A Phase 1 interventional study of Atovaquone Oral Suspension and Standard of care chemotherapy in Locally Advanced Non-Small Cell Lung Cancer, sponsored by University of Oxford. Completed at 3 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-29.
Sponsored by University of Oxford · Phase 1, Interventional, and Treatment
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.
Twice daily oral atovaquone will be added to standard concurrent chemoradiotherapy (CRT): 66 Gy in 33 fractions, once daily, 5 days a week (Monday-Friday), with cisplatin (80 mg/m2 IV on days 1 and 22 of CRT) and vinorelbine (15 mg/m2 IV on days 1, 8, 22 and 29 of CRT). Whilst awaiting CRT to start, patients will receive two weeks (+/- 7 days) of oral atovaquone to ensure steady state is reached (after seven days). Patients will be allocated one of four dose levels: 450 mg, 600 mg, 675 mg or 750 mg (all doses PO BD). Atovaquone dose will be assigned as per the TiTE-CRM statistical model. The first two trial participants will receive 450 mg BD. In the absence of unacceptable toxicity, subsequent patients will be assigned doses up to and including 750 mg BD.
Hypoxia biomarker data will be collected at baseline (start of atovaquone run-in) and following two weeks (+/- 7 days) of atovaquone treatment. Atovaquone will then be continued without break for the duration of CRT, with the CRT schedule remaining constant for all patients at both centres. Assessment for Dose Limiting Toxicities (DLTs) will be from the first scheduled dose of atovaquone until three months after completion of CRT. The CT scan performed at the three-month follow up visit will be reviewed to collect tumour response data.
University of Oxford is the lead sponsor of 794 studies on the registry; 117 are open to participants now.
Counted across the registry records on this site, refreshed daily.
A patient will be eligible for inclusion in this study if all of the following criteria apply:
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
Exclusion Criteria:
Atovaquone: * Taken during an initial run in period (2 weeks +/- 7 days), then continued during standard of care chemoradiotherapy. * One of 4 dose levels is allocated to each patient by a TiTE-CRM statistical model which takes into account all toxicity data to date. * Dose levels - 450 mg, 600 mg, 675 mg or 750 mg (all doses PO BD). * Last dose atovaquone taken on the last day of radiotherapy. * Total duration of atovaquone treatment is 59 days (+/- 7 days), unless stopped earlier for toxicity or any other reason. Chemotherapy: * 2 x 21-day cycles. * 80 mg/m2 cisplatin on day 1 and 22 of chemoradiotherapy. * 15 mg/m2 vinorelbine on days 1,8, 22 and 29 of chemoradiotherapy. Radiotherapy: * 66 Gy in 33 fractions. * Delivered once daily, 5 days a week (Monday-Friday) for 6.5 weeks.
Drug: Atovaquone Oral Suspension · Drug: Standard of care chemotherapy · Radiation: Standard of care radiotherapy
Atovaquone: * Taken during an initial run in period (2 weeks +/- 7 days), then continued during standard of care chemoradiotherapy. * One of 4 dose levels is allocated to each patient by a TiTE-CRM statistical model which takes into account all toxicity data to date. * Dose levels - 450 mg, 600 mg, 675 mg or 750 mg (all doses PO BD). * Last dose atovaquone taken on the last day of radiotherapy. * Total duration of atovaquone treatment is 59 days (+/- 7 days), unless stopped earlier for toxicity or any other reason. Chemotherapy: * 2 x 21-day cycles. * 80 mg/m2 cisplatin on day 1 and 22 of chemoradiotherapy. * 15 mg/m2 vinorelbine on days 1,8, 22 and 29 of chemoradiotherapy. Radiotherapy: * 66 Gy in 33 fractions. * Delivered once daily, 5 days a week (Monday-Friday) for 6.5 weeks.
Drug: Atovaquone Oral Suspension · Drug: Standard of care chemotherapy · Radiation: Standard of care radiotherapy
Atovaquone: * Taken during an initial run in period (2 weeks +/- 7 days), then continued during standard of care chemoradiotherapy. * One of 4 dose levels is allocated to each patient by a TiTE-CRM statistical model which takes into account all toxicity data to date. * Dose levels - 450 mg, 600 mg, 675 mg or 750 mg (all doses PO BD). * Last dose atovaquone taken on the last day of radiotherapy. * Total duration of atovaquone treatment is 59 days (+/- 7 days), unless stopped earlier for toxicity or any other reason. Chemotherapy: * 2 x 21-day cycles. * 80 mg/m2 cisplatin on day 1 and 22 of chemoradiotherapy. * 15 mg/m2 vinorelbine on days 1,8, 22 and 29 of chemoradiotherapy. Radiotherapy: * 66 Gy in 33 fractions. * Delivered once daily, 5 days a week (Monday-Friday) for 6.5 weeks.
Drug: Atovaquone Oral Suspension · Drug: Standard of care chemotherapy · Radiation: Standard of care radiotherapy
Atovaquone: * Taken during an initial run in period (2 weeks +/- 7 days), then continued during standard of care chemoradiotherapy. * One of 4 dose levels is allocated to each patient by a TiTE-CRM statistical model which takes into account all toxicity data to date. * Dose levels - 450 mg, 600 mg, 675 mg or 750 mg (all doses PO BD). * Last dose atovaquone taken on the last day of radiotherapy. * Total duration of atovaquone treatment is 59 days (+/- 7 days), unless stopped earlier for toxicity or any other reason. Chemotherapy: * 2 x 21-day cycles. * 80 mg/m2 cisplatin on day 1 and 22 of chemoradiotherapy. * 15 mg/m2 vinorelbine on days 1,8, 22 and 29 of chemoradiotherapy. Radiotherapy: * 66 Gy in 33 fractions. * Delivered once daily, 5 days a week (Monday-Friday) for 6.5 weeks.
Drug: Atovaquone Oral Suspension · Drug: Standard of care chemotherapy · Radiation: Standard of care radiotherapy
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).
Also known as: Wellvone
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.
Also known as: Cisplatin, Vinorelbine
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.
Number of Dose Limiting Toxicities in Patients Taking Atovaquone in Combination With Radical Concurrent Chemoradiotherapy for Non-small Cell Lung Cancer.
To determine the maximum tolerated dose level (and therefore recommended phase II dose) of atovaquone when administered concomitantly with radical concurrent chemoradiotherapy (CRT) in patients with non-small cell lung cancer (NSCLC). This is the dose of atovaquone associated with no more than 48% dose limiting toxicity (DLT) rate (target toxicity level).
Time frame: From first dose of atovaquone to 3-month follow up visit (up to 25 weeks)
Severity of Worst Adverse Events Per Dose Level of Atovaquone Administered in Combination With Radical Concurrent Chemotherapy for NSCLC According to CTCAE V4.03
Toxicity profile when atovaquone administered in combination with radical concurrent chemotherapy for NSCLC. Worst grade adverse event for each patient by dose schedule (according to the Common Terminology Criteria for Adverse Events, Version 4.03). Grade 1 (mild); Grade 2 (moderate); Grade 3 (severe or medically significant, but not immediately life-threatening); Grade 4 (life-threatening); Grade 5 (death).
Time frame: From first dose of atovaquone until last follow up visit at 6 months post completion of CRT (up to 38 weeks)
Number of Patients for Whom it Was Possible to Derive a Hypoxia Metagene Signature Score From 3'RNA-Seq of Genetic Material From Archival Tumour Samples
To confirm feasibility of measuring hypoxia metagene signature using 3'RNA-Seq on genetic material extracted from diagnostic non-small cell lung tumour samples. The score method was derived by Buffa et al (Buffa et al. Large meta-analysis of multiple cancers reveals a common, compact and highly prognostic hypoxia metagene. Br J Cancer. 2010 Jan 19;102(2):428-35. doi: 10.1038/sj.bjc.6605450).
Time frame: At baseline (diagnosis)
Mean Baseline Tumour Hypoxia Level (TBRvol) Assessed by F18-FMISO PET-CT
The level of hypoxia in patient tumours was calculated using the Tumour-to-Blood Ratio volume (TBRvol) assessed from the patient's baseline PET scan. This scan was conducted with 18F-labelled fluoromisonidazole (F18-FMISO) which has been shown to selectively bind to hypoxic cells and can be quantified with PET imaging (Koh, et al. Imaging of hypoxia in human tumours with \[F-18\]fluoromisonidazole. Int J Radiat Oncol Biol Phys. 1992;22(1)). Tumour outlining of the region of interest on each axial slice was conducted centrally for all patients in consultation with an experienced consultant radiologist and combined to give a volume of interest (VOI). The number of voxels in the VOI with a threshold regional tumor:plasma F18-FMISO ratio of greater than or equal to 1.4 were combined to give the TBRvol (above reference). Patients with a TBRvol at baseline of \<1.5mL were regarded as unevaluable for later endpoints, so are excluded from the report.
Time frame: At baseline (prior to atovaquone treatment)
Mean Baseline Plasma miR-210 Level Assessed Via TaqMan Quantitative PCR
MicroRNA-210 (miR-210) has been found to be upregulated in response to hypoxia-inducing factors (Dang and Myers, The Role of Hypoxia-Induced miR-210 in Cancer Progression, Int. J. Mol. Sci., vol 16, 2015). Additionally, elevated serum levels of miR-210 are indicative of poor clinical outcomes in non-small cell lung cancer (He, et al. Clinical Significance of miR-210 and its Prospective Signaling Pathways in Non-Small Cell Lung Cancer. Physiol. Biochem. Int. J. Exp. Cell. Physiol. Biochem. Pharmacol., vol. 46, 2018). RNA was isolated from blood plasma and miR210 level detected using a two-step TaqMan quantitative PCR, using TaqMan probes for miR-210. An endogenous control miRNA (miR-16), plus an exogenous synthetic miRNA (cel-miR-39) were used for normalisation of miR210 counts. This endpoint was assessed in order to investigate a possible alternative to 18F-FMISO PET-CT scan for assessment of patients' tumour hypoxia level.
Time frame: At baseline (prior to atovaquone treatment)
Mean Percentage Change in Tumour Hypoxia Level Between Baseline and After Two Weeks (+/- 7 Days) of Atovaquone Treatment
The level of hypoxia (Tumour-to-Blood Ratio volume, TBRvol) in patient tumours was calculated at baseline and following two weeks (+/- 7 days) of atovaquone treatment according to the details given in outcome measure 4. The mean percentage difference in TBRvol between the two timepoints at each dose level of atovaquone was calculated and is reported, below. Patients with a TBRvol at baseline of \<1.5mL were regarded as unevaluable as it would not be possible to evaluate a reduction in hypoxic volume between this timepoint and the later timepoint. These patients were excluded from the report.
Time frame: Between baseline (prior to atovaquone treatment) and following two weeks (+/- 7 days) of atovaquone treatment (up to 21 days)
Mean Percentage Change in Plasma miR-210 Level Between Baseline and After Two Weeks (+/- 7 Days) of Atovaquone Treatment, Assessed Via TaqMan Quantitative PCR
The miR-210 in participant plasma samples was calculated at baseline and following two weeks (+/- 7 days) of atovaquone treatment according to the details given in outcome measure 5. The mean percentage difference in miR210 count between the two timepoints for each dose level of atovaquone was calculated and is reported, below. This endpoint was assessed in order to investigate a possible alternative to 18F-FMISO PET-CT scan for assessment of patients' tumour hypoxia level.
Time frame: Between baseline (prior to atovaquone treatment) and following two weeks (+/- 7 days) of atovaquone treatment (up to 21 days)
Objective Tumour Response to Treatment With Atovaquone in Combination With Chemoradiotherapy, as Evaluated by CT or PET-CT Scan and Quantified by RECIST 1.1
Efficacy of the combination (atovaquone and chemoradiotherapy), measured by objective tumour response via RECIST 1.1 (Eisenhauer, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009;45(2):228-247). Scale of response assessed as Progressive Disease (PD) (worst outcome), Stable Disease (SD), Partial Response (PR), Complete Response (CR) (best outcome).
Time frame: At 3 months post completion of chemoradiotherapy (up to 25 weeks after first dose of atovaquone)
| Milestone | Dose Level 1 - 450 mg BD Atovaquone + Concurrent CRT | Dose Level 2 - 600 mg BD Atovaquone + Concurrent CRT | Dose Level 3 - 675 mg BD Atovaquone + Concurrent CRT | Dose Level 4 - 750 mg BD Atovaquone + Concurrent CRT |
|---|---|---|---|---|
| Started | 3 | 2 | 1 | 15 |
| Completed | 3 | 2 | 1 | 15 |
| Not completed | 0 | 0 | 0 | 0 |
To determine the maximum tolerated dose level (and therefore recommended phase II dose) of atovaquone when administered concomitantly with radical concurrent chemoradiotherapy (CRT) in patients with non-small cell lung cancer (NSCLC). This is the dose of atovaquone associated with no more than 48% dose limiting toxicity (DLT) rate (target toxicity level).
| Dose Limiting Toxicities (DLTs) | Dose Level 1 - 450 mg BD Atovaquone + Concurrent CRT | Dose Level 2 - 600 mg BD Atovaquone + Concurrent CRT | Dose Level 3 - 675 mg BD Atovaquone + Concurrent CRT | Dose Level 4 - 750 mg BD Atovaquone + Concurrent CRT |
|---|---|---|---|---|
| Number of Dose Limiting Toxicities in Patients Taking Atovaquone in Combination With Radical Concurrent Chemoradiotherapy for Non-small Cell Lung Cancer. | 0 | 0 | 0 | 2 |
Toxicity profile when atovaquone administered in combination with radical concurrent chemotherapy for NSCLC. Worst grade adverse event for each patient by dose schedule (according to the Common Terminology Criteria for Adverse Events, Version 4.03). Grade 1 (mild); Grade 2 (moderate); Grade 3 (severe or medically significant, but not immediately life-threatening); Grade 4 (life-threatening); Grade 5 (death).
| Participants | Dose Level 1 - 450 mg BD Atovaquone + Concurrent CRT | Dose Level 2 - 600 mg BD Atovaquone + Concurrent CRT | Dose Level 3 - 675 mg BD Atovaquone + Concurrent CRT | Dose Level 4 - 750 mg BD Atovaquone + Concurrent CRT |
|---|---|---|---|---|
| Worst AE: Grade 1 | 0 | 0 | 1 | 0 |
| Worst AE: Grade 2 | 1 | 1 | 0 | 6 |
| Worst AE: Grade 3 | 2 | 1 | 0 | 6 |
| Worst AE: Grade 4 | 0 | 0 | 0 | 1 |
| Worst AE: Grade 5 | 0 | 0 | 0 | 2 |
To confirm feasibility of measuring hypoxia metagene signature using 3'RNA-Seq on genetic material extracted from diagnostic non-small cell lung tumour samples. The score method was derived by Buffa et al (Buffa et al. Large meta-analysis of multiple cancers reveals a common, compact and highly prognostic hypoxia metagene. Br J Cancer. 2010 Jan 19;102(2):428-35. doi: 10.1038/sj.bjc.6605450).
| Participants | Dose Level 1 - 450 mg BD Atovaquone + Concurrent CRT | Dose Level 2 - 600 mg BD Atovaquone + Concurrent CRT | Dose Level 3 - 675 mg BD Atovaquone + Concurrent CRT | Dose Level 4 - 750 mg BD Atovaquone + Concurrent CRT |
|---|---|---|---|---|
| Number of Patients for Whom it Was Possible to Derive a Hypoxia Metagene Signature Score From 3'RNA-Seq of Genetic Material From Archival Tumour Samples | 3 | 2 | 0 | 11 |
The level of hypoxia in patient tumours was calculated using the Tumour-to-Blood Ratio volume (TBRvol) assessed from the patient's baseline PET scan. This scan was conducted with 18F-labelled fluoromisonidazole (F18-FMISO) which has been shown to selectively bind to hypoxic cells and can be quantified with PET imaging (Koh, et al. Imaging of hypoxia in human tumours with \[F-18\]fluoromisonidazole. Int J Radiat Oncol Biol Phys. 1992;22(1)). Tumour outlining of the region of interest on each axial slice was conducted centrally for all patients in consultation with an experienced consultant radiologist and combined to give a volume of interest (VOI). The number of voxels in the VOI with a threshold regional tumor:plasma F18-FMISO ratio of greater than or equal to 1.4 were combined to give the TBRvol (above reference). Patients with a TBRvol at baseline of \<1.5mL were regarded as unevaluable for later endpoints, so are excluded from the report.
| TBRvol (mL) | Dose Level 1 - 450 mg BD Atovaquone + Concurrent CRT | Dose Level 2 - 600 mg BD Atovaquone + Concurrent CRT | Dose Level 3 - 675 mg BD Atovaquone + Concurrent CRT | Dose Level 4 - 750 mg BD Atovaquone + Concurrent CRT |
|---|---|---|---|---|
| Mean Baseline Tumour Hypoxia Level (TBRvol) Assessed by F18-FMISO PET-CT | 282.4 (4.4 to 560.4) | 21.4 (NA to NA) | — | 58.7 (2.6 to 162.0) |
MicroRNA-210 (miR-210) has been found to be upregulated in response to hypoxia-inducing factors (Dang and Myers, The Role of Hypoxia-Induced miR-210 in Cancer Progression, Int. J. Mol. Sci., vol 16, 2015). Additionally, elevated serum levels of miR-210 are indicative of poor clinical outcomes in non-small cell lung cancer (He, et al. Clinical Significance of miR-210 and its Prospective Signaling Pathways in Non-Small Cell Lung Cancer. Physiol. Biochem. Int. J. Exp. Cell. Physiol. Biochem. Pharmacol., vol. 46, 2018). RNA was isolated from blood plasma and miR210 level detected using a two-step TaqMan quantitative PCR, using TaqMan probes for miR-210. An endogenous control miRNA (miR-16), plus an exogenous synthetic miRNA (cel-miR-39) were used for normalisation of miR210 counts. This endpoint was assessed in order to investigate a possible alternative to 18F-FMISO PET-CT scan for assessment of patients' tumour hypoxia level.
| miR210 count (x10^3) | Dose Level 1 - 450 mg BD Atovaquone + Concurrent CRT | Dose Level 2 - 600 mg BD Atovaquone + Concurrent CRT | Dose Level 3 - 675 mg BD Atovaquone + Concurrent CRT | Dose Level 4 - 750 mg BD Atovaquone + Concurrent CRT |
|---|---|---|---|---|
| Mean Baseline Plasma miR-210 Level Assessed Via TaqMan Quantitative PCR | 0.00146 (0.00142 to 0.00149) | 0.00219 (NA to NA) | — | 0.00195 (0.00098 to 0.00451) |
The level of hypoxia (Tumour-to-Blood Ratio volume, TBRvol) in patient tumours was calculated at baseline and following two weeks (+/- 7 days) of atovaquone treatment according to the details given in outcome measure 4. The mean percentage difference in TBRvol between the two timepoints at each dose level of atovaquone was calculated and is reported, below. Patients with a TBRvol at baseline of \<1.5mL were regarded as unevaluable as it would not be possible to evaluate a reduction in hypoxic volume between this timepoint and the later timepoint. These patients were excluded from the report.
| Percentage change in TBRvol | Dose Level 1 - 450 mg BD Atovaquone + Concurrent CRT | Dose Level 2 - 600 mg BD Atovaquone + Concurrent CRT | Dose Level 3 - 675 mg BD Atovaquone + Concurrent CRT | Dose Level 4 - 750 mg BD Atovaquone + Concurrent CRT |
|---|---|---|---|---|
| Mean Percentage Change in Tumour Hypoxia Level Between Baseline and After Two Weeks (+/- 7 Days) of Atovaquone Treatment | -8 (-37 to 22) | -15 (NA to NA) | — | -25 (-91 to 4) |
The miR-210 in participant plasma samples was calculated at baseline and following two weeks (+/- 7 days) of atovaquone treatment according to the details given in outcome measure 5. The mean percentage difference in miR210 count between the two timepoints for each dose level of atovaquone was calculated and is reported, below. This endpoint was assessed in order to investigate a possible alternative to 18F-FMISO PET-CT scan for assessment of patients' tumour hypoxia level.
| Percentage change in miR210 count | Dose Level 1 - 450 mg BD Atovaquone + Concurrent CRT | Dose Level 2 - 600 mg BD Atovaquone + Concurrent CRT | Dose Level 3 - 675 mg BD Atovaquone + Concurrent CRT | Dose Level 4 - 750 mg BD Atovaquone + Concurrent CRT |
|---|---|---|---|---|
| Mean Percentage Change in Plasma miR-210 Level Between Baseline and After Two Weeks (+/- 7 Days) of Atovaquone Treatment, Assessed Via TaqMan Quantitative PCR | 53.0 (50.9 to 55.1) | -42.5 (NA to NA) | — | 15.1 (-33.0 to 91.7) |
Efficacy of the combination (atovaquone and chemoradiotherapy), measured by objective tumour response via RECIST 1.1 (Eisenhauer, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009;45(2):228-247). Scale of response assessed as Progressive Disease (PD) (worst outcome), Stable Disease (SD), Partial Response (PR), Complete Response (CR) (best outcome).
| Participants | Dose Level 1 - 450 mg BD Atovaquone + Concurrent CRT | Dose Level 2 - 600 mg BD Atovaquone + Concurrent CRT | Dose Level 3 - 675 mg BD Atovaquone + Concurrent CRT | Dose Level 4 - 750 mg BD Atovaquone + Concurrent CRT |
|---|---|---|---|---|
| Complete Response (CR) | 0 | 0 | 0 | 1 |
| Partial Response (PR) | 2 | 2 | 1 | 7 |
| Stable Disease (SD) | 1 | 0 | 0 | 2 |
| Progressive Disease (PD) | 0 | 0 | 0 | 3 |
Collected over Adverse events (including serious events) are reported from first dose of atovaquone to last follow up visit at 6 months post chemoradiotherapy (up to 38 weeks).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dose Level 1 - 450 mg BD Atovaquone + Concurrent CRT | 0/3 (0%) | 2/3 (66.7%) | 3/3 (100%) |
| Dose Level 2 - 600 mg BD Atovaquone + Concurrent CRT | 0/2 (0%) | 1/2 (50%) | 2/2 (100%) |
| Dose Level 3 - 675 mg BD Atovaquone + Concurrent CRT | 0/1 (0%) | 0/1 (0%) | 1/1 (100%) |
| Dose Level 4 - 750 mg BD Atovaquone + Concurrent CRT | 2/15 (13.3%) | 7/15 (46.7%) | 15/15 (100%) |
| Event | Dose Level 1 - 450 mg BD Atovaquone + Concurrent CRT | Dose Level 2 - 600 mg BD Atovaquone + Concurrent CRT | Dose Level 3 - 675 mg BD Atovaquone + Concurrent CRT | Dose Level 4 - 750 mg BD Atovaquone + Concurrent CRT |
|---|---|---|---|---|
| VomitingGastrointestinal disorders | 0/3 | 1/2 | 0/1 | 0/15 |
| AtaxiaNervous system disorders | 1/3 | 0/2 | 0/1 | 0/15 |
| Angina pectorisCardiac disorders | 1/3 | 0/2 | 0/1 | 0/15 |
| Acute kidney injuryRenal and urinary disorders | 1/3 | 0/2 | 0/1 | 0/15 |
| PneumonitisRespiratory, thoracic and mediastinal disorders | 0/3 | 0/2 | 0/1 | 2/15 |
| DiarrhoeaGastrointestinal disorders | 0/3 | 0/2 | 0/1 | 2/15 |
| HyperglycaemiaMetabolism and nutrition disorders | 0/3 | 0/2 | 0/1 | 1/15 |
| PneumoniaInfections and infestations | 0/3 | 0/2 | 0/1 | 1/15 |
| Chest painGeneral disorders | 0/3 | 0/2 | 0/1 | 1/15 |
| Inflammatory bowel diseaseGastrointestinal disorders | 0/3 | 0/2 | 0/1 | 1/15 |
| Event | Dose Level 1 - 450 mg BD Atovaquone + Concurrent CRT | Dose Level 2 - 600 mg BD Atovaquone + Concurrent CRT | Dose Level 3 - 675 mg BD Atovaquone + Concurrent CRT | Dose Level 4 - 750 mg BD Atovaquone + Concurrent CRT |
|---|---|---|---|---|
| Gastrointestinal DisordersGastrointestinal disorders | 3/3 | 2/2 | 1/1 | 14/15 |
| General Disorders & Administration Site ConditionsGeneral disorders | 3/3 | 2/2 | 1/1 | 11/15 |
| Hepatobiliary disordersHepatobiliary disorders | 0/3 | 0/2 | 1/1 | 0/15 |
| Respiratory, thoracic and mediastinal disordersRespiratory, thoracic and mediastinal disorders | 2/3 | 0/2 | 0/1 | 11/15 |
| Cardiac DisordersCardiac disorders | 2/3 | 0/2 | 0/1 | 0/15 |
| Musculoskeletal & Connective Tissue DisordersMusculoskeletal and connective tissue disorders | 2/3 | 1/2 | 0/1 | 3/15 |
| Nervous System DisordersNervous system disorders | 2/3 | 1/2 | 0/1 | 9/15 |
| Skin and subcutaneous tissue disordersSkin and subcutaneous tissue disorders | 2/3 | 0/2 | 0/1 | 4/15 |
| Infections & InfestationsInfections and infestations | 0/3 | 0/2 | 0/1 | 8/15 |
| Metabolism & Nutrition DisordersMetabolism and nutrition disorders | 1/3 | 1/2 | 0/1 | 8/15 |
| Age, Continuous(Years) | Dose Level 1 - 450 mg BD Atovaquone + Concurrent CRT | Dose Level 2 - 600 mg BD Atovaquone + Concurrent CRT | Dose Level 3 - 675 mg BD Atovaquone + Concurrent CRT | Dose Level 4 - 750 mg BD Atovaquone + Concurrent CRT | Total |
|---|---|---|---|---|---|
| Mean | 67.3 ± 17.7 | 48.0 ± 9.9 | 65.0 ± NA | 65.2 ± 16.4 | 63.9 ± 10.7 |
| Sex: Female, Male(Participants) | Dose Level 1 - 450 mg BD Atovaquone + Concurrent CRT | Dose Level 2 - 600 mg BD Atovaquone + Concurrent CRT | Dose Level 3 - 675 mg BD Atovaquone + Concurrent CRT | Dose Level 4 - 750 mg BD Atovaquone + Concurrent CRT | Total |
|---|---|---|---|---|---|
| Female | 0 | 1 | 0 | 6 | 7 |
| Male | 3 | 1 | 1 | 9 | 14 |
| Ethnicity (NIH/OMB)(Participants) | Dose Level 1 - 450 mg BD Atovaquone + Concurrent CRT | Dose Level 2 - 600 mg BD Atovaquone + Concurrent CRT | Dose Level 3 - 675 mg BD Atovaquone + Concurrent CRT | Dose Level 4 - 750 mg BD Atovaquone + Concurrent CRT | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 3 | 2 | 1 | 9 | 15 |
| Unknown or Not Reported | 0 | 0 | 0 | 6 | 6 |
| Smoking status(Participants) | Dose Level 1 - 450 mg BD Atovaquone + Concurrent CRT | Dose Level 2 - 600 mg BD Atovaquone + Concurrent CRT | Dose Level 3 - 675 mg BD Atovaquone + Concurrent CRT | Dose Level 4 - 750 mg BD Atovaquone + Concurrent CRT | Total |
|---|---|---|---|---|---|
| Never smoked | 1 | 1 | 0 | 0 | 2 |
| Ex-smoker | 2 | 0 | 1 | 13 | 16 |
| Current smoker | 0 | 1 | 0 | 2 | 3 |
| Non-small cell lung cancer sub-type(Participants) | Dose Level 1 - 450 mg BD Atovaquone + Concurrent CRT | Dose Level 2 - 600 mg BD Atovaquone + Concurrent CRT | Dose Level 3 - 675 mg BD Atovaquone + Concurrent CRT | Dose Level 4 - 750 mg BD Atovaquone + Concurrent CRT | Total |
|---|---|---|---|---|---|
| Adenocarcinoma | 3 | 1 | 0 | 4 | 8 |
| Squamous cell carcinoma | 0 | 1 | 1 | 11 | 13 |
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