Last reviewed · How we verify

NCT03958045

Combination Rucaparib With Nivolumab in Small Cell Lung Carcinoma

Completed Phase 2 Results posted Last updated 22 October 2024
What this trial tests

Phase 2 trial testing Rucaparib and Nivolumab in Small Cell Lung Cancer in 33 participants. Completed in 15 November 2022.

Timeline
4 September 2019
Primary endpoint
15 November 2022
15 November 2022

Quick facts

Lead sponsorZhonglin Hao
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment33
Start date4 September 2019
Primary completion15 November 2022
Estimated completion15 November 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Zhonglin Hao

Who can join

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 Survival Primary · 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

GroupValue95% CI
Patients With Stage IV SCLC1110 – 13
Disease Control Rate Secondary · 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

GroupValue95% CI
Patients With Stage IV SCLC33.3
Overall Survival Secondary · 0-2 years

Percentage of surviving participants at 1 and 2 years

1 year
GroupValue95% CI
Patients With Stage IV SCLC93.55
2 years
GroupValue95% CI
Patients With Stage IV SCLC52.82
Objective Response Rate Secondary · 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

GroupValue95% CI
Patients With Stage IV SCLC4
Quality of Life Scale Baseline Secondary · 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
GroupValue95% CI
Patients With Stage IV SCLC76.1± 17
Role Functioning
GroupValue95% CI
Patients With Stage IV SCLC69.3± 27.8
Emotional Functioning
GroupValue95% CI
Patients With Stage IV SCLC78.1± 19.6
Cognitive Functioning
GroupValue95% CI
Patients With Stage IV SCLC81± 22.6
Social Functioning
GroupValue95% CI
Patients With Stage IV SCLC72.4± 26.1
Global health status
GroupValue95% CI
Patients With Stage IV SCLC65.2± 17.7
Quality of Life Scale 4 Months Secondary · 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
GroupValue95% CI
Patients With Stage IV SCLC70.5± 14.7
Role Functioning
GroupValue95% CI
Patients With Stage IV SCLC65± 30.9
Emotional Functioning
GroupValue95% CI
Patients With Stage IV SCLC75.6± 24.1
Cognitive Functioning
GroupValue95% CI
Patients With Stage IV SCLC78.3± 26.1
Social Functioning
GroupValue95% CI
Patients With Stage IV SCLC73.3± 25.1
Global health status
GroupValue95% CI
Patients With Stage IV SCLC65.8± 14.4
Quality of Life Scale at Disease Progression Secondary · 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
GroupValue95% CI
Patients With Stage IV SCLC66.7± 0
Role Functioning
GroupValue95% CI
Patients With Stage IV SCLC41.7± 35.4
Emotional Functioning
GroupValue95% CI
Patients With Stage IV SCLC45.8± 41.2
Cognitive Functioning
GroupValue95% CI
Patients With Stage IV SCLC41.7± 35.4
Social Functioning
GroupValue95% CI
Patients With Stage IV SCLC50± 23.6
Global health status
GroupValue95% CI
Patients With Stage IV SCLC50± 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)

ReactionSystemPatients With Stage IV SCLC
AnemiaBlood and lymphatic system disorders
Enterocolitis infectiousInfections and infestations
Lung infectionInfections and infestations
Alanine aminotransferase increasedInvestigations
Aspartate aminotransferase increasedInvestigations
HypokalemiaMetabolism and nutrition disorders
Thrombotic thrombocytopenic purpuraBlood and lymphatic system disorders
ConstipationGastrointestinal disorders
DysphagiaGastrointestinal disorders
Flu like symptomsGeneral disorders
Alkaline phosphatase increasedInvestigations
Blood bilirubin increasedInvestigations
Neutrophil count decreasedInvestigations
White blood cell decreasedInvestigations
HyponatremiaMetabolism and nutrition disorders
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specifyNeoplasms benign, malignant and unspecified (incl cysts and polyps)
EncephalopathyNervous system disorders
SeizureNervous system disorders
Other adverse events (45 terms — click to expand)

ReactionSystemPatients With Stage IV SCLC
FatigueGeneral disorders
NauseaGastrointestinal disorders
Alanine aminotransferase increasedInvestigations
Aspartate aminotransferase increasedInvestigations
Lymphocyte count decreasedInvestigations
Platelet count decreasedInvestigations
HypokalemiaMetabolism and nutrition disorders
HyponatremiaMetabolism and nutrition disorders
VomitingGastrointestinal disorders
Alkaline phosphatase increasedInvestigations
White blood cell decreasedInvestigations
AnemiaBlood and lymphatic system disorders
DiarrheaGastrointestinal disorders
HypoalbuminemiaMetabolism and nutrition disorders
Rash maculo-papularSkin and subcutaneous tissue disorders
Creatinine increasedInvestigations
DyspneaRespiratory, thoracic and mediastinal disorders
AnorexiaMetabolism and nutrition disorders
HyperglycemiaMetabolism and nutrition disorders
DizzinessNervous system disorders
Blood bilirubin increasedInvestigations
HypoglycemiaMetabolism and nutrition disorders
PruritusSkin and subcutaneous tissue disorders
Thyroid stimulating hormone increasedInvestigations
DysgeusiaNervous system disorders
Thrombotic thrombocytopenic purpuraBlood and lymphatic system disorders
ConstipationGastrointestinal disorders
PainGeneral disorders
Lung InfectionInfections and infestations
Neutrophil count decreasedInvestigations
Weight lossInvestigations
HypomagnesemiaMetabolism and nutrition disorders
Back painMusculoskeletal and connective tissue disorders
MyalgiaMusculoskeletal and connective tissue disorders
Blurred VisionEye disorders
Mucositis OralGastrointestinal disorders
FeverGeneral disorders
Generalized EdemaGeneral disorders
ShinglesInfections and infestations
SinusitisInfections and infestations

Most-reported serious reactions: Anemia, Enterocolitis infectious, Lung infection, Alanine aminotransferase increased, Aspartate aminotransferase increased, Hypokalemia, Thrombotic thrombocytopenic purpura, Constipation.

Data from ClinicalTrials.gov NCT03958045 adverse events section.

Sponsor's own description

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):

  1. Improvement of the anticancer efficacy of PD-1/PD-L1 blockade via combination therapy and PD-L1 regulation.
    Wu M, Huang Q, Xie Y, Wu X, et al · · 2022 · cited 336× · PMID 35279217 · DOI 10.1186/s13045-022-01242-2
  2. Alterations of DNA damage response pathway: Biomarker and therapeutic strategy for cancer immunotherapy.
    Jiang M, Jia K, Wang L, Li W, et al · · 2021 · cited 236× · PMID 34729299 · DOI 10.1016/j.apsb.2021.01.003
  3. Combined PARP Inhibition and Immune Checkpoint Therapy in Solid Tumors.
    Peyraud F, Italiano A. · · 2020 · cited 163× · PMID 32526888 · DOI 10.3390/cancers12061502
  4. New Approaches to SCLC Therapy: From the Laboratory to the Clinic.
    Poirier JT, George J, Owonikoko TK, Berns A, et al · · 2020 · cited 141× · PMID 32018053 · DOI 10.1016/j.jtho.2020.01.016
  5. The role of DNA damage repair (DDR) system in response to immune checkpoint inhibitor (ICI) therapy.
    Shi C, Qin K, Lin A, Jiang A, et al · · 2022 · cited 60× · PMID 36071479 · DOI 10.1186/s13046-022-02469-0
  6. Immunomodulatory Roles of PARP-1 and PARP-2: Impact on PARP-Centered Cancer Therapies.
    Yélamos J, Moreno-Lama L, Jimeno J, Ali SO. · · 2020 · cited 56× · PMID 32046278 · DOI 10.3390/cancers12020392
  7. PARP Inhibitors in Small-Cell Lung Cancer: Rational Combinations to Improve Responses.
    Knelson EH, Patel SA, Sands JM. · · 2021 · cited 47× · PMID 33578789 · DOI 10.3390/cancers13040727
  8. Targeting DNA Damage Repair for Immune Checkpoint Inhibition: Mechanisms and Potential Clinical Applications.
    Sun W, Zhang Q, Wang R, Li Y, et al · · 2021 · cited 44× · PMID 34026622 · DOI 10.3389/fonc.2021.648687

Verify or expand the search:

Other recruiting trials for Small Cell Lung Cancer

Currently open trials in the same condition.

Other Zhonglin Hao trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing