Printed from Voxsanity (voxsanity.com.au) — NCT05358548 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
Back to Lung Cancer
Phase 2 Lung Cancer Trial, Recruiting
NCT05358548
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
Lung Cancer (Arms 1 and 2)
- People who have been diagnosed with non-small cell lung cancer (NSCLC) that has spread to other parts of the body (Stage IV), or in some cases Stage IIIB/IIIC if chemotherapy combined with radiation is not an option for them (confirm with trial site).
- People whose lung cancer is either squamous cell type (Arm 1) or a non-squamous type such as adenocarcinoma (Arm 2); mixed types such as adenosquamous are placed in Arm 1.
- People with any level of PD-L1 protein expression on their tumour — PD-L1 testing is strongly recommended but is not required to be completed for eligibility.
- People who have measurable or non-measurable disease on scans, with imaging done within 4 weeks before joining the trial; even the presence of cancer fluid around the lung alone is sufficient.
- People aged 18 or older.
- People with a general health and activity level rated 0, 1, or 2 on the ECOG scale — a standard medical measure where 0 means fully active and 2 means capable of self-care but unable to work (confirm with trial site).
- People who have not previously received chemotherapy or immunotherapy for advanced (metastatic) NSCLC; prior treatment for earlier-stage disease is allowed if at least 6 months have passed since the last dose.
- People who received low-dose methotrexate for a non-cancer condition, as long as the last dose was at least 14 days before joining (other low-dose chemotherapy for non-cancer conditions may also be considered, but the study chair must review the case).
- People with brain metastases that have already been treated, provided follow-up scans show no signs of the cancer growing there; in some cases, untreated or new small brain metastases may also be eligible if the treating doctor decides immediate brain-specific treatment is not needed (confirm with trial site).
- People who are off steroid medications for at least 7 days before starting treatment on this trial.
- People who have or have had another cancer, as long as that cancer or its treatment is not expected to interfere with the safety or results of this trial.
- People with well-controlled HIV who are on effective treatment and have had an undetectable viral load within the past 6 months.
- People with chronic hepatitis B who are on appropriate suppressive therapy with an undetectable viral load, or people with hepatitis C who have been successfully treated and cured, or who are currently on treatment with an undetectable viral load.
- People whose blood test results within 14 days before joining meet the required levels for blood counts, liver function, kidney function, and blood clotting (confirm with trial site for specific values).
- People who are able to understand the trial and are willing to sign a written consent form.
- Women of childbearing potential, and sexually active males, who agree to use an accepted and effective form of contraception or abstain from sex from the time of joining, throughout treatment, and for 120 days after the last dose.
Head and Neck Cancer (Arm 3)
- People who have been diagnosed with squamous cell carcinoma of the head and neck (in the oropharynx, oral cavity, hypopharynx, or larynx, or from an unknown primary site) that has returned or spread and cannot be cured with local treatments such as surgery or radiation.
- People with any level of PD-L1 expression — PD-L1 testing is strongly recommended but not required to be completed for eligibility.
- People with oropharyngeal cancer where HPV status testing (using a protein marker called p16) is highly desirable but not required for eligibility.
- People who have measurable or non-measurable disease on scans, with imaging done within 4 weeks before joining; the presence of cancer fluid around the lung or bone disease alone is sufficient.
- People aged 18 or older.
- People with a general health and activity level rated 0, 1, or 2 on the ECOG scale (confirm with trial site).
- People who have not previously received chemotherapy or immunotherapy for recurrent or metastatic head and neck cancer; prior chemotherapy or cetuximab given alongside radiation for curative treatment of locally advanced disease is allowed if the cancer progressed at least 6 months after that treatment ended.
- People who have hormone-related conditions (endocrinopathies) that are now stable on hormone replacement and/or a low daily dose of prednisone (10 mg or less per day or equivalent).
- People with treated brain metastases where follow-up scans show no evidence of the cancer growing there.
- People who have or have had another cancer, as long as that cancer or its treatment is not expected to interfere with the safety or results of this trial.
- People with well-controlled HIV who are on effective treatment and have had an undetectable viral load within the past 6 months.
- People with chronic hepatitis B who are on suppressive therapy with an undetectable viral load, or people with hepatitis C who have been successfully treated and cured, or who are currently on treatment with an undetectable viral load.
- People with high blood calcium levels (hypercalcemia) who have had those levels corrected before joining.
- People whose blood test results within 14 days before joining meet the required levels for blood counts, liver function, kidney function, and blood clotting (confirm with trial site for specific values).
- People who are able to understand the trial and are willing to sign a written consent form.
- People of childbearing potential, and those who could father children, who agree to use an accepted and effective form of contraception or abstain from sex for the duration of the trial and for 120 days 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.
Lung Cancer (Arms 1 and 2)
- People whose lung cancer pathology shows any small cell carcinoma component.
- People who have previously received checkpoint inhibitor immunotherapy (such as pembrolizumab) for metastatic lung cancer.
- People in Arm 1 (squamous type) who already have moderate to severe nerve damage (peripheral neuropathy rated Grade 2 or higher), or who have a known allergy to carboplatin, paclitaxel, or nab-paclitaxel.
- People whose tumour has certain specific genetic changes — including EGFR mutations (except exon 20 insertions), BRAF V600 mutations, MET Exon 14 skipping, or ALK or ROS1 gene rearrangements — that are treatable with targeted oral medications.
- People with a known history of active tuberculosis.
- People who have been diagnosed with an immune deficiency condition, or who have received systemic steroid or immunosuppressive therapy within 7 days before the first treatment dose.
- People with a known pre-existing and currently active interstitial lung disease, a past history of non-infectious lung inflammation (pneumonitis) that required steroids, or current pneumonitis.
- People with significant bowel problems where diarrhoea is a major symptom, such as Crohn's disease or malabsorption conditions.
- People who have an autoimmune condition that has required ongoing or intermittent systemic treatment (such as disease-modifying drugs, corticosteroids, or immunosuppressants) at any point in the past 2 years — though hormone or gland replacement therapy (such as thyroid hormone or insulin) is not considered a disqualifying systemic treatment.
- People with known heart disease or a history of treatment with heart-damaging medications who are rated Class III or IV on the New York Heart Association scale — meaning only Class II or better is acceptable (confirm with trial site).
- People with any other serious illness or organ problem that the investigator believes could put them at risk or interfere with assessing the study treatment's safety.
- People who are pregnant or breastfeeding, or who plan to try to conceive or father children from the time of joining through to at least 120 days after the last dose.
- People who have received a live vaccine within 30 days before joining.
- People taking any other experimental (investigational) medications during the trial.
Head and Neck Cancer (Arm 3)
- People whose head and neck squamous cell carcinoma originates in the salivary glands, nasopharynx, or skin.
- People who have previously received checkpoint inhibitor immunotherapy for recurrent or metastatic head and neck cancer.
- People who have had a severe infection within 4 weeks before joining, including hospitalisation for infection complications, bacteria in the bloodstream, or severe pneumonia, or who have active tuberculosis.
- People with a history of non-infectious lung inflammation (pneumonitis) that required prednisone at 10 mg per day or more (or equivalent) while on first-line immunotherapy.
- People who have had a solid organ transplant or stem cell transplant.
- People who are taking immunosuppressive medications within 7 days before joining (with some exceptions for low-dose or topical steroids — confirm with trial site).
- People with an active autoimmune disease that has required systemic treatment within the past 2 years (though those on replacement therapy for adrenal or pituitary insufficiency are not excluded).
- People who have had a severe allergic reaction to any of the drugs used in this trial, or to similar types of biological medicines (chimeric or humanised antibodies or fusion proteins).
- People who have received a live vaccine within 30 days before joining or during the study (live vaccines include measles, mumps, rubella, chickenpox, yellow fever, rabies, BCG, and oral typhoid vaccine; intranasal flu vaccines are also not permitted).
- People who are pregnant or breastfeeding, or who plan to conceive or father children during the trial or within 120 days after the last dose.
- People with untreated brain metastases or cancer spread to the membranes around the brain or spinal cord (leptomeningeal disease).
- People with significant heart or cardiovascular disease — such as a heart attack or stroke within the past 3 months, or unstable heart rhythm or unstable chest pain at the time of joining.
- People with any other disease, physical finding, or laboratory result that the investigator believes makes treatment unsafe or would interfere with interpreting the trial results.
- People who need to receive other chemotherapy, immunotherapy, hormone-based anti-tumour therapy, radiation, or experimental medications during the trial (palliative radiation to symptom-causing lesions should be completed before joining).
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.
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: Missak Haigentz, MD, Rutgers Cancer Institute of New Jersey
Phone: 732-235-6031
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
Rutgers, The State University of New Jersey
Registry
ClinicalTrials.gov
Start date
28 April 2022
Est. completion
1 May 2027
Where this trial is recruiting
🇺🇸 United States
Primary endpoints
Confidence Interval (CI) estimate of patients completing induction chemotherapy cycles
Can't join this trial?
Data last synced from ClinicalTrials.gov: 30 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.