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Role of Hydroxychloroquine in therapeutic strategy of Head and Neck cancer and Nonsmall cell lung cancer
EU CTIS ID: 2024-516189-12-00
What this study is testing
To determine the biological effect of Hydroxychloroquine on tumor cells and tumor microenvironment in patients with resectable Head and Neck cancer and Non-small cell lung cancer
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Head and Neck Cancer group: - Adults > or = 18 years of age. - American Joint Committee on Cancer-defined clinical stage I, II, III, IV HN cancer that is deemed locally to be surgically resectable by a multidisciplinary clinical team and will receive radical surgery. - Squamous Cell Carcinoma (SCC) of the oral cavity or larynx - Treatment-naïve patients - Eastern Cooperative Oncology Group (ECOG) performance status 0-2 - Patient capable giving informed consent - QTc interval lower than 450 msec - Measurable or evaluable disease defined by RECIST 1.1 - For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of drug administration. - For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner
- Non-small cell lung cancer group - Adults > or = 18 years of age. - American Joint Committee on Cancer-defined clinical stage IA, IB, IIA, IIB NSCLC that is deemed locally to be surgically resectable by a multidisciplinary clinical team and will receive radical surgery. - Lung Squamous Cell Carcinoma or Adenocarcinoma. - Treatment-naïve patients - PDL1 > 50% - Eastern Cooperative Oncology Group (ECOG) performance status 0-2 - Patient capable giving informed consent - QTc interval lower than 450 msec - Measurable or evaluable disease defined by RECIST 1.1 - For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of drug administration. - For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner
You likely can't join if
- Hypersensitivity to Hydroxychloroquine, Chloroquine or other 4-Aminoquinolines4
- Any regular concomitant medication which is contraindicated in the use together with HCQ
- Diabetes type 1
- Haematopoietic systems diseases
- Myasthenia gravis
- Psoriasis
See the full eligibility criteria
Who can join
- Head and Neck Cancer group: - Adults > or = 18 years of age. - American Joint Committee on Cancer-defined clinical stage I, II, III, IV HN cancer that is deemed locally to be surgically resectable by a multidisciplinary clinical team and will receive radical surgery. - Squamous Cell Carcinoma (SCC) of the oral cavity or larynx - Treatment-naïve patients - Eastern Cooperative Oncology Group (ECOG) performance status 0-2 - Patient capable giving informed consent - QTc interval lower than 450 msec - Measurable or evaluable disease defined by RECIST 1.1 - For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of drug administration. - For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner
- Non-small cell lung cancer group - Adults > or = 18 years of age. - American Joint Committee on Cancer-defined clinical stage IA, IB, IIA, IIB NSCLC that is deemed locally to be surgically resectable by a multidisciplinary clinical team and will receive radical surgery. - Lung Squamous Cell Carcinoma or Adenocarcinoma. - Treatment-naïve patients - PDL1 > 50% - Eastern Cooperative Oncology Group (ECOG) performance status 0-2 - Patient capable giving informed consent - QTc interval lower than 450 msec - Measurable or evaluable disease defined by RECIST 1.1 - For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of drug administration. - For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner
What rules you out
- Hypersensitivity to Hydroxychloroquine, Chloroquine or other 4-Aminoquinolines4
- Any regular concomitant medication which is contraindicated in the use together with HCQ
- Diabetes type 1
- Haematopoietic systems diseases
- Myasthenia gravis
- Psoriasis
- Pregnant or breastfeeding women
- Patients with Nasogastric or PEG feeding tube
- Patients with deterioration of performance status beyond ECOG 2
- Bradycardia or reduction in heart rhythm with arrhythmia
- Uncorrected hypokalemia and/or hypomagnesemia
- Ischemic heart disease (< 5 years)
- Congestive heart failure with use of diuretics
- Pre-existing retinopathy or maculopathy5
- Known Glucose-6-phosphate dehydrogenase deficiency (haemolytic anaemia, Favism)
- Known galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption
- Known prolonged QT syndrome or current use of drugs with known prolongation of QT/QTc interval.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.