Trial Outcomes & Findings for Combination Rucaparib With Nivolumab in Small Cell Lung Carcinoma (NCT NCT03958045)

Last Updated: 2024-10-22

Results Overview

Duration (time) of progression-free survival after response to initial platinum-based therapy. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions from starting maintenance treatment

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

33 participants

Primary outcome timeframe

0-2 years

Results posted on

2024-10-22

Participant Flow

Participant milestones

Participant milestones
Measure	Patients With Stage IV SCLC Patients with extensive stage (IV) SCLC (small cell lung cancer) Rucaparib and Nivolumab: Rucaparib (600mg BID) and Nivolumab (480mg IV q4 wk)
Overall Study STARTED	33
Overall Study COMPLETED	32
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Patients With Stage IV SCLC Patients with extensive stage (IV) SCLC (small cell lung cancer) Rucaparib and Nivolumab: Rucaparib (600mg BID) and Nivolumab (480mg IV q4 wk)
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Combination Rucaparib With Nivolumab in Small Cell Lung Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients With Stage IV SCLC n=33 Participants Patients with extensive stage (IV) SCLC (small cell lung cancer) Rucaparib and Nivolumab: Rucaparib (600mg BID) and Nivolumab (480mg IV q4 wk)
Age, Continuous	59.8 years STANDARD_DEVIATION 7.9 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	31 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 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	28 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	33 Participants n=5 Participants

PRIMARY outcome

Timeframe: 0-2 years

Outcome measures

Outcome measures
Measure	Patients With Stage IV SCLC n=32 Participants Patients with extensive stage (IV) SCLC (small cell lung cancer) Rucaparib and Nivolumab: Rucaparib (600mg BID) and Nivolumab (480mg IV q4 wk)
Progression Free Survival	11 months Interval 10.0 to 13.0

SECONDARY outcome

Timeframe: 8 weeks, 16 weeks and 24 weeks post-treatment

Disease control rate (DCR) is the number of patients who had either complete response (CR, Disappearance of all target lesions), partial response (PR, \>=30% decrease in the sum of the longest diameter of target lesions) or stable disease (SD, less than 30% decrease in the sum of the biggest dimension but no more than 20% increase ) per RECICST 1.0 divided by the total number of patients. DOR= (CR+PR+SD)/Total number on trial x 100%. The timepoints were combined. The best responses were used in calculating disease control rate

Outcome measures

Outcome measures
Measure	Patients With Stage IV SCLC n=33 Participants Patients with extensive stage (IV) SCLC (small cell lung cancer) Rucaparib and Nivolumab: Rucaparib (600mg BID) and Nivolumab (480mg IV q4 wk)
Disease Control Rate	33.3 percentage of participants

SECONDARY outcome

Timeframe: 0-2 years

Percentage of surviving participants at 1 and 2 years

Outcome measures

Outcome measures
Measure	Patients With Stage IV SCLC n=33 Participants Patients with extensive stage (IV) SCLC (small cell lung cancer) Rucaparib and Nivolumab: Rucaparib (600mg BID) and Nivolumab (480mg IV q4 wk)
Overall Survival 1 year	93.55 percentage of participants
Overall Survival 2 years	52.82 percentage of participants

SECONDARY outcome

Timeframe: 8 weeks, 16 weeks and 24 weeks post-treatment

Objective response rate (ORR) is the proportion of patients with complete response or partial response according to RECIST v1.1. Patients with complete response at baseline will be excluded from ORR analysis. The timepoints were combined. The best responses were used in calculating objective response rate

Outcome measures

Outcome measures
Measure	Patients With Stage IV SCLC n=33 Participants Patients with extensive stage (IV) SCLC (small cell lung cancer) Rucaparib and Nivolumab: Rucaparib (600mg BID) and Nivolumab (480mg IV q4 wk)
Objective Response Rate	4 Participants

SECONDARY outcome

Timeframe: Baseline

Population: 3 participants did not answer all questions

Quality of life is assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) questionnaire, which probes function and symptoms. Scores range from 0-100. High scores on functional scales represent a high/healthy level of functioning; high scores symptom scales represent a high level of symptomology.

Outcome measures

Outcome measures
Measure	Patients With Stage IV SCLC n=32 Participants Patients with extensive stage (IV) SCLC (small cell lung cancer) Rucaparib and Nivolumab: Rucaparib (600mg BID) and Nivolumab (480mg IV q4 wk)
Quality of Life Scale Baseline Physical Functioning	76.1 units on a scale Standard Deviation 17
Quality of Life Scale Baseline Role Functioning	69.3 units on a scale Standard Deviation 27.8
Quality of Life Scale Baseline Emotional Functioning	78.1 units on a scale Standard Deviation 19.6
Quality of Life Scale Baseline Cognitive Functioning	81 units on a scale Standard Deviation 22.6
Quality of Life Scale Baseline Social Functioning	72.4 units on a scale Standard Deviation 26.1
Quality of Life Scale Baseline Global health status	65.2 units on a scale Standard Deviation 17.7

SECONDARY outcome

Timeframe: 4 months

Population: Only 10 participants completed the scale at the 4 month timepoint

Outcome measures

Outcome measures
Measure	Patients With Stage IV SCLC n=10 Participants Patients with extensive stage (IV) SCLC (small cell lung cancer) Rucaparib and Nivolumab: Rucaparib (600mg BID) and Nivolumab (480mg IV q4 wk)
Quality of Life Scale 4 Months Physical Functioning	70.5 units on a scale Standard Deviation 14.7
Quality of Life Scale 4 Months Role Functioning	65 units on a scale Standard Deviation 30.9
Quality of Life Scale 4 Months Emotional Functioning	75.6 units on a scale Standard Deviation 24.1
Quality of Life Scale 4 Months Cognitive Functioning	78.3 units on a scale Standard Deviation 26.1
Quality of Life Scale 4 Months Social Functioning	73.3 units on a scale Standard Deviation 25.1
Quality of Life Scale 4 Months Global health status	65.8 units on a scale Standard Deviation 14.4

SECONDARY outcome

Timeframe: Disease Progression up to 2 years

Population: Only 2 subjects have completed the questionnaire at progression. Due to this small sample size, the standard deviation can be 0 if the responses happen to be the same for questions related to "physical functioning"

Outcome measures

Outcome measures
Measure	Patients With Stage IV SCLC n=2 Participants Patients with extensive stage (IV) SCLC (small cell lung cancer) Rucaparib and Nivolumab: Rucaparib (600mg BID) and Nivolumab (480mg IV q4 wk)
Quality of Life Scale at Disease Progression Emotional Functioning	45.8 units on a scale Standard Deviation 41.2
Quality of Life Scale at Disease Progression Cognitive Functioning	41.7 units on a scale Standard Deviation 35.4
Quality of Life Scale at Disease Progression Social Functioning	50 units on a scale Standard Deviation 23.6
Quality of Life Scale at Disease Progression Physical Functioning	66.7 units on a scale Standard Deviation 0
Quality of Life Scale at Disease Progression Role Functioning	41.7 units on a scale Standard Deviation 35.4
Quality of Life Scale at Disease Progression Global health status	50 units on a scale Standard Deviation 23.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 0-3 years

Correlate tumor mutation burden with treatment response.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 0-3 years

A combined positive score (CPS) for Programmed Death Ligand 1 (PD-L1) will be derived from immunohistochemical analysis of tumor tissue.

Outcome measures

Outcome data not reported

Adverse Events

Patients With Stage IV SCLC

Serious events: 12 serious events

Other events: 33 other events

Deaths: 16 deaths

Serious adverse events

Serious adverse events
Measure	Patients With Stage IV SCLC n=33 participants at risk Patients with extensive stage (IV) SCLC (small cell lung cancer) Rucaparib and Nivolumab: Rucaparib (600mg BID) and Nivolumab (480mg IV q4 wk)
Blood and lymphatic system disorders Anemia	6.1% 2/33 • 2 years
Blood and lymphatic system disorders Thrombotic thrombocytopenic purpura	3.0% 1/33 • 2 years
Gastrointestinal disorders Constipation	3.0% 1/33 • 2 years
Gastrointestinal disorders Dysphagia	3.0% 1/33 • 2 years
General disorders Flu like symptoms	3.0% 1/33 • 2 years
Infections and infestations Enterocolitis infectious	6.1% 2/33 • 2 years
Infections and infestations Lung infection	6.1% 2/33 • 2 years
Investigations Alanine aminotransferase increased	6.1% 2/33 • 2 years
Investigations Alkaline phosphatase increased	3.0% 1/33 • 2 years
Investigations Aspartate aminotransferase increased	6.1% 2/33 • 2 years
Investigations Blood bilirubin increased	3.0% 1/33 • 2 years
Investigations Neutrophil count decreased	3.0% 1/33 • 2 years
Investigations White blood cell decreased	3.0% 1/33 • 2 years
Metabolism and nutrition disorders Hypokalemia	6.1% 2/33 • 2 years
Metabolism and nutrition disorders Hyponatremia	3.0% 1/33 • 2 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	3.0% 1/33 • 2 years
Nervous system disorders Encephalopathy	3.0% 1/33 • 2 years
Nervous system disorders Seizure	3.0% 1/33 • 2 years

Other adverse events

Other adverse events
Measure	Patients With Stage IV SCLC n=33 participants at risk Patients with extensive stage (IV) SCLC (small cell lung cancer) Rucaparib and Nivolumab: Rucaparib (600mg BID) and Nivolumab (480mg IV q4 wk)
Blood and lymphatic system disorders Anemia	24.2% 8/33 • 2 years
Blood and lymphatic system disorders Thrombotic thrombocytopenic purpura	9.1% 3/33 • 2 years
Eye disorders Blurred Vision	6.1% 2/33 • 2 years
Gastrointestinal disorders Constipation	9.1% 3/33 • 2 years
Gastrointestinal disorders Diarrhea	24.2% 8/33 • 2 years
Gastrointestinal disorders Mucositis Oral	6.1% 2/33 • 2 years
Gastrointestinal disorders Nausea	45.5% 15/33 • 2 years
Gastrointestinal disorders Vomiting	30.3% 10/33 • 2 years
General disorders Fatigue	51.5% 17/33 • 2 years
General disorders Fever	6.1% 2/33 • 2 years
General disorders Generalized Edema	6.1% 2/33 • 2 years
General disorders Pain	9.1% 3/33 • 2 years
Infections and infestations Shingles	6.1% 2/33 • 2 years
Infections and infestations Sinusitis	6.1% 2/33 • 2 years
Infections and infestations Lung Infection	9.1% 3/33 • 2 years
Injury, poisoning and procedural complications Fall	6.1% 2/33 • 2 years
Investigations Alanine aminotransferase increased	45.5% 15/33 • 2 years
Investigations Alkaline phosphatase increased	30.3% 10/33 • 2 years
Investigations Aspartate aminotransferase increased	45.5% 15/33 • 2 years
Investigations Blood bilirubin increased	15.2% 5/33 • 2 years
Investigations Creatinine increased	21.2% 7/33 • 2 years
Investigations Lymphocyte count decreased	45.5% 15/33 • 2 years
Investigations Neutrophil count decreased	9.1% 3/33 • 2 years
Investigations Platelet count decreased	42.4% 14/33 • 2 years
Investigations Thyroid stimulating hormone increased	12.1% 4/33 • 2 years
Investigations Weight loss	9.1% 3/33 • 2 years
Investigations White blood cell decreased	27.3% 9/33 • 2 years
Metabolism and nutrition disorders Anorexia	18.2% 6/33 • 2 years
Metabolism and nutrition disorders Hyperglycemia	18.2% 6/33 • 2 years
Metabolism and nutrition disorders Hyperkalemia	6.1% 2/33 • 2 years
Metabolism and nutrition disorders Hypoalbuminemia	24.2% 8/33 • 2 years
Metabolism and nutrition disorders Hypoglycemia	15.2% 5/33 • 2 years
Metabolism and nutrition disorders Hypokalemia	39.4% 13/33 • 2 years
Metabolism and nutrition disorders Hypomagnesemia	9.1% 3/33 • 2 years
Metabolism and nutrition disorders Hyponatremia	36.4% 12/33 • 2 years
Metabolism and nutrition disorders Hypophosphatemia	6.1% 2/33 • 2 years
Musculoskeletal and connective tissue disorders Back pain	9.1% 3/33 • 2 years
Musculoskeletal and connective tissue disorders Myalgia	9.1% 3/33 • 2 years
Nervous system disorders Dizziness	18.2% 6/33 • 2 years
Nervous system disorders Dysgeusia	12.1% 4/33 • 2 years
Respiratory, thoracic and mediastinal disorders Dyspnea	21.2% 7/33 • 2 years
Respiratory, thoracic and mediastinal disorders Other	6.1% 2/33 • 2 years
Respiratory, thoracic and mediastinal disorders Sore Throat	6.1% 2/33 • 2 years
Skin and subcutaneous tissue disorders Pruritus	15.2% 5/33 • 2 years
Skin and subcutaneous tissue disorders Rash maculo-papular	24.2% 8/33 • 2 years

Additional Information

Dr. Zhonglin Hao

University of Kentucky

Phone: 859-218-6704

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place