Phase 2 Lung Cancer Trial, Not Yet Recruiting
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 diagnosed with a certain type of lung cancer (non-small cell lung cancer, or NSCLC) that cannot be surgically removed, has spread locally, or has spread to other parts of the body, and whose cancer has worsened or who could not tolerate previous treatments — with specific prior treatment requirements depending on the type of gene mutation present (confirm with trial site for details on prior treatment requirements).
- People diagnosed with unresectable locally advanced or metastatic non-small cell lung cancer who have either received previous systemic treatment or have not received any previous systemic treatment (this applies to a specific expansion phase and one group in the main study phase — confirm with trial site).
- People diagnosed with non-small cell lung cancer at an earlier stage (stage II–III) that is considered surgically removable, with no previous systemic treatment, and whose cancer meets specific criteria about lymph node involvement (confirm with trial site for details).
- People whose previous test results — from tumor tissue, fluid around the lungs, or a blood sample — confirmed a specific gene change called an EGFR mutation.
- People who have at least one measurable area of cancer that can be tracked using standard imaging guidelines.
- People who are generally well enough to carry out normal daily activities with little or no limitation, as measured by a standard medical scale (score of 0 or 1).
- People whose life expectancy is estimated to be more than 12 weeks.
- People whose blood, liver, kidney, and clotting functions have been medically assessed and found to be within acceptable ranges within 7 days before starting the study drug (confirm with trial site for the specific values required).
- People in one specific group of the study (Cohort 2, Phase II) whose lung function has been assessed by a surgeon as adequate to tolerate the planned lung surgery.
- Female patients who are able to become pregnant must have a negative pregnancy blood test within 7 days before the first dose, must use effective contraception during the study and for 90 days after treatment ends, and must not be breastfeeding.
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 taken part in another treatment clinical trial within 28 days before the first dose.
- People who have had major surgery on a major organ within 4 weeks before the first dose, or who are expected to have major surgery during the study.
- People who have received radiotherapy to the lung area or whole-brain radiotherapy within 28 days before the first dose, or palliative local radiotherapy within 14 days before the first dose.
- People who have received anti-cancer traditional Chinese medicine within 1 week before the first dose, or certain local anti-cancer treatments (such as infusions into the chest or abdomen) within 14 days or within 5 half-lives of those treatments, whichever is shorter.
- People who currently have, or have a history of, a different cancer — except for cancers that were fully treated and have not returned within the past 3 years, completely removed basal cell or squamous cell skin cancers, or completely removed early-stage (in situ) cancers of any type.
- People who still have side effects from previous cancer treatment that have not improved to a mild level or resolved, except for effects considered low-risk by the study doctor (such as hair loss or skin darkening).
- People who have taken strong medications known to significantly affect how a particular liver enzyme (CYP3A4) processes drugs, within 7 days before the first dose, or who are expected to take such medications during the study.
- People who have brain or nervous system metastases that are causing symptoms, cancer spread to the membranes around the brain or spinal cord, or a primary brain tumour causing worsening neurological symptoms.
- People with a history of serious heart conditions, including an abnormal heart rhythm measurement above a certain threshold, moderate-to-severe heart failure, or reduced heart pumping function below a certain level (confirm with trial site for specific values).
- People whose high blood pressure remains uncontrolled despite strong treatment, with readings at or above 160/100 mmHg.
- People with active, uncontrolled infections (bacterial, viral, or fungal) despite treatment, active hepatitis B or C meeting certain test thresholds, HIV infection, or active syphilis, or certain serious eye infections.
- People who are unable to swallow tablets or capsules by mouth, or who have a condition that significantly affects the absorption of medication through the digestive system.
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.
If this is close to home
This page includes language about advanced illness, prognosis, or palliative care, because that is how the trial's eligibility criteria are written. Seeing it set out plainly can land hard, whether it is about you or about someone you are caring for. You do not have to be at a crisis point to talk to someone.
- Griefline — grief and loss counselling, 9am to 6pm weekdays and midday to 6pm weekends (AEST/AEDT): 1300 845 745
- Carer Gateway — practical and emotional support if you are caring for someone, 8am to 5pm weekdays: 1800 422 737
- Canteen — for 12 to 25 year olds affected by cancer, their own or a family member's: 1800 945 215
- Palliative Care Australia — directory of palliative care services near you: palliativecare.org.au
- Lifeline — 24/7, for any kind of distress, at any hour the services above are closed: 13 11 14
Palliative care is not the same as giving up on treatment, and it is not only for the last weeks of life. It is symptom and comfort care that can run alongside active treatment, including a clinical trial.
Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of support and crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention.
Voxsanity is not a counselling or medical service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.
Contact this trial
Principal Investigator: Shun Lu M.D, Ph.D., Shanghai Chest Hospital
Phone: 86-21-22200000
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
Where this trial is recruiting
Primary endpoints
Phase Ib： Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]); Phase Ib： Incidence of dose-limiting toxicities (DLT) as defined in the protocol; Phase Ib： Recommended Phase II Dose (RP2D); Phase Ib： Overall Response Rate (ORR）; Phase II： To evaluate the efficacy of PLB1004 in combination with platinum-based doublet chemotherapy at the RP2D in subjects with EGFR mutation positive locally advanced or metastatic NSCLC; Phase II： To evaluate the efficacy of PLB1004 in combination with platinum-based doublet chemotherapy at the RP2D RP2D in newly diagnosed resectable stage II-...
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.