Phase 1 Type 2 Diabetes Trial, Recruiting NCT05142189 Sponsor: BioNTech SE Condition: Type 2 Diabetes
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Phase 1 Type 2 Diabetes Trial, Recruiting

NCT05142189
Recruiting Phase 1 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed with non-small cell lung cancer (NSCLC) confirmed by a tissue sample, and your cancer can be measured on scans (some groups in the trial do not require measurable disease — confirm with trial site)
  • Your cancer is at an advanced stage that cannot be removed by surgery (Stage III or Stage IV), although some groups in the trial have different stage requirements depending on which part of the trial you may join (confirm with trial site)
  • You are generally well enough to carry out some daily activities, as measured by a standard scale used by doctors (called ECOG performance status 0–1, or 0–2 depending on which group in the trial you may join — confirm with trial site)
  • Depending on which group in the trial you may qualify for, you may need to have already received certain previous treatments, such as immunotherapy (a type of drug that helps your immune system fight cancer) and/or platinum-based chemotherapy
  • For some groups, your cancer must show certain levels of a protein called PD-L1 on the tumor cells, as tested by a local lab (confirm with trial site)
  • For some groups, your cancer must have specific gene changes (such as EGFR, ALK, or RET mutations), and you must currently be receiving a standard targeted treatment for those gene changes (these groups are only available at selected US sites — confirm with trial site)
  • For some groups, you must have previously had a combined treatment of chemotherapy and radiation (chemoradiotherapy) for cancer that could not be removed by surgery
  • For one group, your cancer must be considered suitable for surgical removal and for treatment given before surgery (called neoadjuvant treatment)
  • For some groups, you must be able to tolerate a type of immunotherapy drug called an anti-PD-1 therapy, meaning you have not had to permanently stop this type of treatment in the past due to serious side effects

Who may not be able to join:

  • You are currently receiving active cancer treatment for your NSCLC (some exceptions may apply depending on your group — confirm with trial site)
  • Your cancer has a specific gene mutation for which an approved targeted treatment exists, and you are a suitable candidate for that treatment (exceptions exist for the EGFR and ALK/RET groups — confirm with trial site)
  • You have had a significant autoimmune disease (where the immune system attacks the body) in the last 5 years that required strong immune-suppressing medication (some milder autoimmune conditions, such as stable thyroid problems, vitiligo, or psoriasis, may still be eligible — confirm with trial site)
  • Your brain or spinal cancer has been growing or is newly detected during the screening period, or you have cancer spread to the lining around the brain or spinal cord (some exceptions may apply if the brain or spinal spread has been treated and is stable — confirm with trial site)
  • You are currently taking high-dose steroid medication on a long-term basis (a low dose of up to 5 mg per day of prednisolone or equivalent may be acceptable — confirm with trial site)
  • You have received other treatments that significantly suppress your immune system within the last 3 months
  • You are living with HIV with a very low level of certain immune cells (CD4+ count below 350) and have a history of serious HIV-related infections
  • You have had your spleen removed
  • You have a history of, or are at risk of, a serious lung condition called interstitial lung disease, or your blood oxygen level at rest is below 92% without additional oxygen support

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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 22 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: BioNTech Responsible Person, BioNTech SE

Phone: +49 6131 9084

Australian sites

Scientia Clinical Research, Randwick, New South Wales
Royal North Shore Hospital, Sydney, New South Wales
Cancer Research SA, Adelaide, South Australia
Monash Health, Clayton, Victoria

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
BioNTech SE
Registry
ClinicalTrials.gov
Start date
17 June 2022
Est. completion
1 February 2030

Where this trial is recruiting

🇦🇺 Australia 🇩🇪 Germany 🇭🇺 Hungary 🇵🇱 Poland 🇪🇸 Spain Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States

4 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Cohorts 1, 2, 3, 4, 6, 7, 8, 9, 10, 11, EGFR and ALK/RET: Occurrence of Dose-Limiting Toxicities (DLTs) During the DLT Observation Period; Cohorts 1 to 11, EGFR and ALK/RET: Occurrence of Treatment-Emergent Adverse Events (TEAEs) Reported by Relationship, Seriousness, and Grade; Cohort 6 only: Occurrence of Post-Surgical Adverse Events (AEs) Related to BNT116 and Cemiplimab; Cohort 6 only: Occurrence of Treatment-Related Delays to Surgery More Than 9 weeks Post the Last Dose of Neo-Adjuvant Treatment

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: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov