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Immunotherapy in Combination With Chemotherapy in Small-cell Lung Cancer

NCT03568097 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2023-06-02

No results posted yet for this study

Summary

PAVE(Phased Avelumab combined with chemotherapy as first-line treatment for patients with advanced small-cell lung cancer) is a Greek, investigator- initiated, single arm open- label phase II study of Avelumab in combination with cisplatin or carboplatin/ etoposide.

The study will include an initial safety run-in, open-label, singlearm part (Part 1), and the actual phase II study (Part 2). The total number of patients will not change (the safety run-in patients will be included in the final total number of participants). The safety run-in period will not alter the total study timelines, as phase II accrual will follow immediately after the safety run-in.

Conditions

  • Small Cell Lung Carcinoma

Interventions

DRUG

Avelumab

10 mg/kg will be given as intravenous infusion (IV) every two weeks (q 2 weeks) until disease progression.

Sponsors & Collaborators

  • Merck KGaA, Darmstadt, Germany

    collaborator INDUSTRY

  • Hellenic Cooperative Oncology Group

    lead OTHER

Principal Investigators

  • Helena Linardou, MD · 1st Department on Medical Oncology, Metropolitan Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-16
Primary Completion
2022-03-30
Completion
2024-04-30

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03568097 on ClinicalTrials.gov