Phase 3 Lung Cancer Trial, Not Yet Recruiting NCT06335355 Sponsor: Shanghai Shengdi Pharmaceutical Co., Ltd Condition: Lung Cancer
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Phase 3 Lung Cancer Trial, Not Yet Recruiting

NCT06335355
Not Yet Recruiting Phase 3

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 are willing to take part, understand what the study involves, and can sign a consent form agreeing to participate.
  • You are between 18 and 75 years old (inclusive), and there are no restrictions based on gender.
  • You have been diagnosed with advanced or spreading non-squamous non-small cell lung cancer (a specific type of lung cancer), confirmed by a tissue or cell sample test.
  • You have at least one measurable tumor in your body (outside the brain or spinal area) that can be tracked during the study.
  • You are expected to live for at least 12 weeks.
  • Your tumor has a specific genetic change (mutation) in the STK11, KEAP1, or KRAS gene — having more than one of these mutations is also allowed.
  • Your blood counts and organ functions (such as liver and kidneys) are at an acceptable level.

Who may not be able to join:

  • Your lung cancer has been confirmed to be a mixed type that includes small cell lung cancer, sarcomatoid carcinoma, or neuroendocrine carcinoma.
  • You have untreated or active cancer that has spread to your brain or spinal fluid, or you have a history of cancer spreading to the lining around your brain or spinal cord.
  • You have pressure on your spinal cord that has not been fully treated with surgery and/or radiation.
  • Your cancer-related pain is not well managed or controlled.
  • You have had another type of cancer, unless it was a specific type (such as certain skin cancers, early-stage cervical cancer, or certain other cancers) that has been fully cleared for at least 5 years and requires no further treatment during the study (confirm with trial site).
  • You have received herbal anti-cancer treatment in the 2 weeks before starting the study.
  • You still have significant side effects from previous cancer treatments that have not improved to a mild level.
  • You are currently in another clinical trial, or your last clinical trial treatment ended less than 4 weeks ago (or less than five half-lives of that study drug, whichever is shorter).
  • You have received treatment that boosts your immune system within 4 weeks before starting the study.
  • You have received treatment that suppresses your immune system within 2 weeks before starting the study.
  • You have an active or known autoimmune disease (a condition where your immune system attacks your own body).
  • You have serious heart disease.
  • You have had a blood clot in an artery or vein within the 3 months before starting the study.
  • You currently have an active syphilis infection.
  • You have had a serious infection within 4 weeks before starting the study.
  • You have previously had, or are planning to have, a stem cell transplant or an organ transplant from another person.
  • You have had a serious allergic reaction to another antibody-based medicine in the past.
  • You are pregnant, breastfeeding, or planning to become pregnant during the study.
  • You have a history of misusing alcohol, recreational drugs, or other addictive substances.
  • You have a medical condition, mental health condition, or personal circumstances that the study doctor believes could affect your safety, your rights, or the reliability of the study results (confirm with trial site).

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 2 July 2026
Phase 3: approximately ~65% 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.

GP referral letter

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Trial details

Status
Not Yet Recruiting
Phase
Phase 3
Sponsor
Shanghai Shengdi Pharmaceutical Co., Ltd
Registry
ClinicalTrials.gov
Start date
1 March 2024
Est. completion
1 October 2028

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Investigator-assessed Objective Response Rate (Phase One); Overall Survival (Phase Two)

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: 2 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