A Phase 2 interventional study of Rucaparib and Nivolumab in Small Cell Lung Cancer, sponsored by Zhonglin Hao. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-22.
Sponsored by Zhonglin Hao · Phase 2, Interventional, and Treatment
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.
Small cell lung cancer (SCLC) is one of the most aggressive malignancies with a 5-year survival rate of less than 7%. SCLC is characterized by rapid doubling time, high growth fraction and early development of widespread metastases. SCLC accounts for roughly 93% of all high-grade neuroendocrine carcinomas. The prognosis for SCLC is extremely poor with a median survival less than a year for extensive-stage disease. Therapeutic options have not advanced significantly in over two decades, with frontline treatment consisting of platinum doublet therapy for 3-6 cycles. While most patients show an initial favorable response to Carboplatin/cisplatin + etoposide, this response is usually short-lived. Most patients relapse with resistant disease between 3 to 6 months after completion of initial chemotherapy.
Based on preclinical data supporting the role of immune checkpoint and PARP (poly ADP ribose polymerase ) inhibitors in SCLC, combining nivolumab and rucaparib has the potential to prolong progression-free survival and overall survival. These two classes of drugs have non-overlapping toxicities. This novel combination has not been tried in a front-line maintenance setting for SCLC.
Eligible patients will have pathological (biopsy) or cytologically confirmed stage IV SCLC, and have achieved either partial or complete response post frontline chemotherapy with platinum doublet. Patients will be treated with combination rucaparib and nivolumab. The recommended starting dose of rucaparib as a continuously administered oral monotherapy is 600 mg BID. Nivolumab will be administered as an intravenous infusion once every 4 weeks at a fixed dose of 480 mg. In the absence of treatment delays due to adverse event(s), treatment may continue for 24 months.
Progression-free survival, overall survival, disease control rates, objective response rate, quality of life, and tumor mutation burden will be evaluated during this study (up to 2 years).
1,234 studies on the registry are indexed under Small Cell Lung Carcinoma; 350 are open to participants now.
This study's enrollment of 33 is below the median of 56 across 1,058 interventional studies indexed under Small Cell Lung Carcinoma.
Browse Small Cell Lung Carcinoma studies →Zhonglin Hao is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria
Patients with extensive stage (IV) SCLC (small cell lung cancer)
Combination Product: Rucaparib and Nivolumab
Progression Free Survival
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
Time frame: 0-2 years
Disease Control Rate
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
Time frame: 8 weeks, 16 weeks and 24 weeks post-treatment
Overall Survival
Percentage of surviving participants at 1 and 2 years
Time frame: 0-2 years
Objective Response Rate
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
Time frame: 8 weeks, 16 weeks and 24 weeks post-treatment
Quality of Life Scale 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.
Time frame: Baseline
Quality of Life Scale 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.
Time frame: 4 months
Quality of Life Scale at Disease Progression
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.
Time frame: Disease Progression up to 2 years
Tumor Mutation Burden
Correlate tumor mutation burden with treatment response.
Time frame: 0-3 years
PD-L1 CPS
A combined positive score (CPS) for Programmed Death Ligand 1 (PD-L1) will be derived from immunohistochemical analysis of tumor tissue.
Time frame: 0-3 years
| Milestone | Patients With Stage IV SCLC |
|---|---|
| Started | 33 |
| Completed | 32 |
| Not completed | 1 |
| Withdrew: Withdrawal by subject | 1 |
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
| months | Patients With Stage IV SCLC |
|---|---|
| Progression Free Survival | 11 (10 to 13) |
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
| percentage of participants | Patients With Stage IV SCLC |
|---|---|
| Disease Control Rate | 33.3 |
Percentage of surviving participants at 1 and 2 years
| percentage of participants | Patients With Stage IV SCLC |
|---|---|
| 1 year | 93.55 |
| 2 years | 52.82 |
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
| Participants | Patients With Stage IV SCLC |
|---|---|
| Objective Response Rate | 4 |
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.
| units on a scale | Patients With Stage IV SCLC |
|---|---|
| Physical Functioning | 76.1 ± 17 |
| Role Functioning | 69.3 ± 27.8 |
| Emotional Functioning | 78.1 ± 19.6 |
| Cognitive Functioning | 81 ± 22.6 |
| Social Functioning | 72.4 ± 26.1 |
| Global health status | 65.2 ± 17.7 |
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.
| units on a scale | Patients With Stage IV SCLC |
|---|---|
| Physical Functioning | 70.5 ± 14.7 |
| Role Functioning | 65 ± 30.9 |
| Emotional Functioning | 75.6 ± 24.1 |
| Cognitive Functioning | 78.3 ± 26.1 |
| Social Functioning | 73.3 ± 25.1 |
| Global health status | 65.8 ± 14.4 |
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.
| units on a scale | Patients With Stage IV SCLC |
|---|---|
| Physical Functioning | 66.7 ± 0 |
| Role Functioning | 41.7 ± 35.4 |
| Emotional Functioning | 45.8 ± 41.2 |
| Cognitive Functioning | 41.7 ± 35.4 |
| Social Functioning | 50 ± 23.6 |
| Global health status | 50 ± 23.6 |
Correlate tumor mutation burden with treatment response.
Results for this outcome have not been posted.
A combined positive score (CPS) for Programmed Death Ligand 1 (PD-L1) will be derived from immunohistochemical analysis of tumor tissue.
Results for this outcome have not been posted.
Collected over 2 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patients With Stage IV SCLC | 16/33 (48.5%) | 12/33 (36.4%) | 33/33 (100%) |
| Event | Patients With Stage IV SCLC |
|---|---|
| AnemiaBlood and lymphatic system disorders | 2/33 |
| Enterocolitis infectiousInfections and infestations | 2/33 |
| Lung infectionInfections and infestations | 2/33 |
| Alanine aminotransferase increasedInvestigations | 2/33 |
| Aspartate aminotransferase increasedInvestigations | 2/33 |
| HypokalemiaMetabolism and nutrition disorders | 2/33 |
| Thrombotic thrombocytopenic purpuraBlood and lymphatic system disorders | 1/33 |
| ConstipationGastrointestinal disorders | 1/33 |
| DysphagiaGastrointestinal disorders | 1/33 |
| Flu like symptomsGeneral disorders | 1/33 |
| Event | Patients With Stage IV SCLC |
|---|---|
| FatigueGeneral disorders | 17/33 |
| NauseaGastrointestinal disorders | 15/33 |
| Alanine aminotransferase increasedInvestigations | 15/33 |
| Aspartate aminotransferase increasedInvestigations | 15/33 |
| Lymphocyte count decreasedInvestigations | 15/33 |
| Platelet count decreasedInvestigations | 14/33 |
| HypokalemiaMetabolism and nutrition disorders | 13/33 |
| HyponatremiaMetabolism and nutrition disorders | 12/33 |
| VomitingGastrointestinal disorders | 10/33 |
| Alkaline phosphatase increasedInvestigations | 10/33 |
| Age, Continuous(years) | Patients With Stage IV SCLC |
|---|---|
| Mean | 59.8 ± 7.9 |
| Sex: Female, Male(Participants) | Patients With Stage IV SCLC |
|---|---|
| Female | 18 |
| Male | 15 |
| Ethnicity (NIH/OMB)(Participants) | Patients With Stage IV SCLC |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 31 |
| Unknown or Not Reported | 2 |
| Race (NIH/OMB)(Participants) | Patients With Stage IV SCLC |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 28 |
| More than one race | 3 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Patients With Stage IV SCLC |
|---|---|
| United States | 33 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Sep 2019 to primary completion in Nov 2022, 38 months.
Results were first posted in Dec 2023, 1 year 1 month after primary completion.
Of 151 non-industry phase 2 interventional studies under Small Cell Lung Carcinoma, half reached primary completion within 51 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 75. This study's 38 months is below that.
Counting every sponsor, half of 200 studies reached it within 44 months; a quarter within 29 and three quarters within 75.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Rucaparib · Nivolumab
Zhonglin Hao