Trial Outcomes & Findings for Subsequent Line Gemcitabine and Nivolumab in Treating Participants With Metastatic Small Cell Lung Cancer (NCT NCT03662074)

NCT ID: NCT03662074

Last Updated: 2023-08-02

Results Overview

Objective RR (complete response \[CR\] + partial response \[PR\]) will be compared between this study sample and a historical benchmark value of 10%. For this comparison we will use a one-sample test of proportion. * Complete Response (CR): Disappearance of all target lesions. * Partial Response (PR): Decrease by ≥ 30% in sum of longest diameter of target lesions. * Stable Disease (SD): Not meeting criteria for CR, PR, or PD. * Progressive Disease (PD): Increase by ≥ 20% in sum of longest diameter of target lesions or the appearance of one or more new lesions. The response in non-target lesions is defined as follows: * Complete Response (CR): Complete disappearance of all non-target lesions. * Stable Disease (SD): Persistence of one or more non-target lesion(s). * Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

14 participants

Primary outcome timeframe

Up to 8 weeks

Results posted on

2023-08-02

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Gemcitabine, Nivolumab) Participants receive gemcitabine IV over 30 minutes and nivolumab IV over 60 minutes on day 1. Treatment repeats every 2 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity Gemcitabine: Given IV Nivolumab: Given IV
Overall Study STARTED	14
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Subsequent Line Gemcitabine and Nivolumab in Treating Participants With Metastatic Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Gemcitabine, Nivolumab) n=14 Participants Participants receive gemcitabine IV over 30 minutes and nivolumab IV over 60 minutes on day 1. Treatment repeats every 2 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity Gemcitabine: Given IV Nivolumab: Given IV
Age, Continuous	60.8 years STANDARD_DEVIATION 8.9 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 8 weeks

Outcome measures

Outcome measures
Measure	Treatment (Gemcitabine, Nivolumab) n=14 Participants Participants receive gemcitabine IV over 30 minutes and nivolumab IV over 60 minutes on day 1. Treatment repeats every 2 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity Gemcitabine: Given IV Nivolumab: Given IV
Number of Participants With Positive Responses to Therapy Per Response Evaluation Criteria in Solid Tumors (RECIST) Lost to follow up	2 Participants
Number of Participants With Positive Responses to Therapy Per Response Evaluation Criteria in Solid Tumors (RECIST) Partial response	1 Participants
Number of Participants With Positive Responses to Therapy Per Response Evaluation Criteria in Solid Tumors (RECIST) Progressive disease	11 Participants

SECONDARY outcome

Timeframe: Duration of time from the start of treatment to date of death, assessed up to 2 years

OS will be estimated using standard Kaplan Meier survival analysis methods.

Outcome measures

Outcome measures
Measure	Treatment (Gemcitabine, Nivolumab) n=14 Participants Participants receive gemcitabine IV over 30 minutes and nivolumab IV over 60 minutes on day 1. Treatment repeats every 2 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity Gemcitabine: Given IV Nivolumab: Given IV
Overall Survival (OS) - Number of Participants Deaths - any reason	8 Participants
Overall Survival (OS) - Number of Participants Survivors	6 Participants

SECONDARY outcome

Timeframe: Duration of time from the start of treatment to date of death, assessed up to 2 years

A median value (months) of overall survival will be estimated using standard Kaplan Meier survival analysis methods.

Outcome measures

Outcome measures
Measure	Treatment (Gemcitabine, Nivolumab) n=14 Participants Participants receive gemcitabine IV over 30 minutes and nivolumab IV over 60 minutes on day 1. Treatment repeats every 2 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity Gemcitabine: Given IV Nivolumab: Given IV
Overall Survival (OS) - Months	3.2 months Interval 1.7 to 9.2

SECONDARY outcome

Timeframe: Duration of time from the start of treatment to the time of investigator assessed progression or death, assessed up to 2 years

Progression-free survival will be estimated using standard Kaplan Meier survival analysis methods. Progression-Free Survival (PFS) is defined as the duration of time from the start of treatment to the time of investigator assessed progression or death. Progressive Disease (PD): Increase by ≥ 20% in sum of longest diameter of target lesions or the appearance of one or more new lesions

Outcome measures

Outcome measures
Measure	Treatment (Gemcitabine, Nivolumab) n=14 Participants Participants receive gemcitabine IV over 30 minutes and nivolumab IV over 60 minutes on day 1. Treatment repeats every 2 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity Gemcitabine: Given IV Nivolumab: Given IV
Progression-free Survival (PFS) - Number of Participants Participants that had disease progression	11 Participants
Progression-free Survival (PFS) - Number of Participants Participants that did not have disease progression	3 Participants

SECONDARY outcome

Timeframe: Duration of time from the start of treatment to the time of investigator assessed progression or death, assessed up to 2 years

A median value (months) of progressive-free survival will be estimated using standard Kaplan Meier survival analysis methods. Progressive Disease (PD): Increase by ≥ 20% in sum of longest diameter of target lesions or the appearance of one or more new lesions

Outcome measures

Outcome measures
Measure	Treatment (Gemcitabine, Nivolumab) n=14 Participants Participants receive gemcitabine IV over 30 minutes and nivolumab IV over 60 minutes on day 1. Treatment repeats every 2 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity Gemcitabine: Given IV Nivolumab: Given IV
Progression-free Survival (PFS) - Months	1.8 months Interval 1.6 to 8.6

SECONDARY outcome

Timeframe: Up to 2 years

Toxicity rates will be estimated by responder status and presented overall and by body site per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Outcome measures

Outcome measures
Measure	Treatment (Gemcitabine, Nivolumab) n=14 Participants Participants receive gemcitabine IV over 30 minutes and nivolumab IV over 60 minutes on day 1. Treatment repeats every 2 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity Gemcitabine: Given IV Nivolumab: Given IV
Number of Adverse Events	12 Number of adverse events reported

Adverse Events

Treatment (Gemcitabine, Nivolumab)

Serious events: 1 serious events

Other events: 11 other events

Deaths: 8 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Gemcitabine, Nivolumab) n=14 participants at risk Participants receive gemcitabine IV over 30 minutes and nivolumab IV over 60 minutes on day 1. Treatment repeats every 2 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity Gemcitabine: Given IV Nivolumab: Given IV
Metabolism and nutrition disorders Hyponatremia	7.1% 1/14 • Number of events 1 • 2 years

Other adverse events

Other adverse events
Measure	Treatment (Gemcitabine, Nivolumab) n=14 participants at risk Participants receive gemcitabine IV over 30 minutes and nivolumab IV over 60 minutes on day 1. Treatment repeats every 2 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity Gemcitabine: Given IV Nivolumab: Given IV
Gastrointestinal disorders Diarrhea	7.1% 1/14 • Number of events 1 • 2 years
Gastrointestinal disorders Fecal incontinence	7.1% 1/14 • Number of events 1 • 2 years
Gastrointestinal disorders Gastrointestinal pain	7.1% 1/14 • Number of events 1 • 2 years
Gastrointestinal disorders Nausea	7.1% 1/14 • Number of events 1 • 2 years
Gastrointestinal disorders Vomiting	7.1% 1/14 • Number of events 1 • 2 years
General disorders Fatigue	7.1% 1/14 • Number of events 1 • 2 years
General disorders Fever	7.1% 1/14 • Number of events 1 • 2 years
Infections and infestations Lung infection	14.3% 2/14 • Number of events 2 • 2 years
Nervous system disorders Syncope	7.1% 1/14 • Number of events 1 • 2 years
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	7.1% 1/14 • Number of events 1 • 2 years

Additional Information

Study Nurse

Wake Forest Baptist Comprehensive Cancer Center

Phone: 336-716-0230

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place