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CompletedPhase 2NCT03958045
Official study title

Combination Rucaparib With Nivolumab in Small Cell Lung Carcinoma

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedRucaparib and Nivolumab

The study team can explain what participation involves.

Who it may be forSmall cell lung cancer (SCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 22, 2024 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Zhonglin Hao

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Zhonglin Hao
Interventions being studied
Combination Product: Rucaparib and Nivolumab
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Small cell lung cancer (SCLC)→
Treatment approach
Immunotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • 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
Reasons someone may not be able to joinExclusion criteria
  • 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Markey Cancer Center, University of KentuckyLexington, Kentucky

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 22, 2024. Always confirm current availability with the study team.

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