Phase 2 Lung Cancer Trial, Not Yet Recruiting NCT07158840 Sponsor: Akeso Condition: Lung Cancer
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Phase 2 Lung Cancer Trial, Not Yet Recruiting

NCT07158840
Not Yet Recruiting Phase 2

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not 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 may be able to join

  • People who have voluntarily signed the consent form for the study.
  • People aged between 18 and 75 years (inclusive), of any gender.
  • People with a general health and activity level rated as 0 or 1 on a standard medical scale (meaning fully active or able to carry out light work), known as ECOG performance status.
  • People with a life expectancy of at least 3 months.
  • People who have been confirmed through tissue or cell testing to have locally advanced (stage IIIB or IIIC) or metastatic (stage IV) non-squamous non-small cell lung cancer (a specific type of lung cancer).
  • People who have at least one confirmed specific genetic change in their cancer (called an actionable genomic alteration, or AGA) from a list including EGFR, ALK, ROS1, NTRK, RET, BRAF, and MET — confirmed by tumour, cell, or blood testing before joining the trial.
  • People whose cancer has stopped responding to a targeted therapy drug (called a TKI) that was aimed at their specific genetic change.
  • People who have at least one measurable tumour outside the brain, as defined by standard medical measurement guidelines.
  • People whose liver, kidney, and other organs are functioning adequately (confirm with trial site).

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • People whose cancer testing shows it contains small-cell carcinoma cells, or is mainly made up of squamous cell carcinoma.
  • People whose genetic test results show a common type of EGFR mutation known as a sensitising mutation.
  • People who have previously received immunotherapy treatment.
  • People who have previously received any cancer treatment for advanced-stage (IIIB–IV) lung cancer other than AGA-targeted TKI therapy.
  • People who are currently taking part in another clinical trial, unless it is an observational study or the follow-up phase of a previous interventional trial.
  • People who have received AGA-targeted TKI therapy, or non-specific immune-modifying therapy, within 2 weeks before the first dose of this trial.
  • People whose scans during the screening period show the tumour is wrapped around major blood vessels, or shows significant breakdown or hollow areas in the tumour, where the study doctor considers this to be a bleeding risk.
  • People whose scans during the screening period show the tumour is growing into surrounding vital organs or blood vessels.
  • People with cancer that has spread to the fluid and membranes surrounding the brain and spinal cord (called leptomeningeal metastases); people with brain metastases that the study doctor determines do not need local treatment may still be considered (confirm with trial site).
  • People who have had a different cancer (other than this lung cancer) within the 3 years before the first dose, unless that other cancer was fully treated and cured with local treatment only.
  • People who have an active autoimmune disease that has required systemic (whole-body) treatment at any point in the 2 years before the first dose.
  • People who have a history of serious medical conditions within the 1 year before the first dose (confirm with trial site for specific conditions).

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 31 July 2026

Contact this trial

Phone: 0760-89873925

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

GP referral letter

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Trial details

Status
Not Yet Recruiting
Phase
Phase 2
Sponsor
Akeso
Registry
ClinicalTrials.gov
Start date
5 September 2025
Est. completion
1 September 2028

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Overall response (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator

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: 31 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