A Study of Pemetrexed Maintenance With or Without ADXS11-001 Immunotherapy in Patients With Human… (NCT02531854) | Clinical Trial Compass
WithdrawnPhase 2
A Study of Pemetrexed Maintenance With or Without ADXS11-001 Immunotherapy in Patients With Human Papillomavirus Positive (HPV+), NSCLC Following First-Line Induction Chemotherapy
Stopped: Study was withdrawn per sponsor decision
0Started 2018-12
Plain-language summary
* Open label
* Enrollment in the order of confirmation of eligibility and HPV+ tumor status
* Prospective stratification based on 3 factors, epidermal growth factor receptor (EGFR) mutation status, performance status and first-line induction chemotherapy outcome;
* Randomization (2:1 ratio): (82 patients receiving the combination of pemetrexed plus ADXS11-001 vs. 42 patients receiving pemetrexed alone)
* Treatment Arm: Pemetrexed plus ADXS11-001 immunotherapy
* Control Arm: Pemetrexed only
* Positive control: pemetrexed chemotherapy
Who can participate
Age range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female patients, ≥ 20 years of age
. Patients with NSCLC
. Patients whose disease has either responded or not progressed following 4-6 cycles of first-line induction chemotherapy.
. Patients with documented/confirmed intra-tumor positivity for HPV
. Patients with no major existing co-morbidities or medical conditions that will preclude administration of therapy, in the opinion of the Investigator
. Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
. Patients will use contraception during the study
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of study participants with objective tumor response as assessed by Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 and Immune-Related Response Evaluation Criteria in Solid Tumors (irRECIST)
Timeframe: 2 years
2
Number of study participants with progression free survival as assessed by Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 and Immune-Related Response Evaluation Criteria in Solid Tumors (irRECIST)
. Patients with the ability to understand and give written informed consent for participation in this trial
Exclusion criteria
. Women who are pregnant or breast feeding
. Patients with histologically- or cytologically-confirmed squamous cell-classified NSCLC
. Patients with disease progression following first-line induction chemotherapy
. Patients with known active and uncontrolled central nervous system (CNS) or leptomeningeal metastases
. Patients with an active second primary malignancy or history of another malignancy
. Patients with inadequate recovery from an acute toxicity associated with any prior antineoplastic therapy, including ≥ Grade 2 neuropathy
. Patients with inadequate recovery from any previous surgical procedure, or patients having undergone any major surgical procedure within 4 weeks prior to the start of study treatment
. Patients with evidence of inadequate organ function as defined in protocol