Phase 2 Lung Cancer Trial, Recruiting NCT07329322 Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. Condition: Lung Cancer
Back to Lung Cancer

Phase 2 Lung Cancer Trial, Recruiting

NCT07329322
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:

  • Adults aged 18 to 75 years old at the time of signing the consent form
  • People who have been diagnosed with non-small cell lung cancer (NSCLC) confirmed by a laboratory test of tissue or cell samples
  • People who have not had any previous systemic (whole-body) treatment for their cancer
  • People who have not had any previous local treatment (such as surgery or radiation) for their NSCLC
  • People whose lung cancer has a specific gene change called an EGFR sensitizing mutation, confirmed by lab testing
  • People who are generally well enough to carry out light activity, as measured by a standard health scoring scale (ECOG score of 0 or 1), assessed within 7 days before joining the trial
  • People who have at least one measurable area of cancer that can be tracked during the trial
  • People with a life expectancy of at least 24 weeks
  • People whose organs (such as kidneys and liver) and bone marrow are functioning well enough, as determined by the trial team
  • Women who could become pregnant, and men whose partners could become pregnant, who agree to use effective contraception from signing the consent form until 6 months after the last dose
  • People who are willing to join voluntarily, sign the consent form, and are able to attend the required visits and follow the trial procedures

Who may not be able to join:

  • People whose lung cancer includes certain other cancer types in the same tumour, such as small cell lung cancer, neuroendocrine carcinoma, carcinosarcoma, or more than 10% squamous cell carcinoma
  • People who have had another type of cancer within the 3 years before joining the trial
  • People whose resting heart trace (ECG) shows results that the trial team considers clinically significant
  • People with certain heart or blood vessel conditions or related risk factors (confirm with trial site for full details)
  • People with other serious ongoing health conditions that are not well controlled, as judged by the trial doctor
  • People with a history of, or current, lung inflammation conditions such as interstitial lung disease or non-infectious pneumonitis (including cases caused by previous medications)
  • People with serious lung damage caused by complications of a lung condition
  • People who have taken corticosteroid medications (such as prednisone) at doses above 10 mg per day, or other immune-suppressing medications, within the 2 weeks before joining the trial
  • People with known active tuberculosis affecting the lungs
  • People who have previously received an organ transplant or a stem cell transplant from another person
  • People with active hepatitis B infection
  • People who test positive for HIV, have a history of AIDS, or have a known active syphilis infection
  • People with a known allergy or serious sensitivity to the study drugs (osimertinib or sacituzumab tirumotecan) or any of their ingredients, including polysorbate-20, or who have had a severe allergic reaction to other biological medicines
  • People who have received a live vaccine within 30 days before joining the trial, or who plan to receive one during the trial
  • Women who are pregnant or breastfeeding
  • People with any other condition that the trial doctor believes could affect the safety of the participant or the reliability of the trial results

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 9 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

Phone: 028-67252634

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
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Registry
ClinicalTrials.gov
Start date
30 March 2026
Est. completion
31 August 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Major Pathological Response (MPR) 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: 9 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