Role of Hydroxychloroquine in therapeutic strategy of Head and Neck cancer and Nonsmall cell lung cancer

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Ospedale San Raffaele S.r.l.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

completed 18 Jul 2025

Decision date (initial)

2024-07-29

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-516189-12-00

EudraCT number

2021-004189-37

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Others

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

Conditions and MedDRA coding

Patients affected by Resectable Head and Neck (HN) cancer (only Squamous Cell Carcinoma of the oral cavity or larynx), or Resectable Non-small cell lung cancer (NSCLC, only Lung Squamous Cell Carcinoma or Adenocarcinoma).

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. 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
2. 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

Exclusion criteria 17

1. Hypersensitivity to Hydroxychloroquine, Chloroquine or other 4-Aminoquinolines4
2. Bradycardia or reduction in heart rhythm with arrhythmia
3. Uncorrected hypokalemia and/or hypomagnesemia
4. Ischemic heart disease (< 5 years)
5. Congestive heart failure with use of diuretics
6. Pre-existing retinopathy or maculopathy5
7. Known Glucose-6-phosphate dehydrogenase deficiency (haemolytic anaemia, Favism)
8. Known galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption
9. Known prolonged QT syndrome or current use of drugs with known prolongation of QT/QTc interval.
10. Any regular concomitant medication which is contraindicated in the use together with HCQ
11. Diabetes type 1
12. Haematopoietic systems diseases
13. Myasthenia gravis
14. Psoriasis
15. Pregnant or breastfeeding women
16. Patients with Nasogastric or PEG feeding tube
17. Patients with deterioration of performance status beyond ECOG 2

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The biological effect of HCQ will be evaluated using immunohistochemical studies performed for known autophagic and immunological markers (CD3, CD8, CD163, p53, p62, LC3) with quantification of positivity / total cells, intensity, expression pattern. Eventual tumor cytoarchitectural modification and tumor lymphocyte infiltrate will be evaluated and scored using standard grading system.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Ospedale San Raffaele S.r.l.

Sponsor organisation

Ospedale San Raffaele S.r.l.

Address

Via Olgettina 60

City

Milan

Postcode

20132

Country

Italy

Scientific contact point

Organisation

Ospedale San Raffaele S.r.l.

Contact name

Stefano Cascinu

Public contact point

Organisation

Ospedale San Raffaele S.r.l.

Contact name

Stefano Cascinu

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications