Trial Outcomes & Findings for Rucaparib and Pembrolizumab for Maintenance Therapy in Stage IV Non-Squamous Non-Small Cell Lung Cancer (NCT NCT03559049)
NCT ID: NCT03559049
Last Updated: 2026-02-12
Results Overview
The primary endpoint is median progression free survival (PFS) which is defined as the median duration of time from the start of treatment to progression. Progression is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
25 participants
Primary outcome timeframe
Up to 5 years
Results posted on
2026-02-12
Participant Flow
1 patient was deemed an incorrect consent after enrollment and never started on therapy
Participant milestones
| Measure |
Rucaparib and Pembrolizumab Maintenance
All patients received induction therapy with Pembrolizumab (200mg IV on day 1 of every 21 days), Pemetrexed (500mg/m\^2 IV on day 1 of every 21 days), and Carboplatin (AUC5 IV on day 1 of every 21 days).
This was followed by maintenance therapy with Pembrolizumab (200mg IV on day 1 of every 21 days) and Rucaparib (600mg PO BID days 1-21 of each 21 day cycle).
Pembrolizumab: 200mg IV every 21 days
Pemetrexed: 500mg/m\^2 IV every 21 days
Carboplatin: AUC 5 IV every 21 days
Rucaparib: 600mg PO, BID days 1-21 of each 21 day cycle
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
Rucaparib and Pembrolizumab Maintenance
All patients received induction therapy with Pembrolizumab (200mg IV on day 1 of every 21 days), Pemetrexed (500mg/m\^2 IV on day 1 of every 21 days), and Carboplatin (AUC5 IV on day 1 of every 21 days).
This was followed by maintenance therapy with Pembrolizumab (200mg IV on day 1 of every 21 days) and Rucaparib (600mg PO BID days 1-21 of each 21 day cycle).
Pembrolizumab: 200mg IV every 21 days
Pemetrexed: 500mg/m\^2 IV every 21 days
Carboplatin: AUC 5 IV every 21 days
Rucaparib: 600mg PO, BID days 1-21 of each 21 day cycle
|
|---|---|
|
Overall Study
Adverse Event
|
6
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Death
|
1
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Sponsor termination
|
3
|
Baseline Characteristics
Rucaparib and Pembrolizumab for Maintenance Therapy in Stage IV Non-Squamous Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Rucaparib and Pembrolizumab Maintenance
n=25 Participants
All patients received induction therapy with Pembrolizumab (200mg IV on day 1 of every 21 days), Pemetrexed (500mg/m\^2 IV on day 1 of every 21 days), and Carboplatin (AUC5 IV on day 1 of every 21 days).
This was followed by maintenance therapy with Pembrolizumab (200mg IV on day 1 of every 21 days) and Rucaparib (600mg PO BID days 1-21 of each 21 day cycle).
Pembrolizumab: 200mg IV every 21 days
Pemetrexed: 500mg/m\^2 IV every 21 days
Carboplatin: AUC 5 IV every 21 days
Rucaparib: 600mg PO, BID days 1-21 of each 21 day cycle
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=41 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=41 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=41 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=41 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=41 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=41 Participants
|
PRIMARY outcome
Timeframe: Up to 5 yearsPopulation: Per the protocol, the Evaluable population is those patients who received at least one cycle of maintenance.
The primary endpoint is median progression free survival (PFS) which is defined as the median duration of time from the start of treatment to progression. Progression is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions.
Outcome measures
| Measure |
Rucaparib and Pembrolizumab Maintenance
n=14 Participants
All patients received induction therapy with Pembrolizumab (200mg IV on day 1 of every 21 days), Pemetrexed (500mg/m\^2 IV on day 1 of every 21 days), and Carboplatin (AUC5 IV on day 1 of every 21 days).
This was followed by maintenance therapy with Pembrolizumab (200mg IV on day 1 of every 21 days) and Rucaparib (600mg PO BID days 1-21 of each 21 day cycle).
Pembrolizumab: 200mg IV every 21 days
Pemetrexed: 500mg/m\^2 IV every 21 days
Carboplatin: AUC 5 IV every 21 days
Rucaparib: 600mg PO, BID days 1-21 of each 21 day cycle
|
|---|---|
|
Median Duration of Time From Start of Treatment to Time of Progression
|
10.6 months
Interval 8.3 to
The upper confidence limit for the median could not be estimated because there were too few progression events. The upper confidence limit curve never reaches 50 percent, so the upper confidence limit is not estimable.
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Per the protocol, the Evaluable population is those patients who received at least one cycle of maintenance.
The secondary endpoint is median overall survival (OS) which is defined as the median duration of time from the start of treatment until death.
Outcome measures
| Measure |
Rucaparib and Pembrolizumab Maintenance
n=14 Participants
All patients received induction therapy with Pembrolizumab (200mg IV on day 1 of every 21 days), Pemetrexed (500mg/m\^2 IV on day 1 of every 21 days), and Carboplatin (AUC5 IV on day 1 of every 21 days).
This was followed by maintenance therapy with Pembrolizumab (200mg IV on day 1 of every 21 days) and Rucaparib (600mg PO BID days 1-21 of each 21 day cycle).
Pembrolizumab: 200mg IV every 21 days
Pemetrexed: 500mg/m\^2 IV every 21 days
Carboplatin: AUC 5 IV every 21 days
Rucaparib: 600mg PO, BID days 1-21 of each 21 day cycle
|
|---|---|
|
Median Duration of Time From the Start of Treatment Until Death
|
37.6 months
Interval 25.6 to
The upper confidence limit for the median could not be estimated because there were too few progression events. The upper confidence limit curve never reaches 50 percent, so the upper confidence limit is not estimable.
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Per the protocol, the Evaluable population is those patients who received at least one cycle of maintenance.
Percentage of patients who achieve a complete or partial response after at least one cycle of maintenance therapy with rucaparib and pembrolizumab. Response assessed by immune-related Response Evaluation Criteria in Solid Tumors (irRecist).
Outcome measures
| Measure |
Rucaparib and Pembrolizumab Maintenance
n=14 Participants
All patients received induction therapy with Pembrolizumab (200mg IV on day 1 of every 21 days), Pemetrexed (500mg/m\^2 IV on day 1 of every 21 days), and Carboplatin (AUC5 IV on day 1 of every 21 days).
This was followed by maintenance therapy with Pembrolizumab (200mg IV on day 1 of every 21 days) and Rucaparib (600mg PO BID days 1-21 of each 21 day cycle).
Pembrolizumab: 200mg IV every 21 days
Pemetrexed: 500mg/m\^2 IV every 21 days
Carboplatin: AUC 5 IV every 21 days
Rucaparib: 600mg PO, BID days 1-21 of each 21 day cycle
|
|---|---|
|
Response Rate
|
9 Participants
|
Adverse Events
Rucaparib and Pembrolizumab Maintenance
Serious events: 8 serious events
Other events: 14 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Rucaparib and Pembrolizumab Maintenance
n=14 participants at risk
All patients received induction therapy with Pembrolizumab (200mg IV on day 1 of every 21 days), Pemetrexed (500mg/m\^2 IV on day 1 of every 21 days), and Carboplatin (AUC5 IV on day 1 of every 21 days).
This was followed by maintenance therapy with Pembrolizumab (200mg IV on day 1 of every 21 days) and Rucaparib (600mg PO BID days 1-21 of each 21 day cycle).
Pembrolizumab: 200mg IV every 21 days
Pemetrexed: 500mg/m\^2 IV every 21 days
Carboplatin: AUC 5 IV every 21 days
Rucaparib: 600mg PO, BID days 1-21 of each 21 day cycle
|
|---|---|
|
Investigations
Alanine aminotransferase increased
|
21.4%
3/14 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Data was collected up to 5 years.
Per the protocol, the Evaluable population is those patients who received at least one cycle of maintenance.
|
|
Investigations
Alkaline phosphatase increased
|
7.1%
1/14 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Data was collected up to 5 years.
Per the protocol, the Evaluable population is those patients who received at least one cycle of maintenance.
|
|
Blood and lymphatic system disorders
Anemia
|
7.1%
1/14 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Data was collected up to 5 years.
Per the protocol, the Evaluable population is those patients who received at least one cycle of maintenance.
|
|
Investigations
Aspartate aminotransferase increased
|
21.4%
3/14 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Data was collected up to 5 years.
Per the protocol, the Evaluable population is those patients who received at least one cycle of maintenance.
|
|
General disorders
Fall
|
7.1%
1/14 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Data was collected up to 5 years.
Per the protocol, the Evaluable population is those patients who received at least one cycle of maintenance.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
7.1%
1/14 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Data was collected up to 5 years.
Per the protocol, the Evaluable population is those patients who received at least one cycle of maintenance.
|
|
Infections and infestations
Lung infection
|
7.1%
1/14 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Data was collected up to 5 years.
Per the protocol, the Evaluable population is those patients who received at least one cycle of maintenance.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
7.1%
1/14 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Data was collected up to 5 years.
Per the protocol, the Evaluable population is those patients who received at least one cycle of maintenance.
|
|
Infections and infestations
Sepsis
|
7.1%
1/14 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Data was collected up to 5 years.
Per the protocol, the Evaluable population is those patients who received at least one cycle of maintenance.
|
|
Infections and infestations
Urinary tract infection
|
7.1%
1/14 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Data was collected up to 5 years.
Per the protocol, the Evaluable population is those patients who received at least one cycle of maintenance.
|
Other adverse events
| Measure |
Rucaparib and Pembrolizumab Maintenance
n=14 participants at risk
All patients received induction therapy with Pembrolizumab (200mg IV on day 1 of every 21 days), Pemetrexed (500mg/m\^2 IV on day 1 of every 21 days), and Carboplatin (AUC5 IV on day 1 of every 21 days).
This was followed by maintenance therapy with Pembrolizumab (200mg IV on day 1 of every 21 days) and Rucaparib (600mg PO BID days 1-21 of each 21 day cycle).
Pembrolizumab: 200mg IV every 21 days
Pemetrexed: 500mg/m\^2 IV every 21 days
Carboplatin: AUC 5 IV every 21 days
Rucaparib: 600mg PO, BID days 1-21 of each 21 day cycle
|
|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
7.1%
1/14 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Data was collected up to 5 years.
Per the protocol, the Evaluable population is those patients who received at least one cycle of maintenance.
|
|
Investigations
Alanine aminotransferase increased
|
7.1%
1/14 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Data was collected up to 5 years.
Per the protocol, the Evaluable population is those patients who received at least one cycle of maintenance.
|
|
Investigations
Aspartate aminotransferase increased
|
7.1%
1/14 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Data was collected up to 5 years.
Per the protocol, the Evaluable population is those patients who received at least one cycle of maintenance.
|
|
Eye disorders
Blurred vision
|
7.1%
1/14 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Data was collected up to 5 years.
Per the protocol, the Evaluable population is those patients who received at least one cycle of maintenance.
|
|
Cardiac disorders
Chest pain - cardiac
|
7.1%
1/14 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Data was collected up to 5 years.
Per the protocol, the Evaluable population is those patients who received at least one cycle of maintenance.
|
|
Gastrointestinal disorders
Constipation
|
7.1%
1/14 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Data was collected up to 5 years.
Per the protocol, the Evaluable population is those patients who received at least one cycle of maintenance.
|
|
Investigations
Creatinine increased
|
14.3%
2/14 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Data was collected up to 5 years.
Per the protocol, the Evaluable population is those patients who received at least one cycle of maintenance.
|
|
Gastrointestinal disorders
Diarrhea
|
7.1%
1/14 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Data was collected up to 5 years.
Per the protocol, the Evaluable population is those patients who received at least one cycle of maintenance.
|
|
Nervous system disorders
Dysgeusia
|
7.1%
1/14 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Data was collected up to 5 years.
Per the protocol, the Evaluable population is those patients who received at least one cycle of maintenance.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
21.4%
3/14 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Data was collected up to 5 years.
Per the protocol, the Evaluable population is those patients who received at least one cycle of maintenance.
|
|
General disorders
Edema limbs
|
14.3%
2/14 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Data was collected up to 5 years.
Per the protocol, the Evaluable population is those patients who received at least one cycle of maintenance.
|
|
General disorders
Fatigue
|
14.3%
2/14 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Data was collected up to 5 years.
Per the protocol, the Evaluable population is those patients who received at least one cycle of maintenance.
|
|
General disorders
Flank pain
|
7.1%
1/14 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Data was collected up to 5 years.
Per the protocol, the Evaluable population is those patients who received at least one cycle of maintenance.
|
|
Nervous system disorders
Headache
|
7.1%
1/14 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Data was collected up to 5 years.
Per the protocol, the Evaluable population is those patients who received at least one cycle of maintenance.
|
|
Vascular disorders
Hypotension
|
7.1%
1/14 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Data was collected up to 5 years.
Per the protocol, the Evaluable population is those patients who received at least one cycle of maintenance.
|
|
Investigations
Hypothyroidism
|
7.1%
1/14 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Data was collected up to 5 years.
Per the protocol, the Evaluable population is those patients who received at least one cycle of maintenance.
|
|
Psychiatric disorders
Insomnia
|
7.1%
1/14 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Data was collected up to 5 years.
Per the protocol, the Evaluable population is those patients who received at least one cycle of maintenance.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
7.1%
1/14 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Data was collected up to 5 years.
Per the protocol, the Evaluable population is those patients who received at least one cycle of maintenance.
|
|
Gastrointestinal disorders
Nausea
|
21.4%
3/14 • Number of events 6 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Data was collected up to 5 years.
Per the protocol, the Evaluable population is those patients who received at least one cycle of maintenance.
|
|
General disorders
Pain
|
14.3%
2/14 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Data was collected up to 5 years.
Per the protocol, the Evaluable population is those patients who received at least one cycle of maintenance.
|
|
General disorders
Pain in extremity
|
7.1%
1/14 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Data was collected up to 5 years.
Per the protocol, the Evaluable population is those patients who received at least one cycle of maintenance.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.1%
1/14 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Data was collected up to 5 years.
Per the protocol, the Evaluable population is those patients who received at least one cycle of maintenance.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.1%
1/14 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Data was collected up to 5 years.
Per the protocol, the Evaluable population is those patients who received at least one cycle of maintenance.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
7.1%
1/14 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Data was collected up to 5 years.
Per the protocol, the Evaluable population is those patients who received at least one cycle of maintenance.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
14.3%
2/14 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Data was collected up to 5 years.
Per the protocol, the Evaluable population is those patients who received at least one cycle of maintenance.
|
|
Infections and infestations
Sinusitis
|
7.1%
1/14 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Data was collected up to 5 years.
Per the protocol, the Evaluable population is those patients who received at least one cycle of maintenance.
|
|
Ear and labyrinth disorders
Vertigo
|
7.1%
1/14 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Data was collected up to 5 years.
Per the protocol, the Evaluable population is those patients who received at least one cycle of maintenance.
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
1/14 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Data was collected up to 5 years.
Per the protocol, the Evaluable population is those patients who received at least one cycle of maintenance.
|
|
Eye disorders
Watering eyes
|
7.1%
1/14 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Data was collected up to 5 years.
Per the protocol, the Evaluable population is those patients who received at least one cycle of maintenance.
|
|
Investigations
Weight gain
|
7.1%
1/14 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days (non-serious) and 90 days (serious) after the last dose of study treatment. Data was collected up to 5 years.
Per the protocol, the Evaluable population is those patients who received at least one cycle of maintenance.
|
Additional Information
University of Michigan Rogel Cancer Center ClinicalTrials.gov Admin
University of Michigan Rogel Cancer Center
Phone: 734-936-9499
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Participating Site agrees not to publish or publically present the Study Data or Study Results, until Michigan or Michigan's Investigator has first Published the Study Data or Study Results. Thereafter, Participating Site may publish or publically present the Study Data and/or Study Results. If Michigan has not Published the Study Data or Study Results within 12 months after the abandonment or termination of the Study, Participating Site may publish or present the Study Data or Study Results
- Publication restrictions are in place
Restriction type: OTHER