Old malaria drug could boost lung cancer treatment
NCT ID NCT04648033
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tested adding the anti-parasitic drug atovaquone to standard chemotherapy and radiation for people with locally advanced non-small cell lung cancer. The main goal was to find the safest dose of atovaquone in this combination. Twenty-one participants received one of four doses to check for severe side effects. The study is complete, but results are not yet available.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Atovaquone (an anti-parasitic drug) combined with standard chemotherapy (cisplatin and vinorelbine) and radiation therapy
- What this could lead to
- If it works, this could point toward a way to make standard lung cancer treatment more effective by targeting low-oxygen areas in tumors.
- What could go wrong
- This is a very early, small phase 1 trial with only 21 people, focused on safety and dosing. It is not designed to prove the combination works, and side effects may be significant.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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21 people
The number who actually took part.
- Started
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Dec 2020
- Finished
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Oct 2023
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: A patient will be eligible for inclusion in this study if all of the following criteria apply: 1. Histologically or cytologically confirmed diagnosis of locally advanced NSCLC and selected for treatment with full dose radical concurrent CRT 2. At least one measurable lesion greater than 2 cm maximal length in any direction on routine imaging (CT or PET-CT scan performed in the 60 days prior to consent) 3. Male or female, age at least 18 years 4. ECOG performance status 0 or 1 5. Adequate pulmonary function tests for thoracic radiotherapy (FEV1 and TLCO, greater than 40 percent predicted) 6. Haematological and biochemical indices within the ranges shown below: Bilirubin ≤ 1.5 x upper limit of normal (ULN); ALT and/or AST ≤ 2.5 x ULN; Creatinine clearance ≥ 60 mL/min; Absolute Neutrophil Count ≥ 1.5 x 10\*9/L; Platelets ≥ 100 x 10\*9/L; Haemoglobin ≥ 90 g/L; INR ≤ 1.5 7. The patient is willing and able to comply with the protocol scheduled follow-up visits and examinations for the duration of the study 8. Written (signed and dated) informed consent and be capable of co-operating with protocol Exclusion Criteria: 1. Pregnant or breast-feeding women, or women of childbearing potential unless effective methods of contraception are used 2. Previous systemic chemotherapy or biological therapy within 21 days of commencing atovaquone treatment 3. Treatment with any other investigational agent as part of a clinical trial within 28 days of study enrolment 4. Previous thoracic radiotherapy 5. Known previous adverse reaction to atovaquone or its excipients 6. Active hepatitis, gallbladder disease or pancreatitis 7. Impaired gastrointestinal function that may significantly alter absorption of atovaquone 8. Concurrent administration of warfarin in the 14 days prior to starting atovaquone 9. Concurrent administration of known electron transport chain inhibitors (e.g. metformin). A wash-out period prior to administration of atovaquone is required (e.g. 4 days for metformin). 10. An additional cancer diagnosis that the treating clinician feels may significantly impact planned CRT treatment tolerability or treatment outcome 11. Established diagnosis of pulmonary fibrosis 12. Established diagnosis of connective tissue disorder (e.g. scleroderma or systemic lupus erythematosus) 13. Cardiac morbidity such as angina, myocardial infarction in the previous six months, unstable angina or uncontrolled hypertension, left ventricular failure or severe valvular disease
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Churchill Hospital, Oxford University Hospitals
Oxford, OX3 7LE, United Kingdom
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Guy's and St Thomas'
London, SE1 9RT, United Kingdom
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Western General Hospital, NHS Lothian
Edinburgh, EH4 2XU, United Kingdom
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