Trial Outcomes & Findings for Pembrolizumab, Paclitaxel, Carboplatin, and Radiation Therapy in Treating Patients With Stage II-IIIB Non-Small Cell Lung Cancer (NCT NCT02621398)

Last Updated: 2025-12-16

Results Overview

The 3+3 algorithm design will be used to find the MTD. Safety will be evaluated by DLT, defined as grade 4 pneumonitis. Toxicities will be characterized based on seriousness, causality, toxicity grading, and action taken with regard to trial treatment.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

23 participants

Primary outcome timeframe

Up to 30 days

Results posted on

2025-12-16

Participant Flow

Participant milestones

Participant milestones
Measure	Arm 2-6 Weeks Post Treatment After CRT-Pembrolizumab Dose Level: 1 200mg Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Patients undergo 3D CRT or IMRT QD 5 days a week for 6 weeks. Beginning 2-6 weeks after, 2 weeks before the end, or at the start of chemotherapy and radiation therapy, patients also receive pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity. 3-Dimensional Conformal Radiation Therapy: Undergo 3D-CRT or IMRT Carboplatin: Given IV Intensity-Modulated Radiation Therapy: Undergo 3D-CRT or IMRT Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Pembrolizumab: Given IV Dose Level 1 Pembrolizumab 200mg Q3 weeks Dose Level: 1 200mg	2-6 WEEKS AFTERArm: 2 Weeks Before Chemoradiation (CRT) END Dose Level: 2 Pembrolizumab 100mg 2 weeks before the end, or at the start of chemotherapy and radiation therapy Dose Level: 2 Pembrolizumab 100mg Q3 weeks	Arm: 2 Weeks Before Chemoradiation (CRT) END Dose Level: 3 Pembrolizumab 200mg 2 weeks before the end, or at the start of chemotherapy and radiation therapy Dose Level: 3 Pembrolizumab 200mg Q3 weeks	Arm: At Start of CRT Dose Level: 4 Pembrolizumab 100mg CRT Pembrolizumab 200 mg At the start of chemotherapy and radiation therapy Dose Level: 4 Pembrolizumab 100mg Q3 weeks	Arm: At Start of CRT Dose Level: 5 Pembrolizumab 200mg At the start of chemotherapy and radiation therapy Dose Level: 5 Pembrolizumab 200mg Q3 weeks	Arm: At Start of CRT Dose Level: 5-E Pembrolizumab 200mg At the start of chemotherapy and radiation therapy Dose Level: 5E Pembrolizumab 200mg Q3 weeks
Overall Study STARTED	4	4	3	3	3	6
Overall Study COMPLETED	4	4	3	3	3	6
Overall Study NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pembrolizumab, Paclitaxel, Carboplatin, and Radiation Therapy in Treating Patients With Stage II-IIIB Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 2-6 Weeks -Treatment Dose Level -1; Pembrolizumab 100mg Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Patients undergo 3D CRT or IMRT QD 5 days a week for 6 weeks. Beginning 2-6 weeks after, 2 weeks before the end, or at the start of chemotherapy and radiation therapy, patients also receive pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity. 3-Dimensional Conformal Radiation Therapy: Undergo 3D-CRT or IMRT Carboplatin: Given IV Intensity-Modulated Radiation Therapy: Undergo 3D-CRT or IMRT Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Pembrolizumab: Given IV	Arm 2-6 Weeks Post Treatment After CRT-Pembrolizumab Dose Level: 1 200mg n=4 Participants Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Patients undergo 3D CRT or IMRT QD 5 days a week for 6 weeks. Beginning 2-6 weeks after, 2 weeks before the end, or at the start of chemotherapy and radiation therapy, patients also receive pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity. 3-Dimensional Conformal Radiation Therapy: Undergo 3D-CRT or IMRT Carboplatin: Given IV Intensity-Modulated Radiation Therapy: Undergo 3D-CRT or IMRT Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Pembrolizumab: Given IV Dose Level 1 Pembrolizumab 200mg Q3 weeks Dose Level: 1 200mg	Arm: 2 Weeks Before Chemoradiation (CRT) END Dose Level: 2 Pembrolizumab 100mg n=4 Participants 2 weeks before the end, or at the start of chemotherapy and radiation therapy Dose Level: 2 Pembrolizumab 100mg Q3 weeks	Arm: 2 Weeks Before Chemoradiation (CRT) END Dose Level: 3 Pembrolizumab 200mg n=3 Participants 2 weeks before the end, or at the start of chemotherapy and radiation therapy Dose Level: 3 Pembrolizumab 200mg Q3 weeks	Arm: At Start of CRT Dose Level: 4 Pembrolizumab 100mg n=3 Participants At the start of chemotherapy and radiation therapy Dose Level: 4 Pembrolizumab 100mg Q3 weeks	Arm: At Start of CRT Dose Level: 5 Pembrolizumab 200mg n=3 Participants At the start of chemotherapy and radiation therapy Dose Level: 5 Pembrolizumab 200mg Q3 weeks	Arm: At Start of CRT Dose Level: 5-E Pembrolizumab 200mg n=6 Participants At the start of chemotherapy and radiation therapy Dose Level: 5E Pembrolizumab 200mg Q3 weeks	Total n=23 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=387 Participants	0 Participants n=18 Participants	0 Participants n=182 Participants	0 Participants n=3 Participants	0 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants	2 Participants n=387 Participants	0 Participants n=18 Participants	2 Participants n=182 Participants	3 Participants n=3 Participants	7 Participants n=10 Participants
Age, Categorical >=65 years	0 Participants n=6 Participants	4 Participants n=5 Participants	4 Participants n=5 Participants	1 Participants n=387 Participants	3 Participants n=18 Participants	1 Participants n=182 Participants	3 Participants n=3 Participants	16 Participants n=10 Participants
Sex: Female, Male Female	0 Participants n=6 Participants	3 Participants n=5 Participants	0 Participants n=5 Participants	3 Participants n=387 Participants	0 Participants n=18 Participants	1 Participants n=182 Participants	3 Participants n=3 Participants	10 Participants n=10 Participants
Sex: Female, Male Male	0 Participants n=6 Participants	1 Participants n=5 Participants	4 Participants n=5 Participants	0 Participants n=387 Participants	3 Participants n=18 Participants	2 Participants n=182 Participants	3 Participants n=3 Participants	13 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=387 Participants	0 Participants n=18 Participants	0 Participants n=182 Participants	0 Participants n=3 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Asian	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=387 Participants	0 Participants n=18 Participants	0 Participants n=182 Participants	0 Participants n=3 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=387 Participants	0 Participants n=18 Participants	0 Participants n=182 Participants	0 Participants n=3 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Black or African American	0 Participants n=6 Participants	2 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=387 Participants	1 Participants n=18 Participants	0 Participants n=182 Participants	0 Participants n=3 Participants	3 Participants n=10 Participants
Race (NIH/OMB) White	0 Participants n=6 Participants	2 Participants n=5 Participants	4 Participants n=5 Participants	3 Participants n=387 Participants	2 Participants n=18 Participants	3 Participants n=182 Participants	6 Participants n=3 Participants	20 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=387 Participants	0 Participants n=18 Participants	0 Participants n=182 Participants	0 Participants n=3 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=387 Participants	0 Participants n=18 Participants	0 Participants n=182 Participants	0 Participants n=3 Participants	0 Participants n=10 Participants
Region of Enrollment United States	—	4 participants n=5 Participants	4 participants n=5 Participants	3 participants n=387 Participants	3 participants n=18 Participants	3 participants n=182 Participants	6 participants n=3 Participants	23 participants n=10 Participants

PRIMARY outcome

Timeframe: Up to 30 days

Outcome measures

Outcome measures
Measure	All Participants n=23 Participants All participants who received at least one dose of Pembrolizumab; either 100mg or 200 mg.
Maximum Tolerated Dose (MTD) and Dose Limiting Toxicity (DLT) of the Combination of Pembrolizumab With Paclitaxel, Carboplatin and Radiation Therapy According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0	200 mg

SECONDARY outcome

Timeframe: Time of initiation of chemoradiation through study completion (death)

Overall survival is the overall longevity of the patient from time of initiation of chemoradiation to time of death.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time of initiation of chemoradiation through study completion (death)

Best response on treatment was based on RECIST 1.1. Complete response (CR) is complete disappearance of all target lesions; Partial Response (PR) is at least 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference baseline sum. Progressive disease(PD) is at least 20%increase in the sum of the longest diameter of target lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions or progression of non-target lesions. Stable disease is defined as any condition not meeting the above criteria.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time of initiation of chemoradiation through study completion (death)

The length of time from the start of treatment and cancer has not spread to other parts of the body.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time of initiation of chemoradiation through study completion (death)

Progression-free survival is the event without sign of any progression either locally or distantly, measured from the initiation of chemoradiation. Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) for target lesions and assessed by CT or MRI imaging: Complete response (CR) - disappearance of all target lesions; Partial response (PR) - \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) - At least a 20% increase in the sum of the longest diameter of target lesions; or Stable Disease (SD) - neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time of initiation of chemoradiation through study completion (death)

Immune-Related Complete Response (irCR): Complete disappearance of all tumor lesions for at least 4 weeks from the date of documentation of complete response. Immune-Related Partial Response (irPR): The sum of the products of the two largest perpendicular diameters of all index lesions is measured and captured as the SPD baseline. At each subsequent tumor assessment, the sum of the products of the two largest perpendicular diameters of all index lesions and of new measurable lesions are added together to provide the Immune Response Sum of Product Diameters (irSPD). A decrease, relative to baseline of the irSPD compared to the previous SPD baseline, of 50% or greater is considered an immune Partial Response Immune-Related Stable Disease (irSD): irSD is defined as the failure to meet criteria for immune complete response or immune partial response, in the absence of progressive disease

Outcome measures

Outcome data not reported

Adverse Events

Arm 2-6 Weeks -Treatment Dose Level -1; Pembrolizumab 100mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 2-6 Weeks -Treatment Dose Level 1; Pembrolizumab 200mg

Serious events: 2 serious events

Other events: 4 other events

Deaths: 4 deaths

Arm: 2 Weeks Before h Chemoradiation (CRT) END Dose Level: 2 Pembrolizumab 100mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 4 deaths

Arm: 2 Weeks Before h Chemoradiation (CRT) END Dose Level: 3 Pembrolizumab 200mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 1 deaths

Arm: At Start of CRT Dose Level: 4 Pembrolizumab 100mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 1 deaths

Arm: At Start of CRT Dose Level: 5 Pembrolizumab 200mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 2 deaths

Arm: At Start of CRT Dose Level: 5E Pembrolizumab 200mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Arm 2-6 Weeks -Treatment Dose Level -1; Pembrolizumab 100mg Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Patients undergo 3D CRT or IMRT QD 5 days a week for 6 weeks. Beginning 2-6 weeks after, 2 weeks before the end, or at the start of chemotherapy and radiation therapy, patients also receive pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity. 3-Dimensional Conformal Radiation Therapy: Undergo 3D-CRT or IMRT Carboplatin: Given IV Intensity-Modulated Radiation Therapy: Undergo 3D-CRT or IMRT Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Pembrolizumab: Given IV Dose Level -1; Pembrolizumab 100mg	Arm 2-6 Weeks -Treatment Dose Level 1; Pembrolizumab 200mg n=4 participants at risk Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Patients undergo 3D CRT or IMRT QD 5 days a week for 6 weeks. Beginning 2-6 weeks after, 2 weeks before the end, or at the start of chemotherapy and radiation therapy, patients also receive pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity. 3-Dimensional Conformal Radiation Therapy: Undergo 3D-CRT or IMRT Carboplatin: Given IV Intensity-Modulated Radiation Therapy: Undergo 3D-CRT or IMRT Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Pembrolizumab: Given IV Dose Level 1; Pembrolizumab 200mg	Arm: 2 Weeks Before h Chemoradiation (CRT) END Dose Level: 2 Pembrolizumab 100mg n=4 participants at risk 2 weeks before the end, or at the start of chemotherapy and radiation therapy Dose Level 2; Pembrolizumab 100mg	Arm: 2 Weeks Before h Chemoradiation (CRT) END Dose Level: 3 Pembrolizumab 200mg n=3 participants at risk 2 weeks before the end, or at the start of chemotherapy and radiation therapy Dose Level 3; Pembrolizumab 200mg	Arm: At Start of CRT Dose Level: 4 Pembrolizumab 100mg n=3 participants at risk At the start of chemotherapy and radiation therapy Dose Level 4; Pembrolizumab 100mg	Arm: At Start of CRT Dose Level: 5 Pembrolizumab 200mg n=3 participants at risk At the start of chemotherapy and radiation therapy Dose Level 5; Pembrolizumab 200mg	Arm: At Start of CRT Dose Level: 5E Pembrolizumab 200mg n=6 participants at risk At the start of chemotherapy and radiation therapy Dose Level 5-E; Pembrolizumab 200mg
Respiratory, thoracic and mediastinal disorders Dyspnea	— 0/0 • Up to 30 days no data collected for this group	25.0% 1/4 • Number of events 1 • Up to 30 days no data collected for this group	0.00% 0/4 • Up to 30 days no data collected for this group	0.00% 0/3 • Up to 30 days no data collected for this group	0.00% 0/3 • Up to 30 days no data collected for this group	0.00% 0/3 • Up to 30 days no data collected for this group	0.00% 0/6 • Up to 30 days no data collected for this group
Gastrointestinal disorders Colitis	— 0/0 • Up to 30 days no data collected for this group	25.0% 1/4 • Number of events 1 • Up to 30 days no data collected for this group	0.00% 0/4 • Up to 30 days no data collected for this group	0.00% 0/3 • Up to 30 days no data collected for this group	0.00% 0/3 • Up to 30 days no data collected for this group	0.00% 0/3 • Up to 30 days no data collected for this group	0.00% 0/6 • Up to 30 days no data collected for this group
Metabolism and nutrition disorders Hypokalemia	— 0/0 • Up to 30 days no data collected for this group	25.0% 1/4 • Number of events 2 • Up to 30 days no data collected for this group	0.00% 0/4 • Up to 30 days no data collected for this group	0.00% 0/3 • Up to 30 days no data collected for this group	0.00% 0/3 • Up to 30 days no data collected for this group	0.00% 0/3 • Up to 30 days no data collected for this group	0.00% 0/6 • Up to 30 days no data collected for this group
Cardiac disorders Heart failure	— 0/0 • Up to 30 days no data collected for this group	25.0% 1/4 • Number of events 2 • Up to 30 days no data collected for this group	0.00% 0/4 • Up to 30 days no data collected for this group	0.00% 0/3 • Up to 30 days no data collected for this group	0.00% 0/3 • Up to 30 days no data collected for this group	0.00% 0/3 • Up to 30 days no data collected for this group	0.00% 0/6 • Up to 30 days no data collected for this group
Renal and urinary disorders Renal	— 0/0 • Up to 30 days no data collected for this group	25.0% 1/4 • Number of events 1 • Up to 30 days no data collected for this group	0.00% 0/4 • Up to 30 days no data collected for this group	0.00% 0/3 • Up to 30 days no data collected for this group	0.00% 0/3 • Up to 30 days no data collected for this group	0.00% 0/3 • Up to 30 days no data collected for this group	0.00% 0/6 • Up to 30 days no data collected for this group

Other adverse events

Other adverse events
Measure	Arm 2-6 Weeks -Treatment Dose Level -1; Pembrolizumab 100mg Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Patients undergo 3D CRT or IMRT QD 5 days a week for 6 weeks. Beginning 2-6 weeks after, 2 weeks before the end, or at the start of chemotherapy and radiation therapy, patients also receive pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity. 3-Dimensional Conformal Radiation Therapy: Undergo 3D-CRT or IMRT Carboplatin: Given IV Intensity-Modulated Radiation Therapy: Undergo 3D-CRT or IMRT Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Pembrolizumab: Given IV Dose Level -1; Pembrolizumab 100mg	Arm 2-6 Weeks -Treatment Dose Level 1; Pembrolizumab 200mg n=4 participants at risk Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Patients undergo 3D CRT or IMRT QD 5 days a week for 6 weeks. Beginning 2-6 weeks after, 2 weeks before the end, or at the start of chemotherapy and radiation therapy, patients also receive pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity. 3-Dimensional Conformal Radiation Therapy: Undergo 3D-CRT or IMRT Carboplatin: Given IV Intensity-Modulated Radiation Therapy: Undergo 3D-CRT or IMRT Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Pembrolizumab: Given IV Dose Level 1; Pembrolizumab 200mg	Arm: 2 Weeks Before h Chemoradiation (CRT) END Dose Level: 2 Pembrolizumab 100mg n=4 participants at risk 2 weeks before the end, or at the start of chemotherapy and radiation therapy Dose Level 2; Pembrolizumab 100mg	Arm: 2 Weeks Before h Chemoradiation (CRT) END Dose Level: 3 Pembrolizumab 200mg n=3 participants at risk 2 weeks before the end, or at the start of chemotherapy and radiation therapy Dose Level 3; Pembrolizumab 200mg	Arm: At Start of CRT Dose Level: 4 Pembrolizumab 100mg n=3 participants at risk At the start of chemotherapy and radiation therapy Dose Level 4; Pembrolizumab 100mg	Arm: At Start of CRT Dose Level: 5 Pembrolizumab 200mg n=3 participants at risk At the start of chemotherapy and radiation therapy Dose Level 5; Pembrolizumab 200mg	Arm: At Start of CRT Dose Level: 5E Pembrolizumab 200mg n=6 participants at risk At the start of chemotherapy and radiation therapy Dose Level 5-E; Pembrolizumab 200mg
Respiratory, thoracic and mediastinal disorders Respirtory	— 0/0 • Up to 30 days no data collected for this group	100.0% 4/4 • Number of events 14 • Up to 30 days no data collected for this group	100.0% 4/4 • Number of events 36 • Up to 30 days no data collected for this group	100.0% 3/3 • Number of events 9 • Up to 30 days no data collected for this group	100.0% 3/3 • Number of events 18 • Up to 30 days no data collected for this group	33.3% 1/3 • Number of events 2 • Up to 30 days no data collected for this group	100.0% 6/6 • Number of events 52 • Up to 30 days no data collected for this group
Gastrointestinal disorders Gastrointestinal disorders	— 0/0 • Up to 30 days no data collected for this group	100.0% 4/4 • Number of events 13 • Up to 30 days no data collected for this group	75.0% 3/4 • Number of events 33 • Up to 30 days no data collected for this group	100.0% 3/3 • Number of events 12 • Up to 30 days no data collected for this group	66.7% 2/3 • Number of events 6 • Up to 30 days no data collected for this group	100.0% 3/3 • Number of events 16 • Up to 30 days no data collected for this group	100.0% 6/6 • Number of events 33 • Up to 30 days no data collected for this group
General disorders General disorders and administration site conditions	— 0/0 • Up to 30 days no data collected for this group	100.0% 4/4 • Number of events 9 • Up to 30 days no data collected for this group	50.0% 2/4 • Number of events 17 • Up to 30 days no data collected for this group	66.7% 2/3 • Number of events 11 • Up to 30 days no data collected for this group	66.7% 2/3 • Number of events 12 • Up to 30 days no data collected for this group	66.7% 2/3 • Number of events 15 • Up to 30 days no data collected for this group	100.0% 6/6 • Number of events 18 • Up to 30 days no data collected for this group
Metabolism and nutrition disorders Metabolism and nutrition disorders	— 0/0 • Up to 30 days no data collected for this group	75.0% 3/4 • Number of events 9 • Up to 30 days no data collected for this group	100.0% 4/4 • Number of events 10 • Up to 30 days no data collected for this group	33.3% 1/3 • Number of events 5 • Up to 30 days no data collected for this group	33.3% 1/3 • Number of events 3 • Up to 30 days no data collected for this group	100.0% 3/3 • Number of events 7 • Up to 30 days no data collected for this group	50.0% 3/6 • Number of events 5 • Up to 30 days no data collected for this group
Infections and infestations Infections and infestations	— 0/0 • Up to 30 days no data collected for this group	50.0% 2/4 • Number of events 3 • Up to 30 days no data collected for this group	100.0% 4/4 • Number of events 10 • Up to 30 days no data collected for this group	33.3% 1/3 • Number of events 2 • Up to 30 days no data collected for this group	33.3% 1/3 • Number of events 3 • Up to 30 days no data collected for this group	33.3% 1/3 • Number of events 1 • Up to 30 days no data collected for this group	83.3% 5/6 • Number of events 7 • Up to 30 days no data collected for this group
Nervous system disorders Nervous system disorders	— 0/0 • Up to 30 days no data collected for this group	25.0% 1/4 • Number of events 1 • Up to 30 days no data collected for this group	50.0% 2/4 • Number of events 10 • Up to 30 days no data collected for this group	66.7% 2/3 • Number of events 2 • Up to 30 days no data collected for this group	66.7% 2/3 • Number of events 4 • Up to 30 days no data collected for this group	66.7% 2/3 • Number of events 5 • Up to 30 days no data collected for this group	100.0% 6/6 • Number of events 10 • Up to 30 days no data collected for this group
Investigations Investigations	— 0/0 • Up to 30 days no data collected for this group	50.0% 2/4 • Number of events 6 • Up to 30 days no data collected for this group	75.0% 3/4 • Number of events 16 • Up to 30 days no data collected for this group	33.3% 1/3 • Number of events 13 • Up to 30 days no data collected for this group	66.7% 2/3 • Number of events 16 • Up to 30 days no data collected for this group	66.7% 2/3 • Number of events 7 • Up to 30 days no data collected for this group	16.7% 1/6 • Number of events 4 • Up to 30 days no data collected for this group
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders	— 0/0 • Up to 30 days no data collected for this group	50.0% 2/4 • Number of events 2 • Up to 30 days no data collected for this group	50.0% 2/4 • Number of events 4 • Up to 30 days no data collected for this group	66.7% 2/3 • Number of events 5 • Up to 30 days no data collected for this group	66.7% 2/3 • Number of events 10 • Up to 30 days no data collected for this group	66.7% 2/3 • Number of events 2 • Up to 30 days no data collected for this group	50.0% 3/6 • Number of events 3 • Up to 30 days no data collected for this group
Blood and lymphatic system disorders Blood and lymphatic system disorders	— 0/0 • Up to 30 days no data collected for this group	50.0% 2/4 • Number of events 3 • Up to 30 days no data collected for this group	25.0% 1/4 • Number of events 2 • Up to 30 days no data collected for this group	66.7% 2/3 • Number of events 5 • Up to 30 days no data collected for this group	33.3% 1/3 • Number of events 2 • Up to 30 days no data collected for this group	66.7% 2/3 • Number of events 3 • Up to 30 days no data collected for this group	50.0% 3/6 • Number of events 3 • Up to 30 days no data collected for this group
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders	— 0/0 • Up to 30 days no data collected for this group	75.0% 3/4 • Number of events 3 • Up to 30 days no data collected for this group	50.0% 2/4 • Number of events 17 • Up to 30 days no data collected for this group	33.3% 1/3 • Number of events 3 • Up to 30 days no data collected for this group	66.7% 2/3 • Number of events 8 • Up to 30 days no data collected for this group	0.00% 0/3 • Up to 30 days no data collected for this group	33.3% 2/6 • Number of events 2 • Up to 30 days no data collected for this group
Endocrine disorders Endocrine disorders	— 0/0 • Up to 30 days no data collected for this group	0.00% 0/4 • Up to 30 days no data collected for this group	0.00% 0/4 • Up to 30 days no data collected for this group	33.3% 1/3 • Number of events 2 • Up to 30 days no data collected for this group	0.00% 0/3 • Up to 30 days no data collected for this group	33.3% 1/3 • Number of events 1 • Up to 30 days no data collected for this group	0.00% 0/6 • Up to 30 days no data collected for this group
Psychiatric disorders Psychiatric disorders	— 0/0 • Up to 30 days no data collected for this group	0.00% 0/4 • Up to 30 days no data collected for this group	0.00% 0/4 • Up to 30 days no data collected for this group	33.3% 1/3 • Number of events 1 • Up to 30 days no data collected for this group	0.00% 0/3 • Up to 30 days no data collected for this group	0.00% 0/3 • Up to 30 days no data collected for this group	0.00% 0/6 • Up to 30 days no data collected for this group
Cardiac disorders Cardiac disorders	— 0/0 • Up to 30 days no data collected for this group	25.0% 1/4 • Number of events 2 • Up to 30 days no data collected for this group	0.00% 0/4 • Up to 30 days no data collected for this group	0.00% 0/3 • Up to 30 days no data collected for this group	33.3% 1/3 • Number of events 4 • Up to 30 days no data collected for this group	0.00% 0/3 • Up to 30 days no data collected for this group	33.3% 2/6 • Number of events 6 • Up to 30 days no data collected for this group
Renal and urinary disorders Renal	— 0/0 • Up to 30 days no data collected for this group	25.0% 1/4 • Number of events 3 • Up to 30 days no data collected for this group	25.0% 1/4 • Number of events 1 • Up to 30 days no data collected for this group	0.00% 0/3 • Up to 30 days no data collected for this group	33.3% 1/3 • Number of events 1 • Up to 30 days no data collected for this group	0.00% 0/3 • Up to 30 days no data collected for this group	16.7% 1/6 • Number of events 1 • Up to 30 days no data collected for this group
Vascular disorders Vascular	— 0/0 • Up to 30 days no data collected for this group	25.0% 1/4 • Number of events 3 • Up to 30 days no data collected for this group	50.0% 2/4 • Number of events 3 • Up to 30 days no data collected for this group	0.00% 0/3 • Up to 30 days no data collected for this group	0.00% 0/3 • Up to 30 days no data collected for this group	33.3% 1/3 • Number of events 1 • Up to 30 days no data collected for this group	50.0% 3/6 • Number of events 3 • Up to 30 days no data collected for this group

Additional Information

Salma Jabbour, MD

Cancer Institute of New Jersey

Phone: 732-235-8675

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place