Trial Outcomes & Findings for Pembrolizumab and Concurrent Chemoradiotherapy or Radiation Therapy in Treating Patients With Small Cell Lung Cancer (NCT NCT02402920)

Last Updated: 2026-03-10

Results Overview

Safety of MK-3475 plus radiation for extensive-stage small-cell lung cancer (ES-SCLC) based on dose-limiting toxicity (DLT)

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

83 participants

Primary outcome timeframe

Median of 7.3 months (range: 1 to 13 months) following initation of treatment

Results posted on

2026-03-10

Participant Flow

Dates of recruitment period: 07/2015 to 09/2017; Location: Phase 1 single center trial that recruited patients at one hospital (MD Anderson Cancer Center, Houston, TX)

Participant milestones

Participant milestones
Measure	LS-SCLC (Limited-Stage Small Cell Lung Cancer) Chemotherapy (etoposide with platinum agent) + pembrolizumab and thoracic RT; followed with 3 cycles of chemotherapy + pembrolizumab; followed by adjuvant pembrolizumab	ES-SCLC (Extended-Stage Small Cell Lung Cancer) Induction chemotherapy; followed by concurrent chemotherapy/pembrolizumab/RT; followed by adjuvant pembrolizumab
Overall Study STARTED	40	33
Overall Study COMPLETED	37	33
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Reasons for withdrawal
Measure	LS-SCLC (Limited-Stage Small Cell Lung Cancer) Chemotherapy (etoposide with platinum agent) + pembrolizumab and thoracic RT; followed with 3 cycles of chemotherapy + pembrolizumab; followed by adjuvant pembrolizumab	ES-SCLC (Extended-Stage Small Cell Lung Cancer) Induction chemotherapy; followed by concurrent chemotherapy/pembrolizumab/RT; followed by adjuvant pembrolizumab
Overall Study Withdrawal by Subject	1	0
Overall Study Did not receive treatment per protocol	1	0
Overall Study Patient canceled protocol treatment, wanted to get standard of care treatment	1	0

Baseline Characteristics

Pembrolizumab and Concurrent Chemoradiotherapy or Radiation Therapy in Treating Patients With Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LS-SCLC (Limited-Stage Small Cell Lung Cancer) n=37 Participants Chemotherapy (etoposide with platinum agent) + pembrolizumab and thoracic RT; followed with 3 cycles of chemotherapy + pembrolizumab; followed by adjuvant pembrolizumab	ES-SCLC (Extended-Stage Small Cell Lung Cancer) n=33 Participants Induction chemotherapy; followed by concurrent chemotherapy/pembrolizumab/RT; followed by adjuvant pembrolizumab	Total n=70 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=68 Participants	0 Participants n=69 Participants	0 Participants n=137 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=68 Participants	17 Participants n=69 Participants	36 Participants n=137 Participants
Age, Categorical >=65 years	18 Participants n=68 Participants	16 Participants n=69 Participants	34 Participants n=137 Participants
Age, Continuous	63 years n=68 Participants	62 years n=69 Participants	62 years n=137 Participants
Sex: Female, Male Female	21 Participants n=68 Participants	13 Participants n=69 Participants	34 Participants n=137 Participants
Sex: Female, Male Male	16 Participants n=68 Participants	20 Participants n=69 Participants	36 Participants n=137 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=68 Participants	0 Participants n=69 Participants	0 Participants n=137 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=68 Participants	0 Participants n=69 Participants	0 Participants n=137 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	37 Participants n=68 Participants	33 Participants n=69 Participants	70 Participants n=137 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=68 Participants	0 Participants n=69 Participants	0 Participants n=137 Participants
Race (NIH/OMB) Asian	1 Participants n=68 Participants	1 Participants n=69 Participants	2 Participants n=137 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=68 Participants	0 Participants n=69 Participants	0 Participants n=137 Participants
Race (NIH/OMB) Black or African American	3 Participants n=68 Participants	0 Participants n=69 Participants	3 Participants n=137 Participants
Race (NIH/OMB) White	33 Participants n=68 Participants	32 Participants n=69 Participants	65 Participants n=137 Participants
Race (NIH/OMB) More than one race	0 Participants n=68 Participants	0 Participants n=69 Participants	0 Participants n=137 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=68 Participants	0 Participants n=69 Participants	0 Participants n=137 Participants
Region of Enrollment United States	37 participants n=68 Participants	33 participants n=69 Participants	70 participants n=137 Participants

PRIMARY outcome

Timeframe: Median of 7.3 months (range: 1 to 13 months) following initation of treatment

Safety of MK-3475 plus radiation for extensive-stage small-cell lung cancer (ES-SCLC) based on dose-limiting toxicity (DLT)

Outcome measures

Outcome measures
Measure	LS-SCLC (Limited-Stage Small Cell Lung Cancer) n=37 Participants Chemotherapy (etoposide with platinum agent) + pembrolizumab and thoracic RT; followed with 3 cycles of chemotherapy + pembrolizumab; followed by adjuvant pembrolizumab	ES-SCLC (Extended-Stage Small Cell Lung Cancer) n=33 Participants Induction chemotherapy; followed by concurrent chemotherapy/pembrolizumab/RT; followed by adjuvant pembrolizumab
Dose Limiting Toxicity (DLT)	1 Count of DLTs	0 Count of DLTs

SECONDARY outcome

Timeframe: Time from trial enrollment to date of progression/death.

Outcome measures

Outcome measures
Measure	LS-SCLC (Limited-Stage Small Cell Lung Cancer) n=37 Participants Chemotherapy (etoposide with platinum agent) + pembrolizumab and thoracic RT; followed with 3 cycles of chemotherapy + pembrolizumab; followed by adjuvant pembrolizumab	ES-SCLC (Extended-Stage Small Cell Lung Cancer) n=33 Participants Induction chemotherapy; followed by concurrent chemotherapy/pembrolizumab/RT; followed by adjuvant pembrolizumab
Progression Free Survival (PFS)	19.7 Count of PFS months Interval 8.8 to 30.5	6.1 Count of PFS months Interval 4.1 to 8.0

SECONDARY outcome

Timeframe: Time from trial enrollment to date of death.

Outcome measures

Outcome measures
Measure	LS-SCLC (Limited-Stage Small Cell Lung Cancer) n=37 Participants Chemotherapy (etoposide with platinum agent) + pembrolizumab and thoracic RT; followed with 3 cycles of chemotherapy + pembrolizumab; followed by adjuvant pembrolizumab	ES-SCLC (Extended-Stage Small Cell Lung Cancer) n=33 Participants Induction chemotherapy; followed by concurrent chemotherapy/pembrolizumab/RT; followed by adjuvant pembrolizumab
Overall Survival	39.5 Count of OS months Interval 8.0 to 71.0	8.4 Count of OS months Interval 6.7 to 10.1

SECONDARY outcome

Timeframe: Median of 7.3 months (range: 1 to 13 months) following initiation of treatment

Outcome measures

Outcome measures
Measure	LS-SCLC (Limited-Stage Small Cell Lung Cancer) n=37 Participants Chemotherapy (etoposide with platinum agent) + pembrolizumab and thoracic RT; followed with 3 cycles of chemotherapy + pembrolizumab; followed by adjuvant pembrolizumab	ES-SCLC (Extended-Stage Small Cell Lung Cancer) n=33 Participants Induction chemotherapy; followed by concurrent chemotherapy/pembrolizumab/RT; followed by adjuvant pembrolizumab
Overall Response Rate (ORR)	79 Percentage of participants with response Interval 71.0 to 87.0	15.20 Percentage of participants with response Interval 5.1 to 31.9

Adverse Events

LS-SCLC (Limited-Stage Small Cell Lung Cancer)

Serious events: 5 serious events

Other events: 37 other events

Deaths: 11 deaths

ES-SCLC (Extended-Stage Small Cell Lung Cancer)

Serious events: 2 serious events

Other events: 30 other events

Deaths: 20 deaths

Serious adverse events

Other adverse events

Additional Information

James Welsh

MD Anderson Cancer Center

Phone: 713-563-2300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	LS-SCLC (Limited-Stage Small Cell Lung Cancer) n=37 participants at risk Chemotherapy (etoposide with platinum agent) + pembrolizumab and thoracic RT; followed with 3 cycles of chemotherapy + pembrolizumab; followed by adjuvant pembrolizumab	ES-SCLC (Extended-Stage Small Cell Lung Cancer) n=33 participants at risk Induction chemotherapy; followed by concurrent chemotherapy/pembrolizumab/RT; followed by adjuvant pembrolizumab
Skin and subcutaneous tissue disorders Rash	0.00% 0/37 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.	3.0% 1/33 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.
General disorders Asthenia	0.00% 0/37 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.	3.0% 1/33 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.
Nervous system disorders Parasthesia	0.00% 0/37 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.	3.0% 1/33 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.
General disorders Autoimmune disorder	0.00% 0/37 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.	3.0% 1/33 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.
Gastrointestinal disorders Fat Atrophy	2.7% 1/37 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.	0.00% 0/33 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	5.4% 2/37 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.	0.00% 0/33 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.
Infections and infestations Sepsis	2.7% 1/37 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.	0.00% 0/33 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.
Respiratory, thoracic and mediastinal disorders Neutropenia	8.1% 3/37 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.	0.00% 0/33 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	2.7% 1/37 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.	0.00% 0/33 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	5.4% 2/37 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.	0.00% 0/33 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	2.7% 1/37 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.	0.00% 0/33 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.
Infections and infestations Infection	5.4% 2/37 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.	0.00% 0/33 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.
Cardiac disorders Pericarditis	2.7% 1/37 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.	0.00% 0/33 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.
Blood and lymphatic system disorders Anemia	10.8% 4/37 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.	0.00% 0/33 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.
General disorders Fatigue	2.7% 1/37 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.	0.00% 0/33 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.
Musculoskeletal and connective tissue disorders Muscle weakness	0.00% 0/37 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.	3.0% 1/33 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.

Measure	LS-SCLC (Limited-Stage Small Cell Lung Cancer) n=37 participants at risk Chemotherapy (etoposide with platinum agent) + pembrolizumab and thoracic RT; followed with 3 cycles of chemotherapy + pembrolizumab; followed by adjuvant pembrolizumab	ES-SCLC (Extended-Stage Small Cell Lung Cancer) n=33 participants at risk Induction chemotherapy; followed by concurrent chemotherapy/pembrolizumab/RT; followed by adjuvant pembrolizumab
Respiratory, thoracic and mediastinal disorders Cough	43.2% 16/37 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.	6.1% 2/33 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.
Blood and lymphatic system disorders Anemia	32.4% 12/37 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.	6.1% 2/33 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.
General disorders Pain	2.7% 1/37 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.	15.2% 5/33 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.
Gastrointestinal disorders Constipation	18.9% 7/37 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.	6.1% 2/33 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.
Gastrointestinal disorders Dysphagia	51.4% 19/37 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.	24.2% 8/33 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.
Gastrointestinal disorders Esophagitis	45.9% 17/37 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.	24.2% 8/33 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.
General disorders Confusion	2.7% 1/37 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.	0.00% 0/33 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	43.2% 16/37 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.	6.1% 2/33 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.
General disorders Headache	10.8% 4/37 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.	3.0% 1/33 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.
General disorders Fatigue	59.5% 22/37 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.	39.4% 13/33 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.
General disorders Radiation Dermatitis	10.8% 4/37 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.	9.1% 3/33 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.
General disorders Anorexia	0.00% 0/37 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.	9.1% 3/33 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.
General disorders Pruritis	0.00% 0/37 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.	6.1% 2/33 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.
Skin and subcutaneous tissue disorders Rash, Maculopapular	0.00% 0/37 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.	6.1% 2/33 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.
General disorders Muscle weakness	0.00% 0/37 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.	3.0% 1/33 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.
Blood and lymphatic system disorders WBC decrease	0.00% 0/37 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.	3.0% 1/33 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.
Blood and lymphatic system disorders Platelet count decrease	0.00% 0/37 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.	9.1% 3/33 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.
Infections and infestations Infection	8.1% 3/37 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.	0.00% 0/33 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	13.5% 5/37 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.	3.0% 1/33 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.
Cardiac disorders Atrial Fibrillation	2.7% 1/37 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.	0.00% 0/33 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.
Cardiac disorders Cardiac Chest Pain	2.7% 1/37 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.	0.00% 0/33 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.
Gastrointestinal disorders Colitis	2.7% 1/37 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.	0.00% 0/33 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.
Gastrointestinal disorders Diarrhea	18.9% 7/37 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.	0.00% 0/33 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.
Gastrointestinal disorders Nausea	35.1% 13/37 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.	0.00% 0/33 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.
Gastrointestinal disorders Vomiting	5.4% 2/37 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.	0.00% 0/33 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.
Musculoskeletal and connective tissue disorders Arthralgia	18.9% 7/37 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.	0.00% 0/33 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.
General disorders Dizziness	2.7% 1/37 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.	0.00% 0/33 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.
General disorders Fever/Chills	10.8% 4/37 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.	0.00% 0/33 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.
Renal and urinary disorders Acute Kidney Injury	2.7% 1/37 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.	0.00% 0/33 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.
Gastrointestinal disorders Dysgeusia	8.1% 3/37 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.	0.00% 0/33 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.
Nervous system disorders Peripheral neuropathy	5.4% 2/37 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.	0.00% 0/33 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.
Gastrointestinal disorders Xerostomia	2.7% 1/37 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.	0.00% 0/33 • Baseline to median of 5.0 months (range, 0.4 to 19.0 months) for arm 1 and baseline to median of 7.3 months (range: 1 to 13 months) for arm 2 following initiation of treatment.