Locally Advanced Non-Small Cell Lung Cancer Clinical Trial
Official title:
A Phase I Trial of the Hypoxia Modifier Atovaquone in Combination With Radical Concurrent Chemoradiotherapy in Locally Advanced Non-Small Cell Lung Cancer
This is a phase I, single arm, 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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00702975 -
Study of Combination Therapy of Carboplatin -Gemcitabine Plus Bevacizumab Beyond Progression in Patients With Locally Advanced and/or Metastatic Non-small Cell Lung Cancer (NSCLC) Who Have Not Received Prior Systemic Therapy
|
Phase 2 | |
| Recruiting |
NCT05339568 -
Patient's Whole Process Follow-up Management(HOPE-1)
|
||
| Recruiting |
NCT04749394 -
A Study of Camrelizumab Plus Apatinib as Consolidation Therapy in Non-Small Cell Lung Cancer Patients Treated With Chemoradiotherapy
|
Phase 2 | |
| Recruiting |
NCT06287320 -
The Predictive Biomarkers in Patients With Locally Advanced Non-small Cell Lung Cancer
|
||
| Completed |
NCT01537991 -
ISoToxic Accelerated RadioTherapy in Locally Advanced Non-small Cell Lung Cancer: The Phase I/II I-START Trial
|
N/A | |
| Completed |
NCT01059552 -
Treatment of Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
|
Phase 1 | |
| Not yet recruiting |
NCT04153734 -
Pembrolizumab + Platinum Doublets Without Radiation for Programmed Death-ligand 1 (PD-L1) ≥50% Locally Advanced NSCLC
|
Phase 2 | |
| Completed |
NCT03371550 -
A Phase II Trial of Cisplatin-Docetaxel Induction Plus Concurrent 3-D Conformal Radiotherapy and Weekly Chemotherapy
|
Phase 2 | |
| Terminated |
NCT00614484 -
Chemotherapy and Proton Radiation for the Treatment of Locally Advanced Lung Cancer
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT05620199 -
Upfront Resection of Locally Advanced NSCLC Followed by Chemoradiotherapy
|
N/A | |
| Withdrawn |
NCT05481775 -
Evaluating Efficacy and Safety of Anlotinib Combined With Concurrent Chemoradiotherapy Followed by Consolidation Immunotherapy for Locally Advanced Non-small Cell Lung Cancer
|
Phase 2 |