Printed from Voxsanity (voxsanity.com.au) — NCT06028633 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 2 Lung Cancer Trial, Not Yet Recruiting
NCT06028633
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
- Adults aged 18 or older who have been diagnosed with a specific type of advanced lung cancer (non-squamous non-small cell lung cancer that has spread to other parts of the body), confirmed by tissue testing.
- People whose cancer got worse while being treated with a combination of immunotherapy (anti-PD-1/PD-L1 medication) and platinum-based chemotherapy as their first treatment — with disease worsening confirmed on scans and documented within 12 weeks of the last immunotherapy dose.
- People whose cancer does not have certain gene changes (EGFR, ALK, or ROS1) that would point to a different targeted treatment, and who have not already received targeted therapy for those gene changes.
- People who have at least one measurable area of cancer visible on a CT or MRI scan.
- People who are in relatively good general health, rated 0 or 1 on a standard medical fitness scale (ECOG), assessed within 7 days before starting the study.
- People with a life expectancy of at least 3 months and whose organs (such as kidneys, liver, and heart) are functioning adequately.
- People whose blood pressure is reasonably controlled (150/90 mmHg or below), with or without blood pressure medication, and whose blood pressure medications have not changed in the week before starting treatment.
- People who are able to give written consent to take part in the trial (or whose legal representative can do so).
- Men who agree to use contraception or remain abstinent during the treatment period and for at least 180 days after the last dose, and who agree not to donate sperm for at least 120 days after the last dose of one of the study medications (lenvatinib) — unless they have had a vasectomy or have another medical reason for having no sperm.
- Women who are not pregnant and not breastfeeding, and who either cannot become pregnant, or who agree to use highly effective contraception and have a negative pregnancy test before starting the study — and who agree not to donate or store eggs for reproduction during the treatment period and for a set time after the last dose.
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.
- Women who could become pregnant and have a positive pregnancy test before starting treatment.
- People who have previously received certain anti-tumour blood vessel–blocking medications (such as bevacizumab, lenvatinib, anlotinib, or apatinib), whether used alone or alongside immunotherapy, at any point in their treatment history.
- People who have previously received certain chemotherapy drugs (paclitaxel, docetaxel, or albumin-paclitaxel) at any stage of their cancer treatment.
- People who have had radiotherapy within the 2 weeks before starting the study, or who received high-dose radiation to the lungs within the past 6 months, or who have not recovered from radiation side effects.
- People who have had major surgery within 3 weeks before starting the study, or whose surgical wounds have not healed adequately.
- People who have coughed up significant amounts of bright red blood within the 3 weeks before starting the study.
- People whose scans show that the cancer has grown into or around major blood vessels.
- People who have a pre-existing severe (Grade 3 or higher) abnormal opening or tunnel between organs (fistula) in the digestive tract or elsewhere.
- People with a high level of protein in their urine (1 gram or more in 24 hours).
- People with a lower-than-normal heart pumping function, or with a specific abnormality in the heart's electrical activity detected on a heart tracing (ECG).
- People who have a condition that affects how the body absorbs medications through the digestive tract.
- People who have received a live or live-weakened vaccine within 30 days before starting the study.
- People who are currently taking part in, or have recently taken part in, another clinical trial involving an experimental treatment within the past 4 weeks.
- People who have had significant heart or blood vessel problems in the past 12 months, such as severe heart failure, unstable chest pain, a heart attack, stroke, or serious heart rhythm problems that affected blood flow (medically controlled heart rhythm problems may be permitted — confirm with trial site).
- People who have an immune system disorder, or who are taking high-dose steroid medication or other immune-suppressing drugs.
- People who have had another cancer in the past, unless they have been free of that cancer for at least 3 years after treatment — with some exceptions for certain minor or easily treated skin or other cancers (confirm specific exceptions with trial site).
- People with active cancer that has spread to the brain or the lining of the brain, unless previously treated brain spread has been stable on scans for at least 4 weeks and has not required steroid treatment for at least 14 days.
- People who have an active autoimmune disease that has needed medical treatment in the past 2 years (hormone replacement therapies for certain conditions are generally not considered in this category — confirm with trial site).
- People who have a history of, or currently have, inflammation of the lungs (pneumonitis or interstitial lung disease) that required steroid treatment.
- People who currently have an active infection requiring medical treatment.
- People who have had a severe allergic reaction (Grade 3 or higher) to pembrolizumab or any of its ingredients.
- People who are known to be sensitive to any ingredients in albumin-paclitaxel or lenvatinib.
- People with a known history of HIV infection.
- People with active hepatitis B or hepatitis C infection.
- People who are pregnant, breastfeeding, or planning to become pregnant or father a child during the study period and for 120 days after the last dose of treatment.
- People who have received an organ or tissue transplant from another person.
- People with known psychiatric conditions or substance use problems that would make it difficult to participate in the trial.
- People with any other condition, treatment history, or circumstance that, in the treating doctor's judgement, would make participation unsafe or unsuitable.
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.
Contact this trial
Principal Investigator: Shikai Wu, Peking Univerisity First Hospital
Phone: (86)18910715326
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
Peking University First Hospital
Registry
ClinicalTrials.gov
Start date
1 October 2023
Est. completion
1 October 2024
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.
Where this trial is recruiting
🇨🇳 China
Primary endpoints
Objective response rate
Can't join this trial?
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.