Phase 3 Lung Cancer Trial, Recruiting NCT07668752 Sponsor: Genfleet Therapeutics (Shanghai) Inc. Condition: Lung Cancer
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Phase 3 Lung Cancer Trial, Recruiting

NCT07668752
Recruiting Phase 3

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 chosen to take part voluntarily and have signed the consent form.
  • People aged 18 or older at the time of signing the consent form, of any gender.
  • People who have been diagnosed through laboratory testing with locally advanced, inoperable, or metastatic non-small cell lung cancer (a type of lung cancer that has spread or cannot be surgically removed).
  • People who can provide suitable tumour tissue samples, or who are willing to have a biopsy taken, so a central laboratory can confirm the presence of a specific genetic change called KRAS G12D mutation.
  • People whose cancer has continued to grow, or who could not tolerate the side effects, after receiving at least one prior treatment course that included platinum-based chemotherapy and a type of immunotherapy (anti-PD-1/PD-L1 therapy).
  • People who have at least one measurable area of cancer that can be tracked using standard imaging criteria (RECIST version 1.1).
  • People whose doctor estimates they have a life expectancy of at least 12 weeks.
  • People whose kidneys, liver, bone marrow, and other organs are functioning at an adequate level.
  • People who are able to communicate clearly, attend scheduled follow-up visits, and follow the study requirements.

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 lung cancer involves other specific genetic driver mutations, or who have other KRAS or RAS mutations alongside the KRAS G12D mutation.
  • People who have had another cancer that has been actively growing or required treatment within the past 3 years before joining the trial.
  • People who have cancer that has spread to the membranes surrounding the brain or spinal cord, or who have brain or central nervous system metastases that are causing symptoms or getting worse.
  • People who have serious existing or potential bone damage caused by cancer spread to the bones, or bone pain that is not well controlled.
  • People who have previously received a treatment specifically targeting KRAS G12D, or any treatment targeting RAS or KRAS more broadly.
  • People who have previously been treated with a chemotherapy drug called docetaxel as part of their cancer treatment.
  • People who have had radiotherapy or another local cancer treatment within 4 weeks before joining the trial.
  • People who have received other anti-cancer treatments within 28 days or 5 half-lives before joining the trial, or cell-based therapies within the past 3 months (confirm with trial site).
  • People with a serious heart or blood vessel condition that is clinically significant.
  • People who have had a stroke or other serious brain blood vessel event within the past 6 months.
  • People with a major ongoing or long-term infectious disease.
  • People with other serious health conditions that are not well managed.
  • People with a severe mental health condition, a history of drug misuse, or severe alcohol misuse.
  • People who are pregnant or currently breastfeeding.
  • People who the trial doctor considers unsuitable for the study for any other reason.

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 27 July 2026

Contact this trial

Principal Investigator: Shun Lu, MD, Shanghai Lung Cancer Center, Shanghai Key Laboratory of Thoracic Tumor Biotherapy, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine

Phone: +8615521118409

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 3
Sponsor
Genfleet Therapeutics (Shanghai) Inc.
Registry
ClinicalTrials.gov
Start date
15 July 2026
Est. completion
30 June 2030

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Objective Response Rate(ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. as assessed by blinded independent central review (BICR); Progression-Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. as assessed by blinded independent central review (BICR); Overall Survival (OS)

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: 27 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