorders
ANOREXIA
|
33.3%
2/6 • Number of events 2 • Adverse events had been recorded from time of signed informed consent until 90 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 13 months.
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Psychiatric disorders
ANXIETY
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16.7%
1/6 • Number of events 1 • Adverse events had been recorded from time of signed informed consent until 90 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 13 months.
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Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
16.7%
1/6 • Number of events 1 • Adverse events had been recorded from time of signed informed consent until 90 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 13 months.
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Investigations
BLOOD BILIRUBIN INCREASED
|
16.7%
1/6 • Number of events 1 • Adverse events had been recorded from time of signed informed consent until 90 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 13 months.
|
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Musculoskeletal and connective tissue disorders
CHEST WALL PAIN
|
16.7%
1/6 • Number of events 1 • Adverse events had been recorded from time of signed informed consent until 90 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 13 months.
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Gastrointestinal disorders
CONSTIPATION
|
66.7%
4/6 • Number of events 6 • Adverse events had been recorded from time of signed informed consent until 90 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 13 months.
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Respiratory, thoracic and mediastinal disorders
COUGH
|
50.0%
3/6 • Number of events 6 • Adverse events had been recorded from time of signed informed consent until 90 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 13 months.
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Injury, poisoning and procedural complications
DERMATITIS RADIATION
|
16.7%
1/6 • Number of events 3 • Adverse events had been recorded from time of signed informed consent until 90 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 13 months.
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Gastrointestinal disorders
DIARRHEA
|
33.3%
2/6 • Number of events 2 • Adverse events had been recorded from time of signed informed consent until 90 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 13 months.
|
|
Nervous system disorders
DIZZINESS
|
33.3%
2/6 • Number of events 2 • Adverse events had been recorded from time of signed informed consent until 90 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 13 months.
|
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Gastrointestinal disorders
DRY MOUTH
|
16.7%
1/6 • Number of events 1 • Adverse events had been recorded from time of signed informed consent until 90 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 13 months.
|
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Skin and subcutaneous tissue disorders
DRY SKIN
|
16.7%
1/6 • Number of events 1 • Adverse events had been recorded from time of signed informed consent until 90 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 13 months.
|
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Nervous system disorders
DYSGEUSIA
|
16.7%
1/6 • Number of events 1 • Adverse events had been recorded from time of signed informed consent until 90 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 13 months.
|
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Gastrointestinal disorders
DYSPEPSIA
|
16.7%
1/6 • Number of events 2 • Adverse events had been recorded from time of signed informed consent until 90 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 13 months.
|
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Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
33.3%
2/6 • Number of events 3 • Adverse events had been recorded from time of signed informed consent until 90 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 13 months.
|
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Reproductive system and breast disorders
ERECTILE DYSFUNCTION
|
16.7%
1/6 • Number of events 1 • Adverse events had been recorded from time of signed informed consent until 90 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 13 months.
|
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Gastrointestinal disorders
ESOPHAGITIS
|
66.7%
4/6 • Number of events 6 • Adverse events had been recorded from time of signed informed consent until 90 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 13 months.
|
|
Eye disorders
EYE DISORDERS - OTHER, SPECIFY
|
16.7%
1/6 • Number of events 1 • Adverse events had been recorded from time of signed informed consent until 90 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 13 months.
|
|
General disorders
FATIGUE
|
100.0%
6/6 • Number of events 7 • Adverse events had been recorded from time of signed informed consent until 90 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 13 months.
|
|
General disorders
FEVER
|
16.7%
1/6 • Number of events 4 • Adverse events had been recorded from time of signed informed consent until 90 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 13 months.
|
|
General disorders
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - OTHER, SPECIFY
|
16.7%
1/6 • Number of events 1 • Adverse events had been recorded from time of signed informed consent until 90 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 13 months.
|
|
Nervous system disorders
HEADACHE
|
33.3%
2/6 • Number of events 2 • Adverse events had been recorded from time of signed informed consent until 90 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 13 months.
|
|
Metabolism and nutrition disorders
HYPOKALEMIA
|
16.7%
1/6 • Number of events 4 • Adverse events had been recorded from time of signed informed consent until 90 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 13 months.
|
|
Vascular disorders
HYPOTENSION
|
16.7%
1/6 • Number of events 1 • Adverse events had been recorded from time of signed informed consent until 90 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 13 months.
|
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Injury, poisoning and procedural complications
INFUSION RELATED REACTION
|
16.7%
1/6 • Number of events 1 • Adverse events had been recorded from time of signed informed consent until 90 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 13 months.
|
|
Psychiatric disorders
INSOMNIA
|
16.7%
1/6 • Number of events 1 • Adverse events had been recorded from time of signed informed consent until 90 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 13 months.
|
|
Injury, poisoning and procedural complications
INTRAOPERATIVE ARTERIAL INJURY
|
16.7%
1/6 • Number of events 1 • Adverse events had been recorded from time of signed informed consent until 90 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 13 months.
|
|
Infections and infestations
LUNG INFECTION
|
16.7%
1/6 • Number of events 1 • Adverse events had been recorded from time of signed informed consent until 90 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 13 months.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS LOWER LIMB
|
16.7%
1/6 • Number of events 1 • Adverse events had been recorded from time of signed informed consent until 90 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 13 months.
|
|
Gastrointestinal disorders
NAUSEA
|
83.3%
5/6 • Number of events 8 • Adverse events had been recorded from time of signed informed consent until 90 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 13 months.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
16.7%
1/6 • Number of events 1 • Adverse events had been recorded from time of signed informed consent until 90 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 13 months.
|
|
General disorders
PAIN
|
33.3%
2/6 • Number of events 4 • Adverse events had been recorded from time of signed informed consent until 90 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 13 months.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
33.3%
2/6 • Number of events 2 • Adverse events had been recorded from time of signed informed consent until 90 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 13 months.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
16.7%
1/6 • Number of events 1 • Adverse events had been recorded from time of signed informed consent until 90 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 13 months.
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
16.7%
1/6 • Number of events 1 • Adverse events had been recorded from time of signed informed consent until 90 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 13 months.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
33.3%
2/6 • Number of events 2 • Adverse events had been recorded from time of signed informed consent until 90 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 13 months.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY
|
16.7%
1/6 • Number of events 1 • Adverse events had been recorded from time of signed informed consent until 90 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 13 months.
|
|
Infections and infestations
SINUSITIS
|
16.7%
1/6 • Number of events 1 • Adverse events had been recorded from time of signed informed consent until 90 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 13 months.
|
|
Vascular disorders
THROMBOEMBOLIC EVENT
|
16.7%
1/6 • Number of events 1 • Adverse events had been recorded from time of signed informed consent until 90 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 13 months.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
16.7%
1/6 • Number of events 2 • Adverse events had been recorded from time of signed informed consent until 90 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 13 months.
|
|
Gastrointestinal disorders
VOMITING
|
16.7%
1/6 • Number of events 3 • Adverse events had been recorded from time of signed informed consent until 90 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 13 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place