Phase 2 Lung Cancer Trial, Not Yet Recruiting NCT06282536 Sponsor: Shanghai Pulmonary Hospital, Shanghai, China Condition: Lung Cancer
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Phase 2 Lung Cancer Trial, Not Yet Recruiting

NCT06282536
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

  • Patients who have signed the informed consent form agreeing to take part in the study.
  • Adults aged 18 years or older.
  • People who have been diagnosed with non-small cell lung cancer (a type of lung cancer) confirmed by a tissue or cell sample, assessed as stage III or stage IVA, and found to have a specific gene change called ALK-positive through genetic testing.
  • People whose general health and ability to carry out daily activities is rated as 0 or 1 on a standard scale (meaning fully active or able to carry out light activity).
  • People whose cancer has been reviewed by a specialist medical team — including a chest surgeon who focuses on cancer — and considered potentially able to be fully removed by surgery.
  • People who have at least one measurable area of cancer that can be tracked using standard imaging guidelines.
  • People whose liver, kidneys, and blood system are functioning well enough to participate.
  • People whose lung function is good enough to safely undergo surgery.
  • Women who are able to become pregnant must agree to use effective contraception throughout the study and for at least 120 days after completing chemotherapy or the last dose of the study drug toripalimab (whichever is later), and must have a negative pregnancy test within 7 days before joining.
  • Men who have not had sterilisation must agree to use effective contraception throughout the study and for at least 120 days after the study ends (confirm with trial site for full details).

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 who have previously received targeted therapy (such as TKI medications or monoclonal antibody treatments), immunotherapy, or any experimental drug treatment for their lung cancer.
  • People whose cancer has been confirmed by testing to be a mixed type containing both small cell and non-small cell lung cancer.
  • People who have had another cancer in the five years before the trial starts — with some exceptions, such as certain cured skin cancers, early stomach or bowel cancers removed by endoscopy, cervical carcinoma in situ, a type of early breast cancer (ductal carcinoma in situ), papillary thyroid cancer, or any other cancer considered fully cured and unlikely to affect current survival.
  • People who have any unstable ongoing health conditions, including active infection, uncontrolled high blood pressure, unstable or recent chest pain (angina starting in the last three months), a moderate-to-severe heart condition called congestive heart failure, a heart attack within the last 6 months, serious irregular heartbeat requiring medication, or significant liver, kidney, or metabolic disease.
  • People with a weakened immune system present from birth or developed over time, such as those living with HIV.
  • People who have had a major surgical procedure (other than a diagnostic procedure) within the 4 weeks before the trial starts, or who are expected to need major surgery during the study.
  • People who are known to be allergic to the study drug or any of its ingredients.
  • People who have a history of widespread scarring or inflammation throughout both lungs, or a known history of serious (grade 3 or 4) lung inflammation or scarring conditions — such as pneumonia caused by treatments, allergic lung reactions, or pulmonary fibrosis — but not including lung damage limited to a specific area from past radiation treatment.
  • Women who are pregnant or breastfeeding.
  • People who have difficulty absorbing medications through the digestive system.
  • People with neurological or psychiatric conditions that would prevent them from cooperating with the study.
  • People whom the research team considers unsuitable for the trial 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 22 July 2026

Contact this trial

Phone: 021-65115006

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
Not Yet Recruiting
Phase
Phase 2
Sponsor
Shanghai Pulmonary Hospital, Shanghai, China
Registry
ClinicalTrials.gov
Start date
1 March 2024
Est. completion
1 June 2025

This date has passed while the registry still lists the trial as open to participants. Sponsors often update a trial's status without revising its projected end date, so it may well still be recruiting — but the record is out of date in at least one respect. Check with the study contact before relying on either.

Primary endpoints

Objective response rate (ORR)

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: 22 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