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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT04333914

NCT04333914
Completed Phase 2

Who may be able to join

Who might be able to join this trial:

  • Women aged 18 or older, or men aged 60 or older at the time of joining the trial
  • You have a confirmed diagnosis of an advanced or spreading blood cancer or solid tumour (any type, anywhere in the body), confirmed by laboratory testing
  • You have a confirmed COVID-19 diagnosis from a certified laboratory, and do not need to be moved to an intensive care unit; for the milder group (Cohort 1), no more than 7 days should have passed since your first symptoms; for the more severe group (Cohort 2), no more than 10 days
  • Cohort 2 only: You have pneumonia confirmed by a chest scan, and your blood oxygen levels are at or below a certain level while breathing normal air (confirm with trial site)
  • A medical team has agreed that you are not suitable for transfer to an intensive care unit, either because of your overall health condition or because no beds are available
  • Your doctors expect you to live for more than 3 months
  • Your blood counts, liver, and kidney are working at an acceptable level based on recent blood tests (confirm exact values with trial site)
  • You are willing and able to follow all the study requirements
  • You have read and signed a consent form showing you understand and agree to take part in the trial
  • Women who could become pregnant must have a negative pregnancy blood test within 72 hours before starting treatment
  • Women who could become pregnant and male participants must agree to use highly effective contraception during the trial and for up to 6 months after finishing treatment
  • You have medical insurance coverage

Who may not be able to join:

  • Cohort 1 only: You are currently receiving a specific type of treatment called an anti-NKG2A therapy (confirm with trial site)
  • Cohort 2 only: You are currently receiving a specific type of treatment called an anti-C5aR therapy (confirm with trial site)
  • You have a known allergy or serious reaction to the study drugs (monalizumab for Cohort 1, or avdoralimab for Cohort 2), or a severe allergic reaction to any similar antibody-based medicine
  • Cohort 1 only: You are known to be intolerant or allergic to chloroquine or related medicines (such as hydroxychloroquine or quinine); or you have taken these medicines and have not stopped them at least 72 hours before joining
  • You have an active autoimmune disease (where the immune system attacks the body) that has needed treatment in the past 3 months, or a serious history of such a condition, or you need high doses of steroid or immune-suppressing medicines (some exceptions apply — confirm with trial site)
  • You need major surgery or live vaccines (such as measles, mumps, rubella, or chickenpox vaccines) during the study treatment period
  • You have significant heart problems, such as a recent heart attack within the past 3 months, serious irregular heartbeat, unstable chest pain, or poor heart pumping function (confirm with trial site)
  • You have active hepatitis B, active hepatitis C, or a known HIV infection
  • You have previously had a bone marrow transplant from a donor or a solid organ transplant at any time in the past
  • Your doctor believes your health condition, other treatments, or test results could interfere with the trial or that participation would not be in your best interest
  • You have a known psychiatric condition or substance use problem that would make it difficult to follow the trial requirements
  • You are pregnant, breastfeeding, or planning to become pregnant during the trial or within 6 months of the last dose of the study medicine

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 2
Sponsor
Centre Leon Berard
Registry
clinicaltrials_gov
Start date
15 April 2020
Est. completion
6 July 2021

Where this trial is recruiting

🇫🇷 France

Primary endpoints

28-day survival rate

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov