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Atovaquone With Radical ChemorADIotherapy in Locally Advanced NSCLC

NCT04648033 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2026-01-29

Study results available
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Summary

This is a phase I, open-label trial that will utilise a Time To Event Continual Reassessment Method (TiTE-CRM) to determine the maximum tolerated dose (MTD) of atovaquone in combination with concurrent CRT in NSCLC. Twenty evaluable participants will be recruited at three centres.

Conditions

  • Locally Advanced Non-Small Cell Lung Cancer

Interventions

DRUG

Atovaquone Oral Suspension

Atovaquone, cisplatin and vinorelbine are all considered Investigational Medicinal Products (IMPs) in this trial due to the investigation of these drugs in a novel combination. Patients will be allocated one of four doses of atovaquone: 450 mg, 600 mg, 675 mg or 750 mg (all doses PO BD).

DRUG

Standard of care chemotherapy

Atovaquone, cisplatin and vinorelbine are all considered Investigational Medicinal Products (IMPs) in this trial due to the investigation of these drugs in a novel combination. Patients will receive two 21-day cycles of cisplatin and vinorelbine chemotherapy, comprising 80 mg/m2 cisplatin on days 1 \& 22 of their CRT treatment and 15 mg/m2 vinorelbine on days 1, 8, 22 \& 29.

RADIATION

Standard of care radiotherapy

Thoracic radiotherapy will commence on day one of chemotherapy and be delivered in 66 Gy in 33 fractions, once daily, 5 days a week (Monday-Friday) for 6.5 weeks.

Sponsors & Collaborators

  • Cancer Research UK

    collaborator OTHER

  • National Institute for Health Research, United Kingdom

    collaborator OTHER_GOV

  • NHS Lothian

    collaborator OTHER_GOV

  • Oxford University Hospitals NHS Trust

    collaborator OTHER

  • NHS Research Scotland

    collaborator OTHER

  • Guy's and St Thomas' NHS Foundation Trust

    collaborator OTHER

  • University of Oxford

    lead OTHER

Principal Investigators

  • Geoffrey Higgins · University of Oxford

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-07
Primary Completion
2023-10-02
Completion
2023-10-02

Countries

  • United Kingdom

Study Locations

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Entities

Companies

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 NCT04648033 on ClinicalTrials.gov