18 and older, any sex, with Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression Free SurvivalPrimary· 0-2 years
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
Group
Value
95% CI
Patients With Stage IV SCLC
11
10 – 13
Disease Control RateSecondary· 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
Group
Value
95% CI
Patients With Stage IV SCLC
33.3
Overall SurvivalSecondary· 0-2 years
Percentage of surviving participants at 1 and 2 years
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
Group
Value
95% CI
Patients With Stage IV SCLC
4
Quality of Life Scale BaselineSecondary· Baseline
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.
Physical Functioning
Group
Value
95% CI
Patients With Stage IV SCLC
76.1
± 17
Role Functioning
Group
Value
95% CI
Patients With Stage IV SCLC
69.3
± 27.8
Emotional Functioning
Group
Value
95% CI
Patients With Stage IV SCLC
78.1
± 19.6
Cognitive Functioning
Group
Value
95% CI
Patients With Stage IV SCLC
81
± 22.6
Social Functioning
Group
Value
95% CI
Patients With Stage IV SCLC
72.4
± 26.1
Global health status
Group
Value
95% CI
Patients With Stage IV SCLC
65.2
± 17.7
Quality of Life Scale 4 MonthsSecondary· 4 months
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.
Physical Functioning
Group
Value
95% CI
Patients With Stage IV SCLC
70.5
± 14.7
Role Functioning
Group
Value
95% CI
Patients With Stage IV SCLC
65
± 30.9
Emotional Functioning
Group
Value
95% CI
Patients With Stage IV SCLC
75.6
± 24.1
Cognitive Functioning
Group
Value
95% CI
Patients With Stage IV SCLC
78.3
± 26.1
Social Functioning
Group
Value
95% CI
Patients With Stage IV SCLC
73.3
± 25.1
Global health status
Group
Value
95% CI
Patients With Stage IV SCLC
65.8
± 14.4
Quality of Life Scale at Disease ProgressionSecondary· Disease Progression up to 2 years
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.
Physical Functioning
Group
Value
95% CI
Patients With Stage IV SCLC
66.7
± 0
Role Functioning
Group
Value
95% CI
Patients With Stage IV SCLC
41.7
± 35.4
Emotional Functioning
Group
Value
95% CI
Patients With Stage IV SCLC
45.8
± 41.2
Cognitive Functioning
Group
Value
95% CI
Patients With Stage IV SCLC
41.7
± 35.4
Social Functioning
Group
Value
95% CI
Patients With Stage IV SCLC
50
± 23.6
Global health status
Group
Value
95% CI
Patients With Stage IV SCLC
50
± 23.6
Adverse events — posted to ClinicalTrials.gov
Time frame: 2 years.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Patients With Stage IV SCLC
Serious: 12/33 (36%)
Deaths: 16/33
Serious adverse events (18 terms)
Reaction
System
Patients With Stage IV SCLC
Anemia
Blood and lymphatic system disorders
—
Enterocolitis infectious
Infections and infestations
—
Lung infection
Infections and infestations
—
Alanine aminotransferase increased
Investigations
—
Aspartate aminotransferase increased
Investigations
—
Hypokalemia
Metabolism and nutrition disorders
—
Thrombotic thrombocytopenic purpura
Blood and lymphatic system disorders
—
Constipation
Gastrointestinal disorders
—
Dysphagia
Gastrointestinal disorders
—
Flu like symptoms
General disorders
—
Alkaline phosphatase increased
Investigations
—
Blood bilirubin increased
Investigations
—
Neutrophil count decreased
Investigations
—
White blood cell decreased
Investigations
—
Hyponatremia
Metabolism and nutrition disorders
—
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The purpose of this study is to evaluate survival and response rate of the combination rucaparib and nivolumab as maintenance therapy in platinum-sensitive small cell lung carcinoma.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Zhonglin Hao
Last refreshed: 22 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03958045.