Phase 2 Lung Cancer Trial, Recruiting NCT05061550 Sponsor: AstraZeneca Condition: Lung Cancer
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Phase 2 Lung Cancer Trial, Recruiting

NCT05061550
Recruiting Phase 2

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:

  • People who have been newly diagnosed with non-small cell lung cancer (NSCLC) that can be surgically removed, at a stage classified as IIA through IIIB.
  • People whose general health and ability to carry out daily activities is rated as 0 (fully active) or 1 (restricted in strenuous activity but able to do light work) on a standard medical scale.
  • People whose organs (such as kidneys and liver) and bone marrow are functioning well enough to meet the trial's requirements.
  • People who are able to provide a tumour tissue sample — either a new sample or one taken within the last 6 months — so that certain tumour markers (PD-L1 status, EGFR, and ALK) can be tested.
  • People whose lungs are functioning well enough to meet the trial's requirements.

Who may not be able to join:

  • People whose lung cancer has specific genetic changes known as EGFR mutations or ALK translocations.
  • People whose tumour tests show a PD-L1 expression level below 1% (this applies to certain arms of the trial only — confirm with trial site).
  • People who have, or have previously had, an autoimmune or inflammatory condition (such as rheumatoid arthritis or inflammatory bowel disease).
  • People who have uncontrolled or serious ongoing health conditions, including uncontrolled high blood pressure, unstable chest pain (angina), uncontrolled irregular heartbeat, active bleeding disorders, serious ongoing gut conditions involving diarrhoea, or mental health or personal circumstances that would make it difficult to follow the trial requirements.
  • People who have previously had another type of cancer (other than the current diagnosis).
  • People whose lung cancer is classified as small-cell lung cancer or a mixed type that includes small-cell lung cancer.
  • People who have a history of a condition where the immune system does not work properly from birth or early in life (primary immunodeficiency).
  • People who have a history of non-infectious lung inflammation (interstitial lung disease or pneumonitis) that required steroid treatment, currently have this condition, or have possible lung inflammation that cannot be ruled out through scans taken at the start of the trial.
  • People whose treatment plan includes radiotherapy before surgery.
  • People whose surgeon determines at the outset that removing the tumour would require removal of an entire lung, or only a small segment or wedge of lung tissue, rather than a standard lobe removal.
  • People whose heart's electrical activity measurement (a specific reading from an ECG called QTcF) is 470 milliseconds or higher.
  • People for whom chemotherapy treatment is medically unsuitable based on standard prescribing guidelines.
  • People who have moderate or severe heart or cardiovascular disease.
  • People who are currently receiving any other chemotherapy, experimental treatment, biological therapy, or hormonal cancer therapy.
  • People who have received a live vaccine within 30 days before the first dose of the trial treatment.
  • People who have previously received certain types of immune-based cancer treatments, including anti-CTLA-4, anti-TIGIT, anti-PD-1, anti-PD-L1, anti-PD-L2 therapies, or treatments targeting certain other immune pathways (confirm specific agents with trial site).
  • People who have previously been treated with a specific type of targeted drug called a TROP2-targeting antibody-drug conjugate, or a similar drug that works by blocking an enzyme called TOP1.
  • People who are currently taking, or have taken within the last 14 days, medications that suppress the immune system.
  • People who have an active or uncontrolled infection, including hepatitis B, hepatitis C, or HIV.

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 20 July 2026
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.
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: Tina Cascone, MD, MD Anderson Cancer Center Houston, TX 77030

Phone: 1-877-240-9479

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 2
Sponsor
Registry
ClinicalTrials.gov
Start date
14 April 2022
Est. completion
28 May 2030

Where this trial is recruiting

🇧🇪 Belgium 🇨🇦 Canada 🇫🇷 France 🇭🇺 Hungary 🇮🇪 Ireland 🇮🇹 Italy 🇵🇹 Portugal 🇰🇷 South Korea 🇪🇸 Spain 🇹🇼 Taiwan Turkey (Türkiye) 🇺🇸 United States

Primary endpoints

Number of participants with pathological complete response (pCR); Number of participants with adverse events (AEs) and serious adverse events (SAEs)

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: 20 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