NCT03958045

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2019

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 21, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

September 4, 2019

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2022

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

December 22, 2023

Completed
Last Updated

October 22, 2024

Status Verified

October 1, 2024

Enrollment Period

3.2 years

First QC Date

May 13, 2019

Results QC Date

October 26, 2023

Last Update Submit

October 10, 2024

Conditions

Small Cell Lung Cancer

Keywords

rucaparibnivolumabplatinum-sensitivemaintenanceSCLCimmune checkpointPARP

Outcome Measures

Primary Outcomes (1)

  • 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

    0-2 years

Secondary Outcomes (6)

  • Disease Control Rate

    8 weeks, 16 weeks and 24 weeks post-treatment

  • Overall Survival

    0-2 years

  • Objective Response Rate

    8 weeks, 16 weeks and 24 weeks post-treatment

  • Quality of Life Scale Baseline

    Baseline

  • Quality of Life Scale 4 Months

    4 months

  • +1 more secondary outcomes

Other Outcomes (2)

  • Tumor Mutation Burden

    0-3 years

  • PD-L1 CPS

    0-3 years

Study Arms (1)

Patients with Stage IV SCLC

EXPERIMENTAL

Patients with extensive stage (IV) SCLC (small cell lung cancer)

Combination Product: Rucaparib and Nivolumab

Interventions

Rucaparib and NivolumabCOMBINATION_PRODUCT

Rucaparib (600mg BID) and Nivolumab (480mg IV q4 wk)

Patients with Stage IV SCLC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with histologically or cytologically confirmed stage IV, extensive stage, small cell lung cancer who achieved either partial or complete remission per RECIST 1.1 post frontline chemotherapy with platinum doublet (Cisplatin or Carboplatin/etoposide).
  • Enrollment is within 6 weeks of last (4th cycle) of chemotherapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  • Adequate Bone Marrow Function
  • Adequate Hepatic Function

You may not qualify if:

  • Prior therapy with any antibody/drug targeting T-cell co-regulatory proteins (immune checkpoints)
  • Major surgery within 4 weeks of initiation of study medication.
  • Current use of (some) immunosuppressants
  • Active infection requiring systemic therapy
  • HIV/AIDS
  • Hepatitis B virus or hepatitis C virus infection at screening
  • Autoimmune disease
  • Persisting toxicity related to prior therapy
  • Pregnancy
  • Vaccination (except inactive) within 4 weeks of the first dose of nivolumab
  • Hypersensitivity to the study drugs
  • Cardiovascular disease
  • Untreated central nervous system (CNS) metastases or leptomeningeal carcinomatosis
  • (Some) active secondary malignancy
  • Active pneumonitis or interstitial lung disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Markey Cancer Center, University of Kentucky

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

rucaparibNivolumab

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Dr. Zhonglin Hao
Organization
University of Kentucky
zhonglin.hao@uky.edu
859-218-6704

Study Officials

  • Zhonglin Hao, MD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 13, 2019

First Posted

May 21, 2019

Study Start

September 4, 2019

Primary Completion

November 15, 2022

Study Completion

November 15, 2022

Last Updated

October 22, 2024

Results First Posted

December 22, 2023

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)